Major Safety Alerts in December 2011

Transcription

Major Safety Alerts in December 2011
Major Safety Alerts in December 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
Source of
Information*
Reference No. by Source
Alert Type by
Source
MHRA
MDA/2011/107
MDA
2011/12/01
HemoCue AB HemoCue Glucose 201+ with Software version 106 and lower
2011/12/02
Sybron Dental Specialities LA 5 Burs
Sybron Dental
N.A.
2011/12/02
Pentron Clinical (Sybron Dental Specialities) Artiste Nano-Hybrid Flowable
Composite
Sybron Dental
N.A.
2011/12/02
Pentron Clinical (Sybron Dental Specialities) Correct Plus Berry Putty Auto Mix
Sybron Dental
N.A.
2011/12/02
GE Healthcare Auxiliary Common Gas Outlet (ACGO) All Aestiva, Aisys,
Aespire and Advance anaesthetic machines
MHRA
MDA/2011/08
2011/12/02
Sybron Dental Specialities
2011/12/06
Metrex Research Pinnacle Syringe Sleeves
2011/12/06
Johnson & Johnson 1•DAY ACUVUE® MOIST® for astigmatism
Sybron Dental
Specialties
Sybron Dental
Specialties
N.A.
N.A.
Firm initiated
filed safety
actions
Firm initiated
field corrective
actions
Firm initiated
field corrective
actions
MDA
Firm Initiated
Field Action
Firm Initiated
Field Action
N.A.
N.A.
N.A.
N.A.
N.A.
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
N.A.
N.A.
N.A.
N.A.
MHRA
2011/011/028/291/001
FSN
MHRA
MHRA
MHRA
MHRA
2011/011/025/291/009
2011/011/030/081/002
2011/012/001/081/014
2011/011/023/081/012
FSN
FSN
FSN
FSN
MHRA
2011/009/015/081/009
FSN
N.A.
N.A.
MHRA
2011/009/015/081/009
FSN
N.A.
N.A.
MHRA
2011/011/024/291/003
FSN
MHRA
MHRA
MHRA
2011/011/017/081/015
2011/011/024/291/015
2011/011/022/081/004
FSN
FSN
FSN
N.A.
Senrex International
Ltd.
Bio-Rad Pacific Ltd.
N.A.
Pfizer Corporation
Hong Kong Limited
Philips Electronic Hong
Kong Ltd
Philips Electronic Hong
Kong Ltd
N.A.
N.A.
MHRA
2011/011/002/291/021
FSN
2011/12/06
Philips Healthcare AXIS and IRIX SPECT Systems
MHRA
2011/011/030/081/028
FSN
2011/12/06
Philips Healthcare All systems having Pinnacle3
MHRA
2011/011/024/291/005
FSN
2011/12/06
2011/12/06
Renishaw Plc Neuro Guide – Electrode Introducer Kit
4Care AG Lenscare SH-System Monatslinse (monthly lens)
MHRA
MHRA
2011/011/025/291/003
2011/011/029/081/005
FSN
FSN
2011/12/06
N.A.
FSN
Pfizer “Pfizer Rheumatology Calculator” iPhone /Android Application
2011/12/06
2543 7442
2011/011/030/081/009
2011/12/06
2011/12/06
Science International
Corp.
MHRA
2011/12/06
2011/12/06
2011/12/06
2011/12/06
2011/12/06
2011/12/06
2011/12/06
Agent Contact
Telephone No.
Johnson & Johnson
Medical (HK)
MAQUET Hong Kong
Limited
N.A.
N.A.
Abbott Laboratories Ltd.
N.A.
Maquet Surgical Appliances Ltd ACROBAT V, ACROBAT SUV, and
ACROBAT mechanical stabilizers and the XPOSE 3, and XPOSE 4 positioners
Newdeal SAS (Integra) Holder IPP-ON - 239030
Origio A/S Cryopette
Abbott Vascular MitraClip Mitral Valve Repair System (Product no. MSK02ST)
Teleflex Rusch Flexislip/Flexi-Slip Endotracheal Tube Stylet with Soft Distal
Tip, 6Fr
Anspach Cutting Burs and Irrigation Cups packaged in a Tyvek pouch/Tube
configuration
Welch Allyn Limited Rigid Reusable & Single use Sigmoidoscopes,
Anoscopes, and Accessories Cleaning, Disinfection and Sterilisation
Biomet UK Ltd Acetabular Low Profile Screw 6.5 x 45mm (Item Number
103536, Lot Number 1600346)
Bard Limited Bard® EnCor® Biopsy Probes
Bio-Rad Medical Diagnostics GmbH TANGO Optimo pipetting system
ELLA-CS FerX-ELLA esophageal stent (Boubella)
2011/12/06
Local Agent
2738 6027
N.A.
N.A.
N.A.
2593 2211
N.A.
N.A.
2311 8938
2272 8926
N.A.
28119711
2821 5480
2821 5480
N.A.
N.A.
2011/12/13
Becton Dickinson Diagnostics BD Oncomark CD79b FITC/Anti-Kappa
PE/CD19 PerCP-Cy5.5 Catalog No. 335837, Lot No. 23364
Biomet UK Ltd DA 360--revision knee system (labelled as Vanguard DA 360)
Stryker Endoscopy Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy
Probe (Model number) 279-351-300
Microm International Gmbh Thermo Scientific Microm: Rotary Microtome: REF
HM 355S-3
Abbott Laboratories ARCHITECT Cyclosporine
Beckman Coulter UK Ltd COULTER® LH 750 Analyzer, COULTER® LH 780
Analyzer, COULTER® LH 500 Analyzer
Ceragem CERAGEM-E massage bed
Diagnostica Stago S.A.S. COMBINED USE OF STA® - LIATEST® FM (REF.
00543) WITH
STA-R® / STA-R EVOLUTION® EQUIPPED WITH CAP PIERCING (PTB)
Smiths Medical Graseby Mr10 neonatal repiration monitor
2011/12/13
Spacelabs Healthcare Lifescreen ECG Screening System V3
2011/12/06
2011/12/06
2011/12/07
2011/12/08
2011/12/08
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
Stryker Visum LED surgical light P10235 (camera ready) - 0682001253,
P10234 - 0682001252, P12875 (camera ready, low ceiling) - 0682400138,
P12874 (low ceiling) - 0682400137
Thermo Fisher Scientific Oxoid Ready Poured Plate Columbia Agar Base with
2% Salt (4mm depth), Lot number 1194021
Varian HD120 MLC multileaf collimator, including C-Series and TrueBeam
configurations
Integra LifeSciences OPTIPLUG® Biodegradable Cement Restrictor - Size 10
Linet LINET ELEGANZA 3 Model Bedframes
Olympus KeyMed ESG-100 electrosurgical generator (with lots of serial
numbers)
P3 Medical Ltd Gas Flow Stopper device (part of the Connecting Set), product
reference 40600
Smith & Nephew Endoscopy 5.5mm DYONICS ELECTROBLADE Resector,
Item Code: 7205962 (with lots of serial numbers)
MHRA
2011/012/001/081/011
MHRA
2011/011/028/291/016
FSN
N.A.
25758668 EXT
252
N.A.
FDA
Z-0265-2012
Class II
Stryker China Ltd
2518 6915
FDA
Z-0039-2012
Class II
N.A.
N.A.
FDA
Z-0162-2012
Class II
2593 2211
MHRA
2011/012/002/601/003
FSN
MHRA
2011/010/031/291/011
FSN
Abbott Laboratories Ltd.
Beckman Coulter Hong
Kong Ltd
Ceragem Hong Kong
FSN
BD
Healthpro Technology
Co. Ltd
2240 6150
2370 0218
MHRA
2011/012/006/291/023
FSN
MHRA
2011/011/029/291/009
FSN
MHRA
2011/012/008/081/003
FSN
MHRA
2011/011/016/081/006
FSN
MHRA
2011/012/001/601/004
FSN
MHRA
2011/011/016/081/014
FSN
MHRA
MHRA
2011/012/005/291/012
2011/008/002/401/006
FSN
FSN
MHRA
2011/011/016/081/006
FSN
MHRA
2011/012/001/601/004
FSN
N.A.
N.A.
MHRA
2011/011/016/081/014
FSN
Smith & Nephew Ltd.
2648 7700
Type II
GE Medical Systems
Hong Kong Ltd.
N.A.
Ortho Clinical
Diagnostics
Sanko Medical
Systems (HK) LTD
N.A.
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
N.A.
N.A.
Schmidt Bio Med Tech
(H.K.)
Stryker China Ltd
Thermo Fisher
Scientific (HK)
Varian Medical
Systems Pacific Inc.
N.A.
Janley Limited
Olympus Hong Kong
and China Ltd
N.A.
N.A.
2620 8329
2518 6915
2885 4613
2724 2836
N.A.
24877077
2170 5678
2011/12/13
GE Medical Systems Advantage Workstation Server (Model no. 5317169-X)
Health Canada
68684
2011/12/13
Health Canada
68810
Type II
Health Canada
68859
Type III
Health Canada
68829
Type III
Health Canada
68643
Type III
Health Canada
68375
Type I
Health Canada
68862
Type I
Smith & Nephew Ltd.
2648 7700
2011/12/13
2011/12/13
2011/12/13
Pelton and Crane Delta Q Sterilizer (Model no. 054200, AF)
Ortho Clinical Diagnostics Vitros Chemistry Calibration Kit 16 (Product Code
6801700)
Toshiba Medical Systems Corporation Aquilion 64 System (Model no. TSX101A/H, TSX-101A/HX)
Numed Canada Inc Nucleus-X Catheters
GE Healthcare A) Safesheath CSG Hemostatic Introducer
B) Safesheath Lateral Vein Introducer
Smith & Nephew, Inc., Endoscopy Division Dyonics Electroblade Resector Full Radius
SCC Soft Computer Softbank II V.23.2/25.0/25.1
Elekta Sequencer
Teleflex Medical DuraHook Scalp Retractor and DermaHook Skin Retractor
Health Canada
Health Canada
Health Canada
68455
68776
69006
Type II
Type II
Type II
N.A.
2891 2208
N.A.
2011/12/13
Life Technologies Corporation SPOT-LightTM HER2 [email protected] Kit
Health Canada
69187
Type II
2011/12/13
Varian Medical Systems, Inc Truebeam (Radiotherapy Configuration)
Health Canada
69035
Type II
N.A.
Elekta Ltd
N.A.
Life Technologies
Corporation
Varian Medical
Systems Pacific Inc.
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2011/12/13
2737 5504
23840688
N.A.
2783 1838/
2100 6318
N.A.
2724 2836
2011/12/13
B. Braun Medical Inc Outlook 621-ES100
Health Canada
68771
Type II
B. Braun Medical Hong
Kong
2529 2009
2011/12/13
Cardinal Health A) Custom Sterile Cataract Pack B) Sterile Eye Custom Pack
C) Custom Eye Preparation Pack D) Eye Pack E) Day Surgery Pack F) Cartoid
Pack G) Custom Sterile Plastics Pack
Health Canada
68861
Type II
N.A.
N.A.
2011/12/13
CareFusion Alaris PC Model 8015
Health Canada
69106
Type II
CareFusion Hong Kong
Ltd.
2891 8730
Health Canada
68646
Type II
Stryker China Ltd
2518 6915
Elekta Ltd
200 01 103 041
FSCA
Elekta Ltd
2892 4323
FDA
Z-0195-2012 to Z-0199-2012
Class II
Stryker China Ltd
2518 6915
FDA
Z-0341-2012
Class II
Radiometer China
(RCHN)
6056 3846
FDA
Z-0356-2012, Z-0357-2012, Z0358-2012
Class II
Milverton Limited
23678123
Medtronic
N.A.
Firm Initiated
Field Action
Integmed Limited
3527-3026
2011/12/13
2011/12/14
2011/12/16
2011/12/16
2011/12/16
2011/12/19
2011/12/20
2011/12/20
2011/12/20
HowMedica Osteonics Corporation Osteonics Restoration Hip System Reduced Neck Hip Stem - Straight
Elekta Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S,
Infinity, Axesse
Stryker 1) IBO Blade, Right
2) IBO Blade, Left,
3) Right/Left IBO Blade Set,
4) Right IBO Blade
5) Left IBO Blade,
Radiometer Medical ApS TC pCO2 Electrodes, Model/Part #945-655-E5260,
510(k) #K043003
Integra LifeSciences Integra Surgical Luxtec MLX Light Source Catalog
Numbers: 00MLX, 00MLXAU, 00MLXEU
Medtronic DLP® Single Stage Venous Cannulae
Varian 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (client build
8.2.2x through 10.0.34) with 4D Planning
Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Discs
AMC30 Amoxycillin/Clavulanic Acid, CT0223B Lot 1009130 and 1072461
Thermo Fisher Scientific Oxoid Diagnostic Discs FOX10 Cefoxitin DD0026B
Lot: 1072465
MHRA
2011/011/030/081/010
FSN
MHRA
2011/012/015/601/004
FSN
MHRA
2011/012/007/601/004
FSN
Varian Medical
Systems Pacific Inc.
Thermo Fisher
Scientific (HK)
Thermo Fisher
Scientific (HK)
GE Medical Systems
Hong Kong Ltd.
N.A.
N.A.
2724 2836
2885 4613
2885 4613
2783 1838/
2100 6318
N.A.
N.A.
2011/12/20
GE Healthcare Advantage Window Server (AWS)
MHRA
2011/012/012/081/010
FSN
2011/12/20
2011/12/20
Mast Group Ltd Metronidazole 5μg Cartridge Discs MZ5C lot: 291745
Natus Europe GmbH Echo-Screen Plus
MHRA
MHRA
2011/012/014/601/004
2011/012013/081/009
FSN
FSN
2011/12/20
cartridge (DF33A), lots GA2196, GA2203, DC2221, DB2221, GA2229 and
FA2237
MHRA
2011/011/024/601/002
FSN
Siemens Healthcare
Diagnostic Limited
2870 7533
MHRA
2011/012/012/081/006
FSN
N.A.
N.A.
MHRA
2011/012/012/081/007
FSN
N.A.
N.A.
2011/12/20
2011/12/20
Code: HS351, Batch Number: 112510
HS356, Batch Number: 110910
Thermo Fisher
Scientific (HK)
Accuray Asia Ltd
Busse Hospital
Disposables
Trinity Trading
Philips Electronic Hong
Kong Ltd
2011/12/20
Thermo Fisher Scientific
MHRA
2011/012/012/291/001
FSN
2011/12/20
Accuray Inc. CyberKnife Systems with Lung Optimized Treatment Option
MHRA
2011/011/024/291/006
FSN
2011/12/20
Busse Hospital Disposables Povidone Iodine Prep Pads (H&P Industries)
MHRA
2011/012/006/291/025
FSN
2011/12/20
Church & Dwight UK Sterimar Isotonic 100ml Batches FE1248b & FE1249 only
MHRA
2011/011/028/291/004
FSN
2011/12/20
Phillips Respironics DEAS SRL Humidification Chamber 1035609
MHRA
2011/011/015/601/003
FSN
MHRA
2011/012/014/291/018
FSN
Elekta Ltd
2891 2208
FDA
Z-0286-2012 to Z-0291-2012
Class II
N.A.
N.A.
2011/12/20
2011/12/22
Elekta Digital Accelerator (Modulator Reverse Diode) machine range 105361
to 152584
ImmuneTech ImmuneTech brand MyAllergyTest (containing recalled Triad
alcohol pad)
2885 4613
N.A.
N.A.
23856044
2821 5480
2011/12/22
Johnson & Johnson 1-DAY ACUVUE® TruEye™ Brand (narafilcon B) Brand
Contact Lenses
Johnson &
Johnson
Medical (HK)
Goodman
Medical
Supplies Ltd.
Health Canada
Health Canada
Firm Initiated
Field Action
Johnson & Johnson
Medical (HK)
2737 5562
Firm-initiated
recall
Goodman Medical
Supplies Ltd.
2332 4455
69302
Type III
68858
Type III
Health Canada
69169
Type III
N.A.
2011/12/29
Smiths Medical A) Level 1 D/DI-60HL Normothermic IV Fluid Administration
Sets;
B) HOTLINE Blood and IV Fluid Warming Sets (Codes L-70, LN-70NI, L-80, LPrecision Biologic Inc Cryocheck Abnormal 2 Reference Control (Model ARP210)
Beckman Coulter, Inc AMH Gen II ELISA and AMH Gen II Calibrators and
Controls
Siemens Dimension Vista Cardiac Troponin I Calibrator (Model: KC678; lot
1DD085)
Revolution Sante (FASRS) Hospital Bed (Model: RS508)
Health Canada
69293
Type III
2011/12/29
Nestle Healthcare Nutrition Inc. Compat Enteral Delivery Sets
Health Canada
68865
Type III
2011/12/29
GE Medical Systems SCS AW Volumeshare 2 with Functool Application and
AW Volumeshare 4 with Functool Application
Health Canada
69654
Type III
2011/12/29
Roche Diagnostics GMBH Elecsys Digoxin
Health Canada
69662
Type III
2011/12/29
Edwards LifeSciences Venous Arterial Blood Management System (VAMP)
Wallac OY A) 1235 Autodelfia System - PAPP-A (Part no. B098-201)
B) Delfia Xpress 6000 Immunoanalyzer System - PAPP-A Assay (Part no.
6003-0020)
Hospira Inc. 150 ml Burette Set
Fisher and Paykel Healthcare Ltd Infant Radiant Warmers (Model No.: IW910,
IW920, IW930, IW931, IW932, IW933, IW934, IW950, IW951, IW952, IW953,
IW954, IW960, IW970, IW980, IW990) (Lot No.: 9891JEU00024 - 200198JEU00195, 010824 - 100930)
Beckman Coulter, Inc. Coulter Cyto-Trol Control Cells Kit (Model No.:
6604248) (Lot No.: 7319028K, 7319029K, 7319030K, 7319031K)
Varian Varian brand GammaMed 12i and Accessory, Ref: BT-00264, Model 1H63 and Model 2-H63
Atom Medical Group 1) Dual Incu i (Atom Infant Incubator Model 100);
2) Incu i (Atom Infant Incubator Model 101);
3) Rabee Incu i (Atom Infant Incubator Model 102);
4) Infa Warmer i (Atom Infant Warmer Model 103).
Health Canada
66473
Type II
N.A.
Beckman Coulter Hong
Kong Ltd
Siemens Healthcare
Diagnostic Limited
N.A.
HONGKONG,HealthCar
e Nutrition
GE Medical Systems
Hong Kong Ltd.
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Health Canada
68863
Type II
N.A.
N.A.
Health Canada
68808
Type II
Hospira Limited
2898 2886
Health Canada
68668
Type II
Fisher & Paykel
Healthcare Limited
2116 0032
Health Canada
68310
Type II
FDA
Z-0329-2012 to Z-0330-2012
Class II
FDA
Z-0337-2012 to Z-0340-2012
Class II
2011/12/23
2011/12/29
2011/12/29
2011/12/29
2011/12/29
2011/12/29
2011/12/29
2011/12/29
2011/12/30
2011/12/30
Beckman Coulter Hong
Kong Ltd
Varian Medical
Systems Pacific Inc.
N.A.
N.A.
2240 6150
2870 7533
N.A.
2859 8750
2783 1838/
2100 6318
2485 7510
N.A.
2240 6150
2724 2836
N.A.
Major Safety Alerts in November 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
2011/11/01
2011/11/01
2011/11/01
Synthes A2FN Reamer product code 03.010.368
Abbott FreeStyle InsuLinx Blood Glucose Monitoring System, ADC FA10902011
Acutronic Mistral jet ventilator
2011/11/01
CareFusion AVEA ventilator (all models)
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Synthes (Hong Kong)
Ltd
Abbott Laboratories Ltd.
N.A.
CareFusion Hong Kong
Ltd.
Coloplast (Hong Kong)
Ltd
Johnson & Johnson
(Hong Kong) Ltd.
Elekta Ltd
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
2891 2208
2783 1838/
2100 6318
2783 1838/
2100 6318
Synthes (Hong
Kong) Ltd
MHRA
MHRA
2011/010/025/291/007
2011/008/030/601/004
Firm Initiated
Field Action
FSN
FSN
MHRA
2011/009/026/081/010
FSN
MHRA
2011/010/024/081/017
FSN
MHRA
2011/010/025/291/002
FSN
N.A.
Agent Contact
Telephone No.
2724 2032
2593 2211
N.A.
2891 8730
2011/11/01
Coloplast A/S Simpla All Silicone Foley Female catheter 10ml balloon with
Ampoule
DePuy International Ltd DePuy SIGMA HP FB TIBIAL TRAY IMPACTOR, Part
Number - 950501306
Elekta kV generator
MHRA
2011/010/021/081/017
FSN
2011/11/01
GE Healthcare MSK 1.5T Extreme system
MHRA
2011/008/024/291/002
FSN
2011/11/01
GE Healthcare VMX and VMX Plus Mobile X-ray Systems
MHRA
2011/010/028/291/002
FSN
MHRA
2011/010/027/291/013
FSN
N.A.
N.A.
MHRA
MHRA
MHRA
MHRA
2011/010/019/081/002
2011/010/019/081/003
2011/010/014/401/014
2011/010/025/081/001
FSN
FSN
FSN
FSN
N.A.
N.A.
N.A.
N.A.
MHRA
2011/010/025/081/005
FSN
MHRA
2011/010/027/291/010
FSN
MHRA
MHRA
2011/010/024/081/004
2011/010/003/601/004
FSN
FSN
Chindex
Chindex
N.A.
N.A.
Philips Electronic Hong
Kong Ltd
QIAGEN Hong Kong
Pte. Limited
N.A.
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
Hospira Limited
2011/11/01
2011/11/01
3628 7428
2738 6027
2011/11/01
2011/11/01
Integra LifeSciences Integra Ultrasonic Surgical Aspiration systems CUSA
Excel and CUSA Excel+ (Models CUSAEXCEL8 and CUSAEXCEL9)
Intuitive Surgical Inc Intuitive Surgical® da Vinci® System
Intuitive Surgical Inc EndoWrist™ Monopolar Curved Scissors
LeMaitre Vascular GmbH AlboGraft Polyester Vascular Graft (Lot no. 33322)
NEWDEAL SAS TIBIAXYS compression guide, Ref: 159635
Philips Medical Systems Brilliance 64, Brilliance Big Bore, Ingenuity CT,
Brilliance iCT, Brilliance iCT SP
Qiagen Manchester, Inc. therascreen KRAS PCR Kit, CE-IVD (Product Code:
871011, Lot no. 339804)
Sybron Dental Specialities Pinnacle Cure Sleeve 4511 (Lot no. 201008270110)
Vygon SA Octopus device (Product code: 0841361, batch: 080411AE)
2011/11/01
DePuy International Ltd Duraloc Polished HA Shell 52mm
MHRA
2011/010/026/291/001
FSN
2011/11/01
Hospira Inc. Plum A+ Family of Infusers List no. 12391, 20792
Philips Medical Systems A) BV Pulsera Mobile C-Arm System-9 inch. and 12
inch versions (Model no. 718095); B) BV Endura Mobile C-Arm System (Model
no. 718074)
Nova Century Scientific Inc A) NCS Strep A Twist Rapid Test Device; B) NCS
Strep A Rapid Test Device
MHRA
2011/010/006/081/009
FSN
Health Canada
67586
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
Health Canada
67280
Type II
N.A.
N.A.
Health Canada
67204
Type II
Health Canada
67281
Type II
2783 1838/
2100 6318
2783 1838/
2100 6318
Health Canada
67583
Type II
Health Canada
MHRA
67276
MDA/2011/102
Type III
MDA
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
Philips Electronic Hong
Kong Ltd
N.A.
N.A.
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/01
2011/11/03
GE Medical Systems SCS Senographe 2000D Mammography System
Medi-Physics Inc., D.B.A. GE Healthcare Rapid Strand Rx Pre-loaded
Brachytherapy Kit
Philips Healthcare Philips Precedence System-16 Slice, Philips Precedence
System-6 Slice, and SKYLight Gamma Camera Systems
Tremblay Harrison Inc Tremblay Harrison Minute Lab Strep A Rapid Test
Device
Lifecare Hospital Supplies Ltd Venturi L4102/24%, L4102/35%, L4002/60%
2821 5480
3652-3664
N.A.
N.A.
2738 6027
2898 2886
2821 5480
N.A.
N.A.
2011/11/04
2011/11/04
2011/11/07
2011/11/08
2011/11/08
2011/11/08
2011/11/08
2011/11/08
2011/11/08
2011/11/08
2011/11/08
Microgen Bioproducts Limited M404 Mercia Syphilis M kit lots 052X1, 053X1
and 05411A
MHRA
MDA/2011/104
MDA
N.A.
N.A.
Advisories and
Warnings
Firm initiated
FSN
Colgate-Palmolive
Hong Kong
Varian Medical
Systems Pacific Inc.
28301705/9641
3221
Colgate
Health Canada
N.A.
Varian TrueBeam and TrueBeam STx
Varian Medical
Systems
CP-06381
MHRA
2011/011/002/291/004
FSN
N.A.
N.A.
MHRA
MHRA
2011/010/031/291/017
2011/011/001/291/001
FSN
FSN
N.A.
N.A.
MHRA
2011/011/002/291/014
FSN
N.A.
Tiger Medical Products
Johnson & Johnson
(Hong Kong) Ltd.
MHRA
2011/010/003/081/023
FSN
MHRA
2011/010/020/291/003
FSN
Hoya Corporation (Supplied by Hitachi Medical Systems UK) PENTAX
ultrasound endoscope
Innogenetics INNOTEST HIV Ag mAb (art. code 80563)
NHS Supply Chain “Choice for Health” Denture Cleansing Tablets (NPC
MRB532)
Depuy Mitek Lupine – Suture Anchors (Lot # 210704, 210708,210709, 210711,
and 222980)
DJO Surgical (Encore Medical) RSP Socket Reamer and RSP Baseplate Rim
Planer
Hamilton Bonaduz AG Pooling software Version 3.x for the HAMILTON
Microlab STAR
Coopersurgical Inc. Illuminatus DXA Software with the DICOM Option (Part
Number 434A133) version 4.2.0 through 4.3.1.
Abbott Laboratories ARCHITECH Cyclpsporine reagents
MHRA
2011/011/001/291/009
FSN
MHRA
2011/010/014/601/014
FSN
2011/11/08
Abbott Point of Care Inc. i-STAT cTnl cartridges
MHRA
2011/010/004/081/005
FSN
2011/11/08
Beckman Coulter UK Ltd Navios Flow Cytometer
MHRA
2011/010/028/601/002
FSN
2011/11/08
Beckman Coulter UK Ltd Coulter LH500/HmX/HmX Autoloader
MHRA
2011/010/031/601/003
FSN
2011/11/08
2011/11/08
Biomet Merck France SARL T.E.S.S. Shoulder Prosthesis Glenoid Reamer
RaySearch Laboratories AB (TomoTherapy) TomoTherapy SharePlan 1.1
MHRA
MHRA
2011/009/012/081/010
2011/010/021/081/011
FSN
FSN
2011/11/08
Roche 1) Accu-Chek Inform II meter; 2)Accu-Chek Inform II meter with RF-card
MHRA
2011/010/031/291/009
FSN
MHRA
2011/007/020/081/011
FSN
2011/11/08
2011/11/08
Spectranetics Corporation Turbo-Booster Laser Guide (Product no. 518-043
and 518-063) Specific lot produced from 30 Oct 2009 to 12 Jul 2011
Thermo Fisher Scientific Oxoid Ready Poured Plate Brilliance MRSA 2 Agar,
PO1210A, Lot Number 1190949
2011/11/08
Zimmer Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis
2011/11/11
Philips Healthcare Philips Software MDC PACS - release R2.3 SP1
2011/11/14
Boston Scientific
2011/11/14
BrainLAB BrainSCAN versions 5.31 and 5.32 only
2011/11/15
Smith & Nephew Inc Smith & Nephew ACUFEX™ DIRECTOR ELITE ACL Drill
Guide System Tray (PN 72201731)
2011/11/15
2011/11/15
2011/11/15
2011/11/15
Spacelab Healthcare Spacelabs Healthcare ABP Monitor, Model 90217A
Stryker Solis Trial Cage (Model no. 8741206 - 8741209 - 8741404 - 8741406 8741407)
bioMérieux Slidex Pneumo Kit (Model: 58821)
Moog Medical Devices Group A) Painsmart IOD (Ambulatory Infusion Pump);
B) 6000 CMS (Ambulatory Infusion Pump); C) 4000 CMS (Ambulatory Infusion
MHRA
2011/010/027/601/001
FSN
MHRA
2011/010/026/081/007
FSN
FDA
Z-0032-2012
Class II
Boston Scientific
N.A.
BrainLAB
11-08-30.FIS.1
MHRA
2011/011/007/291/021
Firm Initiated
Corrective
Firm Initiated
Field Action
2724 2836
2738 6027
N.A.
N.A.
N.A.
N.A.
Anchor Medical
Services
Abbott Laboratories Ltd.
Bio-Asia Diagnostics
Co Ltd., Abbott
Laboratories Ltd.
Beckman Coulter Hong
Kong Ltd
Beckman Coulter Hong
Kong Ltd
N.A.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Thermo Fisher
Scientific (HK)
Zimmer PTE Ltd.
(Hong Kong branch)
Philips Electronic Hong
Kong Ltd
Boston Scientific Hong
Kong Ltd
2735 8323
2593 2211
Bio Asia:
27870906,
Abbott: 2593
2211
2240 6150
2240 6150
N.A.
N.A.
2485 7510
N.A.
2885 4613
2992 0968
2821 5480
2960 7136
BrainLAB Ltd
2417 1881
FSN
Smith & Nephew Ltd.
2648 7700
2620 8329
MHRA
2011/010/018/081/001
FSN
Schmidt Bio Med Tech
(H.K.)
MHRA
2011/011/008/081/007
FSN
Stryker China Ltd
2518 6915
Health Canada
67824
Type II
62624
Type I
bioMerieux China Ltd.
Moog Controls Hong
Kong Ltd.
2195 9348
Health Canada
2635 3200
Roche Diagnostics
(Hong Kong) Ltd
Roche Diagnostics
(Hong Kong) Ltd
Roche Diagnostics
(Hong Kong) Ltd
2011/11/15
Roche Diagnostics GMBH Cobas Integra Theophylline for Cobas C Systems
Health Canada
67460
Type III
2011/11/15
Roche Diagnostics GMBH Cobas E 411 Immunoassay Analyzer
Health Canada
67569
Type III
Health Canada
68127
Type III
Health Canada
67622
Type III
N.A.
N.A.
Health Canada
68240
Type III
bioMerieux China Ltd.
2195 9348
2011/11/15
2011/11/15
2011/11/15
Roche Diagnostics GMBH A) Hitachi LDL-Cholesterol, No Pretreatment, LDLC Plus 2nd GEN; B) Hitachi LDL-C Plus; C) Cobas C111 LDL-Cholesterol
Keeler Ltd A) Cryomatic System - Retinal Probe
B) Cryomatic System - Intra Vitreal Probe
C) Cryomatic System - Curved Cataract Probe
D) Cryomatic System - Collins Trichiasis
bioMérieux Inc. A) VITEK 2 Compact 30 System
B) VITEK 2 Compact 60 System
C) VITEK 2 System
D) VITEK 2 XL System
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Innotronik Hong Kong
Limited
Mekim Ltd
GE Medical Systems
Hong Kong Ltd.
Zimmer PTE Ltd.
(Hong Kong branch)
Philips Electronic Hong
Kong Ltd
2485 7510
2485 7510
2485 7510
2011/11/15
Roche Diagnostics Ltd. Cobas Ampliprep Sample Tubes
Health Canada
68298
Type III
2011/11/15
Anspach Various Drills and Burr
Health Canada
67146
Type II
2011/11/15
Sorin CRM S.R. L. Isoline 2CR6 Defibrillation Leads
Health Canada
67993
Type II
2011/11/15
Greiner Bio-One QuickShield with Snappy Safety Holder
Health Canada
67933
Type II
2011/11/15
GE Medical System LLC Revolution XRD X-ray Systems
Health Canada
67286
Type II
2011/11/15
Zimmer Nexgen CKS Prolong-LPS Mobile Articular
Health Canada
68044
Type II
2011/11/15
Philips Medical Systems NM Application Suite
Howmedica Osteonics (Stryker) A) Kinematic II Rotating Hinge Total Knee
System
B) HowMedica Modular Resection System - Proximal Tibia
C) Souter Strathclyde Elbow Prothesis Ulnar Component
D) Modular Replacement System - Kinematic Rotating Hinge KN Met Tib Insert
E) Modular Replacement Sytem - Kinematic Knee All Poly Tibial Plug
F) Eius Knee System - Tibial Components
G) Modular Rotating Hinge Knee System - Femoral Components
H) Modular Rotating Hinge Knee System - Tibial Inserts / Components/ Sleeve
I) Modular Rotating Hinge Knee System - Bumpr Insert / Axle
J) Kinematic II - Duration Poly Dome Patella with 3 Pegs
K) Avon Patello-Femoral Joint - Patella Component
L) Duracon ISA Mobile Bearing Knee Tibial Insert
M) Global Modular Replacement System - Bushing
N) Global Modular Replacement System - Proximal Tibial Insert
O) Kinemax Plus Total Knee System - Stabilizer Tibial Components
P) Kinemax Plus Total Knee System - Patellar Components
Q) Kinemax Plus Total Knee System - Condylar Tibial Components
R) Duracon Total Knee System - CS Lipped Tibial Insert
Abbott UK FreeGo enteral feeding pump
Cory Bros Suction Irrigation Electrodes
EDAP TMS Sonolith i-sys with the following versions: Visio Track with/ without
IHM3
GE Healthcare CARESCAPETM Monitor B650
Health Canada
67756
Type II
Health Canada
67002
Type II
Stryker China Ltd
2518 6915
MHRA
MHRA
MHRA
2011/010/011/291/016
2011/010/017/601/005
2011/010/004/401/015
FSN
FSN
FSN
MHRA
2011/010/031/291/013
FSN
Abbott Laboratories Ltd.
N.A.
N.A.
GE Medical Systems
Hong Kong Ltd.
2593 2211
N.A.
N.A.
2783 1838/
2100 6318
2011/11/15
2011/11/15
2011/11/15
2011/11/15
2011/11/15
2485 7510
N.A.
2877 6787
27748337
2783 1838/
2100 6318
2992 0968
2821 5480
FSN
GE Medical Systems
Hong Kong Ltd.
N.A.
2783 1838/
2100 6318
N.A.
2011/010/021/081/020
FSN
Vastec Medical Ltd
2897 1912
MHRA
2011/010/020/291/005
FSN
N.A.
N.A.
MHRA
2011/010/026/081/011
FSN
N.A.
N.A.
MHRA
2011/010/021/081/020
FSN
Vastec Medical Ltd
2897 1912
MHRA
Varian Medical
Systems
Varian Medical
Systems
CooperVision
Inc.
CooperVision
Inc.
2011/010/020/291/005
FSN
Firm initiated
FSN
Firm initiated
FSN
Firm Initiated
Field Action
N.A.
N.A.
N.A.
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
CooperVision Hong
Kong Limited
Oculus Optical (H.K.)
Co., Ltd.
2503 5511 /
9739 1594
MHRA
2011/011/001/291/012
FSN
N.A.
N.A.
MHRA
2011/009/029/091/008
FSN
中儀有限公司
28877640
MHRA
MHRA
2011/011/015/081/002
2011/008/028/601/001
FSN
FSN
N.A.
61130092
MHRA
2011/011/011/081/005
FSN
N.A.
Fujifilm Medical Ssytem
Goodman Medical
Supplies Ltd
MHRA
2011/011/017/291/010
FSN
Schmidt Bio Med Tech
(H.K.)
2620 8329
MHRA
MHRA
2011/011/014/081/008
2011/011/001/291/011
FSN
FSN
N.A.
Stryker China Ltd
N.A.
2518 6915
MHRA
2011/011/015/601/004
FSN
N.A.
N.A.
MHRA
2011/011/014/601/009
FSN
MHRA
2011/011/016/081/003
FSN
MHRA
2011/011/015/081/024
FSN
MHRA
10/002/004/291/013
FSN
MHRA
2011/009/005/081/011
FSN
TERUMO
CHINA (H.K.)
AA-2011-016-R
Firm Initiated
Field Action
Beckman Coulter Hong
Kong Ltd
N.A.
MR Holdings (HK)
Limited
GE Medical Systems
Hong Kong Ltd.
Olympus Hong Kong
and China Ltd
TERUMO CHINA
(H.K.) LTD.
FDA
Z-0145-2012
Class II
N.A.
2011/11/15
GE Healthcare GE Centricity Critical Care
MHRA
2011/011/003/291/022
FSN
2011/11/15
Handicare BV- Holland Puma, Beatle, Alex and Ibis XP power wheelchairs
International Technidyne Corporation (ITC) Power Adapter for Seiko Thermal
Printer used with the ITC HEMOCHRON® Signature Plus and
HEMOCHRON® Signature Elite Microcoagulation Systems
Newdeal Integra Life Luxtec UltraLite Pro Headlight
MHRA
2011/010/026/081/011
MHRA
Handicare BV- Holland Puma, Beatle, Alex and Ibis XP power wheelchairs
International Technidyne Corporation (ITC) Power Adapter for Seiko Thermal
Printer used with the ITC HEMOCHRON® Signature Plus and
HEMOCHRON® Signature Elite Microcoagulation Systems
Newdeal Integra Life Luxtec UltraLite Pro Headlight
Varian Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module)
Release 10 (Client Build 10.0.28 or Build 10.0.34)
2011/11/15
2011/11/15
2011/11/15
2011/11/15
2011/11/15
2011/11/17
2011/11/17
Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
2011/11/17
CooperVision Inc. Avaira/ Biocomfort XO daily wear contact lenses
2011/11/18
Oculus FreshKon Airis-1
2011/11/22
ELLA-CS Danis procedure pack and Danis procedure pack basic - guide wire
non-vascular
EV3 Arterial catheter - Marathon Flow Directed Micro Catheter (catalogue
number 105-5055, batch number 9374210)
Covidien BIS bilateral sensor
Fujifilm Medical Ltd Fujifilm FDR AcSelerate system
Smiths Medical Bivona® Neonatal, Pediatric and Flextend Tracheostomy
Tubes (Lot Numbers 1631477 through 1923406)
Spacelab Healthcare Spacelab kits Aria, CardioCall, Flashcorder, LifeCard 12,
LifeCard, 483, Aria VLC, EVO containing Alcohol non-sterile prep pads (B339)
manufactured by Professional Disposables International (PDI)
Straub Medical Aspirex® S, Catheter
Stryker Triathlon® Tibial Alignment Handle and Nav Tibial Alignment Handle
Alba Bioscience IHQC Blood Group Serology Controls (Product Code: Z494)
and ALBAcheck-BGS Whole Blood Controls (Product Code: Z489)
Beckman Coulter UK Ltd Access Immunoassay Systems*, Ostase Calibrator,
QC and Reagent Kits
Codan Argus AG Syringe pump A600S
2011/11/22
Mindray V series monitor
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
2011/11/22
GE Healthcare GE Centricity™ PACS RA1000 Workstation; Software
Versions: 2.1.x and 3.0.x
Olympus Keymed Caster Replacement on WM-P1 Series Workstations, Model
WM-NP-1, WM-DP1 and WM-WP1
2011/11/23
Terumo CVS Sarns Sternal Saw I System
2011/11/24
Merz Aesthetics MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC,
Injectable Implant (Part Number 8071M9)
CP-05277
CP-05007
N.A.
N.A.
2724 2836
2724 2836
37180601
2332 4455
2240 6150
N.A.
25110701
2783 1838/
2100 6318
2170 5678
28660811
N.A.
2011/11/28
Cordis SUPER TORQUE® MB Angiographic Catheter
2011/11/29
2011/11/29
2011/11/29
AngioDynamics Inc VenaCureEVLT NeverTouch Procedure Kits
Edwards Life Sciences Inc VolumeView Thermodilution Cable
Baxter Healthcare Ltd Covidien Quinton BETA-CAP adapter - product code
8814-661001
Abbott Vascular RX Accunet Embolic Protection System
2011/11/29
Otto Bock GB Primary Adapter for Power Supply
2011/11/29
Scimedx Scimedx Scanlisa H.pylori HM-CAP ELISA assay
Thomas Medical Products (a GE Healthcare company) SafeSheath® CSG®
Coronary Sinus Guide Braided Core Hemostatic Introducer, SafeSheath®
Worley Telescopic Braided Series & Situs LDS 2 Lead Delivery System
2011/11/29
2011/11/29
2011/11/29
Sybron Dental Specialities Freedom Cordless LED Headlight
2011/11/29
Trium CTG Online Trium CTG Online
2011/11/29
2011/11/29
2011/11/30
2011/11/30
2011/11/30
2011/11/30
2011/11/30
2011/11/30
2011/11/30
2011/11/30
2011/11/30
Covidien Ligasure Dolphine tip Sealer/divider Instruments (LS1500 and
LS1520)
Vital Image Vitrea Entreprise Suite 1.2, 1.3, 6.0, 6.1
Protech Professional Products Inc A) Soft Reline Kits (Both Heat and Self Cure)
B) Self Cure Repair Acrylic
C) Heat Cure Denture Acrylic
D) Tooth Acrylics
E) Silver and Gold post solder
F) Super Bonding Kit
G) UBAR Kit (Metal Bonding Acrylic)
Biomet Orthopaedics Biomet Arcom Patella Components
Smith & Nephew, Inc. Ambi Compression Hip Screw System - Standard Barrel
Plates
Howmedica Osteonics Corporation. Triathlon Slap Hammer
Senorx Bard Encor Biopsy Probes
Invivo Corporation 3160 MRI Patient Monitoring System (Precess Unit)
Vital Signs Inc. A) Broselow/Hinkle Pediatric Emergency System Kit
B) Broselow/Hinkle Pediatric Emergency System Flying Carpet
C) Broselow/Hinkle Pediatric Emergency System IV Module
D) Broselow/Hinkle Pediatric Emergency System Intubation Module
E) Broselow/Hinkle Pediatric Emergency System Intraosseous Module
F) Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Module
G) Broselow/Hinkle Pediatric Emergency System Pouch, Bag and Tag Pack
bioMérieux Inc. OBSERVA Database Management System
Siemens Healthcare Diagnostics Inc. Advia Centaur XP HUV AG/AB Combo
(Chiv) Assay
Johnson &
Johnson
Medical (HK)
MHRA
MHRA
N.A.
N.A.
Johnson & Johnson
Medical (HK)
2738 6027
2011/011/017/291/013
2011/011/021/291/002
FSN
FSN
N.A.
N.A.
N.A.
N.A.
MHRA
2011/011/022/081/017
FSN
Baxter Healthcare Ltd
2807 8516
Abbott Vascular
N.A.
FSN
MHRA
2011/010/026/081/019
FSN
2598 9772
MHRA
2011/008/016/291/003
FSN
N.A.
Otto Bock Asia Pacific
Limited
N.A.
2783 1838/
2100 6318
N.A.
N.A.
MHRA
2011/011/018/291/002
FSN
GE Medical Systems
Hong Kong Ltd.
Sybron Dental
N.A.
Firm initiated
field corrective
actions
CITICON
2127 4693
MHRA
2011/008/017/291/017
FSN
2783 1838/
2100 6318
MHRA
2011/011/015/081/009
FSN
MHRA
2011/011/021/081/016
FSN
GE Medical Systems
Hong Kong Ltd.
Tyco Healthcare
(HKSAR) Ltd
N.A.
Health Canada
66738
Type II
N.A.
N.A.
Health Canada
67768
Type II
N.A.
N.A.
Health Canada
68305
Type II
Smith & Nephew Ltd.
2648 7700
Health Canada
Health Canada
Health Canada
67749
68766
68277
Type II
Type II
Type II
Stryker China Ltd
N.A.
N.A.
2518 6915
N.A.
N.A.
Health Canada
67377
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
Health Canada
68288
Type III
Health Canada
68460
Type III
2011/11/30
Ortho Clinical Diagnostics. VITROS Chemistry Products DT Calibrator Kit
Health Canada
68304
Type III
2011/11/30
Respironics Inc Trilogy 200
Health Canada
68381
Type II
2011/11/30
Wright Medical Technology Inc Anchorlok Soft Tissue Anchor System
Health Canada
68581
Type II
bioMerieux China Ltd.
Siemens Healthcare
Diagnostic Limited
Ortho Clinical
Diagnostics
Philips Electronic Hong
Kong Ltd
Wright Medical
Technology Inc
3157 7220
N.A.
2195 9348
2870 7533
2737 5504
2332 3366
2821 5480
N.A.
2011/11/30
2011/11/30
2011/11/30
Cerner Corp Cerner ProVision Document Imaging
Fenwal Inc Blood Administration Set
Hospira Inc. Symbiq Infuser
Health Canada
Health Canada
Health Canada
67343
67763
68256
Type II
Type II
Type II
2011/11/30
Toshiba Medical Systems Corporation Catheterization Table
Health Canada
68228
Type II
2011/11/30
Agfa Corporation Curix Opthos H 35x43cm, NIF (model no. 35HJQ)
Health Canada
67769
Type III
2011/11/30
Steris Corp. A) Steris 5085 Surgical Table (Ref no. ST014101); B) Steris
5085SRT Surgical Table (Ref no. ST014101)
Health Canada
68312
Type III
2011/11/30
Ortho Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 24
(Product Code 6801708)
Health Canada
68645
Type III
2011/11/30
Seradyn Inc Vancomycin Calibrators (Model no. 196076)
Health Canada
68675
Type III
2011/11/30
Meridien BioScience Inc. Premier EHEC (Model no. 608096)
Health Canada
67996
Type III
Cerner Corp
Fenwal, Inc
Hospira Limited
Sanko Medical
Systems (HK) LTD
AGFA Hong Kong
Limited
Swedish Trading Co.
Ltd.
Ortho Clinical
Diagnostics
Thermo Fisher
Scientific (HK)
N.A.
N.A.
N.A.
2898 2886
23840688
2555 9421
Ms Chiu 6199
0634
Ms Cheung
2953 5154
2737 5504
2885 4613
N.A.
Major Safety Alerts in October 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
2011/10/03
Synthes Anspach® Single-use Cutting Burs and Irrigation Clips
2011/10/03
Varian Medical Systems Flexible Probe with Blocking Washer (part of
Segmented Cylinder Set)
2011/10/04
Therakos, Inc. Therakos Cellex Photopheresis System
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Synthes (Hong Kong)
Ltd
Varian Medical
Systems Pacific Inc.
Ortho Clinical
Diagnostics
Synthes (Hong
Kong) Ltd
1045834-090211-006R
Firm Initiated
Field Action
FDA
Z-3055-2011
Class II
Health Canada
66808
Type II
Health Canada
66901
Type III
Agent Contact
Telephone No.
2705 6305
2724 2836
2737 5504
2011/10/04
Anthogyr Endodontic Reducer Contra Angle Handpiece (Model no. 815-9008,
815-9010)
Siemens Healthcare Diagnostics Inc. Dimension EXL System - (Troponin) TNI
Assay (Model: RC621, Lot: ED2098, EA2111, FB2134, ED2147)
Micrus Endovascular Corporation Micrusphere Xl 10 Microcoil System (Model:
SSR 100514-20, Lot: G10559, G10560)
Ventana Medical Systems Inc. Symphony Automated Staining System (P/N
06114270001, P/N 900-SYM3, S/N 390000 and higher)
Immucor Inc. Galileo Echo Instrument
2011/10/04
Siemens AG Mammomat Inspiration
Health Canada
66721
Type I
2011/10/04
2011/10/04
bioMérieux Inc. Vitek 2 Yeast Identification Card (YST) (lot: 243210940)
Cincinnati Sub-Zero Products Warmair Model 134
GE OEC Medical Systems Inc A) Instatrak 3000 - Sensor Cables, B) Instatrak
3500 - Sensor Cables, C) Instatrak 3500 Plus - Sensor Cables
Ortho-Clinical Diagnostics A) Reagent Red Blood Cells SELECTOGEN, B)
Reagent Red Blood Cells AFFIRMAGEN, C) Reagent Red Blood Cells
SURGISCREEN, D) ORTHO Confidence System, E) Blood Grouping Reagent
Anti-D (Murine Monoclonal Blend) BioClone for Slide, F) Reagent Red Blood
Cells 0.8% SELECTOGEN, G) Reagent Red Blood Cells 0.8%
SURGISCREEN, H) Blood Grouping Reagent Anti-A (Murine Monoclonal
Blend) BioClone for Slide, I) Blood Grouping Reagent Anti-B (Murine
Monoclonal Blend) BioClone for Slide, J) Blood Grouping Reagent Anti-A,B
(Murine Monoclonal Blend) BioClone for Slide, K) Reagent Red Blood Cells
Health Canada
Health Canada
66785
65793
Type II
Type II
Health Canada
62579
Type III
Health Canada
66317
Type III
Acumed Inc 28 mm & 30 mm AcuTwist Acutrak Compression Screws
Health Canada
66546
Type III
Health Canada
66569
Type III
Health Canada
66631
Type III
Health Canada
66632
Type III
MHRA
2011/008/030/291/011
FSN
MHRA
2011/009/015/081/006
FSN
MHRA
2011/009/023/081/015
FSN
AMO Asia Limited
24015750
Varian Medical
Systems
CP-02040
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/04
2011/10/06
2011/10/06
2011/10/06
2011/10/07
Olympus Medical Sysrtems Corp ViziShot Single Use Aspiration Needles
(Model: NA-201SX-4022 and NA-201SX-4021)
BD Retic-COUNT Reticulocyte Reagent System
Diagnostica Stago SAS Sta-System Control N+P (Model: 00678, Lot: 106775)
Lojer 200-series Treatment Table (Models: 205E, 210E, 215E, 220E, 225E,
230E)
St Jude Medical PressureWire™ Aeris (Batch no. 114783 produced in August
2011)
Abbott Medical Optics Inc AMO Sensar® Intraocular Lenses (IOLs): Sensar®
Foldable IOL with OptiEdge (Model: AR40e)
Varian FrameArray Module (of the Optical Guidance Platform) HZ7, Floorstand
HZ5
Health Canada
66908
Type III
Health Canada
66909
Type III
Health Canada
67043
Type III
Health Canada
66967
Type I
BODE WELL Ltd
Siemens Healthcare
Diagnostic Limited
Johnson & Johnson
Medical (HK)
Roche Diagnostics
(Hong Kong) Ltd
Uninet Technology LTD
Siemens Healthcare
Diagnostic Limited
bioMerieux China Ltd.
N.A.
GE Medical Systems
Hong Kong Ltd.
Ortho Clinical
Diagnostics
Hong Kong Shoulder &
Wrist Centre
Olympus Hong Kong
and China Ltd
BD
Healthpro Technology
Co. Ltd
N.A.
St. Jude Medical (Hong
Kong) Ltd.
N.A.
2870 7533
2738 6027
2485 7510
2838 8423
2870 7533
2195 9348
N.A.
2783 1838/
2100 6318
2737 5504
N.A.
2170 5678
2575 8668
N.A.
N.A.
2996 7688
2011/10/11
2011/10/11
MHRA
MHRA
2011/009/028/051/005
2011/010/005/291/001
FSN
FSN
N.A.
N.A.
N.A.
N.A.
MHRA
2010/009/029/401/011
FSN
N.A.
N.A.
MHRA
2011/010/005/081/003
FSN
MHRA
2011/009/027/081/024
FSN
MHRA
2011/009/028/051/001
FSN
MHRA
2011/010/004/291/003
FSN
2011/10/11
Tosoh Bioscience UK Hemoglobin F and A2 Control for G7 (lot 1020)
Diasorin Inc. Assay ETI-AB-EBK PLUS (Batch 0490430A and/or 0490430A/1)
Park House Healthcare Richmond Ultra low profile bed (Serial numbers
between 22149 and 24282)
Philips Precess MRI Patient Monitoring System (“Precess”, Model Number
3160)
Sysmex Europe GmbH Lynoamp BC, Lot ZS 0008 & ZS 0011
Varian Varian Silhouette Clinacs® and certain non-Silhouette Clinacs in the
specified serial number range
Varian Segmented Cervix Applicator Set GM11004540, GM11002420 Flexible
applicator probe with blocking washer at 234 mm (old design) GM11005170
Guiding tube for segmented cylinders (old design)
Stryker Switchpoint Infinity, Equipment Booms, Surgical Lights Suspensions.
MHRA
2011/009/026/081/012
FSN
2011/10/11
Varian GM11002560 Flexible applicator probe, 3.2 mm, braced PVDF
MHRA
2011/010/004/291/001
FSN
MHRA
2011/010/004/291/002
FSN
MHRA
2011/009/028/601/004
MHRA
2011/009/022/081/015
MHRA
2011/010/004/291/004
2011/10/11
2011/10/11
2011/10/11
2011/10/11
2011/10/11
2011/10/11
2011/10/11
2011/10/11
2011/10/11
2011/10/13
2011/10/13
2011/10/14
2011/10/14
Varian GM11006200: Titanium Fletcher-style applicator set-defined geometryCT compatible
Vygon SA OCTOPUS – 3 x ANTI REFLUX VALVES+CLAMPS
Unomedical-a Convatec Company High Vac 600ml bottle with drain and trocar,
connecting tube & NRV, Ch18, High Vac 600ml bottle with drain and trocar,
connecting tube and NRV, Ch14, Tracheostomy mask, paediatric, Up-Mist
Nebulizer, with "T Piece", mouth piece and 2.1m oxygen tubing, adult
Unomedical-a Convatec Company Female catheter, Nelaton catheter, Rectal
catheter, Mülly suction catheter
Abbott Molecular m2000sp instrument
Dräger Medical GmbH Infinity® Acute Care System (IACS) Monitoring Solution Draeger Medical
with software versions VG1, VG1.2 and VG1.3
Hong Kong Ltd
BD Oral Syringes with Tip Caps, Cat no. 305207, 305217, 305210, 305220,
BD
305208, 305218, 305209, 305219
Cardiac Science Corporation Powerheart Automated External Defibrillator
(AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E,
FDA
CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198,
2011/10/14
Preventing Surgical Fires
2011/10/14
Decorative Contact Lenses
Varian Eclipse eMC Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and
DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25
and 10.0.28)
Invacare Leo Mobility Scooter
Lifecare Hospital Supplies Ltd Tru-Flow Plug on Venturi
NHS Supply Chain Bandage Light Support Type 2 without fastening (EVN000,
EVN129, EVN130 & EVN131)
Philips Medical Systems Extended Brilliance Workstation – NM all software
versions (1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q – Field Test period)
Siemens Healthcare Diagnostics Inc. ADVIA Centaur® Tobramycin kit REF
numbers 00835186 and 03329524
Siemens Healthcare Diagnostics Inc. ADVIA Centaur Systems T4 reagent lots
XXXXX146, XXXXX147, XXXXX148 and above (Systems: ADVIA Centaur® ,
ADVIA Centaur® XP, ADVIA Centaur® CP)
2011/10/17
2011/10/18
2011/10/18
2011/10/18
2011/10/18
2011/10/18
2011/10/18
2011/10/18
Abbott Molecular
Varian TrueBeam 1.0™ Linear Accelerators
N.A.
N.A.
N.A.
Z-3265-2011
FDA
N.A.
FDA
N.A.
Philips Electronic Hong
Kong Ltd
Sysmex Hong Kong Ltd.
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
2821 5480
N.A.
2724 2836
2724 2836
2518 6915
FSN
Stryker China Ltd
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
N.A.
FSN
N.A.
N.A.
FSN
N.A.
N.A.
2724 2836
2724 2836
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
Firm Initiated
Field Action
N.A.
N.A.
Draeger Medical Hong
Kong Ltd
2877-3077
BD
2575 8668
Class II
Pacific Medical Systems
21084005
N.A.
N.A.
Safety
communication
Public Education
N.A.
N.A.
CP-04133
Firm initiated
FSN
Varian Medical
Systems Pacific Inc.
2724 2836
MHRA
MHRA
2011/010/006/081/011
2011/008/002/291/005
FSN
FSN
Direct Health Ltd.
N.A.
25281109
N.A.
MHRA
2011/010/010/601/003
FSN
N.A.
N.A.
MHRA
2011/009/029/051/004
FSN
MHRA
2011/009/029/601/003
FSN
MHRA
2011/010/005/601/005
FSN
Siemens Healthcare
Diagnostic Limited
2870 7533
MHRA
2011/010/005/291/003
FSN
Varian Medical
Systems Pacific Inc.
2724 2836
Varian Medical
Systems
Philips Electronic Hong
Kong Ltd
Siemens Healthcare
Diagnostic Limited
2821 5480
2870 7533
CaridianBCT (Hong
Kong) Ltd
Fujifilm Medical Ssytem
Abbott Laboratories Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
61130092
2593 2211
FSN
AMO Asia Limited
2401 5750
A357
Firm Initiated
Field Action
Elekta Ltd
2891 2208
Health Canada
67099
Type III
Synthes (Hong Kong)
Ltd
2724 2032
Health Canada
67173
Type III
Health Canada
67285
Type III
Health Canada
Health Canada
67371
67376
Type III
Type III
Health Canada
67378
Type III
2011/10/20
2011/10/20
2011/10/20
3M Health Care Steri-Drape Roll Prep Drape
Trinity Biotech Bartels Clostridium Difficile Antioxin (Model no. B1029-70C)
Siemens Healthcare Diagnostics Products GMBH Berichrom Pai (Model no.
OWOA15)
Wallac OY LifeCycle for Prenatal Screening
Accuray Inc. Synchrony Respiratory Tracking System
Accuray Inc. CyberKnife Standard Treatment Couch
Health Canada
Health Canada
Health Canada
66240
67213
67217
Type II
Type II
Type II
2011/10/20
Maquet Gmbh & Co. KG Magnus Hybrid operating table columns
Health Canada
66892
Type II
Health Canada
66935
Type III
Health Canada
67098
Type III
Health Canada
67167
Type III
Medtronic International
Ltd.
Synthes (Hong Kong)
Ltd
Bio-Rad Pacific Ltd.
Health Canada
67267
Type II
N.A.
N.A.
Health Canada
66987
Type II
N.A.
N.A.
Health Canada
67203
Type II
2011/10/18
Caridian BCT CaridianBCT Spectra Optia Apheresis System
MHRA
2011/010/006/081/007
FSN
2011/10/18
2011/10/18
Fujifilm Medical System FCR Consoles – non-serial number specific
Abbott Laboratories Clinical Chemistry Urea Nitrogen
MHRA
MHRA
2011/009/030/601/006
2011/010/010/601/006
FSN
FSN
2011/10/18
DePuy International Ltd Corail AMT Size 9 and Size 10 Hip Implant
MHRA
2011/008/015/081/007
FSN
2011/10/18
Abbott Medical Optics Inc Abbott Medical Optics (AMO) Femtosecond Laser
Systems
MHRA
2011/010/013/081/002
2011/10/19
Elekta XVI 4.5 and 4.6
Elekta Ltd
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
2011/10/20
Synthes A) Zero-P Technique Guide - Parallel Sterile
B) Zero-P Technique Guide - Lordotic Sterile
C) Zero-P Technique Guide - Convex Sterile
Bio-Rad Laboratories Diagnostics D-10 Hemoglobin A1C Program Reorder
Pack
Siemens Medical Solutions Syngo Dynamics (Model no. 100-90-480)
Medtronic DLP Pressure Display with Remote Alarm Box (Model no. 60000,
63000, 64000, 66000) and DLP Pressure Display Set (Model no. 61000,
61006, 62000, 62006)
Synthes T-Pal Spacer Brochure
Bio-Rad Laboratories Diagnostics Group Variant II B-Thalassemia Short
Program Reorder Pack (2702154)
BOMImed Inc Adult Disposable Manual Resuscitator (Model: OL-500101-00,
OL-500102-00, Lot: 072111, 082411, 082511, 082611, 082911, 090711)
Nipro Corporation Nipro Bloodline (Model: A230TR/V810TR, Lot: 10F16,
10F18, 10F19)
Philips Medical Systems (Cleveland) Inc Brightview XCT Imaging System-Tilt
System
2011/10/21
CareFusion EnVe™ ventilators
2011/10/21
2011/10/25
Westone Oto-Ease® Ear Lubricant
Immucor Gamma Complement Control Cells, Lot No. 34161 (product no.
0007930)
Draeger Delta, Delta XL, Vista XL, Gamma XXL and Kappa (Software version
VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2)
Penlon Ltd. Crystal ® Metal Disposable Blades (sizes Mac 4 and Mac 3)
2011/10/25
2011/10/25
2011/10/24
2011/10/24
2011/10/25
Bio-Rad Pacific Ltd.
Siemens Healthcare
Diagnostic Limited
3M Hong Kong Ltd
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
Accuray Asia Ltd
Accuray Asia Ltd
MAQUET Hong Kong
Limited
Philips Electronic Hong
Kong Ltd
CareFusion Hong Kong
Ltd.
N.A.
FDA
N.A.
Class I
TGA
Uninet
Technology Ltd.
Draeger Medical
Hong Kong Ltd.
MHRA
RC-2011-RN-01010-3
2011/010/021/081/001
Class II
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
Roche cobas c 311
MHRA
2011/010/018/291/008
FSN
Stryker Cervicore Chisel Guide (Model no. 48290110)
Weinmann Geräte für Medizin GmbH & Co. Weinmann MEDUMAT Transport
with CO2 Measurement
MHRA
2011/010/007/081/019
FSN
Draeger Medical Hong
Kong Ltd.
Goodwin Health Care
Ltd
Roche Diagnostics
(Hong Kong) Ltd
Stryker China Ltd
MHRA
2011/010/007/291/007
FSN
N.A.
N.A.
N.A.
Uninet Technology Ltd.
22830710
2738 6027
2272 8926
2870 7533
2806 6111
N.A.
2870 7533
N.A.
N.A.
N.A.
N.A.
2919 1362
2724 2032
2272 8926
2821 5480
2891 8730
N.A.
2838 8423
2877-3077
2408-8838
2485 7510
2518 6915
N.A.
2011/10/25
Microgen Bioproducts Limited M404 Mercia Syphilis M kit lots 052X1 and
053X1
NHS Supply Chain “Choice for Health” Brand Stockinettes (Product Code:
EVN133, EGJ145)
NHS Supply Chain “Choice for Health” Various Products (EJA052, EJA054,
EJA055, EJA056, EVG012, etc)
Astra Tech Lofric Sense (Ref No.: 4161025, Lot No.: 93192, 93680)
MHRA
2011/010/017/601/001
FSN
2011/10/25
Codman & Shurtleff Inc MEDSTREAM Implantable Drug Infusion Pump
MHRA
2011/010/017/291/015
FSN
2011/10/25
Beckman Coulter Inc UniCel DxI immunoassay systems
MHRA
2011/010/018/601/004
FSN
2011/10/25
Gate Rehab Development AB StandTall walker “Bure Double”
Philips Healthcare Inc. PCR Eleva Radiological Image Processing System with
software R.1.2
Software version 1.2 Models: 732040, 732042, 732044, 732048, 732050,
732052, 732080, 732082
MHRA
2011/010/017/081/015
FSN
FDA
Z-3205-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
Boston Scientific
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
2011/10/25
2011/10/25
2011/10/25
2011/10/28
2011/10/31
Boston Scientific SCS REMOTE CONTROL (RC), CHARGER, ETS, TRIAL
PATIENT BELT & CHARGER BELT
MHRA
2011/009/001/081/006
FSN
N.A.
N.A.
MHRA
2011/009/021/601/001
FSN
N.A.
N.A.
MHRA
2011/010/014/601/011
FSN
N.A.
N.A.
N.A.
Johnson & Johnson
Medical (HK)
Beckman Coulter Hong
Kong Ltd
N.A.
N.A.
2738 6027
2240 6150
N.A.
Major Safety Alerts in September 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
Siemens Healthcare Diagnostics Dimension Calcium Flex Reagent (Lot #
2011/09/02
EA2153)
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
Z-3039-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2011/09/02
Steris Corp. a) Amsco V-PRO 1 and b) Amsco V-PRO 1 Plus Low
Temperature Sterilization Systems Model #MLR.
FDA
Z-3041-2011
Class II
Swedish Trading Co.
Ltd.
Ms Chiu 6199
0634
Ms Cheung
2953 5154
2011/09/02
Siemens Medical Solutions USA, Inc. ONCOR/PRIMUS Linear Accelerator
systems with RTT v2.x and an ARTISTE Linear Accelerator/RT Therapist v4.1
system with the LANTIS OIS
FDA
Z-2789-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2011/09/02
Philips Medical Systems Brightview Gamma Camera System
FDA
Z-2867-2011 to Z-2872-2011
Class II
2011/09/02
Varian Medical Systems Eclipse Treatment Planning System
FDA
Z-2788-2011
Class II
2011/09/06
Varian Medical Systems Clinac® iX, 21EX, 23EX, CX, DHX, Novalis Tx
Trilogy™ and TrueBeam™ Linear Accelerators (Varian Ref: CP-04926)
MHRA
2011/008/030/081/016
FSN
2011/09/06
Siemens Healthcare Diagnostics, Inc CA19-9 Flex reagent cartridges
MHRA
2011/008/025/601/007
FSN
2011/09/06
Rocket Medical. Rocket Microsyringe
Ortho Clinical Diagnostics. VITROS® ECi / ECiQ immunodiagnostic systems
software versions 3.8 and below when using VITROS® immunodiagnostic
products total β-hCG II reagent packs lots 0484 and above (Cat no. 6802220).
Nopac Healthcare Ltd. Caricare Sling
One Lambda Inc LABScreen single antigen HLA class class II antibody
detection test- Group 1
MHRA
2011/008/003/401/003
FSN
MHRA
2011/008/026/601/002
FSN
Ortho Clinical
Diagnostics
2737 5504
MHRA
2010/005/004/261/002
FSN
N.A.
N.A.
MHRA
2011/008/030/291/002
FSN
N.A.
N.A.
N.A.
66207
Firm Initiated
Field Action
Not specified
Type III
TERUMO CHINA
(H.K.) LTD.
N.A.
N.A.
Health Canada
66152
Type III
bioMerieux China Ltd.
2195 9348
Health Canada
65974
Type III
N.A.
N.A.
Health Canada
65559
Type III
N.A.
N.A.
Health Canada
65949
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
2011/09/06
2011/09/06
2011/09/06
2011/09/07
Terumo Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor
2011/09/07
2011/09/08
Ventilators
I-Flow Corporation ON-Q Pumps with Select-A-Flow
bioMérieux Inc. Slidex Staph Plus (Model no. 73115, 73116, Lot no.
1011103570, 1011103604, 1007103265, 1007103205)
Biomet Microfixation, Inc. Center Drive Blade 2.0 (Model no. 01-9047)
Express Diagnostics International Inc A) 5 Panel Drugcheck NxStep Cups
(Model no. 60505, Lot No. 505031911, 505032311, 505022511)
B) 10 Panel Drugcheck NxStep Cups (Model no. 61020, Lot no. 020021411)
C) Drugcheck NxStep Cups with Alcohol (Model no. 60500 A, Lot. No. A500
022111, A500040711)
D) Drugcheck 2 Panel Dips (Model no. 30200, Lot no. 200012411, 200020311)
E) 6 Panel Drugcheck NxScan Cups (Model no. 70610, Lot no. 610042111)
GE Medical Systems, LLC Lightspeed VCT CT Scanner System (Model no.
5212920-3XX)
2011/09/08
2011/09/08
2011/09/08
2011/09/08
TERUMO
CHINA (H.K.)
FDA
Health Canada
AA-2011-011-C
Philips Electronic Hong
Kong Ltd
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
Siemens Healthcare
Diagnostic Limited
N.A.
2821 5480
2724 2836
2724 2836
2870 7533
N.A.
28660811
N.A.
N.A.
2011/09/08
2011/09/08
Express Diagnostics International Inc A) Drugcheck Dip Drug Tests (Model no.
30100, 30110, 30111C, 30120, 30130, 30130C, 30140, 30140C, 30150,
30160, 30163, 30170, 31005)
B) AlcoCheck Breath Alcohol Screening (Model no. 40902, 40908)
C) Alcocheck Saliva Alcohol Screening (Model no. 40900)
D) DrugCheck Urine Alcohol Screening (Model no. 40901, 40901C)
E) DrugCheck NxStep 14 Panel Cups (Model no. 61401)
F) Diagnostics Oraline Swab 4 Panel Drug Test (Model no. 40940)
G) QED Alcohol Saliva Test (Model no. N/A.)
H) Drug Adulteration Test Strip (Model no. D700-25)
Warm Buddy Comp Soothing Heat Cold Pack (Model no. 1200,1200B, 1200C,
5009A, 6001, 6005, 6006, 6008, 6012, 8009, 8012, 8012B, 8013, 8015, 8018,
8019, 8020, 8028, 8028B, 8028C, 8029, 8030, 8030B, 8030C, 8031, 8032,
8035, 8035P, 8040)
Health Canada
65563
Type III
N.A.
N.A.
Health Canada
66141
Type III
N.A.
N.A.
2518 6915
2011/09/08
Stryker Neptune 2 Waste Management System - Rover
Health Canada
65943
Type III
2011/09/08
Beckman Coulter Inc Synchron LX Systems Apoa Reagent
Health Canada
66071
Type III
2011/09/08
Kerr Corporation, also trading as Pentron Clinical TempSpan CMT
Health Canada
66108
Type III
Health Canada
64744
Type III
Health Canada
Health Canada
65583
65795
Type III
Type III
Stryker China Ltd
Beckman Coulter Hong
Kong Ltd
BAUHINIA DENTAL
LIMITED, CITICON
HONG KONG LIMITED
BAUHINIA DENTAL
LIMITED, CITICON
HONG KONG LIMITED
N.A.
Stryker China Ltd
Health Canada
65958
Type III
bioMerieux China Ltd.
2011/09/08
2011/09/08
2011/09/08
2011/09/08
Kerr Corporation, also trading as Pentron Clinical A) 37% Phosphoric Acid
Etching Gel, B) Etch Gel, C) Cement-It - Cementation System Kit, D) Mojo
Veneer Cement
Alere San Diego, Inc Triage Drugs of Abuse Plus TCA Test Kit
Stryker Medical 30" Transport Stretcher
Biomerieux, Inc. A) VITEK 2 Compact 30 System, B) VITEK 2 Compact 60
System, C) VITEK 2 System, D) VITEK 2 XL System
2011/09/08
Ormco Corporation Wick Lip Bumper
Health Canada
66136
Type III
2011/09/08
Mizuho Orthopedic Systems, Inc Mizuho OSI Modular Table Systems
Health Canada
66074
Type III
2011/09/08
Kerr Corporation OptiBond FL
Health Canada
66168
Type III
2011/09/08
2011/09/08
Pentron Clinical Technologies, LLC Breeze Self-Adhesive Resin Cement
Smith & Nephew, Inc Spider 2 Limb Positioner
Health Canada
Health Canada
66129
66017
Type III
Type III
2011/09/08
Supersonic Imagine Aixplorer Ultrasound system
Health Canada
66102
Type III
2011/09/08
Applied Medical Resources Corporation Direct Drive Disposable Laparoscopic
Grasper
Health Canada
66179
Type III
Health Canada
65948
Type III
2011/09/08
Smith & Nephew Inc A) Twist Drill Bit
B) Tip Threaded Guide Pin
C) Guide Pin Bayonet Point
D) Guide Pin Trocar Point
E) Peri-Loc Periarticular System - K-Wire with Trocar Point
F) Swanson Finger Wire
G) Cobalt Chrome Trochar Tip Wire
H) Cobalt Chrome Drill Tpe Threaded Wire
I) Cobalt Chrome Drill Tip Wire
J) Drill
2240 6150
2305-2100/
21274693
2305-2100/
21274693
N.A.
2518 6915
2195 9348
Citicon (Hong Kong)
N.A.
Ltd., D & R Dental
N.A.
N.A.
BAUHINIA DENTAL
2305-2100/
LIMITED, CITICON
21274693
HONG KONG LIMITED
N.A.
N.A.
Smith & Nephew Ltd.
2648 7700
Prism Technologies
27863233
Limited
Long Hin Medical
28150250/2170
Limited/ Olympus Hong
5678
Kong and China Limited
Smith & Nephew Ltd.
2648 7700
2011/09/08
2011/09/08
2011/09/08
2011/09/08
2011/09/09
2011/09/12
GE Medical Systems SCS A) Senographe DS Full Mammography System
B) Senographe Essential Mamography System
SCC Soft Computer SoftPath GUI versions 3.17.5 to 3.17.9, 4.2.1 to 4.2.3 and
4.3.0 to 4.3.0.4
SCC Soft Computer SoftPath GUI versions 4.2.3.3 to 4.2.3.6 and 4.3.0.5 to
4.3.0.12
Ormco Corporation Mini Twin Brackets-left and right
Termo Fisher Scientific ProSpecT Rotavirus Microplate Assay (Ref: R240396)
Varian Medical Systems Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™
accelerators
Health Canada
65770
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
Health Canada
66148
Type III
N.A.
N.A.
Health Canada
66258
Type III
N.A.
Health Canada
66138
Type III
N.A.
Varian Medical
Systems
N.A.
N.A.
N.A.
Citicon (Hong Kong)
Ltd., D & R Dental
Gene Co. Ltd
Varian Medical
Systems Pacific Inc.
Cochlear (Hong Kong)
Ltd.
N.A.
N.A.
Elekta Ltd
GE Medical Systems
Hong Kong Ltd.
CP-05645
FSN
N.A.
2896 6283
2724 2836
2011/09/14
Cochlear Nucleus CI500 cochlear implant range
Cochlear Ltd.
N.A.
2011/09/14
2011/09/14
2011/09/14
Drive Medical Ltd WA007 Rollators
Drive Medical Ltd Nimbo Paediatric Walker
Elekta Ltd Dynamic Multileaf Collimator (DMLC)
MHRA
MHRA
MHRA
2010/008/012/291/012
2010/010/023/401/001
2011/006/002/081/002
Firm Initiated
Field Action
FSN
FSN
FSN
2011/09/14
GE Healthcare Vital Signs enFlow IV Fluid Warmer-#980105VS
MHRA
2011/009/005/291/005
FSN
MHRA
2011/009/006/081/007
FSN
Stryker China Ltd
2518 6915
MHRA
2011/008/022/081/036
FSN
N.A.
N.A.
MHRA
2011/007/027/081/004
FSN
N.A.
N.A.
MHRA
2011/008/002/291/005
FSN
N.A.
Medtronic International
Ltd.
Philips Electronic Hong
Kong Ltd
Johnson & Johnson
Medical (HK)
N.A.
N.A.
29031008
N.A.
N.A.
2891 2208
N.A.
2011/09/14
Stryker Orthopaedics Duration® packaging distributed by Stryker
Orthopaedics, Limerick, Ireland (Specific lot with a device expiration date
between August 19 2008 and June 2016)
Nikkiso Europe GmbH Aquarius Hemofiltration Device
Impromediform GMBH Alaris Amber Opaque Extension Set manufactured by
Impromediform
Lifecare Hospital Supplies Ltd L4102/24% and L4102/35% Venturi
2011/09/14
Medtronic EnRhythm and EnRhythm MRITM SureScan Pacemaker
MHRA
2010/002/010/081/003
FSN
2011/09/14
Philips Healthcare NM3 Monitors and FloTrak Elite Modules
MHRA
2011/009/006/081/009
FSN
2011/09/16
LifeScan Inc. OneTouch Verio blood glucose monitoring system
TGA
RC-2011-RN-00924-3
Class II
2011/09/19
TiSport TiLite ZR and ZRA Series 2 (Model no. Z2FS1and Z2FS2)
Varian Medical Systems High-Definition 120 Multileaf Collimator HD 120 (MLC
is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx
and Trilogy linear accelerators) (Model no.: H56)
FDA
Z-3161-2011
Class II
FDA
Z-3052-2011
Class II
2011/09/19
Varian Medical Systems BrachyVision, versions 8.2, 8.5, 8.6 and 8.9
FDA
Z-3103-2011
Class II
2011/09/19
Varian Medical Systems Varian Treatment version 6.6.5052
FDA
Z-3105-2011
Class II
2011/09/19
FDA
N.A.
Class I
MHRA
2011/009/009/601/011
FSN
MHRA
2011/009/006/081/020
FSN
N.A.
N.A.
MHRA
2011/009/009/081/017
FSN
2011/009/013/081/002
2011/008/018/081/002
2011/009/008/081/005
2011/09/21
Penlon
MHRA
MHRA
MHRA
Goodwin Health
Care Ltd
FSN
FSN
FSN
Firm Initiated
Field Action
N.A.
Senrex International
Ltd.
N.A.
N.A.
Goodwin Health Care
Ltd
N.A.
2011/09/20
2011/09/20
2011/09/20
Lee Medical Internation Inc Custom Dialysis Trays/Kits
Siemens Healthcare Diagnostics ADVIA® 120/2120/2120i Hematology
Systems
TOSOH Europe G8 Hemoglobin F&A2 Calibrator (Catalogue no. 0021932),
Hemoglobin F and A2 Control (Catalogue no 0997050)
Acumed Inc 3.5mm x 20mm Locking Cortical Screw (Part Number: COL-3200S, Lo: 250091)
Bard Limited BARDPORT* TITANIUM PORT (Catalogue Number: 0602290)
Cory Bros 33cm Monopolar Scissor (Affected part code: CB3550EN, Lot:
0211009)
Planmeca Delight light bulb
2011/09/14
2011/09/14
2011/09/14
2011/09/19
2011/09/20
2011/09/20
2011/09/20
N.A.
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
N.A.
Siemens Healthcare
Diagnostic Limited
2919 1362
2821 5480
2738 6027
N.A.
2724 2836
2724 2836
2724 2836
N.A.
2870 7533
2311 8938
N.A.
N.A.
2408-8838
2011/09/22
Immucor Gamma Panocell® -10, Cat. No.0003032 Lot: 331472
Uninet
Technology Ltd.
N.A.
Firm Initiated
Field Action
2011/09/22
Siemens Syngo Plaza (S/N 100011)
Health Canada
66199
Type II
2011/09/22
2011/09/22
Elekta Limited Synergy XVI (version 4.5.0)
Lina Medical APS Lina Loop
Health Canada
Health Canada
66455
66458
Type II
Type II
2011/09/22
Siemens Syngo Dynamics (S/N 92241)
Health Canada
66598
Type II
2011/09/22
Siemens Syngo Imaging SX (S/N 1225, S/N 2006, S/N 2163)
Health Canada
66599
Type II
FDA
Z-2978-2011
Class II
Uninet Technology Ltd.
Siemens Healthcare
Diagnostic Limited
Elekta Ltd
N.A.
Siemens Healthcare
Diagnostic Limited
Siemens Healthcare
Diagnostic Limited
Varian Medical
Systems Pacific Inc.
2838 8423
2870 7533
2891 2208
N.A.
2870 7533
2870 7533
FDA
Z-3214-2011
Class II
2011/09/22
2011/09/22
Varian Medical Systems Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear
Accelerators
Terumo Sarns 8000 Cardioplegia Monitor, a) Catalog Number 16414; also
known as PROG COMP BD AMPRO 420 CPG 8K, (Serial Numbers 2060,
3305, 3763, 3823, 3834, 3835, 3851-3876, 3878-3899, 3901, 3902, 3904,
3906-3913, 3915-3933 and 3935); b) Catalog Number 816373, (Serial
numbers 491212, 498329, 505891, 505892, 509307, 510221, 512688,
514493, 517238, 522537, 524438, 527767, 534182, 541101, 545173, 551503,
557425, 563225, 568962 and 576045)
McKesson Medical Imaging Company Horizon Medical Imaging (HMI)
Hologic, Inc. Fluoroscan Mini C-Arm Office Mate
Health Canada
Health Canada
64937
66535
Type II
Type II
2011/09/22
Siemens AG Syngo Imaging XS VA70A
Health Canada
66198
Type II
2011/09/22
Etac AB Etac Premium Handling Belt
Health Canada
66367
Type II
2011/09/22
Siemens Healthcare Diagnostics Inc. Dimension Vista Cuvettes
Health Canada
66119
Type III
2011/09/22
2011/09/22
Gyn Disposables, Inc. IUD Insertion Kit
TriPath Imaging, Inc. Centrifuge Tube Racks for Prestain
Siemens Healthcare Diagnostics Inc. Dimension EXL System - (Troponin) TNI
Assay
Abbott Laboratories Diagnostic Division A) Cell-Dyn 3500 Haematology
System - CS Analyzer, B) Cell-Dyn 3500 Haematology System - Refurbished
CS Analyzer, C) Cell-Dyn 3500 Haematology System - Sl Analyzer, D) CellDyn 3500 Haematology System - Refurbished Sl Analyzer
Health Canada
Health Canada
66030
65792
Type III
Type III
Health Canada
66699
Type III
Health Canada
56461
Type III
Abbott Laboratories Ltd.
2593 2211
St Jude Medical
St Jude Medical
N.A.
Firm Initiated
Field Action
St Jude Medical
2996 7688
MHRA
2011/009/021/601/004
FSN
N.A.
N.A.
MHRA
2010/005/012/401/006
FSN
N.A.
N.A.
MHRA
2011/009/020/081/021
FSN
N.A.
N.A.
2992 0968
2011/09/22
2011/09/22
2011/09/22
2011/09/22
2011/09/23
2011/09/27
2011/09/27
Rocket Medical Rocket® Pleuraseal 1 Chest Drainage Bottle (Product Code:
R54559 & R54563) produced between September 2010 and 2011
Theraposture „Rotoflex‟ and „Theracare‟ electrically adjustable beds
Trinity Biotech Trinity Biotech HbA1c Calibraotr (Product Code: 01-04-0018)
Lot 23600 and HbA1c Control (Product Code: 01-04-0015)Lot 3580
Zimmer Zimmer® Trabecular Metal Humeral and/or Trabecular Metal Reverse
Shoulder Systems
Gambro Lundia AB Gambro Conventional Bloodline - bl101d bl105 bll50d
bl148sn bl121p bl130psn.
Drive Medical Ltd Endres Riviera bathlift
Abbott Diagnostics Limited m2000rt
2011/09/27
Acumed Inc 13 Hole Scapula Medial Boarder Plate
MHRA
2011/009/021/081/005
FSN
2011/09/27
Animas Corporation Animas Vibe Insulin Pump
MHRA
2011/009/008/081/004
FSN
2011/09/27
2011/09/27
2011/09/27
2011/09/27
2011/09/27
TERUMO CHINA
(H.K.) LTD.
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
BD
Siemens Healthcare
Diagnostic Limited
2724 2836
28660811
N.A.
N.A.
2870 7533
N.A.
2870 7533
N.A.
N.A.
2870 7533
MHRA
2010/009/015/081/006
FSN
Zimmer PTE Ltd.
(Hong Kong branch)
MHRA
2011/009/021/081/012
FSN
Gambro Lundia AB
2839 9710
MHRA
MHRA
2010/008/009/401/001
2011/009/016/601/001
FSN
FSN
N.A.
Abbott Laboratories
LTD.
Hong Kong Shoulder &
Wrist Centre
Johnson & Johnson
Medical (HK)
N.A.
2593 2211
N.A.
2738 6027
2011/09/27
2011/09/27
B Braun Medical Celsite ST301OTW, Celsite Implantofix, Celsite Brachial
Bausch & Lomb
2011/09/28
Terumo CVS CDI Blood Parameter Monitoring System 500
2011/09/28
Resuable laryngoscope handles (All models)(All manufacturer)
MHRA
Bausch & Lomb
TERUMO
CHINA (H.K.)
MHRA
2011/009/013/081/015
N.A.
AA-2011-014-C
MDA/2011/0096
FSN
Firm Initiated
Field Action
Firm Initiated
Field Action
MDA
B. Braun Medical Hong
Kong
2529 2009
Bausch & Lomb
2213 3179
TERUMO CHINA
(H.K.) LTD.
N.A.
28660811
N.A.
Major Safety Alerts in August 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
Instrumentation Laboratory Co. GEM Premier 4000 PAK Cartridges for Use on
2011/08/02
the GEM Premier 4000 System
Vital Signs Vital Signs Hygroscopic Condenser Humidifier (HCH) / Anesthesia
2011/08/02
Breathing Circuit
Zimmer NexGen® Complete Knee Solution Stemmed & Rotating Hinge
2011/08/02
KneeTibial Broach Impactors (Part Number 00-5977-011-00 and 00-5881-080ArjoHuntleigh ROLKO strap and handle assembly fitted to a monkey pole ,
2011/08/02
model TGN-R100GR
bioMérieux IVDS, viral microbiology, instrumentation. Vidas® Chlamydia Kit
2011/08/02
(reference 30101) (Lot no.: 867467801)
Care-Ability Healthcare Leg sling. Leg Lifter (CA1000 Special) (serial no.:
2011/08/02
15238, 15239, 15240, 15241, 15242, 15243, 15244, 15245).
Draeger Medical Systems Monitors, patient: multi parameter monitor. Delta
2011/08/02
and Gamma XXL
2011/08/02 Nucletron Flexitron HDR systems with TCC software version 1.2
2011/08/02 Redax ATS BULB Set, Medium Vacuum w/trocar codes 10721 and 10723
2011/08/02 Smiths Medical International CADD® -Solis Ambulatory Infusion Pumps
2011/08/02 Smiths Medical International Omnifuse and Omnifuse PCA Syringe Pumps
Arrow International Inc Arrow NextStep Antegrade Chronic Hemodialysis
2011/08/04 Catheter (Product no. CS-15192-IXM, CS-15232-IXM, CS-15272-IXM, CS15312-IXM, CS-15422-IX, CS-15502-IX)
Brainlab Brainlab Skull ReferenceBase (Art. No. 52121B, 52129 & 52129A),
2011/08/04 Brainlab Disposable Self-Tapping Screw 1.5x6MM (Art. No.52128), KLS Martin
Cross-Drive Screw 1.5x6mm (Art. No. 25-678-06)
Philips Healthcare Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura
2011/08/04 Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura
Xper FD20/20 and Allura CV20
Boston Scientific Katzen Infusion Wire Material number(UPN)M001461930,
2011/08/04
Catalog number 46-193, Lot/Batch#14270326, Expiration date March 2014
Newport Medical Instruments Newport HT70 Ventilator. Model #HT70 (Serial
2011/08/05 numbers: N10HT700810209 - N10HT700810218, N10HT700910219 N10HT700910225)
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
Varian Medical Systems Optical Guidance Platform, version 2.6 and 2.6.1
W & H Dental Werk Buermoos GMBH Arthrex Reciprocating Saw Attachment
Type: V-600SR
Physio Control Inc. 12-lead ECG Cable with limb lead attachment part
no.:3302822-000-AHA;3302822-002-AHA;3302822-001-IEC;3302822-003IEC. Precordial lead attachment part no.:3302823-000-AHA & 3302823-001Barrx Medical, Inc. HALO Ultra Ablation Catheter (Model number: 90-9200)
Varian Medical Systems Inc RT Chart, a function of ARIATM versions 8.0 and
8.1
Varian Medical Systems Inc Clinac Linear Accelerator; Model numbers H14,
H27 and H29
Source of
Information*
Reference No. by Source
Alert Type by
Source
FDA
Z-2805-2011
Class I
FDA
N.A.
Firm Press
Release
MHRA
2011/006/024/081/015
FSN
MHRA
MDA/2011/088
MDA
MHRA
MHRA
MHRA
MHRA
MHRA ref:
2011/007/026/601/004
MHRA Ref:
2011/004/021/401/005
MHRA ref:
2010/006/009/081/001
2011/005/026/081/020
2011/007/011/401/004
2011/007/005/081/010
2009/008/003/401/003
FDA
MHRA
MHRA
Local Agent
Agent Contact
Telephone No.
Beckman Coulter HK
Ltd
GE Medical Systems
Hong Kong Ltd.
Zimmer PTE Ltd.
(Hong Kong branch)
Arjo Huntleigh (Hong
Kong) Ltd.
2814 0481
2897 1912
FSN
bioMerieux China Ltd.
N.A.
FSN
N.A.
N.A.
2783 1838
2992 0968
2508 1416
FSN
FSN
FSN
FSN
Draeger Medical Hong
Kong Ltd.
N.A.
N.A.
N.A.
N.A.
Z-2883-2011
Class I
N.A.
N.A.
BrainLAB
N.A.
FSN
N.A.
N.A.
Philips
N.A.
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
Boston
Scientific Hong
N.A.
Firm Initiated
Field Action
N.A.
29607136
FDA
Z-2406-2011
Class II
N.A.
N.A.
Varian Medical
Systems
CP-04207
Firm Initiated
Field Action
FDA
Z-2879-2011
FSN
Varian Medical
Systems Pacific Inc.
W & H Dental Werk
Buermoos GMBH
FDA
Z-2625-2011
FSN
N.A.
FDA
Z-2745-2011
Class II
FDA
Z-2763-2011
Class II
FDA
Z-2764-2011
Class II
Sky Medi-tech Ltd.
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
MHRA
FSN
N.A.
N.A.
N.A.
N.A.
N.A.
2724 2836
N.A.
N.A.
23929900
2724 2836
2724 2836
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/05
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
Varian Medical Systems Inc TrueBeam Linear Accelerators (aka Trilogy Mx)
(Model numbers: H14, H19, H27, H29)
Beckman Coulter, Inc Manual Inhibin A ELISA Reagent Kit; Part Number DSL10-28100-1, Part Number DSL-10-28100t-1, Part Number DSL-10-28100-4
and Part Number DSL-10-28100t-4
Covidien LP non-absorbable braided nylon sutures/ non-absorbable silk
sutures / non-absorbable polyester sutures
Medtronic Navigation, Inc DICOM Query/Retrieve, version 1.1.4. Individual part
# 9733808, or as part of a system order, DICOM Q/R Software Kit, part #
Del Mar Reynolds Medical Pathfinder Holter Analyzer
Terumo Cardiovascular System Corporation Pressure Monitoring Kit and
Cardiovascular procedure kit
Computerized Medical Systems Inc. Interplant Radiation Treatment Planning
System
Integrated Orbital Implants Inc Coated Bio-Eye Orbital Implant w/ Conformer.
Maquet Critical Care AB Servo-I Ventilator Systems
Unomedical S.A. de C.V. 1)First Breath Adult Oxygen Mask with Tubing,
2)First Breath 3 in 1 Oxygen Mask with Reservoir Bag and Tubing, 3)First
Breath Adult Aerosol Mask (Non-Latex), 4)First Breth ADULT Elongated NonRebreather Oxygen Mask, 5) First Breath PEDIATRIC Medium Concentration
Oxygen Mask, 6) First Breath Pediatric Aerosol Mask, 7) First Breath Adult
Face Tent, 8)First Breath Adult Face Tent with Tubing, 9) First Breath Adult
Venturi Oxygen Mask with Corrugated Tubing, 10) Value Pack General
Instrumentation Laboratory Co. Instrumentation Laboratory GEM Premier 3500
Blood Gas Analyzer
Caridian BCT Spectra Optia Apheresis System
Medacta International SA Versafitcup Double Mobility Liner Inserter
Hospira Gemstar docking station (model number: 13075)
Anika Therapeutics S.R.L. Merogel Injectable (Model no. 15-18000, Lot no.
32300, 31700, 31900, 32000, 32100)
Siemens A) Magnetom Aera (Model no. 10432914)
B) Magnetom Skyra (Model no. 10432915)
Siemens Siemens Symbia T (Model no. 10275010)
Maquet Cardiopulmonary AG HL-20 Perfusion System - Consoles (Model no.
706187, 706189, 706193, 706195, 706197, 706199)
Maquet Cardiopulmonary AG HL-20 Perfusion System - Roller Pump Modules
(Model no. TPM 20-330)
Neo Medical, Inc Neo Medical V-CATH PICC SL Tray Catheter
Smiths Medical ASD, Inc A) Level 1 Normothermic IV Fluid Admin. Sets
(Model no. DI-150, DI-350, DI-65HL, DI-75)
B) Level 1 F-50 Gas Vent Filter Assembly (Model no. F-50)
FDA
Z-2766-2011
Class II
Varian Medical
Systems Pacific Inc.
2724 2836
FDA
Z-2772-2011 to Z-2775-2011
Class II
Beckman Coulter Hong
Kong Ltd
2240 6150
FDA
Z-2810-2011 to Z-2830-2011
Class II
FDA
Z-2781-2011
Class II
FDA
Z-2611-2011
Class II
FDA
Z-2613-2011 to Z-2621-2011
Class II
FDA
FDA
FDA
z-2622-2011
Z-2624-2011
Z-2628-2011
Class II
Class II
Class II
Tyco Healthcare
(HKSAR) Ltd
Medtronic International
Ltd.
Del Mar Reynolds
Medical Ltd
TERUMO CHINA
(H.K.) LTD.
Elekta Ltd
N.A.
Maquet Critical Care
FDA
Z-2647-2011 to Z-2656-2011
Class II
N.A.
N.A.
FDA
N.A.
Class II
Vastec Medical Limited
28971912
FDA
FDA
Hospira HK Ltd.
Z-2674-2011
Z-2709-2011
N.A.
Class II
Class II
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Health Canada
62260
Type II
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
Siemens Healthcare
Diagnostic Limited
MAQUET Hong Kong
Limited
MAQUET Hong Kong
Limited
N.A.
3157 7220
2919 1362
N.A.
2866 0811
2891 2208
N.A.
N.A.
Health Canada
64900
Type II
2870 7533
Health Canada
65177
Type II
Health Canada
65466
Type II
Health Canada
65469
Type II
Health Canada
64396
Type II
Health Canada
64851
Type II
Goodman Medical
Supplies Ltd
2332 4455
2870 7533
23939511
23939511
N.A.
2011/08/09
Varian Medical Systems Optical Guidance Platform (OGP) v 2.6 and 2.6.1
Health Canada
65196
Type II
Varian Medical
Systems Pacific Inc.
2724 2836
2011/08/09
Roche Diagnostics GMBH A) Hitachi Phosphorus, B) Hitachi Unsaturated Ironbinding Capacity (UIBC)
Health Canada
65098
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2011/08/09
Synca Marketing Inc STiK! Etch
Health Canada
65543
Type III
2011/08/09
Siemens AG Lantis (Model No.: 4503178)
Health Canada
65472
Type II
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
2870 7533
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
2011/08/09
Philips Medical Systems DMC GMBH EasyDiagnost Eleva (Model No. 426058)
SCC Soft Computer SoftPath GUI v. 4.3.0.10-11-12 (Model No.: 566698)
Edwards Lifesciences LLC EndoPlege Coronary Sinus Catheter (Model No.:
EP)
Teleflex Medical A) Rusch Female Catheter (Model No.: 238300080,
238300100, 238300120, 238300140, 238300160)
B) Robinson/Nelaton PVC Catheter (Model No.: 238500100, 238500120,
238500140, 238500160, 238500180, 238500200, 238500220, 238500240)
A-dec, Inc. A-dec 311 Dental Chair (Model No.: 311)
Ventana Medical Systems Inc Ultra View Universal DAB Detection Kit (760500, ROCHE CAT # 05269806001)
Roche Diagnostics GMBH
A) Cobas Integra System - Salicylate (20753580322); B) Roche Hitachi /
Salicylate (11815172216); C) SALI (Salicylate for Roche/Hitachi Cobas C311
and C501/502 Systems) (20753580322)
Baxter Healthcare Corporation Interlink, Non-DEHP IV Catheter Extension Set
Gambro Dialysatoren GMBH Theralite High Cut-Off Dialyzer
Roche Diagnostics GMBH A) Elecsys Ferritin, B) Online TDM Carbamazepine
(CARB2) for Cobas C System
Varian Medical Systems, Inc A) Eclipse Ocular Proton Planning V1.1, B)
Eclipse Smart Segmentation, C) Rapidarc, also known as Dose Dynamic Arc,
D) Eclipse TPS V8.8
Health Canada
Health Canada
65596
65682
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
Type II
N.A.
N.A.
Health Canada
65591
Type II
N.A.
N.A.
Health Canada
65593
Type II
N.A.
N.A.
Health Canada
65645
Type II
N.A.
N.A.
Health Canada
64948
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
Health Canada
65702
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
Health Canada
Health Canada
65550
65588
Type III
Type III
Health Canada
63730
Type III
Health Canada
65752
Type II
Varian Medical
Systems Pacific Inc.
2724 2836
Baxter Healthcare Ltd
Gambro Lundia AB
Roche Diagnostics
(Hong Kong) Ltd
2807 8516
2839 9710
2485 7510
2011/08/09
Vital Signs Inc. Cuff-Able Blood Pressure Cuff
Health Canada
65773
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2011/08/09
Vital Signs Inc. A) Cuff-Able Blood Pressure Cuffs, B) Broselow/Hinkle
Pediatric Emergency System Kits - Oxygen Masks, C) Broselow/Hinkle
Pediatric Emergency System Flying Carpet - Cuffable BP Cuffs, D)
Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Module Oxygen Masks, E) Broselow/Hinkle Pediatric Emergency System Pouch, Bag
Health Canada
65774
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2011/08/09
Gen-Probe Life Sciences Ltd Elucigene
Health Canada
64649
Type II
2011/08/09
Vital Signs Inc. Infusable Pressure Infusor
Health Canada
65772
Type II
2011/08/09
Ormco Corporation. MadaJet XL Part Number 601-0000
Health Canada
65825
Type III
MHRA
2011/007/027/081/004
FSN
N.A.
N.A.
MHRA
2011/007/027/601/003
FSN
Siemens Healthcare
Diagnostic Limited
2870 7533
MHRA
2011/008/001/291/006
FSN
2011/08/10
Impromediform GMBH Alaris Amber Opaque Extentsion Set manufactured by
Impromediform (Product Ref. MFX1641 Lot27J10, MFX2276 lot 17J10)
Siemens Healthcare Diagnostics ADVIA® 1200, ADVIA 1650, ADVIA 1800,
and ADVIA 2400 Chemistry Systems 1) ADVIA Chemistry Gentamicin_2
(GENT_2) Lot Numbers: GENT_2, PN 10377507 (Lot Numbers 174889,
175988, and 187802); 2) Valproic Acid_2 (VPA_2): Reagent Kit Lots May Have
Increased Imprecision (VPA_2, PN 10377508 (Lot Numbers 192627 and
HemoCue AB HemoCue Glucose 201 RT system and HemoCue Glucose 201
DM RT system
Invacare Aquatec Ocean 1534327, 1534328, 1534329
MHRA
2011/007/028/301/001
FSN
2011/08/10
Beckman Coulter UK Ltd Access Immunoassay Systems Total T4 Calibrators
MHRA
2011/008/001/601/001
FSN
2011/08/10
Aesculap AG Joint prothesis, hip prothesis. Metha modular hip
endoprosthesis system
MHRA
2011/007/029/291/009
FSN
2011/08/10
2011/08/10
2011/08/10
bioMerieus China
Limited
GE Medical Systems
Hong Kong Ltd.
Citicon (Hong Kong)
Ltd., D & R Dental
Science International
Corp.
Direct Health Ltd.
Beckman Coulter Hong
Kong Ltd
B. Braun Medical Hong
Kong
2356 7033
2783 1838
N.A.
2543 7442
25281109
2240 6150
2529 2009
2011/08/10
2011/08/10
2011/08/12
2011/08/12
2011/08/12
2011/08/12
Alba Bioscience ALBAcheck BGS high titre control kits, IHQC blood group
serology controls, Bio-Rad whole blood controls, Ortho Confidence whole
blood controls, sensitivity control kit, INVITROQC-C
Anspach Surgical power tools: cutting bur used with micro curve attachment
Cardiac Science Corp Automated External Defibrillator (non-wearable). Model
number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive
Welch Allyn Protocol, Inc. Aruba Wireless Network Access Points, Model 65
utilized by the Acuity Central Monitoring System
Computerized Medical Systems Inc XiO Radiation treatment Planning System,
XiO Release 4.2.0 and above
Terumo Cardiovascular Systems Corp Advanced Perfusion System 1 Base
110V (Cat. No. 801763); System 1 Base 220V (Cat. No. 801764); Large Roller
Pump 6" Diameter (Cat No. 816571, 801041)
MHRA
2011/007/013/601/003
FSN
N.A.
N.A.
MHRA
2010/011/003/081/002
FSN
N.A.
N.A.
FDA
Z-2917-2011
Class II
N.A.
N.A.
FDA
Z-2918-2011
Class II
Umedco (Far East) Ltd.
N.A.
FDA
Z-2578-2011
Class II
Elekta Ltd
2891 2208
FDA
Z-2735-2011- Z-2738-2011
Class II
TERUMO CHINA
(H.K.) LTD.
2866 0811
FDA
Z-2893-2011
Class II
Boston Scientific
90697732FA
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
Boston Scientific Hong
Kong Ltd
2011/08/12
Varian Medical Systems, Inc. Clinac Linear Accelerator; H14, H27 and H29
2011/08/15
Boston Scientific ExpectTM Endoscopic Ultrasound Aspiration Needle
2011/08/16
Smiths Medical International Ltd 2 and 3 lumen Logicath 12 F hemodialysis
central venous catheters.
MHRA
2011/008/004/291/003
FSN
N.A.
N.A.
2011/08/16
Spacelabs Healthcare Inc. WA Vital signs monitor model 93300 - élance
MHRA
2011/008/009/291/003
FSN
Schmidt Bio Med Tech
(H.K.)
2620 8329
MHRA
2011/008/008/291/006
FSN
Stryker China Ltd
2518 6915
MHRA
MHRA
2011/004/006/081/005
2011/008/009/291/002
FSN
FSN
N.A.
N.A.
2011/08/16
2011/08/16
Stryker UK Wheeled stretchers models - 742 Sechrist, 748 Transport, 1037
Trauma, 1089 Eye Surgery, 1105 Prime 5th Wheel Stryker medical stretchers
Anspach Surgical power tools: burrs. Drill bit, bur, carbide bur, cutter, carbide
cutter
Trinity Biotech Bartels Legionella urinary antigen kit (lot number 024)
2011/08/16
Beckman Coulter UK Ltd DxH Cell Lyse, part no-628018 (1L) and 628019 (5L)
MHRA
2011/008/005/601/006
FSN
2011/08/16
Coloplast A/S Multi-organ procurement catheter-AJ6516
MHRA
2011/008/011/291/012
FSN
2011/08/16
DePuy International Ltd PFC Sigma 35mm 3 peg oval dome patella
MHRA
2011/008/008/291/009
FSN
2011/08/16
2011/08/16
Elekta Instruments AB Leksell gammaPlan version 10.1
Fenland Laundries Ltd (trading as 'Micronclean') Hypodermic syringe
Microline Surgical Inc ReNew Long Fenestrated Grasper 3262, ReNew SuperAtrau fenestrated grasper 3642
MHRA
MHRA
2011/008/010/291/001
2011/008/008/291/018
FSN
FSN
N.A.
N.A.
Beckman Coulter Hong
Kong Ltd
Coloplast (Hong Kong)
Ltd
Johnson & Johnson
(Hong Kong) Ltd.
Elekta Ltd
N.A.
MHRA
2011/008/008/291/034
FSN
N.A.
2011/08/16
2011/08/16
2011/08/17
2011/08/18
2011/08/18
2011/08/19
2011/08/19
2011/08/19
2011/08/19
Terumo Cardiovascular Systems Corporation Level Sensor II Pads
Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump
Battery Performance
Varian medical systems 4D Integrated Treatment Console version 8.1 SP2 to
10.0 SP1, Model: H48
Varian Titanium Fletcher-style Applicator Set - Defined Geometry - CT
Compatible with Titanium intrauterine probe with stopper; 1) length 40 mm, 30
degree angle; 2) length 60 mm, 30 degree angle; 3) length 80 mm, 30 degree
angle; 4) length 30 mm, 30 degree angle; 5) length 50 mm, 30 degree angle;
and 6) length 70 mm, 30 degree angle
Animas Animas 2020 Insulin Infusion Pump
Linet LINET ELEGANZA STANDARD & DELUXE MODEL BEDFRAMES
(PREFIX 1GS... & 1GL...)
Spacelabs Healthcare Ultraview Spacelabs Medical Multigas Analyzer, Model
91518, V1.00.14
TERUMO
CHINA (H.K.)
Medtronic
International Ltd.
Varian Medical
Systems
Ref: AA-2011-010-R
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
2724 2836
2960 7136
2240 6150
3628 7428
2738 6027
2891 2208
N.A.
N.A.
TERUMO CHINA
28660811ext130
(H.K.) LTD.
Medtronic International
2919 1362
Ltd.
Varian Medical
2724 2836
Systems Pacific Inc.
CP-03940
Firm initiated
FDA
Z-3000-2011
Class II
Varian Medical
Systems Pacific Inc.
2724 2836
FDA
Z-3017-2011
Class II
Johnson & Johnson
Medical (HK)
2738 6027
MHRA
MDA/2011/092
MDA
N.A.
N.A.
Class III
Schmidt Bio Med Tech
(H.K.)
2620 8329
FDA
Z-2902-2011
2011/08/19
2011/08/19
2011/08/23
2011/08/23
2011/08/23
2011/08/23
2011/08/23
2011/08/23
DUET TRSTM Universal Straight and Articulating Single Use Loading Units
(SULU)
Avaira ™ Toric daily wear contact lenses
Stryker Howmedica Osteonics Howmedica Modular Resection System Proximal Tibia
GE Medical Systems LLC Advantage Workstation with FuncTool version 6.3xx9.3xx
Varian Medical Systems Plastic Needle with Mandrin (Model no. GM11007560,
GM11007570, GM11007580)
Pride Mobility Products Corp Victory 10, 3 Wheel (SC610) and Victory 10, 4
Wheel (SC710)
GE Medical Systems LLC Discovery MR750, Discovery MR450, Optima 450
WD and Optima 450 WE
GE Medical Systems LLC Optima MR360 1.5T (Model 5312366 (M50002BB))
Covidien PTE
Ltd
CooperVision
Inc.
N.A.
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
Covidien PTE Ltd
31577220
CooperVision Hong
Kong Limited
37180601
Stryker China Ltd
2518 6915
GE Medical Systems
Hong Kong Ltd.
Varian Medical
Systems Pacific Inc.
2783 1838/
2100 6318
Health Canada
65586
Type II
Health Canada
65987
Type II
Health Canada
66002
Type II
Health Canada
65743
Type II
2724 2836
N.A.
N.A.
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
2783 1838/
2100 6318
Health Canada
65949
Type II
Health Canada
65950
Type II
Health Canada
65099
Type II
bioMerieux China Ltd.
N.A.
Health Canada
62337
Type II
Bio-Rad Pacific Ltd.
Roche Diagnostics
(Hong Kong) Ltd
Roche Diagnostics
(Hong Kong) Ltd
Johnson & Johnson
(Hong Kong) Ltd.
2272 8926
2011/08/23
bioMérieux Inc A) VITEK 2 System - VITEK 2 Instrument; B) VITEK 2 System VITEK 2 XL Instrument
Bio-Rad Laboratories Diagnostics Group D-10 Dual Program Reorder Pack
2011/08/23
Roche Diagnostics Ltd PSM Software
Health Canada
65956
Type I
2011/08/23
Roche Diagnostics Ltd PSM Software
Health Canada
65957
Type I
2011/08/23
Micro Typing Systems Inc Ortho Provue Analyzer
Health Canada
65840
Type III
2011/08/23
Siemens Healthcare Diagnostics Inc. Advia Chemistry System-Hemoglobin
A1C (A1C) Assay, Advia Chemistry System-Hemoglobin A1C (HBA1C) Assay
Health Canada
65465
Type III
Stockert GMBH Stockert EP Shuttle System
TOSOH Corporation G7 Automtated Glycohemoglobin System - F & A2
Roche
Diagnostics GMBH MagNA Pure LC 2.0 Instrument - Software version
Calibrators
1.1.23 and 1.1.24 and MagNA Pure LC 1.0 Instrument - Software version
3.0.11
Health Canada
65913
Type III
Health Canada
65968
Type III
Health Canada
65960
Type III
Ormco Corporation CK-3 Large Full Radius Scalpel
Health Canada
63869
Type III
MHRA
2011/008/012/601/004
FSN
MHRA
2011/007/026/081/008
FSN
N.A.
N.A.
MHRA
MHRA
2011/008/015/291/011
2011/007/029/081/024
FSN
FSN
N.A.
2735 8323
MHRA
2011/008/015/081/014
FSN
MHRA
MHRA
MHRA
Health Canada
2011/006/022/401/008
2011/008/012/291/006
2011/008/010/291/002
N.A.
TGA
N.A.
FSN
FSN
FSN
Notice
Health
professional
information &
education
N.A.
Anchor Medical
Services
Johnson & Johnson
(Hong Kong) Ltd.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2011/08/23
2011/08/23
2011/08/23
2011/08/23
2011/08/23
2011/08/24
2011/08/24
2011/08/24
2011/08/24
Ortho-Clinical Diagnostics Intermixed Images using Software Version 2.4 on
CELLTRACKSAnalyzer II
Salient Surgical Technologies, Inc. Aquamantys 2.3 bipolar sealer (Model # 23113-1)
Trinity Biotech Plc Ultra 2 Combo Analyzer and Ultra 2 Variant Analyzer
Coopersurgical Inc. Mystic II Disposable Vacuum Assisted Delivery Products
Ethicon Endo-Surgery ENDOPATH® ETS Compact Flex 45mm (240mm shaft
length) articulating linear cutters
Quadratech Diagnostics Ltd Check4 Pregnancy Cassettes
Biomet France Sarl Optilavage splash shield
Biomet UK Ltd Juggerknot System part number 912000
All Product Make Central Vascular Access Devices
2011/08/26
All Product Make Endoscopes
2011/08/24
2011/08/24
2011/08/24
2011/08/24
2011/08/24
Siemens Healthcare
Diagnostic Limited
Johnson & Johnson
(Hong Kong) Ltd.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
Citicon (Hong Kong)
Ltd., D & R Dental
Ortho Clinical
Diagnostics
2485 7510
2485 7510
27386028
N.A.
27386028
N.A.
2485 7510
N.A.
2737 5504
2738 6027
N.A.
N.A.
N.A.
N.A.
2011/08/26
2011/08/29
King International ShoulderFlex Massager
Varian Eclipse 10 (Client builds 10.0.28 and 10.0.34)
FDA
Varian Medical
Systems
Abbott
Laboratories Ltd
Alerts and
Notices
N.A.
N.A.
CP-05308
Firm initiated
Varian Medical
Systems Pacific Inc.
2724 2836
FA26AUG2011
Firm Initiated
Field Action
Abbott Laboratories Ltd.
2593 2211
2011/008/005/601/003
FSN
N.A.
N.A.
N.A.
2011/08/31
Abbott Laboratories Clinical Chemistry Alkaline Phosphatase (Ref no. 7D5521, 7D55-31)
SonoSite, Inc. SonoSite® MicroMaxx® ultrasound system and M-Turbo®
ultrasound system
Spacelabs Healthcare Inc. WA Spacelabs Medical Patient Monitors (Models
91369, 91370, 91387 and 91393)
Spectrum Dynamics D-SPECT™ Cardiac Scanner
2011/08/31
Tomotherapy Tomotherapy devices with multileaf collimator (MLC)
2011/08/31
2011/08/31
Kunststoffwerk Kremsmunster GmbH Dosing spoon, 1.25/2.5/5ml
One Lambda Inc LABScreen MICA single antigen – group 1
MHRA
Transmedic
China Limited
MHRA
MHRA
2011/08/31
Thermo Fisher Scientific Oxoid Microbact Listeria 12L MB1128A
MHRA
2011/008/022/601/003
FSN
2011/08/31
Robinson Healthcare Cotton Gauze Tissue BP 45x90cm
Becton Dickinson Diagnostics BD Multitest™ CD3/CD16+56/CD45/CD19 with
BD Trucount Beads
MHRA
2011/008/017/601/004
FSN
Schmidt Bio Med Tech
(H.K.)
N.A.
Transmedic China
Limited
N.A.
N.A.
Thermo Fisher
Scientific (HK)
N.A.
MHRA
2011/008/023/081/022
FSN
BD
2011/08/31
ArjoHuntleigh Entroy pool lifters
MHRA
2011/007/025/291/001
FSN
2011/08/31
2011/08/31
Brandon Medical Co Ltd Astralite LED Mobile
JOMA Kunststofftechnik GmbH & CoKG Measuring spoon
MHRA
MHRA
2011/007/029/081/001
2011/007/018/291/006
2011/08/31
Becton Dickinson Diagnostics BD Trucount™ Beads
BD Biosciences
P/N 23-13590-00 Rev.01
FSN
FSN
Firm Initiated
Field Action
2011/08/30
2011/08/31
2011/08/31
2011/08/31
MHRA
MHRA
2011/008/010/291/015
FSN
2011/007/021/081/018
FSN
Ref: 5174
N.A.
2011/007/018/291/007
2011/008/002/291/016
FSN
FSN
Arjo Huntleigh (Hong
Kong) Ltd.
N.A.
N.A.
BD
2620 8329
N.A.
2107 4668
N.A.
N.A.
2885 4613
N.A.
N.A.
2508 1416
N.A.
N.A.
25758668 EXT
252
Major Safety Alerts in July 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
IGC Dorel Pty Ltd Safety 1st Complete Healthcare Kits (Item Number: 49773;
2011/07/04
Barcode Number 8439254291)
2011/07/05 Baxa Baxa EVA & Multilayer Bags for Total Parenteral Nutrition (TPN), all Sizes
Beckman Coulter SYNCHRON Rheumatoid Factor (RF) Reagent (P/N
2011/07/05
475136, all Lots)
2011/07/05 bioMérieux, Inc VITEK 2 60 and XL System Instrument Issue
2011/07/05 Newdeal SAS (Integra) Kalix II sterile (ref. 141010/ 141011)
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
TGA
RC-2011-RN-00630-3
Class II
N.A.
N.A.
MHRA
2011/006/017/601/011
FSN
MHRA
2011/006/027/601/004
FSN
MHRA
MHRA
2011/006/024/601/010
2011/004/005/081/001
FSN
FSN
JASPO Limited
Beckman Coulter Hong
Kong Ltd
bioMerieux China Ltd.
N.A.
Ortho Clinical
Diagnostics
2011/07/05
Ortho Clinical Diagnostics VITROS® PHBR Slides (Product code: 8221384)
MHRA
2011/006/028/601/003
FSN
2011/07/05
Ortho Europe Non-Alignable Hip Unit Aluminium Alloy Type Part Number
1HP101 and Alignable Hip Unit Aluminium Alloy Type Part Number 1HP102
MHRA
2010/003/004/081/012
FSN
2011/07/05
2011/07/05
2011/07/07
2011/07/08
2011/07/08
2011/07/08
GE Healthcare Vital Signs Cuffable® Blood Pressure Cuffs
Instrumentation Lab Ltd GEM TEST PT Cartridges
Varian Medical Systems, Inc. Eclipse Treatment Planning System, versions
7.3.10 to 10.0.34
Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System, Part
Number: 629029
Spacelabs Healthcare Inc. WA Ultraview Sl - 91517
Biomet, Inc. 1) Bio-modular reverse shoulder humeral tray with lock ring, 44
mm 10 degree angle, sterile, single use, REF 11-113685.
2) Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard,
sterile, single use, REF 11-113680.
3) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10
mm, sterile, single use, REF 115348.
4) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5
mm, sterile, single use, REF 115345.
5) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm
standard, sterile, single use, REF 115340.
6) Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF
CP561548.
7) Custom solar comprehensive reverse humeral tray with lock ring 44 mm
+5mm, sterile, REF CP561659.
8) Custom biomodular humeral tray 44 mm sterile, REF CP561686.
9) Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15
mm & + 18 mm sterile, REF CP561705.
10) Custom comprehensive reverse shoulder bio-modular base 44 mm
humeral tray standard, REF CP561510.
MHRA
MHRA
2011/006/029/081/010
2011/006/024/081/013
FSN
FSN
Varian Medical
Systems
CP-03626
Firm Initiated
Field Action
FDA
Z-2172-2011
Class II
FDA
Z-2573-2011
Class II
FDA
Z-2541-2011 to Z-2550-2011
Class II
92336893
2240 6150
2195 9348
N.A.
2737 5504
N.A.
N.A.
1. GE Medical Systems
Hong Kong Ltd.
2. Synergy Medical
Supply Co., Ltd.
Vastec Medical Limited
Werfen Hong Kong Ltd
Beckman Coulter HK
Varian Medical
Systems Pacific Inc.
Beckman Coulter Hong
Kong Ltd
Schmidt Bio Med Tech
(H.K.)
1. 2783 1838/
2100 6318
N.A.
N.A.
2. 2892 0033
2897 1912
2792 7773
2814 0481
2724 2836
2240 6150
2620 8329
2011/07/08
2011/07/08
2011/07/11
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/12
2011/07/13
2011/07/13
2011/07/13
2011/07/13
2011/07/13
Philips Medical Systems 1) Brightview XCT, 3/8" Philips Medical Systems
FDA
Z-2155-2011 to Z-2156-2011;
2) Brightview XCT, 3/4" Philips Medical Systems
StatSpin Statspin Express 4 Centrifuge Model Number: SSH4
FDA
Z-2169-2011
Smith & Nephew Endoscopy Tendon Stripper, slotted, 5.0 mm I.D. x 12”
Smith & Nephew
N.A.
working length
Smith & Nephew - 128047 ‐ GUIDE PIN TROCAR POINT 1.3MM X 140MM
- 71161012 ‐ PERI‐LOC K‐WIRE 1.25MM X 150MM LENGTH TROCAR
POINT
- 128039 ‐ GUIDE PIN BAYONET POINT 1.3MM X 140MM
- 71161016 ‐ PERI‐LOC K‐WIRE 1.6MM X 150MM LENGTH TROCAR POINT
- 71101413 ‐ 1.1MM DRILL TIP WIRE 150MM
- 71161020 ‐ PERI‐LOC K‐WIRE 2.0MM X 150MM LENGTH TROCAR POINT
- 71101521 ‐ 0.9MM TROCAR TIP WIRE 150MM
- 71173502 ‐ 2.7MM SHORT DRILL BIT W/QUICK CONNECT
MHRA
2011/007/001/601/004
- 71123200 ‐ 2.4MM X 152MM INTERMEDIATE GUIDE PIN STERILE
- 71175701 ‐ 3.2MM X 358MM DRILL TIP GUIDE PIN
- 71134064 ‐ INTERMEDIATE TWIST DRILL ‐ 2.7MM ‐ STERILE
- 71176025 ‐ 2.5 DRILL BIT QUICK COUPLING 110/85MM {} GOLD STER
- 71161010 ‐ K‐WIRE 1.0MM X 150MM LENGTH TROCAR POINT
- 71176032 ‐ 3.2MM DRILL BIT QUICK COUPLING 145/120MM STERILE
- 71173801 ‐ 2.0MM DRILL 130MM
- 71176045 ‐ 4.5MM DRILL BIT QUICK COUPLING 145/120MM STERILE
- 71173803 ‐ 2.7MM DRILL 130MM
Spacelabs Healthcare EVO Holter recorder with Holter Analyzer software
MHRA
2011/007/001/291/004
Sentinel V7.1.x and Pathfinder V9.019
Trumpf Medical Systems Ltd. Trumpf klinoPORT and incarePORT
MHRA
2010/008/012/081/017
Applied Medical Europe BV Direct Drive Grasper (model number C4130 and
MHRA
2011/007/001/081/001
C4140 various lots)
Chiltern Invadex Ltd Wispa Portable Hoist and Attachment Handle (Part
MHRA
2011/007/005/601/002
Numbers: OHWPUK, OHWPEU, OHWPUS and OHWPL01)
Farla Medical Ltd Cord Clamp Batch Number 81010
MHRA
2011/006/022/401/002
Haag-Streit AG Instrument Table IT01 for Perimeter Octopus 300 and
MHRA
2011/005/013/291/004
Instrument Table IT02 for Perimeter Octopus 900
Intuitive Surgical Inc Intuitive Surgical® da Vinci Si Surgical System (IS3000)
MHRA
2011/007/004/081/007
Medtronic Ltd MEDTRONIC SELF-TAPPING SCREW MODULE, Ref. 176-513,
MHRA
2011/007/005/081/005
used with the ATLANTIS® Anterior Cervical Plate System,
Medtronic Ltd CD HORIZON® LEGACY™ Multi-Axial Screw and VERTEX®
MHRA
2011/007/007/081/013
Cortical Screw
Zimmer Zimmer Contoured Small Blade (Model no. 00-7804-001-06, Lot no.
Health Canada
64817
61494028, 61669212)
Beckman Coulter A) PK7300 Automated Microplate System - Instrument Class
3 and
B) Beckman Coulter PK7300 Automated Microplate System (Donor Screening) Health Canada
64395
- Instrument (Model no. PK7300)
Nobel Biocare Impression Coping Open Tray CC NP 5 x 14mm (Model no.
36261, Lot no. 742552)
ConMed Linvatec Xenon Universal Light Source (Model no. LS7700)
Cook Cook Sydney IVF Hyaluronidase Kits (Model no. K-SIHY-1-5 , Lot no.
A877629, A877483)
Class II
Class II
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
Vastec Medical Ltd.
2821 5480
2897 1912
Smith & Nephew Ltd.
2648 7700
FSN
Smith & Nephew Ltd.
2648 7700
FSN
N.A.
N.A.
FSN
N.A.
N.A.
FSN
N.A.
N.A.
FSN
N.A.
N.A.
FSN
N.A.
N.A.
FSN
The VITA CO. Ltd.
2548 7483
FSN
Chindex
Medtronic International
Ltd.
Medtronic International
Ltd.
Zimmer PTE Ltd.
(Hong Kong branch)
FSN
FSN
Type III
N.A.
2919 1362
2919 1362
2992 0968
Type III
Beckman Coulter Hong
Kong Ltd
2240 6150
Health Canada
64562
Type III
Nobel Biocare Asia Ltd
2845 1266
Health Canada
63916
Type III
N.A.
N.A.
Health Canada
64304
Type III
Cook Asia Ltd.
3472 1640
2011/07/13
Siemens AG Coherence Therapist (Model no. 8147667, Lot no. 10013, 10018,
071206-WI, P011206_R1, 11060)
Beckman Coulter Access Testosterone Reagent Pack and Calibrator (Model
no. 33560, 33565)
Dentsply Endodontics Dentsply ProTaper Universal Gutta Percha (Lot no.
110381)
Stryker Endoscopy Instruction for use for 45cm Laparoscopic Instruments
Sterilization Trays (Model no. 0250-015-704)
Vitalaire Canada Inc. EZ-OX Plus Oxygen Regulator
2011/07/13
AGFA Healthcare N.V. Impax for Cardiology - Clinical Review Station
Health Canada
64646
Type II
2011/07/13
AGFA Healthcare N.V. Impax Cardiovascular (CV) Admin Tool
Health Canada
64647
Type II
2011/07/13
AGFA Healthcare N.V. Impax for Cardiology
Health Canada
64648
Type II
2011/07/13
Siemens AG Axiom Artistos MX
Health Canada
64399
Type II
2011/07/13
Siemens AG A) Artiste MV - Linear Accelerator - Syngo RT Therapist Assisit
B) Artiste MV - Linear Accelerator - Syngo RT Therapist
Health Canada
64565
Type II
2011/07/13
Beckman Coulter, Inc. Leukosure Enumeration Kit
Health Canada
64567
Type II
2011/07/13
Philips Medical Systems Brightview Gamma Camera System with 3/8" Crystal
Health Canada
64897
Type II
Health Canada
64949
Type II
N.A.
N.A.
Health Canada
64659
Type II
Vastec Medical Limited
28971912
Health Canada
64677
Type II
N.A.
N.A.
Health Canada
64424
Type II
Health Canada
64816
Type II
Health Canada
Health Canada
Health Canada
63192
64640
63830
Type II
Type II
Type II
FDA
Z-2702-2011
Class II
N.A.
Zimmer PTE Ltd.
(Hong Kong branch)
N.A.
N.A.
N.A.
Varian Medical
Systems Pacific Inc.
FDA
Z-2706-2011
Class II
N.A.
N.A.
FDA
Z-2720-2011 to Z-2721-2011
Class II
N.A.
N.A.
2011/07/13
2011/07/13
2011/07/13
2011/07/13
2011/07/13
2011/07/13
2011/07/13
Davol, Inc., Subsidiary of C.R. Bard Inc. A) Avitene Microfibrillar Collagen, Web
B) EndoAvitene Microfibrillar Collagen
C) Syrine Avitene Microfibrillar Collagen
D) Avitene UltraFoam
E) Avitene Microfibrillar Collagen Flour
Instrumentation Lab (UK) Ltd Gem Premier 4000 (lot 0605100 to 11064853)
Vascular Solutions, Inc. Langston Dual Lumen Pigtail Catheter Model 5515 (lot
548264)
W&H Dentalwerk Burmoos GMBH Vinci 600 System - Reciprocating Saw
Zimmer Inc. Versys Advocate Hip System, Femoral Stem and Versys
Advocate Hip System, Femoral Stem, Extended Offset
B&B Medical Technologies StabilTube, E.T. Tape and E.T. Tape II
Invivo Corporation Expression MRI Patient Montoring System-Main Unit
Hologic, Inc. Biopsy Site Identification Markers and Hologic Breast Biopsy Kit
2011/07/14
Varian Eclipse Radiation Treatment Planning System, model H48
2011/07/13
2011/07/13
2011/07/13
2011/07/13
2011/07/13
2011/07/14
2011/07/14
Staar Surgical Co. STAAR Surgical Collamer Ultraviolet-Absorbing Posterior
Chamber Single Piece, also known as the nanoFLEX IOL (Model no.
CC4204BF and CC4204A)
Cincinnati Sub-Zero 1) ECMO Heater Model 333, Cardiopulmonary bypass
temperature controller. Part Number: 86130, Serial number: 864-E1180
through 924-E2528;
2) ECMO Heater Model: 333W, Cardiopulmonary bypass temperature
controllers. Part Number: 86135 (115V), 86136 (230V) and 86138 (240V),
Serial Number: 942-E2979 through 031-E5150
Health Canada
63462
Type III
Health Canada
64584
Type III
Health Canada
64898
Type III
Siemens Healthcare
Diagnostic Limited
Beckman Coulter Hong
Kong Ltd
N.A.
Health Canada
64651
Type II
Stryker China Ltd
2518 6915
Health Canada
64020
Type II
N.A.
AGFA Hong Kong
Limited
AGFA Hong Kong
Limited
AGFA Hong Kong
Limited
Siemens Healthcare
Diagnostic Limited
Siemens Healthcare
Diagnostic Limited
Beckman Coulter Hong
Kong Ltd
Philips Electronic Hong
Kong Ltd
N.A.
2870 7533
2240 6150
N.A.
2555 9421
2555 9421
2555 9421
2870 7533
2870 7533
2240 6150
2821 5480
N.A.
2992 0968
N.A.
N.A.
N.A.
2722 8123
2011/07/14
Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse (POP)
FDA
N.A.
MedWatch/Pres
s
N.A.
N.A.
2011/07/14
Covidien URI-DRAIN Medium Male External Catheter and URI-DRAIN Male
Urinary Control Device
FDA
Z-2392-2011; Z-2393-2011; Z2394-2011
Class II
Tyco Healthcare
(HKSAR) Ltd
3157 7220
2011/07/14
2011/07/14
2011/07/19
2011/07/19
2011/07/20
2011/07/20
2011/07/20
2011/07/20
2011/07/20
2011/07/20
2011/07/20
Computerized Medical Systems Inc. Monaco Radiation Treatment Planning
Workstation. Monaco Release 2.03.00 and above.
Arcadia Medical Corp. Silicone CTS (Close to Shaft) Cuff Adjustable Neck
Flange Tracheostomy Tube (Wire Reinforced)
Abbott Medical Optics Inc Abbott Medical Optics (AMO) STAR S4 IR Excimer
Laser System Software Versions 5.00 - 5.30 and 5.00 - 5.22
TomoTherapy Inc. Tomotherpy Treatment Systems, Hi·Art versions 4.0.x, and
HD versions 1.0.x
Aspen Ophthalmic Simcoe Cannula
Conmed 24k100, 24k® Arthroscopy Outflow/Suction Tubing Set
GE Healthcare (Image Diagnost International) MammoWorkstation versions
v.4.5.0, v.4.5.2, v.4.5.3 and v.4.6.0 with IDI Reporting module installed
Global Focus Marketing & Distribution, Ltd. The Silencer® S2200 Centrifuge
Siemens Healthcare AXIOM Artis U (Material no. 7008530 and material
number 10094012, serial numbers are 11XXX, 12XXX, 13XXX, 22XXX, 10XX,
20XXX and 21XXX)
Siemens Healthcare Diagnostics RAPIDQC® Complete™ controls, lot
numbers 362003, 363003, 361004, 362004, and/or 363004, for RAPIDPoint®
405 Systems, RAPIDLab® 800 Series Systems, RAPIDLab® 1200 Systems
Boston Scientific Resolution® II Clip
FDA
Z-2561-2011
Class II
Elekta Ltd
2891 2208
N.A.
N.A.
AMO Asia Limited
2401 5750
FDA
Z-2657-2011
Class II
AMO Asia
Limited
TomoTherapy
Inc.
MHRA
MHRA
FSN 2011-08 & FSN 2011010
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
FSN
MHRA
2011/007/008/081/001
FSN
FDA
Transmedic China
Limited
N.A.
N.A.
GE Medical Systems
Hong Kong Ltd.
N.A.
N.A.
2783 1838/
2100 6318
N.A.
Firm Press
Release
N.A.
N.A.
MHRA
2011/007/004/081/006
FSN
Siemens Healthcare
Diagnostic Limited
2870 7533
MHRA
2011/006/013/601/00
FSN
Siemens Healthcare
Diagnostic Limited
2870 7533
Boston Scientific
90693806
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
FDA
Z-2795-2011
Class II
N.A.
N.A.
Varian Medical
Systems
CP-03556
Varian Medical
Systems Pacific Inc.
2722 8123
Baxter
BS 11-023/2011-076-BS
Baxter Healthcare Ltd
2807 8516
5203
2011/007/008/601/002
2011/007/012/081/021
2107 4668
2011/07/27
Vitrolife, Inc XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3
mmol/ml, 50 mL, REF 99019
Varian 4D Integrated Treatment Console v8.3 and v8.6 with ARIA RT Chart
v8.5
Baxter Coseal Surgical Sealant (Product Code 934074 Lot Number HA090947
Expiry Date 08/31/11)
Talley Group Ltd. Pressure Area Care Mattresses and Cushions
MHRA
2009/009/011/301/001
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
2011/07/27
Beckman Coulter, Inc. J6-MI High-Capacity Centrifuge
Health Canada
64583
Type III
2011/07/27
Ventana Medical Systems Inc. Amplification Kit
Health Canada
64991
Type III
Health Canada
65178
Type III
N.A.
N.A.
Health Canada
65406
Type III
N.A.
N.A.
2011/07/22
2011/07/25
2011/07/26
2011/07/27
2011/07/27
GE Medical Systems, LLC Discovery CT750 HD Computed Tomography XRay System
Coopersurgical Inc. A) Mystic II Pump with M-Style Mushroom Cap
B) Mystic II Pump with Mitysoft Bell Cup
N.A.
Beckman Coulter Hong
Kong Ltd
Roche Diagnostics
(Hong Kong) Ltd
Beckman Coulter Hong
Kong Ltd
N.A.
N.A.
N.A.
2240 6150
2485 7510
2011/07/27
Beckman Coulter, Inc. Synchron LX Systems APO-B Reagent
Health Canada
63541
Type III
2011/07/27
2011/07/27
Stryker Medical XPRT Advanced Pulmonary Therapy Surface
Wallac OY Delfia Xpress 6000 Immunoanlyzer System - Free HCGB Assay
Beckman Coulter, Inc. A) Synchron LX20 System Analyzer - Class 2
B) Synchron LX20 System Analyzer - Class 3
C) Synchron LXI 725
D) Synchron LX20 PRO
Medrad Inc. Medrad Veris Temperature Sensor Probe
Medrad Inc. A) Avanta Fluid Management Injection System - Main Unit with
Pedestal
Karma Sparrow wheelchair
Philips Philips IntelliVue Clinical Information Portfolio Release D.03, E.00, and
E.01
Health Canada
Health Canada
64895
65168
Type III
Type III
Health Canada
63157
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
Health Canada
65096
Type II
N.A.
N.A.
Health Canada
65097
Type II
N.A.
N.A.
MHRA
MHRA
2011/005/018/301/001
2011/007/015/081/010
FSN
FSN
N.A.
Philips Healthcare
N.A.
2821 5480
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2240 6150
N.A.
N.A.
2011/07/27
2011/07/27
2011/07/27
2011/07/27
Prism Medical UK Waverley Glen Transactive (TA) Hoists and Waverley Glen
Transportable (TP) supplied
between June 2000 and August 2003
Varian Medical Systems Aria Practice Management - 4D Integrated Treatment
Console (4DITC) V8.1.2, V8.6, V8.8
Varian Medical Systems A) On Board Imager (Model no. OBI)
B) TrueBeam (Radiotherapy Configuration) (Model no. TRUEBEAM, Serial no.
H191038, H191071, H191044, H191069)
Varian Medical Systems A) Clinac IX High Energy Linear Accelerator (Serial
no. H294383, H294766, H294675, H294683, H294838, H294317, H294364)
B) Trilogy High Energy Linear Accelerator (Serial no. H294551, H140836)
C) Novalis TX High Energy Linear Accelerator (Serial no. H294674)
2011/07/27
2011/07/27
Generic Medical Devices Universal Urinary Incontinence Sling (Model no.
1010)
Stryker Medical Impression Matress Cover (Fire Barrier Option)
GE Medical Systems SCS A) Seno Advantage 2.1 Volumeshare 2/4
B) Seno Advantage 2.2 Volumeshare 2/4
Wallac OY LifeCycle for Prenatal Screening
Uplift Technologies Inc. Uplift Commode Assist
Baxter Healthcare SA Aqarius Software V. 4.01.11/4.01.12
Abbott Laboratories ARCHITECT C-Peptide Reagent Lot No: 03610K000,
00110L000, 01711A000, 01411B000, 00611E000
Biomet UK Ltd RHK Distal Femoral IM Rod Guide, item code 32-421208-03
Dynex Technologies Inc. DSX/Best 2000 Pipette Tubing
GE Healthcare Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW
integration
GE Healthcare CARESCAPETM Monitor B850
IMMUCOR GAMMA Panocell® -16, Cat. No.0002332 Lot: 24019
2011/07/27
Coloplast (Hong Kong) Ltd Alterna ® Sterile Post-Operative ostomy bag
2011/07/28
Prism Medical UK Transactive and Transportable overhead hoists
Dental Equipment, LLC LuxStar Dental Light have the following Agency model
or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000,
TL1000, and UL1000. The product is labeled in part: "Marus Dental"
Triad Triad Sterile Lubricating Jelly 3g sachet (Catalogue No. LG1002)
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/27
2011/07/28
2011/07/29
MHRA
2011/006/028/301/001
FSN
N.A.
N.A.
Health Canada
65197
Type II
Varian Medical
Systems Pacific Inc.
2722 8123
Health Canada
65263
Type II
Varian Medical
Systems Pacific Inc.
2722 8123
Health Canada
65449
Type II
Varian Medical
Systems Pacific Inc.
2722 8123
Health Canada
Health Canada
62622
64147
Type II
Type II
N.A.
N.A.
N.A.
N.A.
Health Canada
64537
Type II
N.A.
N.A.
Health Canada
Health Canada
Health Canada
64569
65162
65217
Type II
Type II
Type II
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
MHRA
2011/007/015/601/003
FSN
N.A.
N.A.
MHRA
MHRA
2011/007/008/401/001
2011/006/027/081/016
FSN
FSN
N.A.
N.A.
N.A.
N.A.
MHRA
2011/007/014/081/009
FSN
N.A.
N.A.
MHRA
MHRA
Coloplast (Hong
Kong) Ltd
MHRA
2011/007/015/081/013
2011/007/020/081/007
N.A.
N.A.
Coloplast (Hong Kong)
Ltd
N.A.
N.A.
N.A.
MDA/2011/085
FSN
FSN
Firm Initiated
Field Action
MDA
FDA
Z-2834-2011
Class II
N.A.
N.A.
TGA
N.A.
Class II
N.A.
N.A.
DKMIF-20110719-1000
3628 7428
N.A.
Major Safety Alerts in June 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
2011/06/02
Instrumentation Laboratory Co. GEM® Premier 4000
2011/06/02
DePuy Mitek 1) DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD
Product Code: 210811
2) DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD Product Code:
210812
3) DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code:
210813
2011/06/02
Verity Medical Ltd. NeurotracTM MyoPlus2
2011/06/03
2011/06/03
2011/06/03
2011/06/03
2011/06/03
St Jude Medical Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788)
Implantable Pulse Generators for Neurostimulation
Tobii Technology AB Tobii C-Series batteries of type TB8A, TB8B and TB12A
(Batteries that shipped between August 1, 2009 and October 2010.)
Alcon Laboratories Ltd. WaveLight® FS200 Femtosecond laser
Baxter Healthcare NIKKISO Blood Tubing Lines for Haemodialysis and
BAXTER Procedure Packs using impacted NIKKISO Blood Tubing Lines for
Beckman Coulter 37305 Access Ostase Calibrators and 37309 Access Ostase
QC
Source of
Information*
Reference No. by Source
Alert Type by
Source
N.A.
Firm Initiated
Field Action
Vastec Medical Limited
28971912
FDA
Z-2208-2011 to Z-2211-2011
Class II
Johnson & Johnson
(Hong Kong) Ltd.
2738 6027
Verity Medical
Ltd.
QF18b-01/11 dated 24-5-2011
Firm Initiated
Field Action
Healthcare & Co
2810-4868
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
MHRA
2011/005/024/081/002
FSN
MHRA
2011/005/013/291/003
FSN
N.A.
N.A.
MHRA
2011/004/019/291/001
FSN
Alcon Hong Kong, Ltd.
2568 0636
MHRA
2011/005/023/081/008
FSN
Baxter Healthcare Ltd
2807 8516
MHRA
2011/005/019/601/002
FSN
Covidien Legendair
MHRA
2011/005/012/291/007
FSN
2011/06/03
GlaxoSmithKline Sensodyne Repair & Protect Toothpaste 75ml
MHRA
2011/005/011/081/004
FSN
2011/06/03
Invitrogen SECORE B Locus Sequencing Kit 2 AMP
MHRA
2011/005/023/081/006
FSN
2011/06/03
Leica Biosystems Bond™ Oracle™ HER2 IHC System
MHRA
2011/005/022/601/001
FSN
2011/06/03
Medicina Enteral Three‐Way Tap/Enteral Stopcock
MHRA
2011/005/017/401/015
FSN
2011/06/03
Siemens Digital Accquisition System, Ysio (Ysio F and Ysio S)
MHRA
2011/005/019/291/006
FSN
2011/06/03
Smith & Nephew HIPSTRUMENTS Hip Arthroscopy Repair Instrument Tray
MHRA
2011/005/025/081/004
2011/06/03
BD Jouan centrifuge model C4i
BD
N.A.
2011/06/07
2011/06/07
Biomet Orthopedics Comprehensive Reverse Shoulder Humeral Trays
Cameron Health SQ-RX® Pulse Generator, Model Number 1010
Unomedical (A ConvaTec Company) 1) HandyVacTM Low Vacuum Surgical
Wound Drainage Systems CH (Fr.) 14
2) Drain spiral CH14/green x-ray
3) Drain CH14 soft/steel trocar
4) Passive drainage set/1drn CH14
5) Female Connector CH14
MHRA
MHRA
2011/005/016/601/002
2011/004/011/081/017
FSN
Firm Initiated
Field Action
FSN
FSN
MHRA
2011/005/004/291/010
GE Healthcare Power supply for TruSat Pulse Oximeter
MHRA
MDA/2011/061
2011/06/07
Agent Contact
Telephone No.
Vastec Medical
Limited
2011/06/03
2011/06/07
Local Agent
Beckman Coulter Hong
Kong Ltd
Tyco Healthcare
(HKSAR) Ltd
GlaxoSmithKline
Limited
Invitrogen Hong Kong
Limited
Leica Microsystems
Limited
N.A.
Siemens Healthcare
Diagnostic Limited
Smith & Nephew Ltd.
2240 6150
3157 7220
3189 8904
N.A.
2564 6699
N.A.
2870 7533
2648 7700
BD
2575 8668
N.A.
N.A.
N.A.
N.A.
FSN
N.A.
N.A.
MDA
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
2011/06/07
Varian ARIA, RT Chart Application v8.0 through 8.9 used with 4DITC v 7.x to
10.x
2011/06/07
Tcoag Tcoag Minutex D-Dimer
2011/06/07
2011/06/07
2011/06/07
2011/06/10
2011/06/10
2011/06/10
Smith & Nephew Drill Tip Wire 1.8mm x 400mm and Drill Tip Wire with
Stopper 1.8mm x 400mm, (Product Code: 71070372 and 71070373, all Lots
prior to and including 11AM08925)
Terumo Cardiovascular Systems Terumo® Coronary Ostia Cannula (Product
Code: 804115, 804117 and 804159)
Vygon Dressing Change Kit, Central Line Dressing Kit, PICC Insertion Tray,
Dressing Change Kit and Dressing Change Kit
Abbott Laboratories 1) CELL-DYN Shear Valve Assembly used on CELL-DYN
3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb);
2) CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer
and CELL-DYN 3700SL Analyzer (refurb);
3) CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer
and CELL-DYN 3500SL Analyzer (refurb);
4) CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer
and CELL-DYN 3200CS Analyzer (refurb);
5) CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer
and CELL-DYN 3200SL Analyzer (refurb);
6) CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. List
Number 08H67-01. Recall # Z-2019-2011;
7) CELL-DYN Sheer Valve Assembly Driver. a) List Number 8921204902
Siemens Medical Solutions ACUSON S2000 ultrasound system
Medela AC Power Adaptor (transformer), TENPAO Model U090100Q31; used
with the Pump In Style Advanced family of breast pumps
2011/06/13
BrainLAB Cranial /ENT Navigation Software
2011/06/13
BD Venflon Pro Safety 18GA, 1.3 x 45mm catheter
2011/06/14
2011/06/14
2011/06/14
Sigma International Sigma Spectrum Infusion Pumps (Model no. 35700)
Gambro Dasco S.P.A Gambro Accessory S-660-C (Hemodialysis Y
Connector) (Model no. 101354-6431233, Lot. No. 1035, 1036, 1037 )
Philips Medical Systems A) BV Pulsera Mobile C-Arm System-9 inch. and 12
inch versions (Model no. 718095);
B) BV Endura Mobile C-Arm System (Model no. 718074)
Varian Medical
Systems
Vastec Medical
Limited
CP-02644
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2722 8123
Vastec Medical Limited
2897 1912
MHRA
2011/006/001/601/004
FSN
Smith & Nephew Ltd.
2648 7700
MHRA
2011/006/001/081/011
FSN
Terumo China (H.K.)
Ltd.
28660811 ext
130
FDA
N.A.
Class I
N.A.
N.A.
FDA
Z-2014-2011 - Z-2020-2011
Class II
Abbott Laboratories Ltd.
2593 2211
FDA
Z-2051-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
FDA
Z-2386-2011
Class II
Celki Medical Company
2332 3366
BrainLAB Ltd
2417 1881
BrainLAB
N.A.
BD
FA-11-045-104
Firm Initiated
Field Action
Firm Initiated
Field Action
BD
2575 8668
2807 8516
Health Canada
63259
Type I
Baxter Healthcare Ltd.
(Hong Kong)
Health Canada
63171
Type II
Gambro Lundia AB
2839 9710
Health Canada
63279
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2011/06/14
Terumo Cardiovascular System Terumo CDI 101 (Serial no. 1000 to 5556)
Health Canada
63652
Type II
Terumo China (H.K.)
Ltd.
28660811 ext
130
2011/06/14
Biomerieux, Inc. IdentiCult Albicans Test Kit (Model no. 302338, Lot. No.
513391-1, 516815-1, 518661-1, 520320-1, 522999-1, 524231-1, 525260-1)
Health Canada
63731
Type II
bioMerieux China Ltd.
2195 9348
2011/06/14
Philips Medical Systems PAS-210 Remote Active Speakers Kit
Health Canada
63448
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2011/06/14
St. Jude Medical A) 1500T14 Cardiac Ablation System-Generator (Model no.
IBI-89017 (89017) (1500T1) ), B) 1500T14 Cardiac Ablation System-Remote
Control (Model no. IBI-89018 (89018))
Health Canada
63649
Type II
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
2011/06/14
Leica Biosystems Leica Peloris Rapid Tissue Processor (Model no. 26.0005)
Health Canada
63137
Type II
2011/06/14
Capsule Technologie Capsule Neuron UMPC (Model no. DC-NU-UMPC)
Health Canada
63995
Type II
Leica Microsystems
Limited
N.A.
2564 6699
N.A.
2011/06/14
LifeScan Europe OneTouch Delica Lancing Device (Model no. 012-839)
Health Canada
64104
Type II
2011/06/14
Siemens Healthcare Diagnostics Immulite 2500 CMV IGG (Model no. 2010101)
Health Canada
63220
Type III
Health Canada
63847
Type III
Health Canada
Health Canada
63843
63909
Type III
Type III
Health Canada
63928
Type III
Health Canada
Health Canada
Health Canada
MHRA
MHRA
63930
63022
63933
2011/006/003/291/015
2011/005/012/401/029
Type III
Type II
Type II
FSN
FSN
MHRA
2011/006/006/081/010
FSN
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
Ventana Medical Systems Inc. Symphony Automated Staining System
Pentron Clinical Technologies Cement-It Dental Cement (Model no. N33,
N33A)
Molnlycke Health Care AB Normlgel (15 Gram) (Model no. 371500)
Roche Diagnostics GMBH A) Hitachi Creatinine Kinase-MB Liquid (CK-MB)
(Model no. 12132834216, 12132893216)
B) Hitachi Creatine Kinase Liquid, Acc. to IFCC (CK) (Model no. B)
04580591190, 04580613190, 12132524216, 12132672216)
C) CK (Creatine Kinase) for Cobas C701 Analyzer (Model no. C) 05168546190)
Clear Catheter Systems PleuraFlow Catheter System (Model no. PF-20, PF32)
Cardinal Health Custom Sterile Breast Packs (Model no. SBA30MAVWA)
Invotec International Inc. External Nasal Splint Kit (Model no. 20-10101)
BD BD FACS TM 7-Color Setup Beads
CODAN Limited 2ml luer lock syringe
GE Healthcare Discovery VCT, Discovery RX VCT, Discovery STE, Discovery
RX and Discovery ST systems with Dimension console.
Johnson & Johnson
Medical (HK)
Siemens Healthcare
Diagnostic Limited
Roche Diagnostics
(Hong Kong) Ltd
N.A.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
2738 6027
2870 7533
2485 7510
N.A.
N.A.
2485 7510
2011/06/14
GE Healthcare Vital Signs Broselow Pediatric Emergency System Kit
MHRA
2011/006/007/081/008
FSN
2011/06/14
GE Healthcare Homecare Ventilator Model Vivo 40
MHRA
2011/005/010/081/009
FSN
2011/06/14
HemoCue AB HemoCue® Glucose 201 Microcuvettes
MHRA
2011/006/002/081/012
FSN
2011/06/14
2011/06/14
2011/06/14
Invacare Ltd Nursing bed Invacare Scanbed 400
Joerns Healthcare Ltd OXFORD Easytrack 2, 3 & 4 Post Systems
Keeler Ltd Cryomatic Probes
Pelican Healthcare Pelispec Vaginal Speculum including Smoke Extractor and
those in the Light Source Packs and IUD Procedure Packs
Roma Medical Wheeled walking frames. Models 2320, 2340, 2462 and 2463
Schiller AG SCHILLER ARGUS PRO LifeCare II
MHRA
MHRA
MHRA
2011/005/023/301/001
2009/010/028/261/001
2011/005/004/601/001
FSN
FSN
FSN
N.A.
N.A.
N.A.
BD
N.A.
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
Science International
Corp.
Direct Health Ltd.
Anchor Medical Ltd
N.A.
MHRA
2011/006/002/291/003
FSN
N.A.
N.A.
MHRA
MHRA
2010/007/023/401/007
2011/006/001/081/010
FSN
FSN
N.A.
2764 5208
MHRA
2011/006/006/081/005
FSN
N.A.
Ultronics Enterprises
Ltd.
SCHMIDT BioMedTech
Asia Ltd.
MHRA
MHRA
MHRA
MHRA
2010/010/005/301/002
2011/005/023/301/002
2011/003/022/301/002
2010/006/016/401/008
FSN
FSN
FSN
FSN
N.A.
25281109
N.A.
N.A.
Health Canada
63846
Type III
Health Canada
63856
Type III
Health Canada
63866
Type III
Health Canada
Uninet
Technology Ltd.
MHRA
63868
Type III
Firm Initiated
Field Action
FSN
N.A.
Direct Health Ltd.
N.A.
Umedco (Far East) Ltd.
Citicon (Hong Kong)
Ltd., D & R Dental
N.A.
Citicon (Hong Kong)
Ltd., D & R Dental
N.A.
Uninet Technology Ltd.
Cyberonics- Asia
Pacific
2838 8423
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/14
2011/06/20
2011/06/21
Spacelabs Healthcare Inc. WA Spacelabs Medical Capnography Module,
Model 91517
Swift Tech Solus 190 Mobile Patient Hoists
Invacare Ltd Jasmine Mobile Lifter
The Helping Hand Company Acheeva Learning Station
Welch Allyn Welch Allyn Viewsonic Large Display
Sybronendo/Ormco Corporation RealSeal .04 Taper Points (Model no. 9722420)
Kerr Corporation, also trading as Pentron Clinical Correct Plus Putty
Sybronendo/Ormco Corporation Short Adhesive Removing Replacement
Carbide Tip
Pentron Clinical Technologies, LLC Bond-1 SF
Immucor Inc. Gamma-clone® Anti-Leb(Murine Monoclonal) Blood Grouping
Reagent (Lot.no. 992006 )
Cyberonics VNS Therapy Generators Models 103 and 104
N.A.
2011/005/017/081/001
N.A.
N.A.
N.A.
2575 8668
N.A.
2783 1838/
2100 6318
2783 1838/
2100 6318
2783 1838/
2100 6318
2543 7442
25281109
2735-8323
N.A.
2620 8329
N.A.
N.A.
N.A.
N.A.
2268 6882
2011/06/21
Roche ACCU-CHEK Performa Strip, Lot #470049
2011/06/21
2011/06/21
2011/06/21
2011/06/21
2011/06/21
2011/06/21
PH Medisavers Caretex Urinals (PHURI046) (Lot no. 1011294)
Schulke and Mayr GmbH Thermosept AF/ED, Thermosept ER
Waters Corporations Waters Ethernet-SATellite Interface (e-SAT/IN) module
Beckman Coulter UK Ltd [email protected] Immunochemistry Systems, Rheumatoid
Factor (RF)
Luminex Molecular Diagnostics, Inc xTAG CYP2D6 Kit v3, Lot No IKO3OB-1
001
Nikkiso Europe GmbH NIKKISO Blood Tubing Lines for Hemodialysis
Nottingham Rehab Supplies NRS and/or Moving Solutions Slings
2011/06/21
Stryker Howmedica Osteonics Corp. Accolade TMZF Plus Hip Stem
2011/06/21
Weinmann Medical Technology Emergency AED device MEDUCORE Easy
Alere San Diego, Inc (Biosite Inc Dba Innovacon Inc.) Cholestech LDX Lipid
Profile GLU test cassettes (Lot number: 245104)
Alere San Diego, Inc (Biosite Inc Dba Innovacon Inc.
) Cholestech LDX Lipid Profile GLU test cassettes (Lot number: 245104)
Computerized Medical Systems Inc. Monaco Radiation Treatment Planning
System, Monaco Release 1.0.0 through 1.0.2.
Computerized Medical Systems Inc. XiO Radiation Treatment Planning
System, XiO Release 4.3.1 through 4.40.00.
Philips Healthcare Inc. 1. Philips SureSigns VM Series Patient Monitors. 2.
Philips SureSigns VS3 Vital Signs Monitor Models
2011/06/21
2011/06/23
2011/06/23
2011/06/23
2011/06/23
2011/06/23
2011/06/23
BD 1.0ml 28G x ½” blister packaged insulin syringe
2011/06/23
Stryker 4.0MM 12 Degree Angled Aggressive Cutter blade
2011/06/27
Pentron Clinical 37% Phosphoric Acid Etching Gel
2011/06/28
LifeScan Inc. OneTouch Ultra Test Strips (Batch 3055301 and 3087330)
2011/06/28
2011/06/28
2011/06/28
2011/06/28
2011/06/28
GE Healthcare Centricity Laboratory-Core Lab (Model no. CORE)
Baxter Healthcare Baxter COLLEAGUE Volumetric Infusion Pump (Model no.
2M8161)
Philips Medical Systems A) Bucky Diagnost (Model no. 9890 010 83821)
B) Trauma Diagnost
Toshiba Medical Systems Aquilion One System - Main Unit (Model no. TSX301A/2)
Elekta A) Elekta Precise Treatment System (Model no. MRT 6001, MRT 6011)
B) Elekta Synergy Platform (Model no. XRT 0401, XRT 0411)
C) Elekta Infinity (Model no. C) XRT 1501, XRT 1511)
FDA
N.A.
Class I
MHRA
MHRA
MHRA
2011/002/017/401/009
2011/006/013/291/017
2011/006/014/291/018
FSN
FSN
FSN
MHRA
2011/006/006/601/001
FSN
MHRA
MHRA
MHRA
Stryker China
Ltd
MHRA
2011/006/013/291/010
2011/006/002/081/010
2011/001/027/401/011
2011/004/026/081/009
FSN
FSN
FSN
Firm Initiated
Field Action
FSN
FDA
Z-2402-2011
FDA
N.A.
2485 7510
N.A.
N.A.
N.A.
2240 6150
N.A.
N.A.
N.A.
Stryker China Ltd
2518 6915
N.A.
N.A.
Class II
N.A.
N.A.
Z-2402-2011
Class II
N.A.
N.A.
FDA
Z-2560-2011
Class II
N.A.
N.A.
FDA
Z-2567-2011
Class II
N.A.
N.A.
FDA
Z-2583-2011 / Z-2584-2011
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
BD
2575 8668
Stryker China Limited
2518 6915
Firm Initiated
Field Action
Firm Initiated
Field Action
BD
N.A.
Stryker China
Ltd
N.A.
Pentron Clinical
N.A.
Firm Initiated
Field Action
MHRA
2011/006/016/081/019
FSN
Health Canada
63451
Type II
Health Canada
64128
Type II
Citicon (Hong Kong)
Limited / Chong Ning
Instruments Co. LTD.
Johnson & Johnson
Medical (HK)
GE Medical Systems
Hong Kong Ltd.
Baxter Healthcare Ltd
Philips Electronic Hong
Kong Ltd
Sanko Medical
Systems (HK) LTD
Health Canada
64032
Type II
Health Canada
64173
Type II
Health Canada
64096
Type II
Elekta Ltd
N.A.
Medtronic International
Ltd.
Terumo China (H.K.)
Ltd.
Stryker China Ltd
Siemens Healthcare
Diagnostic Limited
2011/06/28
Ceodeux M706 (The standard medical integrated valve series M706)
Health Canada
64095
Type II
2011/06/28
Medtronic Sample Tape Kit (Model no. MMT-643)
Health Canada
62956
Type II
2011/06/28
Terumo Corportation Terumo® Runthrough™ NS Tapered
MHRA
2011/006/015/081/010
FSN
2011/06/28
Stryker Spine Bordeaux Mantis Rod Inserter (Inner Shaft + Assembly)
Siemens Healthcare Diagnostics Ltd. MicroScan® Dried Gram Negative
Panels (B1017-409, B1017-404 and B1017-417)
MHRA
2011/006/014/081/019
FSN
MHRA
2011/006/020/601/002
FSN
2011/06/28
Roche Diagnostics
(Hong Kong) Ltd
N.A.
N.A.
N.A.
Beckman Coulter Hong
Kong Ltd
N.A.
N.A.
N.A.
2127 4683 /
2797 8933
2738 6027
2783 1838/
2100 6318
2807 8516
2821 5480
23840688
2891 2208
N.A.
2919 1362
28660811 ext
130
2518 6915
2870 7533
2011/06/28
2011/06/28
2011/06/28
2011/06/28
2011/06/28
Baxter Healthcare Corportation Epidural Solution Administration Set
(GR293209)
Toshiba Medical Systems Corporation Aquilion 64 System (HCB1023750,
HCB1083820, HCB1083821, HCB10X3839)
Diasorin Inc. LIASON 25 OH Vitamin D TOTAL Assay
Bionet Co., Ltd. Patient monitor BM3 (order number: 720-10500)
Cory Bros & Purple Surgical 5cm/33cm Monopolar Lap Electrode L Hook
1. Cory Bros – CB3881 (LOTS 0411108 & 0511087)
2. Purple Surgical – PS3881 (LOTS 0411109 & 0511088)
Health Canada
64503
Type II
2807 8516
Type II
FSN
Baxter Healthcare Ltd
Sanko Medical
Systems (HK) LTD
N.A.
N.A.
Health Canada
64174
Type II
Health Canada
MHRA
64628
2011/005/003/291/010
N.A.
N.A.
MHRA
2011/006/016/601/008
FSN
2011/004/018/291/004
FSN
2011/06/28
DePuy International Ltd Broaches within the Corail Revision Hip System
MHRA
2011/06/28
GE Healthcare GE Centricity™ Laboratory Data Innovations (DI) Instrument
Manager used with PSM.
MHRA
2011/06/28
GE Healthcare Optima MR360 and Brivo MR355 System cabinet.
MHRA
2011/006/022/291/004
FSN
2011/06/28
GE Healthcare Infusable* and InfusaScan* Pressure Infusors
MHRA
2011/005/004/291/011
FSN
2011/06/28
Quest Medical, Inc A) MPS Myocardial Protection System Console
B) MPS2 Console
Health Canada
64204
Type III
2011/005/009/081/009
FSN
2011/06/28
Roche Diagnostics GMBH Anti-HAV Kit
Health Canada
64018
Type III
2011/06/28
Steris Canda Corporation Reliance Vision SC Washer/Disinfector
Philips Children's Medical Ventures 1. Oral / Enteral Syringe 2. Sample Pack
Oral / Enteral Syringe
RaySearch Laboratories AB SharePlan 1.1
GE Healthcare BrightSpeed Excel Select, BrightSpeed Edge Select
,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray
systems with software version 09BW35.11 or 09HW30.4
Varian Eclipse Treatment Planning System with Client software versions 8.0
through 8.6 (Model Number: H48)
Computerized Medical Systems Inc. Monaco Radiation Treatment Planning
System, Monaco Release 2.0.1 and above
Health Canada
63896
Type III
Health Canada
64039
Type III
Health Canada
64415
Type III
2011/06/28
2011/06/28
2011/06/30
2011/06/30
2011/06/30
2011/06/30
Varian Medical Systems Optical Guidance Platform, version 2.6 and 2.6.1
23840688
N.A.
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
2783 1838/
2100 6318
2783 1838/
2100 6318
N.A.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
Swedish Trading Co.
Ltd.
Philips Electronic Hong
Kong Ltd
N.A.
2738 6027
2485 7510
6199 0634
2821 5480
N.A.
FDA
Z-2214-2011
Class II
GE Medical Systems
Hong Kong Ltd.
FDA
Z-2220-2011
Class II
Varian Medical
Systems Pacific Inc.
2722 8123
FDA
Z-2564-2011
Class II
Elekta Ltd
2891 2208
CP-04656
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
Varian Medical
Systems
2783 1838/
2100 6318
Major Safety Alerts in May 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
2011/05/03 Oridion A) Vitaline H Set Infant/Neonatal 25UN (Model no. 010807); B)
Filterline H Set Infant/Neonatal (Model no.: 006324)
2011/05/03 Conmed Adult R2 Non-Radiolucent Electrodes (Model no. 3200-1715, Lot.
1010194)
2011/05/03 Philips Medical Systems A) Diagnost 97 (Model no.: MII 3061, MRC 0651; B)
Diagnost 94 (Model no. B) 70850, 70851)
2011/05/03 Sybaritic Nanolight MP50
2011/05/03 Medtronic A) Bio-Console Drive Unit (550) (Model no. A) 95208); B) Autolog
Autotransfusion System (Model no. B) ATLG110; C) Bio-Console Drive Unit
(560) (Model no. C) 560); D) Magellan Autologous Platelet Separator (Model
no. D) MAG100)
2011/05/03 Immucor Capture-CMV Indicator Red Cells (Model no. 0062791, Lot no.
228143) Inc. Integrated Reusable Fibre Optic Blade
2011/05/03 BOMImed
2011/05/03 Zevex Inc. (Also trading as Moog Medical Devices Group) A) Non-DEHP
Microbore Administration Set
B) Microbore Administration Set
C) Epidural Administration Set
2011/05/03 Stryker Endoscopy IFU for Inflow/Outflow Cannula
2011/05/03 Carl Zeiss Meditec Inc. A) Cirrus HD-OCT B) Cirrus HD-OCT Model 400
2011/05/03
2011/05/03
2011/05/03
2011/05/03
2011/05/03
2011/05/03
2011/05/03
2011/05/03
2011/05/03
2011/05/04
2011/05/04
2011/05/04
2011/05/04
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
Health Canada
62748
Type II Recall
N.A.
N.A.
Health Canada
62596
Type II Recall
N.A.
N.A.
Health Canada
62796
Type II Recall
2821 5480
Health Canada
Health Canada
62866
54391
Type II Recall
Type II Recall
Philips Electronic Hong
Kong Ltd
N.A.
Medtronic International
Ltd.
Health Canada
Health Canada
Health Canada
62791
58635
61461
Type II Recall
Type II Recall
Type II Recall
Uninet Technology LTD
N.A.
Moog Controls Hong
Kong Ltd.
2838 8423
N.A.
2635 3200
Health Canada
Health Canada
62215
62637
Type II Recall
Type III
2518 6915
2991 2845
GE Medical Systems Israel, Functional Imaging Xeleris 2 Workstation Imaging
System and Xeleris Nuclear Medicine Workstation
Pentron Clinical Technologies, LLC Correct Quick Extra Light
Thermo Fisher Scientific OY enGen Laboratory Automation Systems
Dental Equipment, LLC Marus Link Arm Assembly
Baxa Corporation Microbore Administration Set
LifeScan Inc. OneTouch Zoom Pro Diabetes Management Software Version
5.1
Roche Diagnostics Ltd. Process System Manager (PSM) Software
Health Canada
56796
Type III
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
61879
62760
62578
62929
62887
Type III
Type III
Type III
Type III
Type III
Health Canada
62746
Type I
Zest Anchors, LLC Also trading as Zest Anchors, Inc. and Zest Anchors Zest
Locator Abutment Pitt Easy 3.75mm
Ferno, Division of Ferno-Washington, Inc. 35A Series Ambulance Stretcher
GE Healthcare SR Viewer versions 2.4.1 and 2.6.13 on the MR console
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx. Signa
HDxt, Signa HDi, Signa
Vibrant, GE 1.5T Signa HDe, Optima MR360, Brivo MR355
Health Canada
59635
Type III
Stryker China Ltd
Carl Zeiss Far East
Co., Ltd
GE Medical Systems
Hong Kong Ltd.
N.A.
N.A.
N.A.
JASPO Limited
Johnson & Johnson
Medical (HK)
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Health Canada
MHRA
62159
2011/004/026/081/012
Type III
FSN
N.A.
GE Medical Systems
Hong Kong Ltd.
N.A.
2783 1838/
2100 6318
Mölnlycke Biogel Eclipse® Reveal® (608) gloves
Philips Healthcare Microstream® Infant/Neonatal M1923A Filterline H Set and
989803159581 Vitaline H Set
Neuro Resource Group NRG Devices that co-packaged with Triad Group's
Alcohol Pads
MHRA
MHRA
2011/004/026/081/013
2011/004/019/291/011
FSN
FSN
N.A.
2821 5480
MHRA
2011/004/027/081/011
FSN
N.A.
Philips Electronic Hong
Kong Ltd
N.A.
N.A.
2919 1362
2783 1838/
2100 6318
N.A.
N.A.
N.A.
N.A.
2738 6027
2485 7510
N.A.
N.A.
2011/05/04
2011/05/04
2011/05/04
Abbott Vascular MitraClip Mitral Valve Repair System (Product no. MSK02ST)
Siemens A) Mevatron Linear Accelerator
B) Oncor Impression 3D Plus
ArthroCare Magnum 2 and Magnum X Knotless Fixation Devices
Blatchford Products Ltd. Endolite 30mm Pyramid Clamp Adaptors- Part
Number 409054 & (P)409028
DJO Surgical (Encore Medical) Tibial Broach (used With Foundation and
3Dknee)
Ziehm
Imaging GmbH Ziehm 8000, Ziehm Compact, Ziehm Solo, Ziehm
Vision, Ziehm Vision FD, Ziehm Vision FD Vario 3D, Ziehm Vision RFD, Ziehm
Vision R, Ziehm Vision Vario 3D, Ziehm Vista plus
Varian Medical Systems Varian 4D Integrated Treatment Console (4Ditc)
2011/05/04
Terumo CDI 500 Blood Monitoring System
2011/05/05
Boston Scientific Endoscopy and Urology/Women‟s Health medical devices
2011/05/05
Varian Medical Systems Optical Guidance Platform, version 2.6 and 2.6.1
2011/05/06
BD BD MicrotrolTM –Candida albicans, NCPF 3179/ ATCC® 10231
2011/05/06
2011/05/09
Ellex Medical Pty Ltd 1) Ellex Super Q LQP3106 ophthalmic laser.
2) Ellex Ultra Q LQP3106-U ophthalmic laser.
3) Alcon 3000LE ophthalmic laser.
4) Ellex Tango LT5106-T ophthalmic laser.
5) Ellex Solo LT5106-S ophthalmic laser.
Baxa Corp. 1) ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R.
2) ExactaMix EVA Container, 250mL, REF: 737, Sterile R.
3) ExactaMix EVA Container, 500mL, REF: 738, Sterile R.
4) ExactaMix EVA Container, 1000mL, REF: 739, Sterile R.
5) ExactaMix EVA Container, 2000mL, REF: 740, Sterile R.
6) ExactaMix EVA Container, 3000mL, REF: 741, Sterile R.
Teleflex Medical Weck Hem-o-Lok Ligating Clips (Model no.: Weck Hem-o-Lok
ML Medium Large Endo 5 (544230), Weck Hem-o-Lok L Large (544240),
Weck Hem-o-Lok XL Extra Large (544250) and Weck Endo5 Hem-o-Lok
Medium Large (ML) Automatic Endoscopic Applier (543965))
Teva, Sagent, Baxter, and Wockhardt Adenosine and Amiodarone needleless
pre-filled glass syringes
BD BD Microtainer® MAP Microtube for Automated Process with K2EDTA
2011/05/09
BD BD Vacutainer® Push Button Blood Collection Sets
2011/05/11
2011/05/04
2011/05/04
2011/05/04
2011/05/04
2011/05/06
2011/05/06
2011/05/07
2011/05/11
2011/05/11
2011/05/11
MHRA
MHRA
2011/004/027/081/003
2011/002/007/291/008
FSN
FSN
2593 2211
2555 9421
FSN
FSN
Abbott Laboratories
LTD. Kong
AGFA Hong
Limited
N.A.
N.A.
MHRA
MHRA
2011/004/020/081/006
2010/002/017/401/003
MHRA
MHRA
2011/004/019/291/016
2011/004/011/081/020
FSN
FSN
N.A.
N.A.
N.A.
N.A.
MHRA
2011/004/026/081/039
FSN
2724 2836
Terumo China
(H.K.) Ltd.
AA-2011-005-C
Varian Medical
Systems Pacific Inc.
Terumo China (H.K.)
Ltd.
Urgent Medical
Device
Correction
Boston Scientific
N.A.
Firm Initiated
Field Action
Varian Medical
CP-03899
Firm Initiated
Systems
Field Action
BD
N.A.
Firm Initiated
Field Action
FDA
Z-1840-2011 to Z-1844-2011
Class II
N.A.
N.A.
28660811 ext
130
Boston Scientific Hong
Kong Ltd
Varian Medical
Systems Pacific Inc.
BD
2960 7136
N.A.
N.A.
2724 2836
2575 8668
FDA
Z-1962-2011 to Z-1967-2011
Class II
JASPO Limited
N.A.
FDA
N.A.
N.A.
Solar-med Limited
2425 0926
FDA
N.A.
MedWatch
N.A.
N.A.
BD
N.A.
BD
2575 8668
BD
N.A.
BD
2575 8668
Sorin CRM Reply and Esprit pacemakers with European programmer software
version (2.24
Zoll E Series® BLS Defibrillator
MHRA
2011/005/003/291/005
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
2877 6787
MHRA
2011/005/004/291/019
FSN
Smith & Nephew DYONICS POWER Shaver Blades, Full Radius, Long
Curved Convex 4.5 mm (Model no. 7205336, Lot no. 50540107); DYONICS
POWER Shaver Blades, Full Radius, Long Straight 4.5 mm (Model no.
7205341, Lot no. 50561144)
Beckman Coulter UK Ltd Flow-Set™ Fluorospheres Part Number 6607007 Lot
7524013F
Smith &
Nephew Ltd.
N.A.
Firm Initiated
Field Action
Innotronik Hong Kong
Limited
Suburfarm Investment
& Trading Co., Ltd.
N.A.
MHRA
2011/004/028/601/001
FSN
Beckman Coulter Hong
Kong Ltd
2240 6150
2780 9421
N.A.
2011/05/11
Cepheid GX INFINITY Expertise Software 4.1a
MHRA
2011/004/028/081/001
FSN
2011/05/11
2011/05/11
MHRA
MHRA
2010/004/015/401/002
2011/004/019/291/018
MHRA
MHRA
2011/05/11
2011/05/12
Chesham-Ellison Healthcare Ltd Wheeled Rollator
DJO Surgical (Encore Medical) Reverse Shoulder System / Rsp Humeral
Socket Shell
GI Dynamics Inc EndoBarrier® gastrointestinal liner retrieval system
Hill-Rom AvantGuard 1200 Electric Bed (CS/PRS158B) CareAssist Bed
(P/PRSP1170) Hill-Rom 1000 Bed (P/PRS1160) Advanta 2 Bed (P1190A)
Hitachi Medical Systems GmbH Ultrasound Diagnostic Scanner HI VISION
Ascendus / Preirus / Avius Software Version.:( V03-00, V03-02, V03-30,
V03-33 )
Medtronic Ltd Medtronic Model 990018 Multi-Channel RF Ablation GENius
Generator
Life Technologies Corporation SPOT-LightTM HER2 [email protected] Kit includes SSC
Buffer
ORTHOVITA UK Ltd Cortoss Delivery Gun
Siemens Healthcare Diagnostics Inc ADVIA Centaur HIV 1/O/2 Enhanced
(EHIV) kit
SmitCare Limited SmitCare MBS68 Adjustable Bathseat.
Varian Medical Systems Optical Guidance Platform, version 2.6 and 2.6.1
2011/05/13
Termuo Cardiovascular Systems Pressure Monitoring Kit
2011/05/13
2011/05/13
2011/05/16
Nova Biomedical StatStrip Glucose Hospital Monitoring System
Siemens Medical Solutions LANTIS Commander, LANTIS Commander 6.1,
LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1
Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential
Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System, Part
Number: 629029
Bio-Rad Laboratories VARIANT nbs Sickle Program Resin Update CD-ROM;
Model Number: 250-3020, included in 250-3000
Boston Scientific Pinnacle® Pelvic Floor Repair Kit
2011/05/16
Boston Scientific InnovaTM Seif-Expanding Stent System
2011/05/17
Leics Microsystems Leica M720 OH5 Surgical Microscope 400 Watt Upgarde
Kit
Waldemar Link GmbH and Co. HG Unicondylar Sled Prosthesis LINK metalbacked tibial plateau Endo-Model 15-2030/01 through 15-2030/12
Waters IEEE detectors installed with Empower 2 FR5, Empower 3, or Breeze
2 software
VWR ALCO-PREP® ALCOHOL PADS 70% USP (HUARHW-0610H)
Siemens ARTISTE™, ONCOR™ and PRIMUS ™ digital linear accelerators
with syngo RT Therapist 4.1 and 4.2
Siemens ARTISTE™, ONCOR™ equipped with 160 MLC
2011/05/11
2011/05/11
2011/05/11
2011/05/11
2011/05/11
2011/05/11
2011/05/11
2011/05/13
2011/05/13
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
Meditech Ltd (supplied by Teleflex or Unomedical) 28% Air Entrainment
(Venturi) Jets
Beckman Coulter Beckman Inhibin A ELISA Kit, Part No.: DSL-10-28100-1,
DSL-10-28100t-1, DSL-10-28100-4, DSL-10-28100t-4
Edwards LifeSciences NovaFlex Delivery System Models 9350FS23 &
9350FS26
2543 7442
FSN
FSN
Science International
Corp.
N.A.
N.A.
2011/004/028/081/004
2010/005/006/401/002
FSN
FSN
N.A.
N.A.
N.A.
N.A.
MHRA
2011/005/004/291/003
FSN
N.A.
N.A.
MHRA
2011/005/004/291/026
FSN
2919 1362
MHRA
2011/004/014/291/001
FSN
MHRA
MHRA
2011/004/027/081/002
2011/005/003/601/004
FSN
FSN
MHRA
Varian Medical
Systems
Termuo
Cardiovascular
Systems
MHRA
FDA
2011/003/030/601/004
CP-03976
FSN
Firm Initiated
Field Action
Firm Initiated
Field Action
Medtronic International
Ltd.
Life Technologies
Corporation
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
Varian Medical
Systems Pacific Inc.
TERUMO CHINA
(H.K.) LTD.
MDA/2011/044
Z-2151-2011
MDA
Class I
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
2870 7533
FDA
Z-2128-2011
Class II
2240 6150
FDA
Z-1984-2011
Class II
Beckman Coulter Hong
Kong Ltd
Bio-Rad Pacific Ltd.
Boston Scientific
90676917FA
90682113-FA
Leica
Microsystems
MHRA
N.A.
Boston Scientific Hong
Kong Ltd
Boston Scientific Hong
Kong Ltd
Leica Microsystems Ltd.
2960 7136
Boston Scientific
2011/004/026/081/016
Firm Initiated
Field Action
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
N.A.
2963
8037/2564 6699
N.A.
MHRA
2011/004/012/291/007
FSN
N.A.
N.A.
MHRA
MHRA
2011/002/009/291/007
2011/004/012/081/006
FSN
FSN
N.A.
2870 7533
MHRA
2011/004/026/081/008
FSN
MHRA
2011/002/025/401/002
FSN
N.A.
Siemens Healthcare
Diagnostic Limited
Siemens Healthcare
Diagnostic Limited
Solar-med Limited
MHRA
2011/005/010/601/002
FSN
2240 6150
MHRA
2011/005/009/081/014
FSN
Beckman Coulter Hong
Kong Ltd
N.A.
AA-2011-006-R
N.A.
N.A.
N.A.
N.A.
2870 7533
N.A.
2724 2836
2866 0811
2272 8926
2960 7136
2870 7533
2425 0926
N.A.
2011/05/17
Codman Codman, a list of products:
MHRA
2011/003/029/291/016
FSN
Johnson & Johnson
Medical (HK)
2738 6027
2011/05/17
GE Healthcare Optima MR450w, Discovery MR450, Discovery MR750, Signa
HDx. Signa HDxt, Signa HFO, GE 1.5T Signa HDe, GE 1.5T Signa HDsv,
Signa Excite 1.5T & 3T
Diagmed Healthcare PillCam Express Video Capsule Delivery Device, part no
FGS-0367 (3-Pak)
Maquet Servo-i/Servo-s ventilators
MHRA
2011/005/004/291/032
FSN
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
MHRA
2011/004/026/081/015
FSN
N.A.
N.A.
MHRA
2011/005/005/081/005
FSN
23939511
Health Canada
Health Canada
Health Canada
61845
63143
63139
Type III
Type III
Type III
Health Canada
63213
Type III
N.A.
MHRA
2011/004/015/291/009
FSN
Health Canada
63079
Type II
Radiometer China
(RCHN)
B. Braun Medical Hong
Kong
Varian Medical
Systems Pacific Inc.
Health Canada
62636
Type II
2011/05/17
Sybronendo/Ormco Corporation RealSeal .02 Taper Points (Model no. 9722235)
Sybronendo/Ormco
Corporation TMA Archwires (Model no. 211-1402)
Pentron Clinical Technologies, LLC Artiste Nano-Hybrid Flowable Composite
(Model no. N28F, N28VF, N28VXA)
Radiometer Medical APS Solution packs to ABL80 Basic/Flex (Model no. 944174, 944-309)
B. Braun Curlin Ambulatory Infusion Pump Models 6000 CMS (Model no, 3601400)
Varian Medical Systems, Inc. Clinac Linear Accelerator; Clinac IX High Energy
Linear Accelerator; Trilogy High Energy Linear Accelerator; Novalis TX High
Energy Linear Accelerator; Clinac 2100C High Energy Linear Accelerator;
Clinac 21EX High Energy Linear Accelerator and Clinac 23EX High Energy
GE Medical Systems Information Technologies, Inc. Dash 3000 Patient
Monitor; Dash 5000 Patient Monitor and Dash 4000 Patient Monitor
Varian Medical Systems, Inc. Aria Software (Version 6.5)
MAQUET Hong Kong
Limited
N.A.
N.A.
N.A.
Health Canada
62920
Type II
2011/05/17
2011/05/17
Biomet Orthopedics Comprehensive Primary & Fracture Shoulder Stem
Inserter
GE Healthcare Japan Corporation Signa HDE 1.5T MRI System - Magnet
Health Canada
Health Canada
62868
57846
Type II
Type II
2011/05/17
Sybronendo/Ormco Corporation Soft-Core Classic Endodontic Obturator
Health Canada
61830
Type III
2011/05/17
Ortho-Clinical Diagnostics Inc. Vitros 5600 Integrated System
Health Canada
62869
Type III
2011/05/19
Depuy Orthopaedics ASR hip replacement device
TGA
N.A.
FDA
FDA
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/17
2011/05/19
2011/05/19
2011/05/19
Bio-Rad Laboratories Inc. Bio Rad VARIANT II TURBO Hemoglobin Alc
Program, 1600 and 2000
Beckman Coulter Inc. UniCel DxI 800 and 600 Access Immunoassay Systems,
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems
OEC Medical Systems, Inc. Transmitter Sensor Cables, Receiver Sensor
Cables
FDA
N.A.
N.A.
N.A.
2529 2009
2724 2836
2783 1838/
2100 6318
2724 2836
News and
Public Notice
GE Medical Systems
Hong Kong Ltd.
Varian Medical
Systems Pacific Inc.
N.A.
GE Medical Systems
Hong Kong Ltd.
Citicon (Hong Kong)
Ltd., Bauhinia Dental
Limited, D & R Dental
Ortho Clinical
Diagnostics
Johnson & Johnson
(Hong Kong) Ltd.
Z-1932-2011
Class II
Bio-Rad Pacific Ltd.
2272 8926
Z-1938-2011, Z-1940-2011
Class II
Beckman Coulter Hong
Kong Ltd
GE Medical Systems
Hong Kong Ltd.
2783 1838/
2100 6318
Z-1941-2011, Z-1942-2011
Class II
N.A.
2783 1838/
2100 6318
N.A.
2737 5504
2738 6027
2240 6150
2011/05/19
2011/05/23
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
2011/05/24
Covidien Illumena™ 150mL Linden Luer Syringe with Handi-fil™ Straw
B. Braun Braunoderm 250 ml Article No. 3881105 Batch no. 0253M14
American Medical Systems Elevate® Anterior and Apical Prolapse Repair
Systems
American Medical Systems Acticon Neosphincter Control Pump
American Medical Systems 800 Urinary Control Pumps
Beckman Coulter Access Immunoassay Systems PAPP-A Reagent Kit (IVD)
Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System, Part
Number: 629029
Biotronik GmBh & Co Passeo-18 Peripheral Balloon catheter
Beckman Coulter Synchron LX Clinical Systems Ion Selective Electrolyte (ISE)
Flow Cell (Model affected: LX20 - 466200, LX20 PRO - 476100, LXi 725 Medpro International (Thailand) Ltd. Medpro AccuFlo Elastomeric Infusion
Pump (Model no. CT-0020-240, CT-0015-240 and CT-0020-150, Specific Lot.)
Mölnlycke Health Care Surgical Gown of material code 650104-00 from Batch
1007-4422
Ortho Clinical Diagnostics VITROS® Chemistry Products VALP Reagent
(Product Code 6801710)
Smiths Medical LogiCal® , NovaTrans® , and TranStar® Invasive Pressure
Monitoring
SystemsComplete
(Various Knee
product
code and
lots) Retaining Articular
Zimmer NexGen®
Solution
Cruciate
Covidien
N.A.
United Base
(HK) Ltd
MHRA
MHRA
MHRA
MHRA
2011/005/010/291/012
2011/005/010/291/011
2011/005/010/291/010
2011/005/016/601/007
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
FSN
FSN
FSN
MHRA
2011/005/013/601/002
FSN
MHRA
2011/005/013/081/008
FSN
FDA
N.A.
Class I
MHRA
2011/005/006/601/004
FSN
MHRA
2011/005/017/081/007
FSN
N.A.
MHRA
2011/005/017/601/004
FSN
MHRA
2011/005/018/081/018
FSN
MHRA
2011/005/003/291/014
FSN
MHRA
2010/002/019/261/001
FSN
MHRA
2011/005/016/081/001
FSN
2011/05/24
Surface
(Part Number 90-5970-040-10, Lot# 61654085 and,
Part Number 90-5970-050-10, Lot# 61654094)
Etac Etac Supportbelt / Etac Immedia Supportbelt A/S / Immedia A/S
Supportbelt
GE Healthcare Advantage Workstation Thoracic VCAR
2011/05/24
Gen-Probe Life Sciences Ltd Elucigene CF-EU2v2 kits
MHRA
2011/005/017/601/005
FSN
2011/05/24
Haemonetics UK Ltd OrthoPAT® Orthopedic Perioperative Autotransfusion
MHRA
2011/005/010/081/002
FSN
2011/05/24
Instrumentation Lab Ltd Blood gas analyser GEM® PREMIER 3500
International Technidyne Corporation (ITC) HEMOCHRON® Jr. PT Cuvettes
Item: J201
MHRA
2011/005/013/081/010
FSN
MHRA
2011/005/016/081/002
FSN
2011/05/24
2011/05/24
2011/05/24
2011/05/24
Intersurgical Ltd Neonatal Resuscitation Systems
MHRA
2011/001/012/401/011
FSN
2011/05/24
Maquet GmbH & Co. KG Operation Table Accessory. Connection fixtures
1002.65A0 and 1002.65S0
MHRA
2011/005/013/081/001
FSN
2011/05/26
Respironics Philips NM3 Monitors, Philips FloTrak Elite modules
FDA
Z-2167-2011 and Z-21682011
Class II
FDA
Z-2224-2011
Class II
2011/05/26
2011/05/26
2011/05/26
2011/05/27
Varian Medical Systems, Inc. Clinac and TrueBeam, High Energy Linear
Accelerator, Model Numbers: H14, H19, H29
Beckman Coulter Inc COULTER Ac"T" 5diff Fix Reagent (Part Number:
8547171)
Sorin CRM PARADYM ICDs (models VR 8250, DR 8550, CRT-D 8750 and
8770)
Boston Scientific WALLSTENTTM, WALLSTENTTM RP, and WALLGRAFT®
Tracheobronchial Endoprosthesis
FDA
Z-2231-2011
Class II
Innotronik Hong
Kong Limited
N.A.
N.A.
Boston Scientific
90683824
Firm Initiated
Field Action
Tyco Healthcare
(HKSAR) Ltd
3157 7220
United Base (HK) Ltd
29596138
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
BIOTRONIK Hong
Kong Limited
Beckman Coulter Hong
Kong Ltd
3190-4500
2240 6150
N.A.
N.A.
N.A.
N.A.
Ortho Clinical
Diagnostics
Goodman Medical
Supplies Ltd
Zimmer PTE Ltd.
(Hong Kong branch)
2737 5504
2332 4455
2992 0968
N.A.
GE Medical Systems
Hong Kong Ltd.
bioMerieus China
Limited
Haemonetics (Hong
Kong) Limited;
N.A.
N.A.
2783 1838/
2100 6318
Vastec Medical Ltd
N.A.
Shun On Healthcare
Limited
MAQUET Hong Kong
Limited
Celki Medical Company
Philips Electronic Hong
Kong Ltd
Varian Medical
Systems Pacific Inc.
Beckman Coulter Hong
Kong Ltd
Innotronik Hong Kong
Limited
Boston Scientific Hong
Kong Ltd
2356 7033
2116 3166
2897 1912
N.A.
23939511
2332 3366
2821 5480
2724 2836
2240 6150
2877 6787
2960 7136
2011/05/30
Medtronic CoreValve Delivery Catheter System
Medtronic
International Ltd.
N.A.
2011/05/30
Boston Scientific iCrossTM Coronary Imaging Catheter
Boston Scientific
90657289
2011/05/30
BD BD MAXTM Sample Preparation Reagent tube
BD
N.A.
2011/05/31
Beckman Coulter, Inc. ReticPrep Reagent Kit
Health Canada
63103
Type II
2011/05/31
Cook, Inc. Zenith AAA Endovascular Graft TFLE-10-71-ZT
Health Canada
63110
Type II
2011/05/31
Beckman Coulter, Inc. IMMAGE 800 Immunochemistry System
Health Canada
63125
Type II
2011/05/31
B & B Medical Technologies BiteProof Bite Blocks, Part #11040
Huangshan City Shexian Comfort Massage Appliance Company Ltd. ReliaMed
Deluxe Portable Adjusting Table
Invacare Corporation A) Dual Blue-Release Adult Walker-Wheeled B) Blue
Release Junior Walker with 5" Fixed Wheels
Bio-Rad Laboratories Liquichek Hematology 16 Control (Low, Normal & High)
Thermo Fisher Scientific OY enGen Laboratory Automation Systems
(JCT20Q3J, J16XQH4J, JIHX7S4J, J41BCY4J) with centrifuge buckets (part
number 4412-R) Hettich Rotanta 46 RSC robotic centrifuges (models 4815,
Hospira Inc. GemStar SP Infusion Suite Database PC (72613G1, 84832G1)
Waters Corporation Waters Mass Spectrometer TQD (QBB1050)
Integra LifeSciences (Ireland) Limited CUSA EXcel + System (HFL1004101IE,
HFB1100401IE, HFL1004701IE)
Sysmex Reagents America Stromatolyser-IM (Model no. SIM-220A, Lot no.
Y0053, Y3354, Y0055)
Health Canada
55384
Type II
Beckman Coulter Hong
Kong Ltd
Cook Asia Ltd.
Beckman Coulter Hong
Kong Ltd
N.A.
Health Canada
59698
Type II
N.A.
Health Canada
62607
Type II
Direct Health Ltd.
25281109
Health Canada
63257
Type II
Bio-Rad Pacific Ltd.
2272 8926
Health Canada
63392
Type II
N.A.
N.A.
Health Canada
Health Canada
62617
63482
Type II
Type II
Hospira Limited
N.A.
2898 2886
N.A.
Health Canada
63100
Type II
N.A.
N.A.
Health Canada
63134
Type II
Sysmex Hong Kong Ltd.
N.A.
2011/05/31
Beckman Coulter Synchron Systems Glucose Reagent
Health Canada
63159
Type II
2011/05/31
Roche Molecular Systems COBAS AmpliPrep / COBAS TaqMan HCV Test
Health Canada
62989
Type II
2011/05/31
Diasorin Inc. A) Liason Analyzer - Instrument Class III;
B) Liason Analyzer - Instrument Class II
Health Canada
63449
Type II
2011/05/31
Toshiba Medical Systems Aquilion 64 System
Health Canada
63539
Type II
2011/05/31
Biomerieux BacT/Alert - FA Reagent Bottle
Conmed A) STAT 2 Pumpette Primary Set
B) STAT 2 Pumpette Extension Set
Health Canada
62902
Type II
Health Canada
63108
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
2011/05/31
Covidien Uri-Drain Male External Catheter with Skin Prep -Large
Smith & Nephew A) Renasys G Gauze Dressing Kit - Complete Wound
Drainage Kit
B) Renasys G Gauze Dressing Kit with Round Drain
C) Renasys G Gauze Dressing Kit with Flat Drain
D) Renasys G Gauze Dressing Kit with Channel Drain
E) Renasys G Gauze Dressing Kit with Port
Roche Diagnostics GMBH A) Cobas Integra Lipase Colorimetric
B) Lipase Colormetric for Cobas
Sorin CRM S.R.L. A) Paradym DR ICD
B) Paradym VR ICD
T.H.E. Medical A) Ultra Zone 3 Air Mattress
B) Ultracare 10 Air Mattress
Pentron Clinical Technologies, LLC Build-it FR model # A3
Firm Initiated
Field Action
Firm Initiated
Field Action
Firm Initiated
Field Action
Medtronic International
Ltd.
Boston Scientific Hong
Kong Ltd
BD
Beckman Coulter Hong
Kong Ltd
Roche Diagnostics
(Hong Kong) Ltd
2919 1362
2960 7136
2575 8668
2240 6150
3472 1640
2240 6150
N.A.
N.A.
2240 6150
2485 7510
N.A.
N.A.
Sanko Medical
Systems (HK) LTD
bioMerieux China Ltd.
2195 9348
Type II
N.A.
N.A.
3157 7220
2648 7700
23840688
Health Canada
63330
Type II
Tyco Healthcare
(HKSAR) Ltd
Health Canada
63258
Type II
Smith & Nephew Ltd.
Health Canada
63295
Type III
Health Canada
63721
Type III
Health Canada
63320
Type III
N.A.
N.A.
Health Canada
63679
Type III
N.A.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
Innotronik Hong Kong
Limited
2485 7510
2877 6787
2011/05/31
Kerr Corporation, also trading as Pentron Clinical Correct VPS Light Extra Body Health Canada
63677
Type III
2011/05/31
Biosense Webster Inc. Duo-Decapolar Electrophysiology Catheter
Health Canada
63712
Type III
2011/05/31
Siemens AG Luminos DRF
Health Canada
63437
Type III
2011/05/31
2011/05/31
Biomerieux BV NucliSENS EasyQ Enterovirus
Pro-Lab Diagnostics Prolex Staph Latex Kit
1. Haemonetics Corporation 2. D.B.A. Haemoscope Corporation TEG 5000
Hemostatis Analyzer
Remote Diagnostic Technologies Limited Tempus IC Patient Monitor
Health Canada
Health Canada
63389
63296
Type III
Type III
Health Canada
62582
Type III
Health Canada
63234
Type III
2011/05/31
2011/05/31
BAUHINIA DENTAL
LIMITED, CITICON
HONG KONG LIMITED
Johnson & Johnson
Medical (HK)
Siemens Healthcare
Diagnostic Limited
bioMerieux China Ltd.
N.A.
Haemonetics (Hong
Kong) Limited
N.A.
2305-2100/
21274693
2738 6027
2870 7533
2195 9348
N.A.
2116 3166
N.A.
Major Safety Alerts in April 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
2011/04/01 Philips Medical Systems GmbH BuckyDiagnost X-ray system with Optimus
Generator
2011/04/01 GE Healthcare Technologies Discovery MR750 3.0T, Discovery MR450 1.5T
and Optima MR450w 1.5T
2011/04/01 Masimo Corp. Hemoglobin Pronto-7
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
Z-0905-2011
Class II
2821 5480
FDA
Z-1375-2011 to Z-1377-2011
Class II
FDA
Z-1387-2011
Class II
Siemens Medical Solutions V5M TEE Transducer used with an ACUSON
S2000 ultrasound system
Medtronic Medtronic External Nasal Splint Kit
FDA
Z-1392-2011
Class II
FDA
Z-1699-2011 to Z-1700-2011
Class II
Siemens ACUSON AcuNav ultrasound catheters when using SwiftLink
catheter connectors; Model Number: 10348560
BD BD BACTEC® MGIT System Software, Cat. No. 445922 Lot No. V5.02A
FDA
Z-1745-2011
Class II
BD
N.A.
FDA
N.A.
MHRA
2011/003/024/081/011
MHRA
2011/04/06
Centurion Medical Products Certain customized convenience kits that contain
Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
manufactured by Luitpold Pharmaceuticals, Inc.
Molift Group Molift Smart 150 (Article number 0920008) (Serial no. from 20941
to 27299)
Nottingham Rehab Supplies Mobility Care Heavy Duty Rollator - Titanium
L97986, manufactured between 2007 and February 2010
Philips Healthcare Philips iSite PACS with Advanced Visualization Tools (AVT)
Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92 and iSite PACS with iSite
ViewForum Applications Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101,
Stanmore Implants Stanmore METS Tibial Plateau Plates: 1) Tibial Plateau
plates mktp/Std 10 (Lot no. B5470, Expiry date 2013-04); Tibial Plateau plates
mktp/Std 15 (Lot no. B5471, Expiry date 2013-04)
Zimmer Zimmer NexGen® Complete Knee Solution Posterior Referencing
Instruments (13 catalogue no.)
Steris Harmony LA / LED Monitor Arm Adapter
BD BD Nokor Vented Needle (Model no. 305213, Lot no. 0007829)
Siemens Siemens A) Magnetom Espree (Model no. 10018165, all lot). ; B)
Magnetom Trio A Tim System (Model no. 10018221, Lot no. 35109, 35120,
35130, 35368, 35382, 35421, 35434, 35442); C) Magnetom Trio A Tim SystemUpgrade (Model no 10018222, Lot no. 35049, 35056); D) Magnetom Avanto,
System (Model no. 7391167, all Lots)
Roche Roche Precinorm PUC (Model no. 03121313122, Lot no. 157086)
Firm Initiated
Field Action
Firm Press
Release
Philips Electronic Hong
Kong Ltd
GE Medical Systems
Hong Kong Ltd.
Suburfarm Investment
& Trading Co., Ltd.
Siemens Healthcare
Diagnostic Limited
Medtronic International,
Ltd.
Siemens Healthcare
Diagnostic Limited
BD
2011/04/06
2011/04/06
2011/04/01
2011/04/01
2011/04/01
2011/04/04
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2783 1838/
2100 6318
2780 9421
2870 7533
2919 1300
2870 7533
2575 8668
N.A.
N.A.
FSN
N.A.
N.A.
2010/010/020/401/007
FSN
N.A.
N.A.
MHRA
2011/003/024/291/006
FSN
Philips Electronic Hong
Kong Ltd
2821 5480
MHRA
2011/003/023/291/004
FSN
N.A.
N.A.
MHRA
2011/003/023/291/008
FSN
2992 0968
Health Canada
Health Canada
Health Canada
62027
62125
62127
Type III
Type III
Type III
Zimmer PTE Ltd.
(Hong Kong branch)
Swedish Trading Co.
Ltd.
BD
Siemens Healthcare
Diagnostic Limited
Health Canada
61881
Type III
2485 7510
Beckman Coulter Beckman Stem-Trol Control Cells
Health Canada
62031
Type III
Remington Medical, Inc. Remington NAC MLL Needles (Model no.
NAC1410MLL: Lot no. 083384 ), (Model no. NAC1825MLL Lot no. 083383,
Health Canada
62139
Type III
Roche Diagnostics
(Hong Kong) Ltd
Beckman Coulter Hong
Kong Ltd
N.A.
6199 0634
2575 8668
2870 7533
2240 6150
N.A.
2011/04/06
Health Canada
62137
Type III
N.A.
N.A.
Health Canada
61882
Type III
2485 7510
Health Canada
62229
Type III
Roche Diagnostics
(Hong Kong) Ltd
Baxter Healthcare Ltd
Health Canada
61842
Type III
N.A.
N.A.
Health Canada
62096
Type III
2485 7510
MHRA
2011/003/023/081/007
FSN
MHRA
MHRA
MHRA
2010/011/026/401/016
2011/002/008/401/005
2010/012/006/401/001
FSN
FSN
FSN
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2011/04/06
2011/04/06
Siemens A) Mevatron Linear Accelerator
B) Oncor Impression 3D Plus
CME McKinley Medical UK T34L Syringe Pump lead screw
Cory Bros and Purple Surgical Secure Catch Pouches
Flexicare Medical Ltd BASIC BAIN COAXIAL SYSTEM 1.6 METRE, Batch
100750649 3 cartons
Fresenius Kabi Ltd Applix Smart and Applix Vision
Invitrogen Corporation Reli SSO HLATyping Kits & Reli SSO Mastermixes
Roche Diagnostics
(Hong Kong) Ltd
Alcon Hong Kong, Ltd.
MHRA
MHRA
2011/002/025/081/007
2011/003/016/081/003
FSN
FSN
N.A.
N.A.
2011/04/06
Maquet System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon
MHRA
2011/003/022/291/006
FSN
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/08
Mediplus Ltd 6630-4-way TriplePlus set, 2.2m and 6631-4-way TriplePlus set,
3.0m.
Edwards
Lifesciences LLC Balloon Catheter
Ossur Americas Inc. Total Knee 2100
King Systems King Systems LTS-D Airway (KLTSD405)
Stryker Medical Medical Bed Model FLH668DCM
Remel Inc. Haemophilus ID Quad
Medtronic Dual Chamber Pacemaker Series: Kappa (600, 700, 800, 900),
EnPulse, Adapta, Sensia, Relia, Vitatron (Models E50A1, E60A1 and G70A1)
Centurion Medical Products Dressing Trays, Port Assess Trays
1) Universal Insertion Tray Bundle, CV13530
2) Central Line Dressing Change Tray, DT10020;
3) Dressing Change Tray for CVC & PICC Lines, DT12105;
4) Dressing Change Tray for Hickman & Dialysis Catheters, DT12110;
5) Dressing Change Tray, DT12770;
6) Dressing Change Tray, DT13650;
7) Central Line Dressing Change Tray, DT13850;
8) PICC/Central Line Dressing Change Tray, DT14675;
9) OUT-PATIENT Port Access Dressing Tray, DT14875;
10) IN-PATIENT Port Access Dressing Tray, DT14880;
11) Dressing Change Kit, DT15215; 12) Dressing Change Tray, DT5880A
GE Healthcare 1) GE Senographe Essential Full Field Mammography System
(Seno Essential);
2) GE Senographe DS Full Field Mammography System Mammographic Film
Screen System
N.A.
Invitrogen Hong Kong
Limited
MAQUET Hong Kong
Limited
N.A.
N.A.
N.A.
N.A.
Stryker China Ltd
N.A.
Medtronic International,
Ltd.
N.A.
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/06
2011/04/08
2011/04/08
Gendex Dental Systems A) Orthoralix DDE Panoramic Dental X-Ray
System(Model no. 110-0199G2, 110-0199G4, 110-0234G3); B) Orthoralizx
9200 DDE Panoramic Dental X-Ray System (Model no. 51050161WW,
51050181WW) ; C) Orthoralix 9200 DDE Plus CEPH (Model no. P9200DDE,
Roche Roche COBAS AmpliPrep Sample Rack (Model no. 03051315001,
05078903001, 28122172001, Lot no. 2009/10, 2010/02, 2010/06)
Baxter A) INFUSO.R. Pump (Model no.: 2L3100, 6461500); B) Mini Infuser
System (Model no. B) 2M8171, 6465300, 6465300R)
Diasorin Inc. Diasorin A) Liaison Analyzer - Instrument Class III; B) Liaison
Analyzer - Instrument Class II
Roche Roche Pre Clean M (Model no. 03004899190, Lot no. 63330401)
MHRA
2011/003/025/601/001
Health Canada
62082
Health Canada
61927
Health Canada
61402
Health Canada
62361
Health Canada
61992
Medtronic
N.A.
International Ltd.
FDA
Z-1460-2011 to Z-1471-2011
FDA
Z-1043-2011 to Z-1044-2011
FSN
Type II Recall
Type II Recall
Type II Recall
Type II Recall
Type II Recall
Firm Initiated
Field Action
Class I
Class II
GE Medical Systems
Hong Kong Ltd.
2807 8516
2568 0636
23939511
N.A.
N.A.
N.A.
N.A.
2518 6915
N.A.
2919 1300
N.A.
2783 1838/
2100 6318
2011/04/08
2011/04/08
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/12
2011/04/13
2011/04/13
Siemens Medical Solutions Acuson Antares Ultrasound Imaging System with
software versions 4.0 and 5.0. Model numbers: 10032747, 10037592,
10040728;
SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593;
ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202,
Terumo Cardiovascular Systems
FDA
Z-1853-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
Terumo
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
FSN
FSN
TERUMO CHINA
(H.K.) LTD.
Carl Zeiss Far East
Co., Ltd
N.A.
N.A.
N.A.
2866 0811
Medtronic International
Ltd.
Solar-Med Limited
29191362
2011/003/022/601/001
2011/004/004/291/015
Firm Initiated
Field Action
Firm Initiated
Field Action
FSN
FSN
N.A.
2821 5480
2011/004/006/601/004
2010/012/014/601/002
2011/003/031/081/022
FSN
FSN
FSN
MHRA
MHRA
2011/004/008/291/005
2011/003/023/081/010
FSN
FSN
N.A.
Philips Electronic Hong
Kong Ltd
N.A.
N.A.
TERUMO CHINA
(H.K.) LTD.
N.A.
Zimmer PTE Ltd.
(Hong Kong branch)
MHRA
Varian Medical
Systems Pacific,
Inc.
FDA
2001/003/028/081/006
CP-03070
FSN
Firm Initiated
Field Action
N.A.
Varian Medical
Systems Pacific Inc.
N.A.
2724 2836
N.A.
Class I
2635 3200
Philips
N.A.
Moog Controls Hong
Kong Ltd.
Philips Electronic Hong
Kong Ltd
Synapse Therapeutics
Limited
N.A.
N.A.
N.A.
Smith & Nephew Ltd.
2648 7700
PAUL HARTMANN
Asia-Pacific Ltd.
2953 7148
Carl Zeiss Meditec, Ltd Carl Zeiss CirrusTM HD-OCT with Software Versions
Carl Zeiss Far
5.0.0 and 5.0.1
East Co., Ltd
Defibtect DDU-100 Series AEDS Shipped with 2.004 software or earlier
MHRA
A-dec Inc A-dec 311 Double Articulating Headrest
MHRA
Biomet Merck France SARL Knee Prosthesis - Jv540074 Nelipak Blister
MHRA
Sealing Lot 131621110A
Medtronic International Ltd CareLink iPro Internet-based Software (for iPro2
Medtronic
CGM)
International Ltd.
Solar-Med Limited AvantGuard 1200(LI158BX), CareAssist(P1170), Hillrom
Solar-Med
1000(P1160) & Advanta 2 (P1190A) Beds
Limited
Moor Instruments Ltd Moor Instruments MS2 Laser Doppler Mobile Stand
MHRA
Philips Healthcare Philips IntelliVue Clinical Information Portfolio Release D.03,
MHRA
E.00, and E.01
Polyco Healthcare Polyco Examination gloves, LMPF100, FT100, MPF25
MHRA
Synergy Health Sterile Procedure Packs, various product codes
MHRA
Terumo Europe Terumo® Weighted Flexible Sucker
MHRA
TMS International Refa8 physiological amplifiers
Zimmer NEXGEN® Complete Knee Solution Posterior Referencing
Instruments (PRI) –Femoral and Provisional Impactor/Extractor (Model no.
Assembly 00-5901-026-00; and replacement kit 00-5901-026-40)
Kern & Sohn GmbH Kern Lifter Scales MHS 300K 100M
Varian C Series Clinac Type 3 hard wedges
N.A.
N.A.
2011/003/023/291/012
2011/003/029/081/004
N.A.
N.A.
2011/04/13
Moog Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD,
PainSmart, and PainSmart IOD
Philips Field Generator Stand for the Philips or Traxtal PercuNavTM System
2011/04/14
Penumbra Coil 400 (Lot no. F17211 to F18553)
FDA
N.A.
Firm Initiated
Field Action
Class I
2011/04/14
iCAD (formerly Xoft Inc.) Axxent® FlexiShield Mini, Model F5300 (Lot no.
800218, 800239, 800240, 800321, 800334, and 800335)
RUSCH Irrigation Tray with Piston (Catalogue Number 67890) and RUSCH
Irrigation Tray with Bulb (Catalogue Number 68895)
Smith & Nephew REMOVE (4031001), REMOVE CE Universal Adhesive
Remover Wipes 1594031251, UNI-SOLVE' Adhesive Remover Wipes
(402300) and SKIN-PREP protective wipes
PAUL HARTMANN Con-Zellin alcohol swabs
FDA
N.A.
Class I
Health Canada
N.A.
Smith &
Nephew Ltd.
N.A.
Notice to
Hospital
Firm Initiated
Field Action
FDA
N.A.
2011/04/14
2011/04/14
2011/04/15
MedWatch
2991 2845
N.A.
N.A.
N.A.
24250926
N.A.
N.A.
2866 0811
N.A.
2992 0968
2821 5480
31881638
N.A.
2011/04/18
FDA
Z-1368-2011 to Z-1369-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
FDA
Z-1819-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
FDA
FDA
Z-1886-2011
Z-1893-2011
Class II
Class II
N.A.
N.A.
N.A.
N.A.
FDA
FDA
Health Canada
Z-1894-2011
Z-1898-2011
62362
Class II
Class II
Type III
N.A.
Bio-Rad Pacific Ltd.
Baxter Healthcare Ltd
N.A.
2272 8926
2807 8516
Health Canada
62327
Type II
N.A.
N.A.
Health Canada
62529
Type II
Baxter Healthcare Ltd
2807 8516
Health Canada
62268
Type II
Health Canada
62527
Type III
Health Canada
62528
Type II
2011/04/19
2011/04/19
Biomet Sports Medicine Curvtek Eye Needles (Model no. 906764)
Roche Hitachi/Cobas Integra Preciset sTfR (Model no. 12148331122)
Health Canada
Health Canada
62301
62426
Type II
Type II
2011/04/19
AGFA NX Modality Workstationn (Software Versions 2.0 .8100, 3.0 .8100, 2.0
.8200, 3.0 .8200,
2.0 .8300, 3.0 .8300, 2.0 .8400, 3.0 .8400, 2.0 .8500, 3.0 .8500)
Oxoid O.B.I.S. Salmonella (Model no. ID0570M)
Biomet 3i Osseotite Certain Implant (Model no. IOSS413)
Health Canada
62157
Type II
Roche Diagnostics
(Hong Kong) Ltd
Johnson & Johnson
(Hong Kong) Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
AGFA Hong Kong
Limited
2485 7510
2011/04/19
Hollister-Stier Laboratories A) Prick Lancetter; B) Quintest Skin Test Device;
C) Quintip Individual Skin Test Device; D) Small Pox Needle
Baxter Baxter Automated Peritoneal Dialysis Sets (Model no. 5C4480C,
R5C4479C, N5C8305C)
Roche Roche Diagnostics Cobas 4800 - Cobas X480 Module (Model no.
05200890001)
Codman & Shurtleff Codman Enterprise Vascular Reconstruction Device
(Model no. ENF452812)
DePuy Spine Confidence Introducer Needle, Diamond (Model no. 2839-03-611)
Health Canada
Health Canada
62535
62560
Type II
Type II
N.A.
Ositek (HK), Inc. Ltd
Health Canada
60029
Type II
N.A.
Health Canada
62044
Type II
Ultra Care Company
Limited
28875957
MHRA
MHRA
2011/004/014/081/001
2011/001/007/401/013
FSN
FSN
N.A.
N.A.
N.A.
N.A.
2011/04/19
2011/04/19
Teledyne Instruments Teledyne Instruments/ Analytical Instruments Oxygen
Sensor (Model no. R-15)
King Systems A) King LT-D Kit (Size 3, Size 4, Size 5)
B) King LTS-D Kit (Size 3, Size 4, Size 5)
C) King LT-D Kit (Size 2, Size 2.5)
Eckert & Ziegler BEBIG GmbH Ru-Eye Applicator
Harvest Healthcare Ltd
Harvest Telescopic Bed Rails Hospital Type and Harvest Telescopic Bed
Rails Divan Type
Philips Healthcare Transducer Model S8-3t Micro TEE
Spacelabs Healthcare Inc. WA Ultraview Sl - 91387
N.A.
3157
1757/81216601
N.A.
MHRA
MHRA
2011/004/012/081/001
2011/004/006/291/004
FSN
FSN
N.A.
2620 8329
2011/04/19
Sysmex Corporation CS-2x00i
MHRA
2011/001/027/401/014
FSN
N.A.
Schmidt Bio Med Tech
(H.K.)
Sysmex Hong Kong Ltd.
2011/04/18
2011/04/18
2011/04/18
2011/04/18
2011/04/18
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
Philips Healthcare 1) Allura XPER FD 10 and Field Extension for XPER
Cardiovascular System and Allura XPER FD 20 and Allura CV20 (Site
Numbers: 104075, 104497, 537745, and 51333258);
2) Allura XPER FD 20 and Allura CV20; Allura XPER FD 10 and Field
Extension for XPER Cardiovascular System and Allura CV20 (Site Numbers:
103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259)
Philips Healthcare Philips Extended Brilliance Workstation (EBW) a
component of the Computed Tomography X-Ray System Model Numbers
EBW (CT) 728260 & EBW (Portal) 728269 (Software versions v2.0.5, v2.0.11.
v3.0, v3.0.1, v3.0.2, v3.5, v3.5.2, v3.5.3, v3.5.4, v3.5.35, v4.0.1, v4.0.2, v4.0.3,
v4.5.1 and Brilliance Workspace Portal v2.5.1.17, v2.5.1.19)
Steris Corp. Harmony LA/LED Monitor Arm Adapter. Model no. LB61
Gcx Corp., Petaluma, CA Articulating Arm for mounting and positioning of flat
screen monitors.
Beaver-Visitec International Inc. BD Beaver XStar Safety 2.5mm Crescent
Knife
Bio-Rad
Laboratories Inc. VARIANT TM II TURBO Hemoglobin A 1C Cartridge
Set
Baxter A) InterLink System, ClearLink System and various products (total of
26 sets opf products)
2738 6027
2738 6027
N.A.
2485 7510
2555 9421
N.A.
2011/04/19
2011/04/19
Vygon Customised Epidural Pack
Baxter Corporation A) ClearLink System Secondary Medication Set (JC7453)
B) ClearLink Secondary Med Set with Duo-Vent (JC7462)
C) Paediatric Straight Type Blood Set (JC7791)
D) Straight Type Blood Set (JC2038, JC7781, JC7790)
E) Y-Type Blood/Solution Set (JC7627C)
F) Y-Type Blood/Solution Set with Large Standard Filter (JC7724)
G) Y-Type Blood/Solution Set with Standard Blood Filter(JC7751)
H) InterLink System Y-Type Blood/Solution Set (JC6392, JC6714, JC6720,
JC6723)
I) ClearLink Y-Type Blood/Solution with Large Standard (JC8723)
J) ClearLink Y-Type Blood/Solution with Standard Blood (JC8750)
Argon Medical Devices Inc A) Argon Arterial Catheter Kit
B) PCI Kit with Feathered Dilator, Pediactric
Siemens AG A) Siemens Axiom Aristos FX Plus (Model no. 10093864)
B) Siemens Axiom Aristos FX (Model no. 7414803)
Medical Positioning, Inc. Rapid Response HUT Table
Smith & Nephew, Inc. Reflection 3 Acetabular System - INTL Ceramic
Acetabular Liners
bioMérieux, Inc. Portland Selenite Broth
Pelton and Crane Spirit 3000 Dental Chair
LifeScan Inc. SureStep Flexx Blood Glucose Bedside Unit
MHRA
Health Canada
2011/004/013/601/003
62362
FSN
Type III
N.A.
Baxter Healthcare Ltd
N.A.
2807 8516
Health Canada
62404
Type II
N.A.
N.A.
Health Canada
62435
Type III
2870 7533
Health Canada
Health Canada
62293
62299
Type II
Type II
Siemens Healthcare
Diagnostic Limited
N.A.
Smith & Nephew Ltd.
Health Canada
Health Canada
Health Canada
60979
62140
62469
Type III
Type III
Type III
2195 9348
N.A.
2738 6027
Health Canada
62267
Type II
2011/04/21
1. Haemonetics Corporation 2. D.B.A. Haemoscope Corporation TEG
Hemostatis Analyzer-Controls
Sunrise Medical Quickie Neon Swing-Away manual wheelchairs
MHRA
MDA/2011/039
MDA
2011/04/26
BD BBL Oxacillin Screen Agar (Catalogue no. 221952)
BD
N.A.
2011/04/26
Haemonetics 2380 MINI Hand-Held Tube Sealer Power Source
FDA
Z-1899-2011
Firm Initiated
Field Action
Class II
bioMerieux China Ltd.
N.A.
Johnson & Johnson
Medical (HK)
Haemonetics (Hong
Kong) Limited
ANCHOR MEDICAL
SERVICES LTD
BD
2011/04/26
FDA
Z-1900-2011
Class II
2011/04/26
2011/04/26
Siemens V5M TEE Transducer used with an ACUSON S2000 ultrasound
system
Stryker Endoscopy Stryker Inflow/Outflow Cannula
Wisconsin Pharmacal Company Atware Carey First Aid Kits
FDA
FDA
Z-1927-2011
N.A.
2011/04/26
Varian EclipseTM Treatment Planning System
MHRA
MDA/2011/040
Class II
Firm Press
Release
MDA
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
2011/04/19
N.A.
2648 7700
2116 3166
2735-8323
2575 8668
Haemonetics (Hong
Kong) Limited
Siemens Healthcare
Diagnostic Limited
Stryker China Ltd
N.A.
2116 3166
Varian Medical
Systems Pacific Inc.
2724 2836
2870 7533
2518 6915
N.A.
Major Safety Alerts in March 2011 (This page is subject to further review)
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue Description of Product
(YYYY/MM/D
D)
2011/03/01 MAKO Surgical Corp RIO Robotic Arm Interactive Orthopedic System
2011/03/01 Orgenics ImmunoComb II HCV, Catalogue no. 60455002, lot no. 100729
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
MHRA
MHRA
2011/002/014/291/012
2011/002/011/291/016
FSN
FSN
N.A.
N.A.
N.A.
N.A.
2011/03/01
Nobel Biocare NobelClinician version 1.0.2 (Pre-launch)
MHRA
2011/002/017/081/005
FSN
Nobel Biocare Asia Ltd
2845 1266
2011/03/01
Roma Medical Romachair model 4740
MHRA
2011/002/017/301/002
FSN
N.A.
N.A.
2011/03/01
Prodol Airtraq Optical Laryngoscope
MHRA
2010/005/013/401/007
FSN
N.A.
N.A.
2011/03/02
Terumo Advanced Perfusion System 1: Circuit Breaker Guard
Terumo
N.A.
Terumo
2011/03/02
"Smart" Infusion Pump
FDA
N.A.
2866 0811 (ext.
118)
N.A.
2011/03/03
Advanced Sterilization Products Tyvek Self-Seal Pouch with STERRAD
Chemical Indicator 12332, Lot Number: 2020
BD Phoenix Panel NMIC/ID-123
FDA
Z-1393-2011
Firm Initiated
Field Action
Medical Device
Safety
Class II
BD
N.A.
2011/03/04
Cook Medical Single, Double, Triple and Five-Lumen Central Venous Catheter
Trays AND Single and Double Lumen PICC Peripheral Inserted Central
Venous Catheter Trays
FDA
2011/03/05
2011/03/07
2011/03/07
2011/03/07
Davol XenMatrix Surgical Graft
Conmed Linvatec Linvatec CrossFt Suture Anchor with Two Hi-Fi Sutures
Anchor Tissue Retrieval System (Ref no. TRS100SB, TRS175SB)
Fresenius 2008T Hemodialysis System
Z-1195-2011, Z-1208-2011, Z1157-2011, Z-1126-2011, Z1177-2011, Z-1170-2011, Z1173-2011, Z-1104-2011, Z1180-2011, Z-1182-2011
FDA
N.A.
Health Canada
61296
Health Canada
60291
Health Canada
60933
2011/03/07
2011/03/07
Quidel Corporation QuickVue One-Step hCG Urine Test
Siemens AG Sireskop SX/SD Luminos
Health Canada
Health Canada
59757
61361
Type III
Type III
2011/03/07
2011/03/07
2011/03/07
Edwards Lifesciences LLC Continuous Flush Device 55UF130
Thompson Surgical Instruments, Inc. Lite Wand Xe with Storz Cable
Siemens AG Multi M-Luminos TF
Health Canada
Health Canada
Health Canada
60283
61311
61437
Type III
Type III
Type III
2011/03/07
Hologic Discovery QDR Bone Densitometer with Frax Software Tool
Health Canada
61282
Type II
2011/03/07
2011/03/07
NuMED Canada A) Z-Med II (PDZ611) B) Coefficient PTV Catheter (COE125)
Toshiba A) Xario XG - Main Unit B) Aplio XG Ultrasound System - Main
Health Canada
Health Canada
61435
61319
Type II
Type II
2011/03/08
2011/03/08
2011/03/08
Thermo Fisher Scientific Oxoid XLD medium, CM0469, Lot Number 992444
Roma Medical Roma Medical Model 4730/4740 Romachair
Siemens A) Mevatron Linear Accelerator
B) Oncor Impression 3D Plus
MHRA
MHRA
MHRA
2011/002/017/601/001
2010/010/013/401/005
2011/002/021/601/003
FSN
FSN
FSN
2011/03/03
Firm Initiated
Field Action
Class I
Class I
Type II
Type II
Type III
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
BD
Cook Asia Ltd./A.R.
Burkill & Sons (Hong
Kong) Ltd.
N.A.
N.A.
N.A.
Fresenius Medical
Care Hong Kong
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
Prism Technologies
Limited
N.A.
Sanko Medical
Systems (HK) LTD
N.A.
N.A.
N.A.
2738 6027
2575 8668 (ext.
252)
Cook: 3472
1640 /A.R.
Burkill: 2541
1041
N.A.
N.A.
N.A.
2583 0813
N.A.
2870 7533
N.A.
N.A.
2870 7533
2786 3233
N.A.
23840688
N.A.
N.A.
N.A.
2011/03/08
Biomet Vanguard Microplasty Slidex AP sizer
MHRA
2011/002/016/601/001
FSN
Biomet UK Ltd
N.A.
2011/03/08
Dameca Siesta iTS, Siesta i Whispa, MRI 508
MHRA
2011/002/022/081/001
FSN
N.A.
N.A.
2011/03/08
GE Centricity Laboratory software version 3.x and 4.x
MHRA
2011/002/017/081/001
FSN
2783 1838
2011/03/08
GE Greenlight II Laryngoscope Handle and Battery Cartridge
MHRA
2011/003/001/081/005
FSN
2011/03/08
B. Braun Easypump C-Bloc
MHRA
2009/011/023/081/005
FSN
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
B. Braun Medical Hong
Kong
2011/03/08
B. Braun Bicontact Rev 12/14
MHRA
2011/002/011/291/010
FSN
2529 2009
2011/03/08
Beckman Coulter PrepPlus 2 PN:378600
MHRA
2011/001/014/601/005
FSN
2011/03/08
Beckman Coulter Access HAV Ab Reagent REF 34200
MHRA
2011/001/028/601/003
FSN
2011/03/08
Beckman Coulter Unicel® DxH™ 800 Coulter® Cellular Analysis System
MHRA
2011/002/015/601/004
FSN
2011/03/09
Smith & Nephew IV PREP Antiseptic Wipes, (Product ref no. 59421200, Lot
no. 9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259;
0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213)
Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
FDA
N.A.
Recall/Safety
Alerts
B. Braun Medical Hong
Kong
Beckman Coulter Hong
Kong Ltd
Beckman Coulter Hong
Kong Ltd
Beckman Coulter Hong
Kong Ltd
Smith & Nephew Ltd.
FDA
Z-1472-2011
Class II
2737 5504
Unomedical (a ConvaTec company) Endotracheal (ET) tubes, adult and
paediatric sizes
Amvex Click Style Gas Regulator (GRXX-YY (Z) - All Model)
ArjoHuntleigh Maxi Sky 1000 Bariatric Ceiling Lift
MHRA
MDA/2011/025
MDA
Ortho Clinical
Diagnostics
N.A.
MHRA
MHRA
2011/002/022/081/010
2011/003/001/301/001
FSN
FSN
N.A.
2508 1416
MHRA
MHRA
2011/003/004/081/014
2011/002/025/601/003
FSN
FSN
2011/03/15
BeaconMedaes MSC2 Manifold Control Panel
Beckman Coulter Ac.T 5 diff Auto Loader Hematology Analyzer, Part No.
175356
Beckman Coulter LH500/HmX/HmX Autoloader Hematology Analyzer
MHRA
2011/003/007/601/001
FSN
2011/03/15
BHM Medical V10 Bariatric Ceiling Lift
MHRA
2011/002/016/301/001
FSN
2011/03/15
GE CARESCAPE Monitor B650 ST measurement using E-PSM or E-PSMP
module
Rayner Intraocular Lens Superflex Aspheric (Model no. 920H, Batch no.
120E17532)
Roche Diagnostics COBAS INTEGRA 400, COBAS INTEGRA 800, Cobra
c311, c501, c502, c711 (Material no. 20763128 322, Lot no. 630204-01,
Material no 04932650 022, Lot no. 631376-01)
Smith & Nephew TWINFIX Ti 3.5mm Suture Anchors (Part no. 7210302, Lot
no. 50325616, 50327209, 50329816)
Thermo Fisher Scientific Oxoid Ready Poured Plate Actinomyces Selective
Agar (deep fill), PO0932A, lot 1162996
Thermo Fisher Scientific Oxoid Ready Poured Plate Columbia Horse Blood
Agar, PB0122A, lot 1162182
Trumpf TITAN Surgical Table (Model no. 4544260, 1321733); TITAN T
Surgical Table (Model no. 1397903); TITAN U T Surgical Table (Model no.
1465166); TITAN U Surgical Table (Model no 1228073)
MHRA
2011/002/015/291/009
FSN
MHRA
2011/001/031/291/011
FSN
N.A.
Arjo Huntleigh (Hong
Kong) Ltd.
N.A.
Beckman Coulter Hong
Kong Ltd
Beckman Coulter Hong
Kong Ltd
Arjo Huntleigh (Hong
Kong) Ltd.
GE Medical Systems
Hong Kong Ltd.
N.A.
MHRA
2011/002/028/081/006
FSN
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
MHRA
2011/002/024/081/017
FSN
Smith & Nephew Ltd.
2648 7700
MHRA
2011/003/004/601/003
FSN
N.A.
N.A.
MHRA
2011/003/004/601/004
FSN
N.A.
N.A.
MHRA
2011/003/002/081/021
FSN
N.A.
N.A.
2011/03/10
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2783 1838
2529 2009
2240 6150
2240 6150
2240 6150
2648 7700
N.A.
N.A.
2240 6150
2240 6150
2508 1416
2783 1838
N.A.
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/15
2011/03/16
2011/03/18
Venner Medical LoTrach Tracheostomy Tube (Ref. no 7170LTTT/902070,
MHRA
7180LTTT/902080, 7190LTTT/902090, 7160LTET/902060, 7170LTET/902070,
7180LTET/902080, 7190LTET/902090)
Zimmer Instinct Java Persuader Ref. 046W1AN00931 - Lot numbers:
MHRA
A1428202A, 1217310A, A1315814A
GE Healthcare All Reporting Tool versions 2.5 or earlier on Advantage
MHRA
Workstation
HemoCue AB Glucose 201 RT systemand HemoCueGlucose 201 DM RT
MHRA
system
Immucor Galileo EchoBlood Bank Analyzer
MHRA
Instrumentation Lab (UK) Ltd Gem Premier 4000
MHRA
Elekta HeadFIX® system (system number P10103)
MHRA
Boston Scientific Atlantis SR Pro 2 Catheter
Boston Scientific
2010/009/021/081/007
FSN
N.A.
N.A.
2011/003/002/081/009
FSN
2992 0968
2011/002/015/291/009
FSN
2011/002/024/081/022
FSN
2011/002/025/081/008
2011/003/002/081/022
2011/001/019/081/015
N.A.
FSN
FSN
FSN
Firm Initiated
Field Action
Class I
Zimmer PTE Ltd.
(Hong Kong branch)
GE Medical Systems
Hong Kong Ltd.
Science International
Corp.
Uninet Technology LTD
N.A.
Elekta Ltd
Boston Scientific Hong
Kong Ltd
bioMerieus China
Limited
N.A.
Ciba Vision (Hong
Kong) Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
Stryker China Ltd
3972 7300
N.A.
TERUMO CHINA
(H.K.) LTD.
TERUMO CHINA
(H.K.) LTD.
N.A.
2866 0811
2011/03/22
CIBA Vision SoftPerm Contact Lenses
Health Canada
61826
Firm Press
Release
Type II
2011/03/22
DePuy Mitek DePuy Gryphon P BR Anchor with Orthocord (Model no. 210814,
Lot no. 3463735)
Howmedica Osteonics A) Accolade TMZF Hip Stem - 132 (degrees) (Model
no. 6020-0537, 6020-3535, Lot no. 31390203, 31446602R); B) Accolade
TMZF Hip Stem - 127 (degrees) (Model no. 6021-0435, Lot no. 31597206)
American Diagnostica Acticlot dPT (Mode no. 824, Lot no. 101028)
Terumo Cardiovascular System Corporation Sarn's Cardioplegia Sets (Model
no. 16130, Lot no. ME12, MK02)
Terumo Cardiovascular System Corporation A) Cardiovascular Procedure Kit
(conducer no recirc.double spike) (Model no. 71032 Lot no. ME19, ME19R,
MG21, MK09, MN01); B) Cardiovascular Procedure Kit (Cabaret de
Perfusion)) (Model no. 73007, Lot no. MM11)
ICU Medical, Inc. A) Orbit 90 Subcutaneous Infusion Set (Model no. M1861,
M2461, M2491, M3091, M4261, M4291, P1861, P1891, P2461, P2491, P3061,
P3091, P4261, P4291); B) Orbit Micro Subcutaneous Infusion Set (Model no.
P1851, P2451, P3051, P4251)
AGFA Cardiovascular Review Station (Model no. 60+00007792)
Health Canada
61991
Type II
Health Canada
61940
Type II
Health Canada
Health Canada
61637
62094
Type II
Type II
Health Canada
62095
Type II
Health Canada
59838
Type II
N.A.
N.A.
Health Canada
61451
Type II
2555 9421
Roche Diagnostics A) Accu-Chek Inform II Meter (Model no. 05060311001, Lot
no. UU11038344, UU11006762, UU11006763, UU11006766, UU12005334);
B) Accu-Chek Inform II + RF Meter (Model no. 05060303001)
Beckman Coulter AcT 5diff Series Hematology Analyzer (Model: 175356)
Health Canada
61885
Type II
AGFA Hong Kong
Limited
Roche Diagnostics
(Hong Kong) Ltd
Health Canada
61994
Type II
2240 6150
Teleflex Medical Urethral Procedural Tray with Syringe
Abbott Diagnostics Abbott Architect 25-OH Vitamin D - Reagent (Model: 3L5225, Lot no. 01110L000)
Kerr Corporation Maxcem Elite (Model: 34418, Lot no. 3360900)
Health Canada
Health Canada
62126
61697
Type II
Type III
Health Canada
61829
Type III
Sybronendo/Ormco Corporation Sybronendio Soft-Core Classic (Model: ESC03006CL, Lot no. 081006701)
Health Canada
61830
Type III
Beckman Coulter Hong
Kong Ltd
N.A.
Abbott Laboratories
LTD.
BAUHINIA DENTAL
LIMITED, CITICON
HONG KONG LIMITED
Citicon (Hong Kong)
Ltd., Bauhinia Dental
Limited, D & R Dental
2011/03/22
2011/03/22
2011/03/22
2011/03/22
2011/03/22
2011/03/22
2011/03/22
2011/03/22
2011/03/22
FDA
N.A.
2838 8423
N.A.
2891 2208
2960 7136
2011/03/19
2011/03/22
2011/03/22
N.A.
2543 7442
Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M.
tuberculosis Complex, ACCUPROBE M. avium Complex
H&P Provdine Prep Pads
2011/03/22
FDA
2783 1838
2356 7033
N.A.
2738 6027
2518 6915
2866 0811
2485 7510
N.A.
2593 2211
2305-2100/
21274693
N.A.
2011/03/22
2011/03/22
Jolife AB Lucas 2 - Chest Compressor
Kerr Corporation OptiBond FL Adhesive Refill (Model no. 25882)
Health Canada
Health Canada
61861
61848
Type III
Type I
2011/03/22
Health Canada
62013
Type I
2011/03/22
BioLytical Laboratories INSTI 24 Test Kit without Support Materials (Model no.
62013)
Fresenius Medical Care Optiflux F250NRe Dialyzers
Health Canada
61779
Type I
2011/03/22
2011/03/22
Abbott Diagnostics Architect c4000, c4000(integrated), c8000, c16000
B. Braun Sterican 30G needle
MHRA
MHRA
2011/003/014/601/002
2011/003/011/081/009
FSN
FSN
2011/03/22
BeaconMedaes ES-VAC central controller on mVAC systems
MHRA
2011/003/015/081/003
FSN
2011/03/22
2011/03/22
2011/03/22
Elekta XVI R4.5
Integra Dermatome Power Supply Units
Invitrogen RELI SSO Typing Kit 50 tests
MHRA
MHRA
MHRA
2011/003/014/081/008
2011/003/014/291/011
2011/002/024/081/006
FSN
FSN
FSN
2011/03/22
Invitrogen RELI SSO HLA-DRB Typing Kit 50 tests
MHRA
2011/003/015/291/001
FSN
2011/03/22
2011/03/22
2011/03/22
2011/03/22
2011/03/22
Molnlycke Xelma
Newdeal Torx T7 Screwdriver Cat. No. 229 003
Penumbra Coil 400 – All lots 18553
Tornier Glenoid Component – Aequalis Fracture Stem
Beckman Coulter Lin-X Linearity Control
MHRA
MHRA
MHRA
MHRA
Health Canada
2011/002/007/291/006
2011/003/010/081/005
2011/003/009/291/009
2011/002/015/081/009
61777
FSN
FSN
FSN
FSN
Type III
2011/03/22
Siemens Mammomat Inspiration
Health Canada
61945
Type III
2011/03/22
Gyrus ACMI CyberWand Dual Ultrasonic Lithotripsy System
Health Canada
62108
Type III
2011/03/22
Siemens von Willebrand reagent
Health Canada
62032
Type III
2011/03/22
2011/03/23
Vapotherm Precision Flow Disposable Patient Circuit - Low
Millar Instruments
Health Canada
FDA
62122
N.A.
2011/03/24
BD
BD
N.A.
2011/03/24
Allergan
N.A.
2011/03/25
Eithicon
2011/03/29
Beckman Coulter Access Total T4 Reagent Kit for use on Access
Immunoassay Systems REF 33800 all Lots.
KaVo Gendex Dental Systems‟ eXpert® DC Intraoral X‐Ray System
Integra LifeSciences Luxtec® MLX Light Source, Model 00MLX
Varian Medical System All Clinacs using the collimator cover P/N 1106900- xx
Allergan Asia
Limited
Johnson &
Johnson (Hong
Kong)Ltd.
MHRA
Type III
Recall – Firm
Press Release
Firm Initiated
Field Action
Firm Initiated
Field Action
Firm Initiated
Field Action
2011/003/016/601/002
FSN
MHRA
MHRA
MHRA
2010/012/031/081/004
2011/003/021/291/030
2011/003/021/291/016
FSN
FSN
FSN
MHRA
MHRA
MHRA
2011/003/017/081/003
2011/003/017/291/005
MDA/2011/031
FSN
FSN
MDA
2011/03/29
2011/03/29
2011/03/29
2011/03/29
2011/03/29
2011/03/30
Surgical Innovations QuickClinch Part Q21210
Shermond Total Commitment PremierPore VP Island Dressing
Smiths Medical Level 1 Normothermic IV administration set DI-65HL, DI-75
and DI150
N.A.
N.A.
BAUHINIA DENTAL
LIMITED, CITICON
HONG KONG LIMITED
N.A.
N.A.
2305-2100/
21274693
Fresenius Medical
Care Hong Kong
Abbott Laboratories
LTD. Hong
B. Braun Medical
Kong
Atlas Copco China/HK
Ltd.
Elekta Ltd
N.A.
Invitrogen Hong Kong
Limited
Invitrogen Hong Kong
Limited
N.A.
N.A.
N.A.
N.A.
Beckman Coulter Hong
Kong Ltd
Siemens Healthcare
Diagnostic Limited
Olympus Hong Kong
and China Ltd
Siemens Healthcare
Diagnostic Limited
N.A.
N.A.
2583 0813
BD
2575 8668
Allergan Asia Limited
2610 2525
Johnson & Johnson
(Hong Kong) Ltd.
2738 6027
Beckman Coulter Hong
Kong Ltd
N.A.
N.A.
Varian Medical
Systems Pacific Inc.
N.A.
N.A.
Goodman Medical
Supplies Ltd
2240 6150
N.A.
2593 2211
2529 2009
2797 6626
2891 2208
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2240 6150
2870 7533
2170 5678
2870 7533
N.A.
N.A.
N.A.
N.A.
2724 2836
N.A.
N.A.
2332 4455
2011/03/31
Penlon Ltd Crystal Metal Miller Disposable Blades (size 0 and 00) Disposable
Laryngoscope Blade
Goodwin Health
Care Ltd
N.A.
Firm Initiated
Field Action
Goodwin Health Care
Ltd
2408-8838
Major Safety Alerts in February 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/D Description of Product
D)
2011/02/02 IMMUCOR Capture-R® Ready-Id® Extend I
2011/02/07 Arstasis Inc One Access System; Models: AAD100, AAD101, Part Numbers:
FG-02279, FG-03010
2011/02/07 Maquet Cardiovascular, LLC Heartstring II Proximal Seal System
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
MHRA
FDA
2011/001/013/081/001
Z-0993-2011
FSCA
Class I
Uninet Technology LTD
N.A.
2838 8423
N.A.
FDA
Z-0940-2011
Class I
23939511
Johnson &
Johnson (Hong
Kong)Ltd.
Baxter
Healthcare Ltd
MHRA
N.A.
Firm Initiated
Field Action
MAQUET Hong Kong
Limited
Johnson & Johnson
(Hong Kong) Ltd.
N.A.
2011/001/030/291/007
Firm Initiated
Field Action
FSCA
2011/02/07
Ethicon Dermabond Topical Skin Adhersion
2011/02/07
Baxter AUTOMIX 3+3 Automated Nutrition Compounder
2011/02/08
CareFusion International Alaris® GP Infusion Set, Low Sorbing, 0.2mm Filter
2011/02/08
Coloplast Limited FOLYSIL® X-Tra Catheter
MHRA
2010/012/024/401/006
FSCA
2011/02/08
2011/02/08
2011/02/08
Dexcom Seven Plus Continuous Glucose Monitoring System: Seven System
Sensor
MGB
Endoskopische Geräte GmbH ML-G Insufflator
GE Healthcare Power supply boards on Dash 3000, 4000 and 5000 Monitors
MHRA
MHRA
FDA
2011/002/001/291/010
011/001/025/081/009
# Z-0359-2011
FSCA
FSCA
Class II
2011/02/08
Zimmer 1) ZIMMER TRABECULAR METAL SHOULDER
FDA
INSTRUMENTATION, DISTAL PILOT, Catalog Number 00-4310-008/018-13;
2) ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION,
DISTAL PILOT, Catalog Number 00-4310-008/014-17;
3) BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
INTRAMEDULLARY REAMER, Catalog Number 00-4301-006/018-00;
4) TRABECULAR METAL" SHOULDER REAMER CASE, Catalog Number 004312-020-00;
5) Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog
Number: 97-4309-002-00
Stryker 1) Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile
FDA
instruments; Catalog Number 8000-0313;
2) Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Catalog
Number 8001-0313.
Varian RT Chart version 7.3.10 (function in VARiS Vision) Inadvertnet Deletion Varian Medical
of Treatment Accessories from Treatment Fields
Systems Pacific,
Inc.
Hospira UK Ltd GemStar pump sets
MHRA
Solta Medical, Inc. Fraxel re:store Dual Laser System. Model Numbers: MCFDA
SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-DUPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MCSYS-SR1500-D-UPG-INTL
Images, Inc Vital Connect 4.0 & 4.1, VitalConnect version or the Vitrea Core
FDA
component of Vitrea Enterprise Suite (VES) 1.2 adn VES 1.3
Vital Signs Colorado Inc. Laryngoscope Handle, Reusable, Rx, Product Code
FDA
4558GSP or 4559LED
Z-0570-2011 to Z-0576-2011
Class II
Z-0927-2011 to Z-0928-2011
2011/02/08
2011/02/08
2011/02/10
2011/02/10
2011/02/10
2011/02/10
2738 6027
Baxter Healthcare Ltd
2807 8516
CareFusion Hong Kong
Ltd.
Coloplast (Hong Kong)
Ltd
N.A.
N.A.
GE Medical Systems
Hong Kong Ltd.
Zimmer PTE Ltd.
(Hong Kong branch)
2891 8730
Class II
Stryker China Ltd
2518 6915
CP-00569
Firm Initiated
Field Action
Varian Medical
Systems Pacific, Inc.
2722 8123
MDA/2011/012
Z-1010-2011
FSCA
Class II
Hospira Limited
Solta Limited
2898 2886
2145 2533
Z-1021-2011
Class II
N.A.
N.A.
Z-1024-2011
Class II
N.A.
N.A.
3628 7428
N.A.
N.A.
2783 1838
2992 0968
2011/02/10
2011/02/10
Philips HeartStart MRx (M3535A/M3536A) with software versions F.01.00 or
F.01.01
BD Tellurite Agar (Hoyle)
2011/02/15
ArjoHuntleigh Nimbus Paediatric System (Pump)
MHRA
2010/011/012/301/001
Firm Initiated
Field Action
FSCA
2011/02/15
B. Braun Steam Ster Locks
MHRA
2011/002/001/601/001
FSCA
2011/02/15
Beckman Coulter Inc Coulter LH 750 Analyzer, LH 780 Analyzer, LH 500
Analyzer, GEN S Analyzer
Haemonetics UK Ltd CardioPAT®
MHRA
2011/001/026/601/003
FSCA
MHRA
2011/001/031/291/012
FSCA
Henleys Medical Supplies Ltd Tubing Connectors AC3 and AC3BP
Thermo Fisher Scientific enGen™ Laboratory Automation Systems using
TCAutomation™ Software Version 3.1.1
Siemens A) Mevatron Linear Accelerator
B) Oncor Impression 3D Plus
Invitrogen Ltd HLA (human leukocyte antigen) tissue typing kits
MHRA
MHRA
2011/002/002/291/002
2011/002/004/601/002
FSCA
FSCA
Arjo Huntleigh (Hong
Kong) Ltd.
B. Braun Medical Hong
Kong
Beckman Coulter Hong
Kong Ltd
Haemonetics (Hong
Kong) Limited
N.A.
N.A.
MHRA
2011/002/002/291/001
FSCA
N.A.
N.A.
MHRA
MDA/2011/014
MDA
Invitrogen Hong Kong
Limited
Bio-Asia Diagnostics
Co Ltd., Abbott
Laboratories Ltd.
N.A.
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
FDA
N.A.
Class I
BD
N.A.
Philips Electronic Hong
Kong Ltd
BD
2821 5480
2508 1416
2575 8668
2529 2009
2240 6150
2116 3166
N.A.
N.A.
2011/02/15
Abbott Point of Care Inc. i-STAT Celite Act Cartridges, Model no. 07G01-01,
07G01-02
Health Canada
60279
Type III
2011/02/15
Abbott Laboratories Diagnostic Division Abbott Prism Reaction Trays (Model
no. 6A36-04, Lot no. 89898M500, 90044M500, 90359M500, 90579M500)
Diasorin Inc. Liaison N-tact PTH Assay (Model no. 310910)
Connectorate AG Inotech Heparin Adsorbant, (Model no. HA-1-N)
Health Canada
60323
Type III
Health Canada
Health Canada
60448
60454
Type II
Type II
Abbott Laboratories
LTD.
N.A.
Gene Company
Angiotech A) General Utility Tray (Model no. GUTS1000, Lot no. 010220EO,
010220E0, 010320G0, 013120Y1, 028723JE, 82521PQA, 81631NZT)
B) HSG Procedure Tray 5F (Model no. 660005000. Lot no. 00391Z97,
009620AK, 021422A7, 82341PEQ, 90261S5R, 91411UKV, 92721X4R)
Dentsply Endodontics GT Drills (Model no. GTS3DC, Lot no. 5051208)
Baxter Healthcare Corporation Infus O.R. Syringe Pump (Model no. 2L3100,
6461500)
Beckman Coulter COULTER LYSE S III diff Lytic Reagent (Model no. Lytic
Reagent 101554F, Lot no. 6605523, 6605526, 6605360, 723585, 6605632,
178833, 6605122, 6603208)
Smiths Medical A) CADD-Solis Ambulatory Infusion Pump (Model no. 21-21010200-02, 21-2101-51, 21-2102-51, 21-2111-0100-51)
B) CADD-Solis VIP Ambulatory Infusion Pump (Model no. 21-2120-0100-50)
Siemens Healthcare Diagnostics Dimension Clinical Chemistry System (Model
no. DF33A, 10444968, Lot no. CA1260, BB1268)
Trudell Medical Marketing Limited Bouffant Caps (Model no. T16199400DFL,
Lot no. 100315)
Edwards Lifesciences Ascendra 2 Delivery System (Model no. 9320AS23,
9320AS26)
Sybron Implant Solutions Endore Implant (Model no. 01B-7L1)
Abbott Point of Care Inc. i-Stat Cardiac Marker Control Levels 1, 2, 3 and
Calibration Verification (Model no. 06F12-02, 06F13-02, 06F14-02, 06F15-02,
Lot no. M102081, M102082, M102083, M10208)
Health Canada
60042
Type II
N.A.
N.A.
Health Canada
Health Canada
60309
60650
Type II
Type III
N.A.
Baxter Healthcare Ltd
N.A.
2807 8516
Health Canada
60297
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
Health Canada
60660
Type II
Goodman Medical
Supplies Ltd
2332 4455
Health Canada
60301
Type III
2870 7533
Health Canada
56406
Type II
Siemens Healthcare
Diagnostic Limited
N.A.
Health Canada
60740
Type II
N.A.
N.A.
Health Canada
Health Canada
59634
60280
Type III
Type III
N.A.
Bio-Asia Diagnostics
Co Ltd., Abbott
Laboratories Ltd.
N.A.
Bio Asia:
27870906,
Abbott: 2593
2211
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
2011/02/15
Bio Asia:
27870906,
Abbott: 2593
2211
2593 2211
N.A.
2896-6283
N.A.
2011/02/16
2011/02/17
2011/02/17
2011/02/17
2011/02/17
2011/02/17
2011/02/17
2011/02/18
2011/02/21
2011/02/21
2011/02/21
2011/02/21
2011/02/21
2011/02/21
2011/02/21
Triad Group Sterile Lubricating Jelly
Stryker Howmedica Osteonics Corp
1)Omnifit M/S PSL Porous Coated Acetabular Shell
2)Omnifit M/S PSL Shell
3)Omnifit M/S Dual Geom Shell
4)Omnifit PSL M/S 3-Hole Cup
Abaxis Inc Piccolo Comprehensive Metabolic Panel
Hill-Rom, Inc TotalCare Bed, P1900 and P1840
International Technidyne Corp Hemochron Whole Blood Coagulation Systems
Maquet Cardiovascular Heartstring Aortic Cutter 4.3 mm
GE Healthcare LightSpeed 16 Computed Tomography X-ray Systems;
Discovery ST (16 Slice) System; STe (16 slice) System; Discovery RX (16
slice) PET/CT System; Discovery LS (16 slice) System
BD Microlance 30G x 1/2" Needle, Microlance 30G x 1/2" Needle - Non Sterile,
Plastipak 1ml Syringe with Microlance 30G x 1/2" Needle - Sterile
Therakos, Inc. Therakos UVAR XTS Procedural Kits, Model no. XT125
GE Medical Systems A) Carescape Monitor B850 System -C1 CPU
B) Carescape Monitor B850 System - C1 CPU with third video
Carestream Health A) Kodak DirectView CR 850 System
B) Kodak DirectView CR 950 System
Bio-Rad Laboratories Diagnostics System PHD EIA/IFA - Software
Cardinal Health A) Custom Sterile Cystoscopy Pack
B) Custom Sterile ABDOM Hysterectomy Pack
C) Custom Bowel Resection-Lithotomy Pack
D) Custom Sterile Pacemaker
E) Custom Sterile Bowel Resection Pack
F) Custom Sterile FEM POP Pack
G) Custom Sterile Urology Pack
H) General Surgery Pack
I) Custom Sterile Extremity Pack
J) Custom Sterile-Sterile Large LAP Pack
K) Laparoscopy Packs
L) Sterile T.U.R.P. Pack
M) Custom Sterile Kidney Pack
N) Custom General Gastro-Urology Packs
O) Custom Sterile Craniotomy Pack
P) Custom Sterile Dental Pack
Q) Custom Sterile General GYNE Pack
R) Custom Sterile Hysterectomy Packs
S) Custom Sterile Labour & Delivery Pack
T) Breast Packs
U) Laparatomy/Laparoscopy Pack
V) Vascular Pack
W) Aorta/Aneurysm Pack
X) By-Pass Pack
Y) General Cardiovascular Pack
Z) Abdominal Packs
Qiagen HC2 System Software ver. 3.0, Suite 4.0
Depuy Orthopaedics Cement Restrictor, Size 3
FDA
FDA
N.A.
Z-1058-2011 to Z-10598-2011
Class II
Class II
N.A.
Stryker China Ltd
N.A.
2518 6915
FDA
FDA
FDA
FDA
FDA
Z-1066-2011
Z-1220-2011 to Z-1221-2011
Z-1093-2011
Z-1222-2011
Z-0942-2011 to Z-0946-2011
Class II
Class II
Class II
Class II
Class II
N.A.
N.A.
N.A.
Maquet Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
N.A.
N.A.
N.A.
2393 9511
2783 1838/
2100 6318
BD HK
N.A.
BD HK
Health Canada
Health Canada
61343
59088
Firm Initiated
Field Action
Type II
Type II
2575 8668 ext
252
N.A.
2783 1838
Health Canada
61257
Type II
Health Canada
Health Canada
61332
61358
Type II
Type II
Health Canada
Health Canada
61369
61458
Type II
Type II
N.A.
GE Medical Systems
Hong Kong Ltd.
Carestream Health
Hong Kong Limited
Bio-Rad Pacific Ltd.
N.A.
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
2564 9759
2272 8926
N.A.
N.A.
2738 6027
2011/02/21
2011/02/21
Trumpf Medizin Systems Titan Surgical Table
Invitrogen Corporation Invitrogen ABC UniTray with TAQ
Health Canada
Health Canada
61460
60792
Type II
Type III
2011/02/21
2011/02/21
Smith & Nephew, Inc., Endoscopy Division Clear-Trac Flexible Reusable
ObturatorsCoulter, Inc. Synchron Systems Multi-Calibrator
Beckman
Health Canada
Health Canada
60801
59928
Type III
Type III
2011/02/21
Health Canada
61001
Type III
2011/02/21
2011/02/21
2011/02/21
2011/02/21
Dentsply Tulsa Dental Specialties Trading as Dentsply Endodontics Lexicon K
Files Labelled as Lexicon C Files
Yiin Wang Industrial Co. Ltd. Sanvic Pulsatile Nasal Irrigator
Remington Medical, Inc. Remington Medical 600-D Drainage Bag
Integra Radionics, Inc. CRW System - Intubation Head Ring Kit
Roche Diagnostics GMBH Cobas Integra S Transferrin Recept 80T
Health Canada
Health Canada
Health Canada
Health Canada
61012
61102
61135
61312
Type III
Type III
Type III
Type III
2011/02/21
2011/02/21
Inova Diagnostics Inc. QUANTA Lite ANA ELISA
Philips Laser Aiming Device 9” / 12”
Health Canada
Philips
61006
N.A.
2011/02/21
Bausch & Lomb Boston Starter Kit Recall
Bausch & Lomb
N.A.
2011/02/21
Philips Gemini TF 64 PET/CT System - PET Subsystem
Health Canada
60742
Type III
Firm Initiated
Field Action
Firm Initiated
Field Action
Type II
2011/02/22
Siemens Ultrasound, Imaging, ACUSON SC2000 volume imaging ultrasound
system
Smiths Medical Portex® , First Breath® Oxygen Masks, Aerosol
Masks and Face Tents
Stryker Surgical Instruments, Implant. Bit Drill -Triathlon PKR Instruments, Peg
Drill, models: 5650-4-512 (Size 1-2 Peg Drill) and 5650-4-536 (Size 3-6 Peg
Drill).
Toshiba Medical Systems Ultrasound, Imaging: Ultrasound Unit. Toshiba PST65AT Transducer
MHRA
2011/002/011/291/038
FSN
MHRA
2011/002/009/291/003
FSN
MHRA
2011/002/008/291/025
FSN
MHRA
2011/002/008/601/005
FSN
Sanko Medical
Systems (HK) LTD
23840688
2011/02/22
ConMed VCARE Vaginal-Cervical Ahluwalia‟s Retractor-Elevator
MHRA
2011/002/011/291/035
FSN
N.A.
N.A.
2011/02/22
Elekta Desktop Pro R7.01 Service Pack 2
MHRA
2011/002/008/291/001
FSN
Elekta Ltd
2891 2208
2011/02/22
Smirthwaite Samba Chairs
MHRA
2011/002/002/301/004
FSN
N.A.
N.A.
2011/02/22
Intersurgical IS Can CO2 absorbers used with GE ADU Carestation, GE ADU
Plus Carestation with Compact Block/Block II attachment, or any Anmedic
Anaesthetic machines.
Optimum Optilube Lubricating Jelly 150 x 5g sachets Lot 25092010
MHRA
2011/002/005/291/020
FSN
Shun On Healthcare
Limited
N.A.
MHRA
2011/002/002/401/007
FSN
N.A.
N.A.
MHRA
2011/002/004/601/004
FSN
MHRA
2011/002/008/291/014
FSN
Ortho Clinical
Diagnostics
Philips Electronic Hong
Kong Ltd
2737 5504
2011/02/22
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products CMV IgM
Reagent Packs, Lot 0410 CAT No. 6801830
Philips Brilliance 6, 10, 16, 16P, 40, 64, Big Bore, iCT, iCT SP
2011/02/24
GE Healthcare Giraffe Spot PT Lite™ Phototherapy System
FDA
N.A.
N.A.
2783 1838
2011/02/24
Hospira PLUM A+ pump and PLUM XLD pump
Hospira
N.A.
Firm Initiated
Field Action
GE Medical Systems
Hong Kong Ltd.
Hospira Limited
2011/02/22
2011/02/22
2011/02/22
2011/02/22
2011/02/22
N.A.
Invitrogen Hong Kong
Limited
Smith & Nephew Ltd.
Beckman Coulter Hong
Kong Ltd
N.A.
N.A.
N.A.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Philips Electronic Hong
Kong Ltd
Bausch & Lomb (Hong
Kong) Limited
Philips Electronic Hong
Kong Ltd
Siemens Healthcare
Diagnostic Limited
Goodman Medical
Supplies Ltd
Stryker China Ltd
N.A.
N.A.
2648 7700
2240 6150
N.A.
N.A.
N.A.
N.A.
2485 7510
N.A.
2821 5480
2213 3371
2821 5480
2870 7533
2332 4455
2518 6915
2821 5480
2898 2886
2011/02/25
Arrow International
FDA
Z-1343-2011 to Z-1361-2011
Class II
Cemma Enterprise Co.,
Ltd
2412 2310
2011/02/25
FDA
Z-1362-2011 to Z-1366-2011
Class II
N.A.
N.A.
2011/02/25
ConMed Electrosurgical ConMed System 2450 Electrosurgical Generator, REF
60-2450-100, 100 V; REF 60-2450-120, 120 V.; REF 60-2450-220, 220 V.;
REF 60-2450-230, 230V-240V.;REF 60-2450-120-69, 120V, (Refurbished)
Negative pressure wound therapy (NPWT) devices
FDA
N.A.
2011/02/25
Medtronic LUCAS 2 Chest Compressor System
Medtronic
N.A.
2011/02/25
Terumo Cardiovascular Systems Bipolar Cord for use with the VirtuoSaph
Endoscopic Vein Harvesting System
Denture adhesive
Innovative Technologies and Research Pty Ltd Electrical impedance scanner
Meditherm Camera thermographic (MED2000, MED2000 PRO, MED2000
IRIS)
FDA
z-1230-2011
FDA
TGA
TGA
N.A.
N.A.
N.A.
2011/02/26
2011/02/28
2011/02/28
News (Medical
N.A.
Device)
Firm Initiated Medtronic International,
Field Action
Ltd.
Class II
TERUMO CHINA
(H.K.) LTD.
News
N.A.
Alerts/advisories
N.A.
Alerts/advisories
N.A.
N.A.
2919 1300
2866 0811
N.A.
N.A.
N.A.
Major Safety Alerts in January 2011
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/D Description of Product
D)
2011/01/03 Cook Medical Cholangioscopy Access Balloon (DPOC)
Tosoh Europe Automated Enzyme Immunoassay Analyzer (AIA-2000 ST and
AIA-2000 LA) Software version below or equal 1.44
William Cook Europe ApS Zilver Flex 35 Vascular Self-Expanding Stent
MHRA
2010/012/021/081/002
Alert Type by
Source
Firm Initiated
Field Action
FSCA
MHRA
2010/012/023/081/003
FSCA
MHRA
2010/012/021/081/021
FSCA
2011/01/06
Roche 1) COBAS® AmpliPrep/COBAS® TaqMan® HBV v2.0 US-IVD, M/N
05027012190
2) COBAS® AmpliPrep/COBAS® TaqMan® HBV v2.0 CE-IVD, M/N
04894570190
Varian 4DITC all versions up to and including 8.8.17
CP-02518
Firm Initiated
Field Action
Varian Medical
Systems Pacific, Inc.
2722 8123
2011/01/06
Metrax Primedic™ Akupak (M250/M290)
Varian Medical
Systems Pacific,
Inc.
MHRA
2010/012/017/081/015
FSCA
3124 1235
2011/01/06
Draeger Infinity ACS Workstation Neonatal Care - Babylog VN500
MHRA
2010/012/023/291/010
FSCA
2011/01/07
FDA
Z-0589-2011
Class II
FDA
FDA
FDA
FDA
FDA
N.A.
Z-0613-2011
Z-0606-2011
Z-0615-2011
Z-0621-2011
MedWatch
Class II
Class II
Class II
Class II
FDA
FDA
Z-0590-2011
Z-0612-2011
Class III
Class III
N.A.
Bio-Rad Pacific Ltd.
N.A.
2272 8926
2011/01/07
2011/01/07
Cardiac Science GE Responder 2000 Defibrillator / Monitor, models 2025653,
2026109, 2026114
Triad Group Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks
Bio-Rad Laboratories Meridian ANA Screen ELISA Test Kit
BD Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium
Hyaluronate
Endocare Endocare 2.4mm CRYOPROBE
Ansell Healthcare Products ENCORE (R) Microptic (R) Powder-Free Latex
Surgical Gloves
Orthofix Inc Orthofix Bone Marrow Aspiration Needle
Bio-Rad Laboratories Inc Bio-Rad Laboratories Autoimmune EIA ANA
Screening kit
CIVCO Body Pro-Lok SBRT System
Fresenius Cabi Injectomat Tiva Agilia
Brand Meditech (Asia)
Co.,ltd
Draeger Medical Hong
Kong Ltd.
Pacific Medical
Systems Limited
N.A.
Bio-Rad Pacific Ltd.
BD
N.A.
N.A.
MHRA
MHRA
2011/001/004/081/005
2010/012/023/081/005
FSCA
FSCA
N.A.
2583 0813
2011/01/07
2011/01/07
2011/01/11
McKesson Medical Imaging Group Horizon Cardiology Hemo
Unomedical Nasogastric feeding tube
Medtronic Model 3093 and 3889 InterStim Tined Leads
2010/012/030/081/008
MDA/2011/003
N.A.
2011/01/11
2011/01/11
2011/01/11
Oxoid Legionella Growth Supplement
Walter Lorenz Surgical 1.5 mm Plate
Imris A) Imris OR Table Model T2X
B) Imris OR Table Model ORT100
Cincinnati Sub-Zero Temperature Management System
Roche Diagnostics A) Cobas Integra System - Acetaminophen
B) Roche Hitachi – Acetaminophen
Siemens A) Mevatron Linear Accelerator
B) Oncor Impression 3D Plus
MHRA
MHRA
Medtronic
International Ltd.
Health Canada
Health Canada
Health Canada
SR0110C
58413
59398
FSCA
MDA
Firm Initiated
Field Action
Type II
Type II
Type II
N.A.
Fresenius Medical
Care Hong Kong
N.A.
N.A.
Medtronic International
Ltd.
N.A.
Swedish Trading Co.,
Ltd
N.A.
Health Canada
Health Canada
59357
59845
Type II
Type II
N.A.
2485 7510
Health Canada
59311
Type III
N.A.
Roche Diagnostics
(Hong Kong) Ltd
Siemens Healthcare
Diagnostic Limited
2011/01/03
2011/01/05
2011/01/05
2011/01/07
2011/01/07
2011/01/07
2011/01/07
2011/01/07
2011/01/07
2011/01/07
2011/01/11
2011/01/11
2011/01/11
Source of
Information*
Cook Asia Ltd.
Reference No. by Source
1037905
Cook Asia Ltd.
Agent Contact
Telephone No.
3472 1688
N.A.
N.A.
A.R. Burkill & Sons
(Hong Kong) Ltd.
Roche Diagnostics
(Hong Kong) Ltd
25411041 or
22981125
2485 7510
Local Agent
2877 3077
2108 4005
N.A.
2272 8926
2575 8668
N.A.
N.A.
N.A.
N.A.
2919 1362
N.A.
2953 5111
N.A.
2870 7533
2011/01/11
Health Canada
58887
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2011/01/11
2011/01/11
GE A) Discovery ST16 (Multislice) - Main Unit
B) Angioct FP16 System
C) Discovery SET16 PET/CT Scanner System
D) Discovery RX PET/CT Scanner System
E) Lightspeed 16 CT Scanner System
Benlan Foley Catheter Tray
Roche Elecsys Anti-Tg
Health Canada
Health Canada
59025
59326
Type III
Type III
N.A.
2485 7510
2011/01/11
Roche Chemstrip 10A
Health Canada
59429
Type III
2011/01/11
2011/01/11
Ceodeux EZ-OX Plus
Philips IntelliVue Information Center
Health Canada
MHRA
59631
2011/001/006/291/016
Type III
FSCA
2011/01/11
Beckman Coulter, Inc. Access System - Total BHCG Assay (Model 33500,
33505)
Cardinal Health Classic Style Fine Tip Pen with Ruler & Labels (Model
250FPRL)
Siemens Medical Solutions A) Acuson Antares System-Main Unit
B) Acuson Antares System-Refurbished Unit
C) Acuson Antares System-With 5.0 Upgrades
Western/Scott Fetzer Co. EZ-OX Oxygen Regulator (ALQ 1967)
GE Healthcare Signa MR System (various models)
Health Canada
59044
Type II
Health Canada
Health Canada
59306
53440
Type II
Type III
N.A.
Roche Diagnostics
(Hong Kong) Ltd
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Philips Electronic Hong
Kong Ltd
Beckman Coulter Hong
Kong Ltd
N.A.
Siemens Healthcare
Diagnostic Limited
Health Canada
Health Canada
59703
56975
Type III
Type II
Instrumentation Laboratory Co. ACL Elite; ACL Elite Pro; ACL 9000
Philips Medical Systems (Cleveland), Inc. Brilliance CT System (various
models)
BrainLAB Kolibri Spectra Camera Kit
Baxter Healthcare Vial-Mate Adaptor
Depuy Mitek Sterile Intermediary Tube Sets
Health Canada
Health Canada
58956
59355
Type II
Type II
Health Canada
Health Canada
Health Canada
59387
59460
59521
Type II
Type II
Type II
MHRA
2011/001/006/291/015
FSCA
BD
N.A.
Philips
Electronic Hong
MHRA
FSN88200389, 88200394
2011/001/007/081/004
Firm Initiated
Field Action
Firm Initiated
Field Action
FSCA
MHRA
2011/001/010/081/003
FDA
2011/01/11
2011/01/11
2011/01/11
2011/01/11
2011/01/11
2011/01/11
2011/01/11
2011/01/11
2011/01/11
2011/01/12
2240 6150
N.A.
2870 7533
N.A.
2783 1838
BD
2575 8668
Philips Electronic Hong
Kong Ltd
BD
2821 5364
FSCA
Alcon Hong Kong, Ltd.
2568 0636
Z-0712-2011 to Z-0713-2011
Class II
N.A.
N.A.
FDA
Z-0715-2011
Class II
Medtronic International
Ltd.
Philips Electronic Hong
Kong Ltd
Stryker Endoscopy
2919 1362
2011/01/12
2011/01/13
Philips Precedence and SKYLight SPECT Systems
2011/01/14
2011/01/17
Beaver-Visitec Internation (formally BD Medical – Ophthalmic Systems)
Visitec® High Viscosity Injectors
Alcon Laboratories Ltd Alcon Custom Ophthalmic Surgical Paks Containing
Beaver-Visitec Visitec® High Viscosity
Biomet Orthopedics A) Comprehensive reverse Shoulder Humeral Tray with
Locking Ring (ref. 115350); B) Custom Comprehensive Shoulder Bio-Modular
Base (ref. CP561510)
Medtronic Polaris Spectra System Control Unit, StealthStation S7 System
2011/01/17
Philips Traxtal PercuNav MP008R-B Button Probe
FDA
Z-0617-2011
Class II
2011/01/17
Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055,
3910400060, 3910400065, Soft Eyelet Anchor
FDA
Z-0618-2011
Class II
2011/01/17
N.A.
2821 5480
N.A.
GE Medical Systems
Hong Kong Ltd.
N.A.
Philips Electronic Hong
Kong Ltd
BrainLAB Ltd
Baxter Healthcare Ltd
Johnson & Johnson
(Hong Kong) Ltd.
Elekta Ltd
Elekta
• XVI R4.5 Instructions for Use (1010070)
• Elekta Synergy® Clinical Mode User Manual for XVI R4.2 (45133702284)
• Elekta Synergy® Clinical User Manual for XVI R4.0 (45133702284)
• Elekta Synergy® Clinical User Manual for XVI R3.5 (45133702170)
• Elekta Synergy™XVI Clinical User & Service Manual (45133702149)
BD FACS 7-Color Setup Beads
2011/01/14
2485 7510
N.A.
2821 5480
2417 1881
2807 8555
2738 6027
2891 2208
2575 8668
2821 5480
2518 6915
2011/01/17
2011/01/17
2011/01/18
Zimmer Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm,
non-sterile, REF 9363-32-057
Zoll Model 4000 Monitor component of the LifeVest Wearable Defibrillator.
Product number 10A0988-A01
Ev3 The Protege® " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14
mm 60mm 80 cm, REF SERB65-14-60-80
Stryker Inion CPS family of products
GE Centricity PACS Web Diagnostic Software Versions: 1.0.0.x
FDA
Z-0619-2011
Class II
FDA
Z-0625-2011
Class II
FDA
Z-0626-2011
Class II
FDA
MHRA
Z-0630-2011 to Z-0710-2011
2011/001/011/601/001
Class II
FSCA
2011/01/18
2011/01/18
Ortho Europe Aluminium tube clamp Ankle - 6PC574
Siemens ADVIA centaur systems; CA 125 II reagent lot 144
MHRA
MHRA
2010/011/003/401/005
2010/012/015/601/002
FSCA
FSCA
2011/01/19
Smith & Nephew Reusable Obturator, Lime Green & Blue, Specific Lots
Smith &
Nephew Ltd.
MHRA
N.A.
2011/001/013/291/005
Firm Initiated
Field Action
FSCA
2011/01/19
2011/01/19
ArcRoyal Unomedical item 46-25-IDH Bag Urine Night w/lever tap 2L,
ArcRoyal Ref: 10-006030
Ethicon Omrix Pressure Regulator
MHRA
2009/011/017/401/012
FSCA
2011/01/19
2011/01/19
2011/01/19
2011/01/19
2011/01/20
Bard LIFESTENT Vascular Stent System
Stanmore Implants, METS Proximal Humeral Component
Stryker Orthopaedics, Triathlon Cemented Tibial Baseplate Size 4
Pride Mobility Products Australia Pty Ltd
B Braun Outlook 400ES Safety Infusion System
MHRA
MHRA
MHRA
TGA
FDA
2011/001/004/601/004
2010/010/018/081/012
2010/012/021/081/024
N.A.
Z-0837-2011
FSCA
FSCA
FSCA
Class II Recall
Class I
2011/01/20
FDA
Z-0843-2011 to Z-0844-2011
Class I
FDA
Z-0007-2011
Class II
FDA
FDA
FDA
Z-0507-2011
Z-0622-2011
Z-0623-2011
Class II
Class II
Class II
FDA
Z-0628-2011
Class II
FDA
Z-0716-2011
Class II
2011/01/20
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 032695-9 and 03-2795-7
GE Medical HiSpeed X/i Computed Tomography operator consoles with the
Model Number 2153675 and 2247802
Amstech Inc. Aimshot HeatSeeker Model HS3500
Wyeth Consumer Healthcare ThermaCare Menstrual 8 Hour Heat Wraps
Greiner Bio-One Vacuette 2 ml Lithium Heparin, Collection Tube. Venous
blood collection tubes.
Minntech ASP Automatic Endoscope Reprocessor (AER), Product Code:
20300 & 20301
Kerr/Pentron Dba Kerr Corporation SDS Kerr Revolution Formula 2 Flowable
Light Cure Composite
GE Healthcare HiSpeed LXI, LX/1, DX/I, FX/I
FDA
Z-0744-2011 to Z-0788-2011
Class II
2011/01/20
Terumo Air bubble detect module (802110), Occluder module (803480)
FDA
Z-0882-2011 to Z-0883-2011
Class II
2011/01/20
Biosense Webster (a JNJ company) CARTO 3 System Interface Cable
FDA
Z-0884-2011
Class II
2011/01/20
Varian Floorstand, an accessory of the Optical Guidance Platform (HZ5)
FDA
Z-0888-2011
Class II
2011/01/20
2011/01/20
Cardiac Assist TandemHeart Transseptal Cannulas - EF set (THTC-EF)
Zimmer TiTLE 2 Polyaxial Spinal System
FDA
FDA
Z-0889-2011
Z-0887-2011
Class II
Class II
2011/01/20
Kreuzer Gmbh & Co/Trumpf Medical Systems klinoPORT, AC powered
Operating Table, Model number: klinoPORT 706, 806, 906, 1006 and 1306
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, UPN
M00550010, UPN M00550020, UPN M00550011 and UPN M00550021
FDA
Z-0802-2011
Class II
FDA
Z-0809-2011 to Z-0812-2011
Class II
2011/01/17
2011/01/17
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
Zimmer PTE Ltd.
(Hong Kong branch)
Suburfarm Investment
& Trading Co., Ltd.
Sinomed Company Ltd.
2992 0968
Stryker Inion
GE Medical Systems
Hong Kong Ltd.
Ortho Europe Ltd.
Siemens Healthcare
Diagnostic Limited
Smith & Nephew Ltd.
2518 6915
2783 1838
ArcRoyal
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
Senrex International
Ltd.
N.A.
Stryker
N.A.
B. Braun Medical Hong
Kong
Fresenius Medical
Care Hong Kong
GE Medical Systems
Hong Kong Ltd.
N.A.
Pfizer
N.A.
2738 6027
Schmidt BioMedTech
(H.K.) Limited
N.A.
2620 8329
GE Medical Systems
Hong Kong Ltd.
TERUMO CHINA
(H.K.) LTD.
Johnson & Johnson
Medical (HK)
Varian Medical
Systems Pacific, Inc.
N.A.
Zimmer PTE Ltd.
(Hong Kong branch)
N.A.
2783 1838
Boston Scientific Hong
Kong Ltd
2960 7136
2780 9421
2887 7640
N.A.
2870 7533
2648 7700
2311 8938
N.A.
2518 6915
N.A.
2529 2009
2583 0813
2783 1838
N.A.
2811 9711
N.A.
N.A.
2866 0811
2738 6027
2722 8123
N.A.
2992 0968
N.A.
2011/01/20
Steris Reliance EPS Endoscope Processing System, Model numbers:
MB30001, MB30002, MB30003, MB000077, MB000078, MB000079,
MB000080 & MB000081
Encore Medical CLP Instrumentation Removal Hook, distributed by DJO
Surgical, Device Listing Number: A776463. Device Part Number: 803-08-033
Sunrise Medical Quickie LXI (EILXI), Manual Wheelchairs with Transit System
Option
Continental Medical 1) Blood Center Kit w/Chloraprep One-Step
2) Port VAD Kit w/Chloraprep One-Step
FDA
Z-0823-2011
Class II
Swedish Trading Co.
Ltd.
6199 0634
FDA
Z-0828-2011
Class II
N.A.
N.A.
FDA
Z-0831-2011
Class II
N.A.
N.A.
FDA
Z-0894-2011
Class II
N.A.
N.A.
FDA
FDA
Z-0895-2011
Z-0898-2011
Class II
Class II
2518 6915
2412 2310
FDA
FDA
FDA
Class II
Class II
Class II
FDA
Z-0899-2011
Z-0900-2011
Z-0901-2011 and Z-09022011
Z-0904-2011
Stryker China Ltd
Cemma Enterprise Co.,
Ltd
N.A.
N.A.
N.A.
2011/01/20
Stryker Spine Disc Space Distractor
Arrow International Multi Lumen Central Venous Catheterization Set with Blue
FlexTip(R) Catheter
Concentric 7F Balloon Guide Catheter
McKesson Medical Imaging Horizon Cardiology ECG Management
Bunnell 1) Life Pulse High Frequency Ventilator, Catalog Number: 203A
2) Life Pulse High Frequency Ventilator, Catalog Number: 203
Carl Zeiss VISU 200 on S8 Floor Stand
2332 0402
2011/01/20
2011/01/20
2011/01/20
Dymax Corp Bard CritiCore Monitor, Software Version 2.1
Steris Reliance EPS Endoscope Processing System
CareFusion Alaris GP 150ml Burette Set Model 60103E
FDA
FDA
MHRA
Z-0719-2011
Z-0823-2011
2011/001/007/291/008
Class III
Class III
FSCA
2011/01/20
2011/01/20
2011/01/20
2011/01/20
ConMed Electrosurgical System 2450 (100V, 120V, 220V & 230V)
Galil Medical Urethral Warmer System Model number FPRCH3001
Ohio Medical Corp Care E Vac 3 Portable Suction
Philips and Neusoft Medical Systems Co., Ltd, China. NeuViz Dual series
Computed Tomography (CT) Scanner System
Accuray Inc RoboCouch Patient Support System
Bard Access Systems Groshong 3 Fr. Single-Lumen PICC Intermediate Tray
with Safety Introducer
Merit Medical Systems One Step Centesis Drainage Catheter
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Pumps
MHRA
FDA
FDA
FDA
2011/001/007/081/008
Z-0832-2011
Z-0833-2011
Z-0846-2011
FSCA
Class II
Class II
Class II
FDA
FDA
Z-0853-2011
Z-0865-2011
Class II
Class II
FDA
Medtronic
International Ltd.
MHRA
Z-0866-2011
N.A.
2008/008/019/301/001
Class II
Firm Initiated
Field Action
FSCA
Carl Zeiss Far East Co.
Ltd
N.A.
N.A.
CareFusion Hong Kong
Ltd.
N.A.
N.A.
N.A.
Philips Electronic Hong
Kong Ltd
Accuray Asia Ltd
Senrex International
Ltd.
King Health Limited
Medtronic International
Ltd.
Direct Health Ltd.
MHRA
MHRA
2011/001/013/291/006
2011/001/018/081/027
FSCA
FSCA
N.A.
N.A.
N.A.
N.A.
MHRA
MDA/2011/031
MDA
2332 4455
Goodwin Health
Care Ltd
MHRA
MHRA
N.A.
2011/001/020/601/001
2011/001/020/601/003
Firm Initiated
Field Action
FSCA
FSCA
MHRA
2011/001/020/601/002
FSCA
Goodman Medical
Supplies Ltd
Goodwin Health Care
Ltd
Elekta Ltd
GE Medical Systems
Hong Kong Ltd.
Elekta Ltd
2891 2208
2783 1838/
2100 6318
2891 2208
Health Canada
60178
Type II
Stryker China Ltd
2518 6915
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/20
2011/01/21
2011/01/21
2011/01/24
2011/03/30
2011/03/31
2011/01/25
2011/01/25
2011/01/25
2011/01/25
Invacare All powered wheelchairs (including Spectra Plus, Harrier
Plus/HD/XHD, Apollo, Mirage)
Convatec Ltd Oxygen Masks and Face Tent Masks
Mölnlycke Health Care Procedure Pak® (Mölnlycke reference: 2307226-00,
2310229-00 and 2305239-00)
Smiths Medical Level 1 Normothermic IV administration set DI-65HL, DI-75
and DI150
Penlon Ltd Crystal Metal Miller Disposable Blades (size 0 and 00) Disposable
Laryngoscope Blade
Elekta CMS Software Monaco Release 2.03.00 and Higher (January 2010
Forward)
GE
Healthcare Xeleris workstation 1.0, 1.1, 2.0, 2.1, 3.0
Elekta CMS Software Software Release 2.03.00 and Higher (January 2010
Forward)
Stryker Endoscopy A) IFU for Monopolar Cord
B) IFU for Bipolar Cable
Class II
N.A.
N.A.
N.A.
N.A.
N.A.
2891 8730
N.A.
N.A.
N.A.
2821 5480
2247 8628
2311 8938
2481 3787
2919 1362
25281109
2408-8838
2011/01/25
Health Canada
59410
Type II
Johnson & Johnson
(Hong Kong) Ltd.
2738 6027
Health Canada
59933
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
Health Canada
Health Canada
60076
59930
Type III
Type III
N.A.
Beckman Coulter Hong
Kong Ltd
N.A.
2240 6150
2011/01/25
Codman & Shurtleff
A) Codman Disposable Twist Drill
B) Codman Metal Disposable ICP Kit, Adult
C) Ghajar Guide Ventriculostomy Kit
D) Codman Cranial Hand Drill
Siemens
A) Ethanol 2 Assay
B) Ethanol 2 Reagent
Aspen Corneal Marking Pad Sterile
Beckman Coulter
A) Coulter Clone & Cyto-Stat/Coulter Clone T11 Monoclonal Antibody
B) Cyto-Stat/Coulter Clone T11-RD1/B1-FITC Monoclonal Antibody
C) Cyto-Stat/Coulter Clone T11-RD1/B4-FITC Monoclonal Antibody
Siemens Verio Magnetom System
Health Canada
60321
Type III
2870 7533
2011/01/25
2011/01/25
DiaSorin ETI-MAX 3000
Covidien Surgipro Mesh, Model no. SPM-35
Health Canada
Health Canada
56924
59843
Type II
Type II
2011/01/25
2011/01/25
Bio-Rad Platelia Toxo IgG, Model no. 72840
Olympus Pediatric Resection Electrodes, Model No. A37008A, A37009A,
A37010A, A37011A, A37012A, A37013A
Imaging Sciences International Gendex Dental Systems, Expert DC Intraoral XRay System with Wall-Mounting Plate, Model No. 110-0207G1 (120 VAC),
D800WPEXPERT
Radiometer Medical APS ABL80 FLEX CO-OX System Software 1.30,1.31,
Model no. 393-841
Stryker Hydroset Injectable Bone Cement
Siemens Healthcare Diagnostics Inc., Stratus CS Acute Care Cardiac
Troponin-I Testpack, Model no. CCTNI
Boston Scientific Latitude Patient Management Server Software
Health Canada
Health Canada
59953
59976
Type II
Type II
Health Canada
59976
Type II
Siemens Healthcare
Diagnostic Limited
N.A.
Tyco Healthcare
(HKSAR) Ltd
Bio-Rad Pacific Ltd.
Olympus Hong Kong
and China Ltd
N.A.
Health Canada
60032
Type II
N.A.
Health Canada
Health Canada
59942
60053
Type II
Type II
MHRA
2011/001/010/081/001
FSCA
MHRA
2010/012/017/081/022
FSCA
MHRA
2011/001/004/081/009
FSCA
Johnson & Johnson
(Hong Kong) Ltd.
2738 6027
MHRA
MHRA
2010/012/022/081/014
2010/010/011/081/008
FSCA
FSCA
N.A.
2738 6027
MHRA
MHRA
2011/001/010/291/008
2011/001/010/601/001
FSCA
FSCA
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
N.A.
N.A.
2011/01/27
Biomet Prosthesis Shoulder - T.E.S.S. Glenoid - Anatomic Insert PE and
Cementless Baseplate
DePuy Orthopaedic Fixation Plate - Sterile (Model name: Calcaneal X-Large
Plate, Distal Tibia Anterolateral Plate, Fibula Anatomic Locking Plate and
Locking Distal Tibia Medial Plate)
Visage Imaging Visage 7
DePuy International Ltd Wroblewski Acetabular Cup Trimming Aid Supplied
With Acetabular Cup Hip Implant
Medico S.p.A Sophos 151, Sophos 155, Helios 300 implantable pacemaker
ThermoFisher Scientific Microbiology Perth Oxoid Ready Poured Plate
Columbia Agar with Sheep Blood
Breast Implants
Radiometer China
(RCHN)
Stryker China Ltd
Siemens Healthcare
Diagnostic Limited
Boston Scientific Hong
Kong Ltd
N.A.
FDA
N.A.
N.A.
N.A.
2011/01/28
Smiths Medical CADD-Legacy® Duodopa® Pump Software, Revision B or C
MHRA
2010/009/016/081/019
News & Events
(Press
Announcements
FSCA
2332 4455
2011/01/28
Masimo Rad-8 Pulse Oximeter
MHRA
2011/001/025/081/012
FSCA
2011/01/31
Merit Medical Systems Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF
No: PSS-7F-4-038MT, Lot Number: H179575
FDA
Z-0941-2011
Class I
Goodman Medical
Supplies Ltd
Suburfarm Investment
& Trading Co.
King Health Limited
2011/01/25
2011/01/25
2011/01/25
2011/01/25
2011/01/25
2011/01/25
2011/01/25
2011/01/26
2011/01/26
2011/01/26
2011/01/26
2011/01/26
2011/01/26
2011/01/26
N.A.
3157 7220
2272 8926
2170 5678
N.A.
2518 6915
2870 7533
2960 7136
N.A.
N.A.
N.A.
2780 9421
2481 3787
2011/01/31
St Jude Medical MitraXs Atrial Retractor
MHRA
2011/001/025/081/027
FSCA
2011/01/31
GE Medical Systems SCS Safesheath® Sealing Adapter Kit With Extension Kit
MHRA
2011/001/025/081/023
FSCA
2011/01/31
One Lambda Inc HLA Fusion Software
MHRA
2011/001/024/081/011
FSCA
St. Jude Medical (Hong
Kong) Ltd.
GE Medical Systems
Hong Kong Ltd.
N.A.
2996 7688
2783 1838
N.A.
Major Safety Alerts in December 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/D Description of Product
D)
DeRoyal NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH
2010/12/01
ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE. Lot number: 22622679
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
Z-0101-2011
Class II
N.A.
N.A.
2010/12/01
SCC SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.
FDA
Z-0102-2011
Class II
N.A.
N.A.
2010/12/01
Fresenius LIBERTY Automated Peritoneal Dialysis System. PIN: 050-87212;
050-87215; 050-87216
FDA
Z-0103-2011, Z-0104-2011, Z0105-2011
Class II
Fresenius Medical
Care Hong Kong Ltd.
2583 0813
2010/12/01
Varian TrueBeam and TrueBeam STx, Model Number: TMX- H19. Units:
H191001, H191003
FDA
Z-0106-2011
Class II
Varian Medical
Systems Pacific Inc.
2724 2836
2010/12/01
Medtronic Navigation Vertex Max Drill Guide
FDA
Z-0145-2011
Class II
Medtronic International,
Ltd.
2919 1362
2010/12/01
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ
FDA
Z-0159-2011
Class II
Elekta
2892 4323
2010/12/01
Edwards Lifesciences MHANM8 Pressure Slave Cable
FDA
Z-0160-2011
Class II
N.A.
N.A.
2010/12/01
Siemens Medical Solutions 550 TxT Patient Table (Part No. 7346534)
FDA
Z-0166-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/12/01
Capintec Captus 3000 Thyroid Uptake System with Portable Stand Option
(Capintec item no. 5430-2130)
FDA
Z-0167-2011
Class II
N.A.
N.A.
2010/12/01
Biomet Microfixation 2.0/1.0 4 hole long plate (titanium plate). Lot 120150
FDA
Z-0108-2011
Class II
Biomet UK Ltd
N.A.
2010/12/01
Bio-Rad Laboratories in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and
in2it (II) A1c Test Cartridges (Catalog 281-0001)
FDA
Z-0109-2011
Class II
Bio-Rad Pacific Ltd.
2272 8926
2010/12/01
Technidata TD-Synergy software (TD-SYN-01)
DR 26697
Firm Initiated
Field Action
Techidata Medical
Software
(33) 0 4 7604
1300
2010/12/02
Beckman Coulter Access Free T4 Calibrators REF 33885 Lot 014769
PCA-14964-2
Firm Initiated
Field Action
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/12/03
Leckey Mygo Seat used in conjunction with Otto Bock Discovery wheelbase
2010/011/025/301/001
FSCA
N.A.
N.A.
Technidata
Medical
Software
Beckman
Coulter Hong
Kong Ltd
MHRA
2010/12/03
Convatec Careline Easi-Mt Urine Bag
MHRA
2010/011/026/291/017
FSCA
N.A.
N.A.
2010/12/03
MediMark Europe Vitrea Enterprise Suite (VES) Version 1.2 and 1.3
MHRA
2010/011/025/291/010
FSCA
N.A.
N.A.
2010/12/03
AngioScore Angiosculpt® PTA Scoring Balloon Catheter, 0.018" OTW
MHRA
2010/011/024/291/001
FSCA
N.A.
N.A.
2010/12/06
Baxter Interlink Micro-Infusion Manifold. Model number: 2N3410
Health Canada
58316
Type II
Baxter Healthcare Ltd
2807 8555
2010/12/06
Synthes
A) Synthes Modular Blade Plate System 50mm Spiral Blade
B) Synthes Modular Blade Plate System 55mm Spiral Blade
C) Synthes Modular Blade Plate System 60mm Spiral Blade
D) Synthes Modular Blade Plate System 65mm Spiral Blade
E) Synthes Modular Blade Plate System 70mm Spiral Blade
F) Synthes Modular Blade Plate System 75mm Spiral Blade
G) Synthes Modular Blade Plate System 80mm Spiral Blade
H) Synthes Modular Blade Plate System 85mm Spiral Blade
I) Synthes Modular Blade Plate System 90mm Spiral Blade
J) Synthes Modular Blade Plate System 95mm Spiral Blade
K) Synthes Modular Blade Plate System 100mm Spiral Blade
L) Synthes Modular Blade Plate System 105mm Spiral Blade
M) Synthes Modular Blade Plate System 110mm Spiral Blade
N) Synthes Modular Blade Plate System 115mm Spiral Blade
O) Synthes Modular Blade Plate System 120mm Spiral Blade
Health Canada
58438
Type II
Synthes (Hong Kong)
Ltd
2724 2032
2010/12/06
Rocialle Rocialle Nhssc Xrd Swabs
MHRA
2010/011/016/081/010
FSCA
N.A.
N.A.
2010/12/06
W.R. Grace & Co. Sodasorb CO2 Absorbent
Health Canada
58490
Type II
N.A.
N.A.
2737 5504
2010/12/06
Ortho-Clinical Diagnostics Vitros Chemistry Products PHYT Slides
Health Canada
58683
Type II
Ortho Clinical
Diagnostics
2010/12/06
Hospira A) Symbiq One Channel Infuser; B) Symbiq Two Channel Infuser
Health Canada
58787
Type II
Hospira Limited
2898 2886
2010/12/06
Trumpf Medical Systems Ondal Acrobat 2000 Spring Arm
Health Canada
58576
Type II
N.A.
N.A.
2010/12/06
Genzyme Diagnostics Cholesterol Assay, model 226-26, serial no. 37772
Health Canada
58634
Type III
N.A.
N.A.
2010/12/06
Pentron Clinical Technologies Build-It FR Mini Mix, model N32FA, Lot.
3519993, 3536336
Health Canada
58682
Type III
N.A.
N.A.
2010/12/06
Pentron Clinical Technologies A) Artiste Flowable
B) Artiste Flowable Value Pack
Health Canada
58693
Type III
N.A.
N.A.
2010/12/06
Medrad A) Avanta Fluid Injection System - Main unit with pedestal
B) Avanta Fluid Injection System - Main unit with table mount
Health Canada
58685
Type III
Prism Technologies Ltd.
2786 3233
2010/12/06
The Kendall Company Division of Tyco A) Monoject Blood Collection Tube
10.25X64 with Heparin,
B) Monoject Blood Collection Tube 10.25X50 with Heparin
Health Canada
58828
Type III
N.A.
N.A.
2010/12/06
Ortho Organizers ClassOne Nickel Free Buccal Tubes
Health Canada
59032
Type III
Forever Bright Limited
2388 2798
2010/12/06
Stryker Orthopeadics Stryker Rasp & Broach Handle
Health Canada
58657
Type II
Stryker China Ltd
2518 6915
2010/12/06
Galil Medical Ltd. A) Presice Cryosurgical System-Warmer
B) Seenet - Warmer
Health Canada
58754
Type II
N.A.
N.A.
2010/12/06
Elekta Business Area Software Systems
ATA Computerized Medical Systems Inc. XIO Radiation Treatment Planning
System
Health Canada
59023
Type II
Elekta Ltd.
2891 2208
2010/12/08
Electric Mobility Micro Balance Scooters – MB 170
MHRA
2010/011/010/301/003
FSCA
N.A.
N.A.
2010/12/08
Siemens Magnetom MRI Systems
MHRA
2010/012/001/081/004
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/12/08
Accuray Europe Cyberknife® Robotic Radiosurgery System
MHRA
2010/011/029/081/014
FSCA
Accuray Asia Ltd
2247 8628
2010/12/08
GE Healthcare MR Systems
MHRA
2010/012/002/601/003
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/12/08
Roche Diagnostics Acetaminophen Diagnostics System
MHRA
2010/011/016/081/024
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/12/09
CaridianBCT Spectra Optia Apheresis Systems (Cat. No. 61000, Serial No.
1P00100 thru 1P00719)
CaridianBCT
(Hong Kong) Ltd.
N.A.
Firm Initiated
Field Action
CaridianBCT (Hong
Kong) Ltd.
2283 0710
2010/12/10
Hospira Symbiq One-Channel Infuser LIST No. 16026; Symbiq Two-Channel
Infuser, List No. 16027
FDA
Z-0127-2011; Z-0128-2011
Class I
Hospira Limited
2898 2886
2010/12/10
Siemens EasyLink Informatics Systems QCFIRST Custom Rule
FDA
Z-0121-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/12/10
Philips 1) Allura Xper FD10 Monoplane X-ray system. 2) Allura Xper FD10/10
Biplane X-ray system.
FDA
Z-0124-2011; Z-0125-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/12/10
Hospira EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and
7.2.1825.5.
FDA
Z-0126-2011
Class II
Hospira Limited
2898 2886
2010/12/10
EBI ARRAY and POLARIS Spinal System Medium Cross Connector Non
Sterile. Part number: 94672
FDA
Z-0131-2011
Class II
N.A.
N.A.
2010/12/10
Philips Computed Tomography X-Ray System MX 8000 IDT 16. Model #
728120
FDA
Z-0133-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/12/10
BD Biosciences FACS Sample Prep Assistant III
FDA
Z-0316-2011
Class II
BD
2575 8668
2010/12/10
Hill-Rom Excel Care Bariatric Bed, P 610A.
Excel Care ES Bariatric Bed, P 610B.
FDA
Z-0332-2011
Z-0333-2011
Class II
N.A.
N.A.
2010/12/10
Ferndale Laboratories Detachol adhesive remover
FDA
Z-0142-2011
Class II
N.A.
N.A.
2010/12/10
Greatbatch Medical enpath medical Myopore Sutureless Myocardial Pacing
Lead
FDA
Z-0287-2011
Class II
N.A.
N.A.
2010/12/10
NewDeal Panta Support Device Panta Arthrodesis Nail Instrumentation Tray
FDA
Z-0308-2011
Class II
N.A.
N.A.
2010/12/10
Synthes 3.5mm LCP Periarticular Proximal Humerus Plates
FDA
Z-0309-2011
Class II
Synthes (Hong Kong)
Ltd
2724 2032
2010/12/10
FHC 1) microTargeting Drive System with Mounted Accessories Catalog
numbers : 66-ZD-MD-01, MT-DS-01, FC1006) STar Drive System, Catalog
numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME
3) microTargeting Drive DBS Lead Holder 66-CN-DB
4) Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5
FDA
Z-0311-2011 to Z-0314-2011
Class II
N.A.
N.A.
2010/12/10
Ortho Development Corp Distal Centralizer 10 mm
FDA
Z-0315-2011
Class II
N.A.
N.A.
2010/12/10
Covidien LigaSure Blunt Tip Laparoscopic Sealer/Divider
Tyco Healthcare
(HKSAR) Ltd.
N.A.
Firm Initiated
Field Action
Tyco Healthcare
(HKSAR) Ltd.
3157 7220
2010/12/10
Merit Medical Valved One-Step Centesis Drainage Catheter
MHRA
2010/011/029/081/013
FSCA
N.A.
N.A.
2010/12/10
Zimmer Dental Drill Stop Kit
FDA
Z-0444-2011
Type II
N.A.
N.A.
2010/12/10
LeMaitre Vascular AnastoClip GC Vessel Closure System
FDA
Z-0164-2011 to Z-0165-2011
Type III
N.A.
N.A.
2010/12/10
Tyco Healthcare Puritan Bennett 840 ventilator
Tyco Healthcare
N.A.
Adverse
Incident Report
Tyco Healthcare
(HKSAR) Ltd
3157 7220
2010/12/10
Winco Care Cliner recliner
FDA
Z-0147-2011
Class II
N.A.
N.A.
2010/12/10
Integra LifeSciences Corp Licox Brain PMO Probe Kit
FDA
Z-0161-2011
Class II
N.A.
N.A.
2010/12/10
Elekta Leksell Gamma Knife Perfexion with EXTEND Frame System
FDA
Z-0163-2011
Class II
Elekta Ltd
2891 2208
2010/12/10
Theken Spine LLC Bone Void Filler
FDA
Z-0169-2011
Class II
N.A.
N.A.
2010/12/14
Codman Arrow International Epidural Catheterization Kit with FlexTip Epidural
Catheter AP-08100
MHRA
2010/012/008/291/011
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/12/14
Audit Diagnostics Copper and Zinc reagent and calibration material
MHRA
2010/011/017/081/006
FSCA
N.A.
N.A.
2010/12/14
Biocomposites 5mm Doubleplay Suture Implant with #2 Magna Force (Code
22-6050)
MHRA
2010/012/003/601/004
FSCA
N.A.
N.A.
2010/12/15
All makes Umbilical cord clamps
MHRA
MDA/2010/094
MDA
N.A.
N.A.
2010/12/15
GE Healthcare Advantage Workstation: AdvantageSim – Inconsistent DRR
(Digitally Reconstructed Radiographic) Visualization
MHRA
2010/012/008/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/12/16
Philips HeartStart FR2+ AED with ECG Display Model M3860, Model 3840 ;
HeartStart FR2+ AED with Text Display (No ECG) Model M3861, Model 3841 ;
HeartStart FR2+ AED with ECG Display, Model 989803148601 ; HeartStart
FR2+ AED with Text Display, Model 989803148611
FDA
Z-0483-2011 through Z-04882011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/12/16
Micrel Medical Devices Spike Set PN Gravity Prime for Mini Rythmic PN
MHRA
2010/011/026/291/010
FSCA
N.A.
N.A.
2010/12/16
QNET Scalar Wave Laser System
MHRA
2010/012/009/081/003
FSCA
N.A.
N.A.
2010/12/16
Abbott Diagnostics Cell-Dyn Emerald / Emerald CPU Board (List Number
09H39-01)
MHRA
2010/012/003/081/013
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/12/16
Alere Determine HIV-1/2 Ag/Ab Combo
MHRA
2010/012/009/081/023
FSCA
N.A.
N.A.
2010/12/16
GE Healthcare eNTEGRA and Xeleris 1.0, 1.1, 2.0 and 2.1 workstations
MHRA
2010/012/010/601/004
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/12/17
St. Jude Medical Riata & Riata ST Silicone Endocardial ICD Leads
MHRA
2010/009/013/081/021
FSCA
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
2010/12/17
Bayer Diabetes Care Blood Glucose Meters And/Or Strips
MHRA
2010/011/015/601/004
FSCA
Bayer HealthCare Ltd.
28144815/
28145220
2010/12/17
Invacare Deutschland Typhoon II wheelchair
MHRA
2009/012/016/301/001
FSCA
Direct Health Ltd.
25281109
2010/12/17
St. Jude Medical Libra™ (model 6608) and LibraXP™ (model 6644) Deep
Brain Stimulation Implantable Pulse Generators (IPGs)
MHRA
2010/008/002/291/015
FSCA
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
2010/12/17
Covidien Shiley Paediatric tracheostomy tubes - all models and sizes
MHRA
MDA/2010/096
MDA
Tyco Healthcare
(HKSAR) Ltd
3157 7220
2010/12/20
Intuitive Surgical Inc Da Vinci® Endowrist Stabilizer
MHRA
2010/012/010/291/004
FSCA
N.A.
N.A.
2010/12/20
Vygon UK Ltd Lectroflex Extension Line 25cm
MHRA
2010/012/016/601/004
FSCA
N.A.
N.A.
2010/12/20
TomoTherapy Inc. Hi-Art Treatment System
MHRA
2010/012/015/081/032
FSCA
N.A.
N.A.
2010/12/20
Stryker Leibinger GmbH & Co. KG iNtellect Cranial Navigational/planning
version 1.0 and 1.1 Products; SpineMap 3D Version 1.0 Products; OrthoMap
3D Version 1.0 Products
MHRA
2010/012/015/081/018
FSCA
Stryker China Ltd
2518 6915
2010/12/20
Roche Accu-Chek Inform meter
MHRA
2010/001/019/401/008
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/12/20
Vygon UK Ltd Vygon Blood Sets
MHRA
2010/006/011/401/001
FSCA
N.A.
N.A.
2010/12/20
GE Healthcare MR Gradient Cables
MHRA
2010/012/003/601/002
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/12/20
GE Healthcare MR System Blower Box
MHRA
2010/012/003/601/001
FSCA
2010/12/22
Fresenius Red Blood Cell (RBC) Set (catalog number 9007601)
2010/12/22
Varian Oncology System Clinac IX
2010/12/22
2010/12/22
2010/12/22
2010/12/22
2010/12/22
2010/12/22
Tyco Healthcare UK Ltd / Covidien Counterfeit Covidien Nellcor Sp02
Durasensor® (DS-100A) Sensors
William A. Cook Australia Pty Ltd Zenith Branch Endovascular Graft Iliac
Bifurcation
Varian Medical Varian Clinac Linear Accelerator
Trilogy Radiotherapy Delivery System
Clinac IX Radiotherapy Delivery System
Novalis TX Linear Accelerator
Acuity Radiation Therapy Stimulator
Fresenius Medical Care Combiset Blood Volume Monitor Bloodline
Bausch & Lomb 1) Renu Fresh Multi-Purpose Solution
2) Target Up & Up Multi-Purpose Solution
Stryker Endoscopy A) SRU-6X Semi-Rigid Ureteroscope
B) Sterilization Tray
FDA
N.A.
Class I
MHRA
2010/008/019/081/017
FSCA
MHRA
2010/012/015/081/017
FSCA
MHRA
2010/012/006/291/016
FSCA
Health Canada
58925
Type I
Health Canada
59090
Type I
Bausch & Lomb
N.A.
Firm Initiated
Field Action
Health Canada
59260
Type II
GE Medical Systems
Hong Kong Ltd.
Fresenius Kabi
Varian Medical
Systems Pacific Inc.
Tyco Healthcare
(HKSAR) Ltd
AR Burkill & Sons (HK)
Ltd
Varian Medical
Systems Pacific Inc.
Fresenius Medical
Care Hong Kong
Bausch & Lomb (Hong
Kong) Limited
Stryker China Ltd
2784 1838
9195 7500
2724 2836
3157 7220
2541 1041
2724 2836
2583 0813
2213 3371
2518 6915
2010/12/22
Codman & Shurtleff Codman Disposable Twist Drill
Health Canada
59410
Type II
2010/12/22
Immunotech Dehydroepiandrosterone (DHEA) RIA DSL-8900
Baxter A) 3-Way Large Bore Stopcock
B) Stopcock Connector
Biomerieux Mannitol Salt Agar (Model: P1900(302465); Lot 513945-1)
Vital Images, Inc. Vitrea fX
Health Canada
59043
Type II
Johnson & Johnson
Medical (HK)
N.A.
Health Canada
59149
Type II
Baxter Healthcare Ltd
2807 8555
Health Canada
Health Canada
58722
59196
Type II
Type II
bioMerieux China Ltd.
N.A.
2195 9348
N.A.
2010/12/22
2010/12/22
2010/12/22
2738 6027
N.A.
2010/12/22
Hill-Rom A) TotalCare P500 Surface
B) VersaCare P500 Surface
C) P500 Therapy Surface
Health Canada
59085
Type II
2010/12/22
Cook Universa Soft Uteral Stent Set
Health Canada
58423
Type III
2010/12/22
Steris Canada Reliance Hamo Vision Washer/Disinfector
Beckman A) HMX Hematology Analyzer
B) Coulter LH 500 Hematology Analyzer
C) Coulter MAXM Hematology Analyzer
D) Coulter MAXM Hematology Analyzer with Autoloader and Reticlocyte
Health Canada
58694
Type III
Health Canada
59046
Health Canada
2010/12/22
Abbott Cell-Dyn Emerald System - Instrument
Shoppers Drug Mart A) Children's Power Toothbrush-Scooby-Doo
B) Children's Power Toothbrush-Batman
2010/12/22
N.A.
N.A.
A.R. Burkill & Sons
(Hong Kong) Ltd.
N.A.
25411041 or
22981125
N.A.
Type III
Beckman Coulter Hong
Kong Ltd
2240 6150
59048
Type III
Abbott Laboratories
LTD.
2593 2211
Health Canada
59259
Type III
N.A.
N.A.
CardioMed Endotracheal Ventilation Catheter
Health Canada
59361
Type III
N.A.
2010/12/22
Philips Medical Systems Skylight Gamma Camera System
Health Canada
58878
Type II
N.A.
Philips Electronic Hong
Kong Ltd
2010/12/22
Varian Medical System Inc 1) Clinac Linear Accelerator; 2) Trilogy
Radiotherapy Delivery System; 3) Clinac IX Radiotherapy Delivery System; 4)
Novalis TX Linear Accelerator
Health Canada
58985
Type II
2010/12/22
Varian Medical System Inc Eclipse V.6.5
Health Canada
58987
Type II
2010/12/22
Varian Medical System Inc Aria Radiation Oncology Vision (Version 6.5)
Health Canada
59051
Type II
2010/12/23
GE
1) Innova 2121-IQ/3131
2) Innova 2100IQ
3) Innova 3100/3100IQ
4) Innova 4100/4100IQ
FDA
Z-0407-2011 to Z-0410-2011
Class II
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/12/23
Philips Medical Systems Philips EasyVision MM workstation with software
R10.2 and R11.1
FDA
Z-0412-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/12/23
Smith & Nephew
1) Smith & Nephew Fast Fix 360, Straight Needle, Catalog Number; 72202467
2) Smith & Nephew Fast Fix 360, Curved Needle Catalog Number; 72202468
3) Smith & Nephew Fast Fix 360, Reverse Curved Needle, Catalog Number;
72202469
FDA
Z-0419-2011 to Z-0421-2011
Class II
Smith & Nephew LTD
2648 7700
2010/12/23
DiaDexus PLAC Test ELISA Kit; Model Part Number: 90123
FDA
Z-0429-2011
Class II
N.A.
N.A.
2010/12/23
BioMerieux Inc VITEK 2 Gram Negative Susceptibility Card
FDA
Z-0172-2011 to Z-0285-2011
Class I
bioMerieux China Ltd.
2195 9348
2010/12/23
SCC Soft Computer SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15,
and 4.0.1.16
FDA
Z-0344-2011
Class I
N.A.
N.A.
2010/12/23
Elekta, Inc. Elekta Synergy XVI
FDA
Z-0350-2011
Class II
Elekta Ltd
2891 2208
2010/12/23
SCC Soft Computer SoftID.NET versions 2.0.0.6 - 2.0.0.19
FDA
Z-0360-2011
Class II
N.A.
N.A.
2010/12/22
2010/12/22
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
Varian Medical
Systems Pacific Inc.
2821 5480
2724 2836
2724 2836
2724 2836
2010/12/23
SCC Soft Computer SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with
SoftReports
FDA
Z-0362-2011
Class II
N.A.
N.A.
2010/12/23
SCC Soft Computer SA BASE with SoftLab Version 3.1.4.x
FDA
Z-0364-2011
Class II
N.A.
N.A.
2010/12/23
SCC Soft Computer SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10,
4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5
FDA
Z-0365-2011
Class II
N.A.
N.A.
2010/12/23
Sorin Group USA, Inc. OptiPack, Perfusion Tubing Set
FDA
Z-0370-2011 to Z-0391-2011
Class II
IntegMed Limited
3527 3062
2010/12/23
Abbott Glucose Test Strip
Precision Xceed Pro;
Precision Xtra;
Medisense Optium;
Optium;
OptiumEZ; and
ReliOn Ultima
FDA
N.A.
News
Abbott Laboratories
LTD.
2593 2211
2010/12/23
Ascension Orthopedics The Ascension PyroHemiSphere
FDA
Z-0437-2011, Z-0438-2011
Class II
N.A.
N.A.
2010/12/23
Davol, Inc. 1) BARD, Ventrio Small Oval Hernia Patch 3.1" x 4.7"
2) BARD, Ventrio Large Oval Hernia Patch 5.4" x 7.0"
3) BARD, Ventrio Small Circle Hernia Patch 3.0"
FDA
Z-0439-2011 to Z-0443-2011
Class II
N.A.
N.A.
2010/12/23
Medtronic Navigation O-Arm Imaging System, Door Assembly
FDA
Z-0447-2011
Class II
Medtronic International,
Ltd.
2919 1300
2010/12/23
Siemens Medical Solutions ARTISTE MV
FDA
Z-0449-2011
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/12/23
Integra LifeSciences Corp DuraGen XS Dural Regeneration Matrix
FDA
Z-0450-2011 to Z-0454-2011
Class II
N.A.
N.A.
2010/12/23
Siemens Healthcare Diagnostics The Dimension FT4L Flex reagent cartridge
FDA
Z-0458-2011 to Z-0461-2011
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/12/23
GE Healthcare GE Signa MR Excite" 1.5T system
FDA
Z-0462-2011
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/12/23
Troy Inovative Instruments Troy Innovatie Modified Depth Gauge, # CSS-05970-5, CCS-059-55-4, CCS-059-40-4
FDA
Z-0466-2011 to Z-0468-2011
Class II
N.A.
N.A.
2010/12/23
Philips Medical Systems Philips Achieva and Intera 1.5T MR systems, 1.5T
coils and accessories
FDA
Z-0469-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/12/23
GE Healthcare GE Seno Advantage 1.x, Seno Advantage 2.0, Seno
Advantage 2.1, IDI Mammo Workstation
FDA
Z-0476-2011 to Z-0477-2011
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/12/23
Philips Medical Systems Philips Easy Diagnost Eleva Conventional R/F system
FDA
Z-0479-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/12/23
AdvanDx, Inc E. faecalis/OE PNA FISH" (Cat. No. KT007)
FDA
Z-0490-2011
Class II
N.A.
N.A.
2010/12/23
AdvanDx, Inc E. faecalis/OE PNA FISH" (Cat. No. KT008)
FDA
Z-0491-2011
Class II
N.A.
N.A.
2010/12/23
Edwards LifeSciences Edwards Protection Cannulae - Monitoring and Infusion
Set
FDA
Z-0542-2011 to Z-0543-2011
Class II
N.A.
N.A.
2010/12/23
Merit Medical Systems Custom Kits
FDA
Z-0552-2011 to Z-0559-2011
Class II
King Health Limited
2481 3787
2010/12/23
Terumo Cardiovascular Systems Sarns 8000 Roller Pump
FDA
Z-0562-2011 to Z-0563-2011
Class II
TERUMO CHINA
(H.K.) LTD.
2866 0811
2010/12/23
LeMaitre Vascular A) VascuTape Radiopaque Tape
B) Stent Guide
FDA
Z-0433-2011 to Z-0436-2011
Class III
Suburfarm Investment
& Trading Co.
2780 9421
2010/12/23
Bard Rectal Tubes, 22 French, 20 Long, X-Ray Opaque Rubber with Funnel
end, Open Top, One Eye, Non-sterile
FDA
Z-0465-2011
Class III
N.A.
N.A.
2010/12/23
Coloplast PROSTAFLOW Prostatectomy Catheter P.V.C. Latex
MHRA
2010/012/010/291/012
FSCA
Coloplast (Hong Kong)
Ltd
3628 7428
2010/12/28
AGA Medical Corporation Amplatzer® Sizing Balloon II, Model # 9-SB-034, Lot
# 1004282114
MHRA
2010/012/017/081/001
FSCA
Abbott Laboratories Ltd.
25932211
2010/12/28
BIOMERIEUX INC Bact/Alert Culture medium
MHRA
2010/012/010/291/008
FSCA
bioMerieux China Ltd.
2195 9348
2010/12/28
Invitrogen Ltd RELI SSO Typing Kits
MHRA
2010/012/020/291/001
FSCA
Invitrogen Hong Kong
Limited
N.A.
2010/12/28
Siemens Healthcare Diagnostics Reagent - 10379635
MHRA
2010/012/016/601/001
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/12/28
Johnson & Johnson Medical ETHILON Suture, ETHIBOND and MERSILENE
Polyester Fiber SUTURES and MERSILK SUTURES, MULTIPLE LOTS
Johnson &
Johnson
Medical (HK)
Ltd.
N.A.
Firm Initiated
Field Action
johnson & Johnson
Medical (HK)
2738 6027
2010/12/28
Siemens Healthcare Diagnostics ADVIA Centaur HIV Ag/Ab Combo (CHIV)
Assay Quality Control Kit reference Number 06520544
MHRA
2010/012/020/601/002
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/12/28
Emergo Europe Viametrics-E Embryo Assessment System
MHRA
2010/012/020/081/011
FSCA
N.A.
N.A.
2010/12/28
Smith & Nephew Renasys-F/P Port Kit
MHRA
2010/012/020/081/005
FSCA
Smith & Nephew LTD
2648 7700
2010/12/30
Boston Scientific Peristaltic Tubing Kit
FDA
Z-0170-2011
Class II
Boston Scientific Hong
Kong Ltd
2960 7136
2010/12/30
Medefil, Inc Medefil Heparin I.V. Flush Syringe
FDA
Z-0599-2011
Z-0600-2011
Z-0601-2011
Class II
N.A.
N.A.
2010/12/30
Encore Medical Turon Humeral Head Trials
Turon Trial Pegged Glenoid
Turon Pegged Glenoid Drill Guide
FDA
Z-0798-2011
Z-0799-2011
Z-0800-2011
Z-0801-2011
Class II
N.A.
N.A.
2010/12/30
Straumann Manufacturing Inc Straumann T-Sleeve 2.8mm, height 6mm
FDA
Z-0320-2011
Class III
N.A.
N.A.
2010/12/30
Stryker External Compression Device (Lot Number: K228113) and Nail Holding
Screw (Lot Number: K101924, K240627)
FDA
Z-0330-2011 and Z-03312011
Class II
Stryker China Ltd
2518 6915
2010/12/31
Beckman Coulter HmX, HmX AL, MAXM and MAXM AL Haematology analyzer
MHRA
2010/012/014/601/001
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/12/31
Varian Medical Systems High Energy C Series Clinacs
Varian Medical
Systems Pacific
Inc.
CP-00480
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2722 8123
Major Safety Alerts in November 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/D Description of Product
D)
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/11/01
BD 30 Gauge Precision Glide Needles
2010/11/01
Tunstall Healthcare RTX/MyMedic 3370 and 3371 Power Adaptors
MHRA
2010/010/026/291/006
FSCA
N.A.
N.A.
2010/11/02
Ultimate Healthcare Double Adjustable Crutch (Forearm Crutch) - Umoc22839
MHRA
2010/010/020/291/010
FSCA
N.A.
N.A.
2010/11/03
Merit Medical Systems Vaclok/Medallion Syringes
MHRA
2010/010/026/081/014
FSCA
King Health Limited
2481 3787
2010/11/04
Siemens Medical Solutions Axiom Luminos dRF
MHRA
2010/010/026/081/005
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/11/04
DePuy S-ROM® Noiles Distal Femoral Cutting Guide (Model no.: 216311001,
216311004)
MHRA
2010/010/026/081/015
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/11/05
Sonosite PowerPark
FDA
Z-2116-2010
Class II
N.A.
N.A.
2010/11/05
Natus SonaMed Clarity System II; evoked response auditory stimulator.
FDA
Z-2165-2010
Class II
Suburfarm Investment
& Trading Co.
2780 9421
FDA
Z-2167-2010 thru Z-21702010
Class II
Solar-Med Limited
2425 0926
FDA
Z-2173-2010
Class II
N.A.
N.A.
FDA
Z-2207-2010
Class II
N.A.
N.A.
2010/11/05
2010/11/05
2010/11/05
Hill-Rom 1) 305 Bed, P1441B - Non electric; 2) 405 Bed, P1440B, (electric); 3)
Basic Care Bed, P1440A (Electric); 4) Basic Care Bed, P1441A (Non-electric)
Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product
Number 30-100-03 Large. Product expiration and lot number on the outer box
lists: 2013/05 with lot number 051700. Inner package label states 2007/08 with
lot number 091103a
Monarch Labs Medical Maggots with the accessory LeFlap dressing
(previously known as Creature Comforts II), 250-500 per vial.
2010/11/05
Insight 1) Cornea Coat Hydroxypropylmethylcellulose 1.5ml Syringe. Sterile,
Rx Only. 2) BIOM Pack, Contents Individually Sterile. Qty 5 ea.
FDA
Z-2220-2010; Z-2221-2010
Class II
N.A.
N.A.
2010/11/05
Beckman SYNCHRON Gentamicin (GEN) Reagent
FDA
Z-2437-2010
Class II
Beckman Coulter Hong
Kong Ltd
2240 6150
FDA
Z-2460-2010
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
FDA
Z-2206-2010
Class III
Biomet UK Ltd
N.A.
2010/11/05
2010/11/05
Philips Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016,
100018 -100025
Biomet Microfixation “1.5MM” System High Torque (HT) Cross-Drive Screw,
Qty 1, 1.5 X 4MM Titanium. REF 91-1504 1 count and REF 95-1504 – 5 Pack.
Lot # 148530
2010/11/05
Gambro ULTRASteriset
Gambro Hong
Kong Limited
MEY-2010-01
Firm Initiated
Field Action
Gambro Lundia AB
2839 9710
2010/11/06
Confluent Surgical Pleuraseal Lung Sealant System
Health Canada
57467
Type I
Covidien
3157 7220
2010/11/08
WalkMed Triton Pole Mount Infusion Pumps
FDA
N.A.
Firm Press
Release
N.A.
N.A.
2010/11/08
Elekta CMS Software Release 4.51.00 and Higher
MHRA
2010/011/001/601/001
FSCA
Elekta Ltd.
2891 2208
2010/11/08
Terumo Europe N.V. Sarns™ Ultrasonic Air Sensor – Air Sensor Cable
MHRA
2010/011/001/291/006
FSCA
TERUMO CHINA
(H.K.) LTD.
2866 0811
2010/11/08
Maquet Critical Care AB Flow-I - 66 77 200 and 66 77 300
MHRA
2010/011/001/291/004
FSCA
Maquet Hong Kong Ltd.
2393 9511
2010/11/08
Champion Photochemistry Naturecare CD2000 and Naturecare CD2020c
MHRA
2010/010/022/081/001
FSCA
N.A.
N.A.
2010/11/08
aap Biomaterials GmbH PerOssal® 1X6 and 2X6 - 03-01031 And 03-01032
MHRA
2010/010/026/291/003
FSCA
N.A.
N.A.
2010/11/08
Roche DiagnosticsCalcium on COBAS INTEGRA® , cobas c111, c311, c501,
c502, c701, c711
MHRA
2010/009/029/291/009
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/08
G & S Smirthwaite Ltd Bath Corner Chairs (part numbers 7511 and 7512 with
the following serial numbers: from 68892/1 to 68892/9, 69072/1 to 69072/7,
69193/1 to 69193/9, 69840/1 to 69840/8, 69872/1 to 69872/3 and 69890/1)
MHRA
2010/003/010/401/005
FSCA
N.A.
N.A.
2010/11/08
Pro-Lab Diagnostics Salmonella Agglutinating Serum HF
Health Canada
56808
Type II
N.A.
N.A.
2010/11/08
Stryker Instruments InterPulse Handpiece System
Health Canada
57258
Type II
Stryker China Ltd
2518 6915
2010/11/08
GE Healthcare IT Centricity Lab - Instrument Interfacing
Health Canada
56321
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/08
GE Medical Systems Information
A) ApexPro Telemetry System - Clinical Information Centre
B) ApexPro Telemetry System - Telemetry Server
Health Canada
56324
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/08
Roche Diagnostics
A) Cobas Integra Calcium (CA)
B) Cobas C 111 Calcium (CA)
Health Canada
57263
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/08
Biolytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kit
Health Canada
55691
Type II
N.A.
N.A.
2010/11/08
Beckman Coulter AU600/AU640 Analyzer - Class 2
Health Canada
57179
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/11/08
Elekta Instruments EXTEND Frame System
Health Canada
57267
Type II
Elekta Ltd.
2891 2208
2010/11/08
Roche Diagnostics Elecsys Anti-HBc IgM Test Kit
Health Canada
57557
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/08
Stryker Endoscopy Instructions for use for Infravision IR Illuminator
Health Canada
57149
Type II
Stryker China Ltd
2518 6915
2010/11/08
Dixtal Medical Hand Held Pulse Oximeter
Health Canada
57872
Type II
N.A.
N.A.
2010/11/08
Beckman Coulter
A) Unicel DXI 600 Access Immunoassay System -Thyroglobulin Assay
B) Access System - Thyroglobulin Assay
C) Unicel DXI 800 Access Immunoassay System - Thyroglobulin Assay
Health Canada
57887
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/11/08
Ethicon Proceed Surgical Mesh
Health Canada
57914
Type II
Johnson & Johnson
Medical (HK) Ltd.
2738 6027
2010/11/08
Sorin Group A) S5 Heart Lung Machine - Display/Control
B) S5 Heart Lung Machine - Roller Pumps
C) S5 HLM-Mast Mounted Roller Pumps
Health Canada
56588
Type II
IntegMed Limited
3527 3062
2010/11/08
Arrow International A) Ultra IAB Catheter Kit
B) Percutaneous Insertion Tray
C) Ultra 8 Intra-Aortic Balloon
Health Canada
57862
Type II
Cemma Enterprise Co.,
Ltd
2412 2310
2010/11/08
Biomerieux Motility-Indole-Ornithine (MIO) Medium
Health Canada
57458
Type III
bioMerieux China Ltd.
2195 9348
2010/11/08
Beckman Coulter
A) Access Toxo IgG Reagents
B) Unicel DXI 800 Access Immunoassay System - Toxo IgG Assay
C) Unicel DXI 600 Access Immunoassay System - Toxo IgG Assay
Health Canada
56164
Type III
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/11/08
Siemens
A) Mobilett XP X-Ray Generator
B) Mobilett XP Hybrid X-Ray Generator
Health Canada
57335
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Siemens Healthcare Diagnostics Dimension Vista System - V-Lyte Integrated
Multisensor - NA K CL
Health Canada
56325
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Cook Triple Lumen Central Venous Catheter
Health Canada
57510
Type III
A.R. Burkill & Sons
(Hong Kong) Ltd.
25411041 or
22981125
2010/11/08
Siemens A) Mobilett Digital
B) Mobilett XP Hybrid
Health Canada
57886
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Abbott Point of Care i-STAT KAOLIN ACT Cartridge
Health Canada
57341
Type III
Abbott Laboratories
LTD.
2593 2211
2010/11/08
Abbott Point of Care
A) i-STAT Portable Clinical Analyzer
B) i-STAT 1 Analyzer
Health Canada
57885
Type III
Abbott Laboratories
LTD.
2593 2211
2010/11/08
Randox Laboratories Assayed Bovine Serum Level 2
Health Canada
54910
Type III
Randox Laboratories
Hong Kong
3595 0515
2010/11/08
BTE Technologies
A) Primus
B) TechTrainer
C) ER (Model ER and TPS)
D) Multi-Cervical Unit (Model MCU 2)
E) Simulator II (Model SIM II5 and SIM II03)
F) Evaluator
Health Canada
57989
Type III
N.A.
N.A.
2010/11/08
ITO Piezo-DX Quartz Crystal Stimulator
Health Canada
56682
Type III
N.A.
N.A.
2010/11/08
Philips Medical Systems Stressvue Exercise Stress Testing System
Health Canada
56847
Type III
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/08
Beckman Coulter
A) S-CAL Calibrator Kit
B) 6C Cell Control
C) 4C Plus Cell Control
D) 4C-ES Cell Control
E) 5C Cell Control
Health Canada
56086
Type III
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/11/08
Siemens Definition + Definition Flash
Health Canada
57174
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Philips Medizin Systeme Boeblingen EGM - Essential Gas Module
Health Canada
57210
Type III
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/08
3M ESPE Dental Products Unitek Primary Stainless Steel Crowns
Health Canada
57508
Type III
3M Hong Kong Ltd
2806 6111
2010/11/08
Roche Diagnostics Elecsys Progesterone Diluent
Health Canada
57452
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/09
Siemens Healthcare Diagnostics Gentamicin (Gent) Flex® Reagent Cartridge,
K4012
MHRA
2010/011/002/081/011
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/10
Beckman Coulter UniCel® DxC and Synchron® LX Clinical Systems which
utilize the 100μL Sample Syringe (P/N 474171)
MHRA
2010/008/006/601/004
FSCA
Beckman Coulter
2240 6150
2010/11/10
Shimadzu Shimadzu UD 150 B, V, L-40
MHRA
2010/008/004/401/008
FSCA
The Industrial
Promoting Co. Ltd.
2548 0126
2010/11/10
Siemens Behring Coagulation System® (BCS) (Product Code OVIO03)
MHRA
2010/011/003/601/004
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/10
Invacare Action 3 NG
MHRA
2010/002/019/401/009
FSCA
Direct Health LTD
2528 1109
2010/11/10
Philips Healthcare IntelliVue Information Center
MHRA
2010/011/002/291/022
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/10
GE Healthcare CARESCAPE Monitor B650 with the battery option, battery
(item number M1178437, “Battery, FLEX-3S3P, Li-ION, 2036984-001)
MHRA
2010/011/001/081/011
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/10
GE Healthcare OEC 9800 Systems with version 29 software and Celeron
Single Board Computer
MHRA
2010/007/028/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/11/10
Micrus Endovascular Microcoil System
MHRA
2010/010/028/291/012
FSCA
N.A.
N.A.
2010/11/11
Wally‟s Ear Candles
FDA
Z-2487-2010
Class II
N.A.
N.A.
2010/11/11
Organogenesis Apligraf (a living, bi-layered skin substitute)
FDA
Z-2589-2010
Class II
N.A.
N.A.
2010/11/11
Stryker PainPump2. REF 525-350, REF 540-350, REF 575-100, REF 575100S1
FDA
Z-2591-2010 thru Z-25942010
Class II
Stryker China Ltd
2518 6915
2010/11/11
Hemostatix 1) Hemostatix Handle, for use with Models 150 and 600D
Hemostatix Controllers; 2) Model P8400 Handle with Integrated Cable, for use
with Model P8400 Controller
FDA
Z-2595-2010; Z-2596-2010
Class II
N.A.
N.A.
2010/11/11
Pride 1) Jazzy Select with XLR Port Harness. 2) Jazzy Select 6 with XLR Port
Harness.
FDA
Z-2618-2010; Z-2619-2010
Class II
N.A.
N.A.
2010/11/11
Arkray Hypoguard, DiaScreen 4pH,
FDA
Z-2634-2010
Class III
N.A.
N.A.
2010/11/11
International Technidyne Corp. Integrated Data Management System - Version
7.1, 7.2 and 7.3; Product code 464100.
FDA
Z-2438-2010
Class III
N.A.
N.A.
2010/11/11
Abbott Point of Care, Inc GCX Mountable Downloader-Recharger
FDA
Z-2462-2010
Class III
Abbott Laboratories
LTD.
2593 2211
2010/11/11
LifeCell Corp Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.
FDA
Z-2623-2010
Class III
N.A.
N.A.
2010/11/11
Ethicon Endo-Surgery Inc Enseal TRIO Product Code ETRIO335H.
FDA
Z-2635-2010
Class II
N.A.
N.A.
2010/11/11
Polymer Technology Systems, Inc. PTS Panels Test Strips, CHOL +HDL+GLU
Panel (Lot no. 1904)
FDA
Z-2641-2010
Class II
Ultronics Enterprise
Limited
2764 5208
2010/11/11
Integral Process Pressure Monitoring Cable
MHRA
2010/011/002/081/007
FSCA
N.A.
N.A.
MHRA
2010/005/011/401/004
FSCA
AGFA Hong Kong
Limited
2555 9421
Peregrine Surgical Endo Ocular Directional Laser Probe, Model numbers: GA0040061; GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA0040066.
FDA
Z-2652-2010
Class II
N.A.
N.A.
2010/11/11
Integra LifeSciences Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator
System CUSANXT1 and CUSANXT2
FDA
Z-2637-2010; Z-2638-2010
Class II
N.A.
N.A.
2010/11/11
Encore Medical Glenoid Head Inserter (RSP Inserter/Impactor), Part #804-03041
FDA
Z-2636-2010
Class II
N.A.
N.A.
2010/11/11
Hospira Gemstar Pump Set
FDA
Z-2627-2010 to Z-2633-2010
Class II
Hospira Limited
2898 2886
2010/11/12
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter (Lot
Numbers : 00111903 & 07890923)
Zimmer PTE
Ltd. (Hong Kong
branch)
N.A.
Firm Initiated
Field Action
Zimmer PTE Ltd.
(Hong Kong branch)
N.A.
2010/11/13
Sigma Spectrum Infusion Pump Model 35700
FDA
N.A.
Class I
N.A.
N.A.
2010/11/15
pwbHealth Breastlight; model #BL801
Health Canada
N.A.
Advisories and
Warnings
N.A.
N.A.
2010/11/15
Terumo Cardiovascular Systems Sterile blade for Sarns Sternal Saw II System
Terumo China
(Hong Kong)
Limited
AA-2010-005-C
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/11/16
BD 5 ml plastipak syringe luer-lok™ tip (Reference Number: 300911; Lot
Number: 10E05F)
MHRA
2010/011/003/081/006
FSCA
BD
2575 8668
2010/11/16
Beckman Coulter Unicel® DxH™ 800 Coulter® cellular analysis system and
floor cabinet
MHRA
2010/009/028/601/002
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/11/17
Volcano Europe Lumen Xtract™ Aspiration Catheter, 1451-001 size 4.2F and
1451-003 size 5.8F
MHRA
2010/011/012/081/027
FSCA
N.A.
N.A.
2010/11/17
TauroPharm Taurolock™ Heparin 500
MHRA
2010/004/014/081/019
FSCA
N.A.
N.A.
2010/11/17
Ferno Pegasus Stretcher Trolley and Megasus Stretcher Trolley
MHRA
2009/007/006/601/002
FSCA
N.A.
N.A.
2010/11/17
Hospital Metalcraft BA/VH baby crib unit
MHRA
2009/010/016/401/007
FSCA
N.A.
N.A.
2010/11/17
GE Healthcare Centricity™ PACS-IW; Software Versions: 3.7.1, 3.7.2, 3.7.3,
3.7.3.1, 3.7.3.2, 3.7.3.3
MHRA
2010/011/009/081/021
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/17
Penlon Crystal ® Metal Miller 0 Disposable Blades
MHRA
2009/007/016/401/010
FSCA
N.A.
N.A.
2010/11/11
AGFA IMPAX Image Viewer
2010/11/11
2010/11/18
Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN
1700CS (list numbers 03H57-01, 03H57-03)
MHRA
2010/010/021/601/002
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/11/19
Maquet HLM Tubing set with Bioline Coating
FDA
Z-0011-2011
Class II
Maquet Hong Kong Ltd.
2393 9511
2010/11/19
Navilyst Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose
Drainage Catheter with Hydrophilic Coating.
FDA
Z-0015-2011
Class II
N.A.
N.A.
2010/11/19
Atrium HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight - Product
Code 14124; 32 Fr Straight - Product Code 14132.
FDA
Z-0019-2011; Z-0020-2011
Class II
N.A.
N.A.
2010/11/19
Boston Scientific PrecisionTM Implantable Pulse Generator
MHRA
2010/011/005/081/004
FSCA
Boston Scientific Hong
Kong Ltd
2960 7136
2010/11/19
Philips Healthcare Philips IntelliVue Clinical Information Portfolio (ICIP)
Releases D.00 through D.03
MHRA
2010/011/011/081/003
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/19
Philips BABIX holder is an accessory used with the BuckyDiagnost X-ray
system
FDA
Z-0021-2011;Z-0022-2101
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/19
Cenorin LD SYSTEM 520, 540, 540HT and the Routine Service Kit #08239500 or Part #030500-00 for HLD SYSTEM.
FDA
Class II
N.A.
N.A.
2010/11/19
B.Braun Medical A.M.ENDO FEN STD TI 48MM STERILE
MHRA
2010/011/004/601/002
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/11/19
Trinity Biotech Captia Measles IgM Kit (Product Code 2326060, lot 019 and
020)
MHRA
2010/011/012/081/020
FSCA
N.A.
N.A.
2010/11/19
Penumbra Reperfusion Catheter 032 (lot F15020)
MHRA
2010/011/011/081/024
FSCA
N.A.
N.A.
2010/11/19
AidFast, 1st Aid, Powerplast Digital Thermometers
MHRA
N.A.
Press Release
N.A.
N.A.
2010/11/20
Roche Diagnostics A) Factor V Leiden Kit for Light Cycler V2, B) Factor II
(Prothrombin), C) MagNA Pure LC 2.0 Instrument
Health Canada
58282
Type I
Roche Diagnostics
(Hong Kong) Ltd
N.A.
2010/11/22
Animas ezManager Max Diabetes Management. Model number: 100-467-23,
100-467-50. Lot numbers: 3055028, 3061074, 3055029, 3061121
Health Canada
58092
Type III
Johnson & Johnson
Medical (HK)
2738 6027
Z-0036-2011 to Z-0039-2011
2010/11/22
Pentron A) Flow-IT ALC Flowable Composite System with Bond I Kit
B) Lute-IT Esthetic Luting System Refills
C) Bond 1-Primer/Adhesive Kit
D) Bond I - Refills Primer/Adhesive 4ml and 6ml
E) Bond I - C&B Primer/Adhesive
F) Cement-It Universal C&B Resin
G) Alert Syringe Kit
H) Mojo Veneer Cement Kit
Health Canada
55339
Type III
N.A.
N.A.
2010/11/22
AGFA IMPAX Mammography Keypads. Model number: 5O4RU000
Health Canada
58203
Type III
AGFA Hong Kong
Limited
2555 9421
2010/11/22
Ventana Jones Staining Kit. Model number: P/N 860-019. Lot number: 812498
Health Canada
57966
Type III
N.A.
N.A.
2010/11/22
Millar Disposable Angiographic Catheters. Model number: SPC-454D. Lot
number: 466255, 466256, 435426
Health Canada
58310
Type III
N.A.
N.A.
2010/11/22
Medtronic StealthStation S7 - Cart. Model number: 9733856. Lot number:
4500707425 & 4501132005
Health Canada
58454
Type III
Medtronic International,
Ltd.
2919 1300
2010/11/22
Davol Ventrio Hernia Patch. Model number: 0010212 Lot number: HUUG1825
Health Canada
58090
Type III
N.A.
N.A.
2010/11/22
Nipro Europe NV Elisio-21H/10I16C, Elisio-21H/10I20C
MHRA
2010/011/016/081/027
FSCA
N.A.
N.A.
2010/11/22
Emergo Europe Fastx™ Sternal Intraosseous Device
MHRA
2010/011/012/081/008
FSCA
N.A.
N.A.
2010/11/22
Nikkiso Europe GmbH EF-02 D Filter for Dialysate Purification
MHRA
2010/004/019/081/008
FSCA
N.A.
N.A.
2010/11/22
Leica Bond Polymer Refine Detection Ds9800
MHRA
2010/011/005/081/007
FSCA
Leica Microsystems
Limited
2564 6699
Health Canada
58313
Type II
N.A.
N.A.
2010/11/22
2010/11/22
Depuy Spine Mountaineer Skinny LS Caddy
Health Canada
58461
Type II
N.A.
N.A.
2010/11/22
Smith & Nephew SureShot Targeting System - Targeter
Health Canada
58439
Type II
Smith & Nephew LTD
2648 7700
2010/11/22
Microaire Surgical Instruments Keyless Drill Chuck for Series 1000 Powered
Small Bone System - Couplers
Health Canada
58160
Type II
N.A.
N.A.
2010/11/22
Elekta Focal Software CD
Health Canada
58235
Type II
Elekta Ltd.
2891 2208
2010/11/22
Accuray CyberKnife Robotic Radiosurgery System Base CyberKnife (028000, 030000, 032000)
Health Canada
58285
Type II
Accuray Asia Ltd
2247 8628
2010/11/22
Datex-Ohmeda A) Aisys Carestation Anesthesia System
B) GE Datex-Ohmeda Avance Anesthesia System
Health Canada
56153
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/22
Technidata TD-Synergy software (TD-SYN-01)
Health Canada
58406
Type II
N.A.
N.A.
2010/11/22
Philips Healthcare 1) Easy Diagnost - Radiographic/Fluroscopic Diagnostic; 2)
Digital Diagnost; 3) Bucky Diagnosty; 4) Easydiagnost Eleva; 5) Trauma
Diagnost
Health Canada
58409
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/22
Philips Healthcare OmniDiagnost Eleva
Health Canada
58510
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/22
Medefil Heparin I.V. Flush Syringe
Health Canada
58531
Type II
N.A.
N.A.
2010/11/23
ev3 Nanocross™ .014 OTW Dilatation Catheter
MHRA
2010/011/017/081/002
FSCA
Sinomed Company Ltd.
2887 7640
2010/11/23
Aesculap AG Microspeed Arthro Steuereinheit GD665 and GD670
MHRA
2010/011/016/291/008
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/11/23
Abbott / Roche Diagnostics Freestyle / Accu-chek portable blood glucose
meters
TGA
N.A.
Updated
Advisory
N.A.
N.A.
2010/11/23
Terumo Cardiovascular Systems CDI 100, 101 Hemotocrit/Oxygen Saturation
Monitoring System
AA-2010-004-C-100
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/11/23
Terumo Cardiovascular Systems CDI 500 Blood Parameter Monitoring System
AA-2010-004-C-500
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/11/24
Micromedics Surgical Sealant Dispensers; Micromedics Nasal Septal Buttons;
Otological Ventilation Tubes
FDA
N.A.
Class I
N.A.
N.A.
2010/11/24
Ulrich CO2 Insufflator / CO2 Flow
MHRA
2010/011/008/081/001
FSCA
N.A.
N.A.
2010/11/25
Biomet Closed knot pusher REF 902813 Unit: 098750, 278290, 538080,
666270, 864100 and 948870
FDA
Z-0059-2011
Class II
N.A.
N.A.
Terumo China
(Hong Kong)
Limited
Terumo China
(Hong Kong)
Limited
2010/11/25
Baxter Baxter Interlink System Buretrol Solution Set. Lot number: GR288365
FDA
Z-0070-2011
Class II
Baxter Healthcare Ltd
2807 8555
2010/11/25
Beacon Medical Gas Controller Panel
MHRA
2010/008/016/401/008
FSCA
N.A.
N.A.
2010/11/25
Impac Medical Systems Sequencer Verify & Record System
FDA
Z- 0076-2011
Class II
N.A.
N.A.
2010/11/25
Defibtech DDC-6-AA Data Card, an accessory to the Sentry DDU-100
semiautomatic external defibrillator (AED)
FDA
Z-0077-2011
Class II
N.A.
N.A.
2010/11/25
Medica EasyRA Cuvette Segment 1
FDA
Z-0078-2011
Class II
N.A.
N.A.
2010/11/25
Smith & Nephew R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER,
UHMWPE, CO-CR, TI-6AL-4V
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
FDA
Z-0079-2011
Z-0080-2011
Z-0081-2011
Z-0082-2011
Z-0083-2011
Z-0084-2011
Z-0085-2011
Z-0086-2011
Class II
Smith & Nephew LTD
2648 7700
2010/11/25
Theken Spine LLC Anterior Cervical Plate (ACP) System
FDA
Z-0087-2011
Class II
N.A.
N.A.
2010/11/25
Philips Medical Systems Philips BV Pulsera R2.2 Mobile X-Ray system; Philips
BV Endura R2.2 Mobile X-Ray system
FDA
Z-0140-2011; Z-0141-2011
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/25
SCC Soft Computer SoftMic Versions 4.0.4.7, 4.5.1.3
FDA
Z-0088-2011
Class II
N.A.
N.A.
2010/11/26
Medtronic Ablation Frontier Model 990018 GENius Multi-Channel RF Generator
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2919 1362
2010/11/29
Lifecare Hospital Supplies Ltd L2000 & L2001/S Adult Duo Mask and L2009
Clear View Adult Mask
MHRA
2010/010/005/601/001
FSCA
N.A.
N.A.
2010/11/30
Varian C-Series Clinacs (Models H14, H18, H29)
MHRA
MDA/2010/091
MDA
Varian Medical
Systems Pacific Inc.
2724 2836
2010/11/30
Advanced Bionics SARL hires 90K - Ci-1400-01, Ci-1400-02H
MHRA
2010/011/025/291/021
FSCA
Advanced Bionics Asia
Pacific Limited
91013831
2010/11/30
Stanmore METS Tibial Rotating Hinge Metal Cased Assembly, Small, Short
stem batch A7203
MHRA
2010/011/023/291/013
FSCA
N.A.
N.A.
2010/11/30
Ortho-Clinical Diagnostics VITROS® 5600 Integrated & 5,1 FS chemistry
system
MHRA
2010/009/028/601/005
FSCA
Ortho Clinical
Diagnostics
2737 5504
2010/11/30
Innogenetics INNOTEST hTAU Ag; product code 80323; batch 212537
MHRA
2010/011/022/081/013
FSCA
N.A.
N.A.
2010/11/30
Siemens Medical Solutions Immulite 1000/2000/2000 XPi/ Immulite 2500
MHRA
2010/011/019/081/015
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
Major Safety Alerts in October 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
Source of
Alert Type by
(YYYY/MM/D Description of Product
Reference No. by Source
Information*
Source
D)
Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical
2010/10/04
FDA
Z-2286-2010 ; Z-2287-2010
Type II
Sutures; EP4084N; EP1081P
2010/10/04
2010/10/04
2010/10/04
2010/10/04
MDC Acquisition ReliaMed Deluxe Portable Adjusting Table
3m Imtec 3M Red Dot Monitoring Electrode, Catalog #2560; Novaplus
Universal Monitoring Electrode #V2560
Roche ONLINE TDM N-acetylprocainamide reagent; Part number
04642520190
Hospira Hospira brand Symbiq One-Channel Infuser LIST No. 16026; Hospira
brand Symbiq Two-Channel Infuser, LIST No. 16027
Local Agent
Agent Contact
Telephone No.
N.A.
N.A.
FDA
Z-2288-2010
Type II
N.A.
N.A.
FDA
Z-2383-2010
Type II
N.A.
N.A.
FDA
Z-2386-2010
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
FDA
Z-2390-2010 ; Z-2391-2010
Type II
Hospira Limited
2898 2886
2010/10/04
Cardinal Medi-Vac Non-Conductive Tubing (with 9 different dimensions)
FDA
Z-2450-2010 thru Z-24582010
Type II
Solar-Med Limited
2425 0926
2010/10/04
Philips Medical Systems North America Co. Nuclear Magnetic Resonance
Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil
12nc on coil: 4535-671-4188x
FDA
Z-2461-2010
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/10/04
Philips Medical Systems Philips BV Pulsera Mobile X-Ray system with the
extended rotation option; Philips BV Endura Mobile X-Ray system with the
extended rotation option
FDA
Z-2463-2010 ; Z-2464-2010
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/10/04
TransEnterix Spider Flex Monopolar Hook (Spider Surgical Instruments),
TransEnterix. Model number: 9000031
FDA
Z-2465-2010
Type II
N.A.
N.A.
2010/10/04
Medela Breast pump. Article # 67099S, 67116S, 67093S, and 67094S
FDA
Z-2483-2010 thru Z-24862010
Type II
Celki Medical Company
2332 3366
2010/10/04
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation
device, Model Number 01-242208
FDA
Z-2580-2010 ; Z-2581-2010
Type II
N.A.
N.A.
2010/10/04
Integra LifeSciences Integra Suction Reservoir Kit for use with Integra
NeuroSciences Subdural Drainage Catheter; Sterile, Rx only
FDA
Z-2588-2010
Type II
N.A.
N.A.
2010/10/04
Ventus The Provent Nasal Cannula
FDA
Z-2435-2010
Type II
N.A.
N.A.
2010/10/04
BD CD10 Apc, CD10 Pe, CD10 Pe-Cy7, CD10 Fitc And Bd Oncomark
CD5/CD10/CD19
MHRA
2010/009/014/081/017
FSCA
BD
2575 8668
2010/10/04
Rocket Medical Probe - R60547
MHRA
2010/006/022/601/003
FSCA
N.A.
N.A.
2010/10/04
Mountway Smart Charger
MHRA
2010/009/023/301/001
FSCA
N.A.
N.A.
2010/10/04
GE Brightspeed Elite, Brightspeed Excel Select, Brightspeed Edge Select,
Brightspeed Elite Select
MHRA
2010/009/027/081/008
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/04
Starion Instruments Corp Starion Instruments Corp - TLS3 35cm Thermal
Ligating Shears
MHRA
2010/009/016/081/001
FSCA
Ho Yeung Company Ltd
24189130
2010/10/04
Spacelabs Healthcare Ultraview Sl2200, Ultraview Sl2400 and Ultraview
Sl2600 all with Option-X - 91367-X, 91369-X and 91370-X
MHRA
2010/009/029/291/003
FSCA
N.A.
N.A.
2010/10/04
Thermo Fisher HM550 Cold-Disinfection
Microm
International
GmbH
N.A.
Firm Initiated
Field Action
Thermo Fisher
Scientific (HK) Ltd.
2885 4613
2010/10/05
Beckman Coulter Cyto-Stat tetraCHROME reagents - Pn: 6607013 And
6607073
MHRA
2010/009/021/601/004
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/10/05
Joerns Voyager Ceiling Hoist X-Y Gate System
MHRA
2009/010/012/261/001
FSCA
N.A.
N.A.
2010/10/06
Siemens Acuson X300 and X300 PE Diagnostic Ultrasound Systems
MHRA
2010/009/024/051/007
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/10/08
The Helping Hand Standing/Walking Sling, Kloop Sling, Clip Sling, Universal
Loop Sling, Anti-Spasm Sling, Hygiene Sling
MHRA
2010/003/018/401/003
FSCA
N.A.
N.A.
2010/10/08
Siemens Dimension Vista Intelligent Laboratory System with Alpha Pinnacle
10kVA UPS External Battery Pack
FDA
Z-2423-2010
Type II
Siemens Healthcare
Diagnostic Limited
2870 7827
2010/10/08
Lab Vision NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody
(Clone SP4), immunochemistry Reagent and Kit
FDA
Z-2424-2010
Type II
N.A.
N.A.
2010/10/08
First Quality Hygienic Life Brand Regular Absorbency 40 Count Unscented
Plastic Applicator Tampons
FDA
Z-2466-2010
Type II
N.A.
N.A.
2010/10/08
Wright Medical Technology Driver Star #8 Cannulated Dart-Fire (TM),
Compression Screw, Size: #8, REF: DSDS-0008, 1 Each, Rx only Non-Sterile
FDA
Z-2470-2010
Type II
Hong Kin Medical
Instrument Ltd.
2357 0397
2010/10/08
Biomet, Inc 7,8,9,10 MM DISPOSABLE CORING TREPHINE WITH
PROTECTION SLEEVE; 7,8,9,10 MM DISPOSABLE DOWEL HARVEST
TUBE WITH PROTECTION SLEEVE; 8 MM DISPOSABLE CORING
TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE
FDA
Z-2597-2010 thru Z-26052010
Type II
Swedish Trading Co.,
Ltd
2953 5111
2010/10/08
Beckman Coulter Access Immunoassay Systems Free T4
FDA
Z-2658-2010
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/10/08
Otech Medical Sarl A) BD2XV, SAGB Quick Close Swedish Adjustable Gastric
Band including VelocityTM Injection Port and Applier
B) BD3XV, SAGB VC Swedish Adjustable Gastric Band including VelocityTM
Injection Port and Applier
Johnson &
Johnson
Medical (HK)
Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Medical (HK) Ltd.
2738 6027
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2919 1300
ConvaTec (Unomedical) Feeding systems and tubes: naso gastric feeding
tube with male Luer Lock connectors only. Lot number: 332000
MHRA
2010/010/004/081/016
FSCA
N.A.
N.A.
2010/10/11
Zimmer Nexgen® Complete Knee Solution Legacy® Knee Posterior -Stabilized
LPS Components
MHRA
2010/009/024/081/017
FSCA
N.A.
N.A.
2010/10/11
Merck Serono Cortrak
MHRA
2010/009/024/051/002
FSCA
Merck Serono Ltd.
N.A.
2010/10/11
Fresenius Kabi Blood Sampling Device in the Composelect and Compoflex
Bloodbag Systems
MHRA
2010/009/023/081/001
FSCA
Fresenius Kabi Hong
Kong Ltd.
2116 2683
2010/10/11
Ethicon Endo-Surgery (EES) (a J & J Company) Endopath XCEL with
OPTIVIEW technology (B12LT, H12LP, D11LT)
Johnson &
Johnson
Medical (HK)
Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Medical (HK) Ltd.
2738 6027
2010/10/11
Allergan Lap-Band® Gastric Band System (LAGB® ); B-200260 & B-20265
Allergan
N.A.
Firm Initiative
Field Action
Allergan Asia Limited
2610 2525
2010/10/12
Coloplast Rectal Catheter, Peristeen Anal Irrigation System
MRHA
2009/011/004/081/001
FSCA
Coloplast (Hong Kong)
Ltd
3628 7428
2010/10/12
Gambro EverFlow Dolphin Protect hemodialysis catheter MC-GDPK-1521, MCGDPK-1525, C-GDPK-1529
MRHA
2010/010/006/081/025
FSCA
Gambro Lundia AB
2839 9710
2010/10/12
Biomet Disposable Coring Trephine and Disposable Dowel Harvest Tube
MRHA
2010/007/010/601/001
FSCA
Biomet UK Ltd
N.A.
2010/10/12
BD ProbeTec CT/GC/AC Reagent Pack, Lot no. 0158908, 0158969
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668 ext.
252
2010/10/12
Philips Comprehensive Cardiac Analysis (CCA) - Functional Analysis Feature
Philips
Electronic Hong
Kong Ltd
FSN72800509
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5364
2010/10/12
Medtronic Model 5388 Dual-Chamber External Temporary Pulse Generator
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2919 1300
2010/10/13
Systagenix Wound Management Release* Non-Adherent Absorbent Dressing
(Lot 1032, 1033, 1034, 1035 and 1036)
MHRA
2010/010/004/081/015
FSCA
N.A.
N.A.
2010/10/13
BD Vacutainer Push Button Collection Set (PBBCS) 23 gauge .75 in x 12 in
tubing and luer adapter, specific Lot No.
BD (HK) Ltd.
N.A.
Firm Initiated
Field Action
BD
2575 8668 ext.
252
2010/10/08
Medtronic NIM 3.0 Patient Interfaces - All serial numbers
2010/10/11
2010/10/13
CareFusion Alaris PC Unit Model 8015
Health Canada
56561
Type I
CareFusion Hong Kong
Ltd.
2891 8730
2010/10/13
CareFusion Alaris PC Unit Model 8000
Health Canada
56581
Type I
CareFusion Hong Kong
Ltd.
2891 8730
2010/10/13
Hospira A) Symbiq Microbore Sets, B) Symbiq Pump Burette Set, C) Symbiq
Pump Set, D) Hema Primary Symbiq, E) Primary Symbiq Set
Health Canada
56435
Type II
Hospira Limited
2898 2886
2010/10/13
Steris C-Max Surgical Table
Health Canada
56495
Type II
Swedish Trading Co.
Ltd.
6199 0634
2010/10/13
Elliquence FT Series Electrodes
Health Canada
56495
Type II
N.A.
N.A.
2010/10/13
Allied Healthcare CarboLime (Carbon Dioxide Absorbent)
Health Canada
56336
Type II
N.A.
N.A.
2010/10/13
Gaymar A) Medi-Temp III, B) T-Pump, C) Sof-Care Inflator
Health Canada
56580
Type II
N.A.
N.A.
2010/10/13
Baxter A) Non-DEHP Y-Type Catheter Extension Sets, B) Clearlink Y-Type
Catheter Extension Set, C) Extension Set with Stopcock & Interlink, D)
Catheter Extension Set with Luer Valve, E) Micro-Volume Infusion Set with
Needle
Health Canada
56586
Type II
Baxter Healthcare Ltd
2807 8555
2010/10/13
GE Web, Pocket And Cellular Viewers
Health Canada
44728
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/13
Beckman Coulter A) Access System-Total T4 Assay, B) UNICEL DXI 600
Access Immunoassay System- Total T4 Assay, C) UNICEL DXI 800 Access
Immunoassay System-Total T4 Assay
Health Canada
56619
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/10/13
TriPath Imaging PrepStain
Health Canada
56658
Type II
N.A.
N.A.
2010/10/13
Siemens EasyLink Informatics system V3 (Model. 100034941)
Health Canada
01/12/2053
Type III
Siemens Healthcare
Diagnostics Inc.
N.A.
2010/10/13
Verathon A) BladderScan BVI 9600 with AortaScan ConsoleB) BladderScan
BVM 9500 Console
Health Canada
02/08/2055
Type III
Verathon Inc.
N.A.
2010/10/13
Biohorizons Single Stage 3.5mm Healing Abutment (Model: SYHA40, Lot.
0903233)
Health Canada
27/9/2054
Type III
Biohorizons Implant
Systems, Inc.
N.A.
2010/10/13
Beckman Coulter AcT 5 Diff Series Hematology Analyzers (Model: 175356,
6605580, 6605641)
Health Canada
14/6/2053
Type III
Beckman Coulter, Inc.
N.A.
2010/10/14
Lifescan (Johnson & Johnson) One Touch Ultra Test Strips
FDA
Z-2639-2010
Class II
Johnson & Johnson
Medical (HK)
2738 6027
2010/10/14
Olympus Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1DF08E
FDA
Z-2642-2010
Class II
Olympus Hong Kong
and China Ltd
2170 5678
2010/10/14
Multi-Med Huber needles
FDA
N.A.
Class I
N.A.
N.A.
2010/10/14
Fresenius proHD set (Product no. 5085901)
Fresenius
Medical Care
Hong Kong Ltd.
N.A.
Firm Initiated
Field Action
Fresenius Medical
Care Hong Kong Ltd.
2583 0813
2010/10/15
Hemocue AB Glucose 201 DM Analyzer And Hemocue Hb 201 DM Analyzer
MHRA
2010/010/012/081/010
FSCA
Science International
Corp.
2543 7442
2010/10/15
BD PrepStain Vacuum Pump (all Schuco and KNF Neuberger models)
BD (HK) Ltd.
N.A.
Firm Initiated
Field Action
BD (HK) Ltd.
2575 8668 Ext.
252
2010/10/15
Park House Static pressure distribution mattresses
MHRA
2009/011/016/261/004
FSCA
N.A.
N.A.
2010/10/15
Siemens Medical Solutions UK ARTISTE™/ONCOR™/PRIMUS™ Digital
Linear Accelerators Model Number 5857912
MHRA
2010/010/004/081/026
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/10/15
Medtronic Model 8731SC Intrathecal Catheter Kit and Model 8598A Spinal
Segment Revision Kit
MHRA
2010/010/008/291/007
FSCA
Medtronic International,
Ltd.
2919 1300
2010/10/15
GE Healthcare Signa OpenSpeed, 0.7T and Signa Ovation, 0.35T MR System
MHRA
2010/010/008/081/008
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/18
BD Needle 24G 1IN TW VIOLET NS
Syringe 3ml LL 23G 1IN TW
Syringe 3ml LS 24G 1IN TW
Syringe 1ml LS 27G 1/2IN ID
Syringe 1ml LS 28G 1/2IN ID
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/10/18
Varian FastPlan SRS Treatment Planning Systems
Varian Medical
Systems Pacific
Inc.
CP-02327 / CTB-694
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2722 8122
2010/10/18
Olympus Endoscope Washer Disinfector - Olympus Etd3 Plus
MHRA
2010/009/027/081/014
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/10/18
Roche Diagnostics Accu-Chek Multiclix in Accu-Chek Aviva Expert Kits
MHRA
2010/009/030/291/015
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2481 3387
2010/10/18
Smiths Medical Level 1® Normothermic I.V. Fluid Administration Sets, Product
Codes D-60 HL and DI-60HL
MHRA
2010/010/007/081/022
FSCA
N.A.
N.A.
2010/10/21
Leica Microsystems Bond Ready-To-Use Primary Antibody Thyroid
Transcription Factor-1 (SPT24); Lyophilized Mouse Monoclonal Antibody
Thyroid Transcription Factor-1; Liquid Mouse Monoclonal Antibody Thyroid
Transcription Factor-1
FDA
Z-2497-2010 thru Z-24992010
Class II
Leica Microsystems
Limited
2564 6699
2010/10/21
Linvatec GATOR. REF 9263A, 4.2mm Sterling Blade, Sterile RX Only
FDA
Z-2503-2010
Class II
N.A.
N.A.
2010/10/21
Biomet 1) Modular Microplasty Cup inserter 3/8" thread, REF 31-400600; 2)
Modular Microplasty Cup impactor 1/4" - 28 thread insert, REF 31-400605.
FDA
Z-2504-2010, Z-2505-2010
Class II
N.A.
N.A.
2010/10/21
ConvaTec (Unomedical) Engenex Non Acute Care Suction Cup for use with
Engenex Negative Pressure Wound Therapy.
FDA
Z-2609-2010
Class II
N.A.
N.A.
2010/10/21
Covidien AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:
6066; Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code: 6067.
FDA
Z-2656-2010, Z-2657-2010
Class II
Covidien
3157 7220
2010/10/21
Inverness 1) UCG Slide Test; Rapid latex agglutination inhibition slide test for
the detection of hCG in urine. Used in the diagnosis of pregnancy. 2) UCG
Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the
detection of hCG in urine. This test is used for the diagnosis of pregnancy.
FDA
Z-2500-2010, Z-2501-2010
Class III
N.A.
N.A.
2010/10/21
Spacelabs Healthcare TruLink Pre-wired Neonate ECG Electrodes PN:6850037-00 (Lot. 0904014-1007064)
MHRA
2010/010/015/081/019
FSCA
Spacelabs Healthcare
Inc.
N.A.
2010/10/21
Trumpf Orbiter patient transfer system
MHRA
2010/009/008/081/010
FSCA
Trumpf Medizin
Systeme GmbH
N.A.
2010/10/21
Siemens Healthcare Diagnostics Immulite 2500 HCG
MHRA
2010/009/028/291/008
FSCA
N.A.
N.A.
2010/10/21
GBUK Healthcare Suction Catheter TT03-14-T34-N
MHRA
2010/010/004/601/002
FSCA
N.A.
N.A.
2010/10/21
Siemens 4Z1c matrix array transducers on the Acuson SC2000™ volume
imaging ultrasound system
MHRA
2010/010/006/081/021
FSCA
N.A.
N.A.
2010/10/21
Spacelabs Healthcare Inc. WA Elance Vital Signs Monitor, model 93300
MHRA
2010/010/015/081/018
FSCA
Schmidt BioMedTech
(H.K.)
2620 8329
2010/10/21
Stryker Universal Flat Panel Yoke
MHRA
2010/010/012/081/004
FSCA
Stryker China Ltd
2518 6915
2010/10/22
BioMerieux Immuno VIDAS HIV DUO QUICK
bioMerieux
China Ltd.
N.A.
Firm Initiated
Field Action
bioMerieux China Ltd.
2195 9348
2010/10/22
GE Healthcare OEC 9800 C-Arm and OEC 9900 C-Arm
MHRA
2010/010/013/081/012
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/22
Boston Scientifc Expect Enscopic Ultrasound Aspiration Needle
2010/10/22
Philips Allura Xper Systems and Allura Integris Systems Multi Diagnost Eleva
and Omni Diagnost Eleva Systems
2010/10/22
Boston Scientific Matrix 2 Detachable Coil
2010/10/25
Boston
Scientific Hong
Kong Ltd
Philips
Electronic Hong
Kong Ltd
Boston
Scientific Hong
Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
XCR603-100324
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5364
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
Elekta XIO Radiation Treatment Planning System (Release 4.2.0 and higher )
Health Canada
56660
Type II
Elekta Ltd
2891 2208
2010/10/25
Bio-Rad IN2IT (I) A1C Test Cartridges, Kit 072T100 / Cartridge 39088
Health Canada
56751
Type II
Bio-Rad Pacific Ltd.
2272 8926
2010/10/25
Dental Equipment Dental Chair Magnetic Headrest Assembly
Health Canada
53872
Type II
N.A.
N.A.
2010/10/25
Zimmer
A) Bigliani/Flatow Shoulder IM Reamers
B) TM Shoulder Instrument Distal Pilot
Health Canada
56687
Type II
Zimmer PTE Ltd.
(Hong Kong branch)
N.A.
2010/10/25
American Medical Systems Advance Male Sling System
Health Canada
56924
Type II
N.A.
N.A.
2010/10/25
Elekta XIO Radiation Treatment Planning System Release 4.3.0 & Higher
Health Canada
56972
Type II
Elekta Ltd
2891 2208
2010/10/25
Welch Allyn PIC 50
Health Canada
56795
Type II
N.A.
N.A.
2010/10/25
Philips Essenta DR Compact
Health Canada
56346
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/10/25
Medline Industries Evacuator Kit with Drain and Trocar
Health Canada
56615
Type II
N.A.
N.A.
2010/10/25
Beckman Coluter A) UniCel DxC 600 and UniCel DxC 600 PRO
B) UniCel DxC 800 and UniCel DxC 800 PRO
C) UniCel DxC 600I Synchron Access Clinical Analyzer
D) UniCel DxC 880I Synchron Access Clinical Analyzer
E) Synchron LXI 725
F) Synchron LX20 Pro
G) UniCel DxC 660i Synchron Access Clinical Analyzer
H) UniCel DxC 600i Synchron Access Clinical Analyzer
I) UniCel DxC 860i Synchron Access Clinical Analyzer
Health Canada
56657
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/10/25
Linvatec Corporation D.B.A. Conmed Linvatec Arthroscopy Outflow/Suction
Tubing Set (Model: 24K100, Lot: 22747-000, 22749-000)
Health Canada
56697
Type II
N.A.
N.A.
2010/10/25
Beckman Coulter A) Synchron CX5, CX5 Delta and CX5 CE Clinical Systems
(Model: 448700, 468243, 759300)
B) Synchron CX4, CX4 Delta and CX4 CE Clinical Systems (Model: 468233,
756600)
C) Synchron CX7 and CX7 Delta Clinical Systems (Model: 468205, 756601)
D) Synchron CX9 ALX Clinical System (Model: 473513)
Health Canada
56656
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/10/25
Sybron Microseal Master Cones, Model no.: 815-9033
Health Canada
56894
Type III
N.A.
N.A.
2010/10/25
Lab Vision Lab Vision Autostainer
Health Canada
56938
Type III
N.A.
N.A.
2010/10/25
Sybron RealSeal Accessory Points
Health Canada
56974
Type III
N.A.
N.A.
2010/10/25
Verathon ScanPoint Communication Cradle
Health Canada
56806
Type III
Verathon Inc.
N.A.
2010/10/25
Becton Dickinson PrecisionGlide needle 30 gauge
Health Canada
56442
Type III
Becton Dickinson Asia
Ltd.
2575 8668
2010/10/25
TOSOH BIOSCIENCE LTD Tosoh AIA-PACK B12
MHRA
2009/001/014/401/008
FSCA
N.A.
N.A.
2010/10/25
DiaMed GmbH Diaplastin-E Liquid
MHRA
2010/009/021/081/026
FSCA
N.A.
N.A.
2010/10/25
Stryker Scorpio Fixed Femoral AP Sizing Guide, Scorpio Sizing Guides
(Catalog no.: 8000-0313, 8001-0313, Limited to lots beginning with the letters
“RD”)
MHRA
2010/010/012/081/018
FSCA
Stryker Europe, Middle
East & Africa
N.A.
2010/10/25
Philips CS X-ray Ceiling Suspension
MHRA
2010/009/029/291/013
FSCA
Philips Healthcare
N.A.
2010/10/25
MIS Digital image processing unit
MHRA
2010/006/010/401/012
FSCA
MIS Healthcare Ltd, EcomTechnology Limited
N.A.
2010/10/25
Novalung Vision Alpha Ventilator / Metran R 100 (Vision Alphas with Serial
Numbers 139 to 159)
MHRA
2010/009/024/081/012
FSCA
Novalung GmbH
N.A.
2010/10/25
AngioDynamics Habib 4x Kit Bipolar Resection Device
MHRA
2010/009/027/081/005
FSCA
AngioDynamics UK Ltd
N.A.
2010/10/25
MDSS Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog
Number 12-712, Lot # MV0146
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog
Number 12-713, Lot # MC0146
Cholestech LDCX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10982, Lot # SV0146
Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10983, Lot # SC0146
Cholestech LDX Calibration Verification, Levels 1 - 4, Catalog Number 11-255,
Lot # 0146
MHRA
2010/010/011/081/006
FSCA
MDSS (Medical Device
Safety Service) GmbH,
Alere, Inc.
N.A.
2010/10/25
Medtronic Sprint Quatrro Secure S 6935 and Sprint Quattro Secure 6947
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2919 1300
2010/10/26
Varian Exact Couch for Clinac or Acuity (Trapping Zones)
CP-02427E
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2722 8123
2010/10/26
Karl Storz Endoscopy UK Ltd AIDA Compact II Image Capture System
(Software v 2.4)
MHRA
2010/002/015/081/010
FSCA
KARL STORZ
Endoscopy China Ltd.
2865 2411
2010/10/27
Völker-Healthcare Beds 2080, 3010, 3080
MHRA
2010/006/011/081/017
FSCA
Volker AG - Bed
N.A.
2010/10/27
Southern Care Systems SPECTRA X-Y Link Ceiling Track Hoist Model:
HS200XY, H162 & H160 and PARTS Ref: HXYL XY Link
MHRA
2010/003/011/401/011
FSCA
Southern Care
Systems Ltd.
N.A.
Medtronic
International,
Ltd.
Varian Medical
Systems Pacific
Inc.
2010/10/27
Philips Healthcare Philips M1567A & M1568A Single and Dual Disposable
Pressure Transducer (DPT) Kits
MHRA
2010/010/022/081/010
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/10/27
Maquet Power Cord 3113.3659/ 0223.2824 supplied together with the mobile
operating tables of the ALPHACLASSIC, ALPHASTAR, BETASTAR and
ALPHAMAXX series
MHRA
2010/009/015/401/003
FSCA
Maquet Hong Kong Ltd.
2393 9511
Johnson &
Johnson
Medical (HK)
Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
(Hong Kong) Ltd.
2736 2888
2010/10/27
Johnson & Johnson 1 Day Acuvue TruEye Contact Lens
2010/10/28
Trumpf Medical Systems Ltd Trumpf KlinoPORT Ceiling Supply Unit
MHRA
2010/010/022/081/004
FSCA
N.A.
N.A.
2010/10/28
Gambro Lundia AB Gambro Accessory S-660-C
MHRA
2010/010/021/081/026
FSCA
Gambro Lundia AB
2839 9710
2010/10/28
Kirton Healthcare Group Ltd Kirton DBO Chair
MHRA
2010/006/018/291/019
FSCA
N.A.
N.A.
2010/10/28
Conmed Pediatric/Neonatal Pre-attached Wire ECG Electrodes (Neotrade,
Neotrade II, Softrace Neonatal, Softrace Pediatric And Softrace Limb Band)
MHRA
2010/009/027/081/016
FSCA
Conmed Corporation
N.A.
2010/10/29
Independence Technology iBOT 4000 Mobility System Battery pack. Serial
Numbers 020605-001001 to 021007-001451 with Battery Pack(s)
FDA
Z-1775-2010
Class II
Johnson & Johnson
Medical (HK)
2738 6027
2010/10/29
Toshiba PVT-681MV Endocavitary Transducer used with the Aplio XG and
Xario XG Ultrasound Systems
FDA
Z-1997-2010
Class II
Sanko Medical
Systems (HK) LTD
N.A.
2010/10/29
Linvatec Advantage Turbo 2-Button Shaver. Rx Only
FDA
Z-2026-2010
Class II
N.A.
N.A.
2010/10/29
International Technidyne 1) GEM Check Coag CNTRL Normal APTT Whole
Blood Controls Package Insert: IVD. 15/pk. 06260061600. 2) GEM Check
Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD.
06260060100. 15/pk.
FDA
Z-2107-2010; Z-2108-2010
Class II
Vastec Medical Ltd.
2897 1912
2010/10/29
AGFA IMPAX CV Results Manager/Results Manager Administration Tool.
Model No. L9M2100. Software Versions RM 2.08.12.00.00
FDA
Z-2112-2010
Class II
AGFA Hong Kong
Limited
2555 9421
2010/10/29
Spacelabs Healthcare BleaseSirius Anaesthesia System, gas machine
FDA
Z-2113-2010
Class II
N.A.
N.A.
2010/10/29
Smith & Nephew 1) CERCLAGE WIRE, 0.6 MM DIA. X 175 MM Length, SST,
REF 71163006. 2) CERCLAGE WIRE, 0.8 MM DIA. X 200 MM Length, SST,
REF 71163008.
FDA
Z-2197-2010 thru Z-21992010
Class II
Smith & Nephew LTD
2645 8706
2010/10/29
Peregrine 20 GA Endo Ocular Adjustable Laser Probe. Device numbers:
PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52.
FDA
Z-2399-2010
Class II
N.A.
N.A.
2010/10/29
Stryker Sonopet Ultrasonic Surgical System, Model UST-2001
FDA
Z-2640-2010
Class II
Stryker China Ltd
2518 6915
Major Safety Alerts in September 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of
Description of Product
Issue
(YYYY/MM/D
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
Stryker China
Limited
RA 2010-205
Firm Initiated
Field Action
Stryker China Ltd
2518 6915
2010/09/01
Stryker Scorpio /NRG 4-in-1 Cutting Blocks
2010/09/02
GE Centricity Laboratory Core Lab, Software Versions: 3.3A, 3.3GA &
Customers using version of label program
MHRA
2010/008/016/081/005
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
GE Centricity Laboratory; Software Versions: Versions 3.3 GA and prior
MHRA
2010/008/016/291/014
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
GE Giraffe OmniBed / Giraffe Incubator / Giraffe Warmer, In Bed Scales
MHRA
2010/007/021/601/003
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
GE Centricity Laboratory Instrument Interface; Software Versions: 4.0.0 series
(4.0.0.9 or higher only) and 4.1.0 or higher
MHRA
2010/008/016/291/015
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
Siemens Dimension Vista V-LYTE Standard A – Impact on Potassium Results
(K820) lot KA0C03, KA0D01, KA0E01, KA0E02, KA0F01, and/or KA0G01
MHRA
2010/008/020/601/001
FSCA
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/02
Optovue iVue100 OCT
MHRA
2010/008/020/081/013
FSCA
N.A.
N.A.
2010/09/02
BD MGIT AST Starter Kit, Set Carrier, Label Spares
BD
MC 640
Firm Initiated
Field Action
BD
2575 8668
2010/09/03
Fresenius USA, Inc Fresenius 2008H Dialysate Delivery Machine; Fresenius
2008K, 2008K2 and 2008 [email protected] Hemodialysis Machines; Fresenius
Granuflo 1 Mixer Dissolution Unit; Main Power Supply Assembly (50 and 60
Hz) and AC Power cord assembly
FDA
Z-2224-2010; Z-2225-2010; Z2226-2010; Z-2227-2010
Class II
Fresenius Medical
Care Hong Kong
Limited
2583 0813
2010/09/03
Siemens AG AXIOM Artis MP/Artis dMP and Artis zee Multipurpose.
Angiographic x-ray system. Model numbers: 10094139, 5904466, 7555365
FDA
Z-2233-2010
Class II
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/03
Encore Medical 3DKnee Baseplates, Size 8, Left, Part # 333-01-108. Size 8,
Left, Part # 333-01-108. Lot number: A1000003
FDA
Z-2244-2010
Class II
N.A.
N.A.
2010/09/03
Availmed Medtronic Everest 20 / 30 Disposable Inflation Device AC 2200, AC
3200, AC3205P; 1) Lot numbers: 50517330, 50517331,50517332, 50517333,
50517334, 50519716, 50519717, 50519718, and 50519679;
2) Lot numbers: 50517324;
3) Lot numbers: 50517336, 50517337, and 50517339
FDA
Z-2271-2010; Z-2272-2010; Z2273-2010
Class II
N.A.
N.A.
2010/09/03
Arrow Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis
Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801;
RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
FDA
Z-2274-2010
Class II
N.A.
N.A.
2010/09/03
Seisa Medical ABC Bend-A-Beam Handpiece REF 134003; ABC Bend-ABeam Handpiece REF 134006; ABC Bend-A-Beam Handpiece REF 134009;
ABC Probe REF 160656 5 mm Handswitching Probe; ABC Probe REF 160636
5 mm Handswitching Probe; ABC Probe REF 160644 5 mm Handswitching
Probe, 44 cm; ABC PROBE REF 160655 5 mm Footswitching Probe,
FDA
Z-2276-2010; Z-2277-2010; Z2278-2010; Z-2279-2010; Z2280-2010; Z-2281-2010; Z2282-2010
Class II
N.A.
N.A.
2010/09/03
Genzyme Corp Genzyme Biosurgery Essentials Kit, Item Number 82004; Lot
Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690
RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741
RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820
RM00835
FDA
Z-2310-2010
Class II
N.A.
N.A.
2010/09/03
AdvanDx, Inc E. faecalis/OE PNA FISH" (Cat. No. KT003)
FDA
Z-2315-2010
Class II
N.A.
N.A.
2010/09/03
Interpore Cross International LLC Sterile Bio-Eye Hydroxyapatite Orbital
Implant and Conformer
FDA
Z-2292-2010
Class III
N.A.
N.A.
2010/09/03
Smith & Nephew Orthopaedics Genesis II LIS Sizer (Product Code 75018966,
Lot Number C66858)
MHRA
2010/008/023/601/001
FSCA
Smith & Nephew Ltd.
2648 7700
2010/09/06
Prism Medical Freeway T40 Shower Chair Drop down armrests
MHRA
2009/009/018/401/013
FSCA
N.A.
N.A.
2010/09/07
Various Manufacturer IV Extension sets with multiple ports and vented caps
MHRA
MDA/2010/068
MDA
N.A.
N.A.
2010/09/07
Abbott Diagnostics Architect Pre-Trigger Solution
MHRA
2010/008/027/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/08
Hologic ATEC Breast Bippsy and Excision System / ATEC Handpiece (Lot
003016 and only the handpiece)
MHRA
2010/008/027/291/001
FSCA
Prism Technologies
Limited
2786 3233
2010/09/08
Medtronic Neuromodulation Intrathecal Catheters
Catheters (Models : 8709, 8709SC, 8703, 8703W, 8731, 8731SC, 8711, 8749)
Catheter repair kits (Models : 8598, 8598A)
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2919 1300
2010/09/09
Maquet Connector Ref#0286 (1/2"x1/2")
MHRA
2010/009/001/291/016
FSCA
Maquet Hong Kong Ltd.
2393 9511
2010/09/09
RehaMed PAL 1000 (Portable Aquatic Lift)
MHRA
2009/001/016/401/015
FSCA
N.A.
N.A.
2010/09/09
AngioScore AngioSculpt Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system
FDA
Z-2218-2010
Class I
N.A.
N.A.
2010/09/09
Medical Components medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low
Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit
FDA
Z-2235-2010
Class II
N.A.
N.A.
2010/09/09
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1,
SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare
tube model numbers: MAJ-13 and MAJ-15.
FDA
Z-2236-2010
Class II
Olympus Hong Kong
and China Ltd
2170 5678
2010/09/09
Philips and Neusoft NeuViz Dual series Computed Tomography (CT) Scanner
System, X-Ray System. Part Number: 989605651321.
FDA
Z-2237-2010
Class II
N.A.
N.A.
2010/09/09
Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, Model
1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005,
1000093-006, 1000093-007.
FDA
Z-2294-2010
Class II
N.A.
N.A.
2010/09/09
Biomerieux VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use
FDA
Z-2295-2010
Class II
bioMerieux China Ltd.
2195 9348
2010/09/09
G3 Medical V. Mueller Peanut Sponges, Catalog number 23275-470
FDA
Z-2296-2010
Class II
N.A.
N.A.
2010/09/09
Abbott Laboratories VP 2000 Processor Heated Reagent Basins; automated
slide stainer
FDA
Z-2313-2010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/09/09
Boston Scientific Ultraflex Uncovered Esophageal Stent System ;
Tracheobronchial Stent System ; Colonic Stent System
FDA
Z-2316-2010 through Z-23312010
Class II
Boston Scientific Hong
Kong Ltd
2960 7136
2010/09/09
Stryker Worldwide Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees;
Sterile, TI Alloy, Implant; Catalog number 3225-0360S.
FDA
Class II
Stryker China Ltd
2518 6915
2010/09/09
Abbott Laboratories 1) CELL-DYN 3200 CS and SL, Hematology Analyzer.
Waste Reservoir Assembly Part number 8921174802; 2) CELL-DYN 3700 CS
and SL, Hematology Analyzer. Waste Reservoir Assembly Part number
8921174802; 3) CELL-DYN Ruby, Hematology Analyzer. Waste Reservoir
Assembly Part number 8921174802; 4) CELL-DYN Sapphire, Hematology
Analyzer. Waste Reservoir Assembly Part number 8921174802.
FDA
Z-2350-2010 through Z-23532010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/09/09
Stryker Pain Pump; Stryker Sheath ; Poly Stim II Nerve Stimulator ; Single
Shot Needle; Tuohy Catheter Kit ; Tuohy Stimulation Catheter Kit ; Stimulation
Catheter Continuous Nerve Block Tray
FDA
Z-2356-2010 through Z-23792010
Class II
N.A.
N.A.
2010/09/09
Vital Signs enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical pointof-care device designed to warm blood and IV fluids. Model numbers:
9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210,
91000153, 91000154, 91000156.
FDA
Z-2380-2010
Class II
N.A.
N.A.
2010/09/09
Dental EZ Stardental Division Titan 3 5K Low-Speed Motor - Star Titan 3,
5,000 rpm- Lube Free. Part number 262261.
FDA
Z-2354-2010
Class III
N.A.
N.A.
2010/09/10
Aesculap Hydrolift Implants SV004T (Batch 51658397), SV010T (Batch
51647369, 51653357), SV011T (Batch 51660087, 51654664, 51651709),
SV012T(Batch 51652387)
MHRA
2010/009/001/081/004
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/09/13
Roche Diagnostics A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and
Cobas C-System
B) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and Modular P Analyzers
C) Tina-Quant D-Dimer Gen.2 for Roche Cobas C111 Analyzers
Health Canada
51661
Type I
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/13
Biomerieux, Inc. A) Vitek 2 Compact 30 System - Test Cards
B) Vitek 2 Compact 60 System - Test Cards
C) Vitek 2 System - Test Cards
Health Canada
55961
Type II
bioMerieux China Ltd.
2195 9348
2010/09/13
Technidata TD-Synergy
Health Canada
55962
Type II
N.A.
N.A.
Z-2340-2010
2010/09/13
Technidata
A) TDLims
B) TD-Synergy
Health Canada
55963
Type II
N.A.
N.A.
2010/09/13
Beckman Coulter Sex Hormone Binding Globulin (SHBG) Reagent
Health Canada
55983
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/09/13
Gyrus Acmi Pleatman Sac Tissue Removal System
Health Canada
56025
Type II
N.A.
N.A.
2010/09/13
Stryker Orthopeadics Scorpio T72 Insert Tibial Trials
Health Canada
55981
Type II
Stryker China Ltd
2518 6915
2010/09/13
Howmedica Osteonics Series 7000 Total Knee Standard Tibial Tray
Health Canada
56012
Type II
Stryker China Ltd
2518 6915
2010/09/13
Bio-Rad Laboratories Deeside IN2IT - A1C Test Cartridges
Health Canada
56054
Type II
Bio-Rad Pacific Ltd.
N.A.
2010/09/13
Stryker Instruments Instructions for use (IFU) for Painpump2 Block-Aid
Health Canada
56046
Type II
Stryker China Ltd
2518 6915
2010/09/13
Cardinal Health
A) Sterile Craniotomy Pack
B) Sterile Ear Pack
Health Canada
56051
Type II
CareFusion Hong Kong
Ltd.
2891 8730
2010/09/13
Roche Diagnostics
A) Coaguchek XS Monitor
B) Coaguchek XS Plus Monitor
Health Canada
56053
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/13
Ortho-Clinical Diagnostics Vitros Chemistry Products MALB Reagent
Health Canada
56101
Type II
Ortho Clinical
Diagnostics
2737 5504
2010/09/13
Immuontech IGFBP-3 Immunoradiometric Assay (IRMA)
Health Canada
56099
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/09/13
Diasorin Liason Analyzer
Health Canada
56139
Type II
N.A.
N.A.
2010/09/13
Prollenium Medical Technologies Dermal Roller SR
Health Canada
56052
Type III
N.A.
N.A.
2010/09/13
Roche Diagnostics Precicontrol Universal
Health Canada
55469
Type II
2010/09/13
Beckman Coulter, Inc. Synchron Systems Glucose Reagent (GLU)
Health Canada
56165
Type II
2010/09/13
Trinity Biotech PDQ 1 Reagent, 940ml, Lot No. 3339
MHRA
2010/008/031/291/014
FSCA
N.A.
N.A.
2485 7510
Roche Diagnostics
(Hong Kong) Ltd
Beckman Coulter Hong
Kong Ltd
2485 7510
2240 6150
2010/09/13
Roche Diagnostics Elecsys Vitamin D3 assay
Health Canada
55964
Type III
Roche Diagnostics
(Hong Kong) Ltd
2010/09/13
Roche Diagnostics Elecsys Free T4
Health Canada
56041
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/13
Vital Diagnostics Excyte Sliders
Health Canada
54156
Type III
N.A.
N.A.
2010/09/13
Siemens Healthcare Diagnostics
A) ADVIA Centaur Hepatitis B Core Total (HBCT) Assay
B) ADVIA Centaur XP System-HBC Total (HBCT) assay (donor screening for
transplantation)
C) Advia Centaur CP System-HBC Total (HBCT) assay (donor screening for
transplantation)
Health Canada
55559
Type III
Siemens Healthcare
Diagnostic Limited
28707827
Type III
Johnson & Johnson
Vision Care, Johnson &
Johnson (Hong Kong)
Ltd.
2737 5718
54721
Type III
Boston Scientific Hong
Kong Ltd
2960 7136
Health Canada
56152
Type III
Siemens Healthcare
Diagnostic Limited
28707827
Health Canada
56052
Type III
N.A.
N.A.
Varian Oncology Systems Eclipse™ Treatment Planning System and RT Chart
(Aria™ Radiation Oncology)
MHRA
2010/009/006/291/009
FSCA
Varian Medical
Systems Pacific Inc.
2724 2836
2010/09/14
Elekta Linear Accelerator – XVI, Applicable to XVI R4.2.1 or XVI R4.5 with
MOSAIQ® 2.00T2SP5 or later, in the SYNERGISTIQ. configuration.
MHRA
2010/009/006/081/005
FSCA
Elekta Ltd.
2891 2208
2010/09/14
Rocialle RFEO10-1001 - Umbilical Cord Clamp
MHRA
2010/007/001/401/016
FSCA
N.A.
N.A.
2010/09/14
Pentax Europe Light Sources BS-LH1, BS-LH2 and BS-LL1
MHRA
2010/009/009/081/011
FSCA
N.A.
N.A.
2010/09/14
Merck Serono Lubricant Gel - Corflo CuBBy and Gastrostomy Kits (various
sizes, manufactured from 2004 through 2006)
MHRA
2010/009/003/081/001
FSCA
N.A.
N.A.
2010/09/14
Freeway Healthcare Transactive Xtra Hoist - All Models Manufactured with
serial numbers between 11761 & 12316 (inclusive)
MHRA
2010/007/016/261/001
FSCA
N.A.
N.A.
2010/09/15
Sequal Technologies Sequal Eclipse Oxygen System
Health Canada
53321
Type I
Celki Medical Company
2268 9201
2010/09/15
Toshiba Medical Systems Aquilion One
Health Canada
56173
Type II
Sanko Medical
Systems (HK) LTD
N.A.
2010/09/15
Toshiba Medical Systems Aplio Artida
Health Canada
56227
Type II
Sanko Medical
Systems (HK) LTD
N.A.
2010/09/15
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
56238
Type II
Uninet Technology LTD
2838 8423
2010/09/15
Biomet Microfixation Rees Insulated Forceps
Health Canada
55527
Type II
N.A.
N.A.
2010/09/15
Hologic
A) Atec Breast Biopsy & Excision System Sapphire
B) Atec Breast Biopsy & Excision System Emerald
C) Atec Breast Biopsy & Excision System Pearl
Health Canada
56247
Type II
Prism Technologies
Limited
2786 3233
2010/09/13
Johnson & Johnson Vision Care
Acuvue Oasys Brand Contact Lenses for Astigmatism
Health Canada
56160
2010/09/13
Boston Scientific Corporation
A) Sterling Monorail PTA Balloon
B) Sterling Over-The-Wire PTA Balloon
Health Canada
2010/09/13
Siemens
A) Mevatron Linear Accelerators
B) Artiste MV-Linear Accelerator-Main Unit
2010/09/13
Prollenium Medical Technologies Dermal Roller SR
2010/09/14
2010/09/15
Beckman Coulter
A) Access System - Immunoassay Aanalyzers Class 2
B) Unicel DXC 600I Synchron Access Clinical Analyzer
C) Unicel DXI 600 Access Immunoassay System - Instrument Class 2
D) Unicel DXI 600 Access Immunoassay System - Instrument Class 3
E) Unicel DXC 880I Synchron Access Clinical Analyzer
F) Access Immunoassay Analyzers - Class 3
G) Access Immunoassay System - Analyzer Class 3
H) Access System Access 2 Analyzer - Class 2
I) Unicel DXI 800 Access Immunoassay System - Analyzer - Class III
J) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II
K) Synchron LXI 725
L) Unicel DXC 660I Synchron Access Clinical Analyzer
M) Unicel DXC 680I Synchron Access Clinical Analyzer
N) Unicel DXC 860I Synchron Access Clinical Analyzer
Health Canada
56259
Type II
2010/09/15
Zimmer Trabecular Metal Acetabular Porous Shell
Health Canada
56268
Type II
2010/09/15
Beckman Coulter SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent
Health Canada
55480
Type II
2010/09/15
Boston Scientific Ultraflex Precision Colonic Stent
Health Canada
55796
Type II
2010/09/15
Synthes (Canada) Insight Retractor System Frames
Health Canada
56200
Type II
2010/09/15
Spacelabs Medical
A) Ultraview SL2600 Compact Monitor
B) Ultraview SL2200 Compact Monitor
C) Ultraview SL Compact Monitor
Health Canada
56205
Type II
2010/09/15
Draeger Medical Fabius GS Anesthesia System
Health Canada
56304
Type II
2010/09/15
Beckman Coulter Navios Flow Cytometer
Health Canada
55631
Type III
2010/09/15
Beckman Coulter Synchron Systems Enzymatic CO2 (CO2E) Reagent
Health Canada
55665
Type III
2010/09/15
Zimmer Bigliani/Flatow Fukuda Retractors
Health Canada
56271
Type III
2010/09/15
Siemens
A) Axiom Artis DTA
B) Axiom Artis FA Alpha
C) Axiom Artis MP Diagnostic
Health Canada
56246
Type III
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/15
BMS Stopcock with PVC Line Product code 50-3010, Lot number 16201
MHRA
2010/008/020/401/006
FSCA
N.A.
N.A.
2010/09/15
Medtronic CoreValve® Delivery system
MHRA
2010/009/001/291/001
FSCA
2010/09/15
Terumo Advanced Perfusion System 1
MHRA
N.A.
FSCA
2010/09/16
AGA Medical Amplatzer cardiac plug
MHRA
2010/009/003/081/004
FSCA
Abbott Laboratories Ltd.
25932211
2010/09/16
Corin Uniglide unicondylar knee, femoral component
MHRA
2010/009/006/081/003
FSCA
N.A.
.N.A
2010/09/16
Corin Modular screwdriver, 3.5mm A/F hex (ball end)
MHRA
2010/009/006/081/004
FSCA
N.A.
.N.A
Beckman Coulter Hong
Kong Ltd
Zimmer PTE Ltd.
(Hong Kong branch)
Beckman Coulter Hong
Kong Ltd
Boston Scientific Hong
Kong Ltd
Synthes (Hong Kong)
Ltd
N.A.
Draeger Medical Hong
Kong Ltd.
Beckman Coulter Hong
Kong Ltd
Beckman Coulter Hong
Kong Ltd
Zimmer PTE Ltd.
(Hong Kong branch)
Medtronic International,
Ltd.
TERUMO CHINA
(H.K.) LTD.
2240 6150
2992 0968
2240 6150
2960 7136
2724 2032
N.A.
2877 3077
2240 6150
2240 6150
2992 0968
2919 1300
2866 0811
2010/09/16
Hospira Symbiq One- and Two- Channel Infuser
FDA
Z-2381-2010
Type I
Hospira Limited
2898 2886
2010/09/16
Duke Microwave Ovens, Model Number DG-2
FDA
Z-2114-2010
Type II
N.A.
.N.A
2010/09/16
Biomet SpeedPass Disposable Suture Lariat with Nitinol Wire
FDA
Z-2228-2010
Type II
N.A.
N.A.
2010/09/16
Hospira Accessory Power Pack
FDA
Z-2234-2010
Type II
Hospira Limited
2898 2886
2010/09/16
Physio External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P,
LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. Pediatric Paddles
attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK
20/20e Defibrillator/Monitors.
FDA
Z-2312-2010
Type II
Medtronic International,
Ltd.
2919 1300
2010/09/16
Synthes TI N-Hance Rod; N-Hance System; NFix II System; NFlex Straight
monosegmental L; NFlex Stabilization System
FDA
Z-2344-2010, Z-2345-2010Z,
2346-2010, Z-2347-2010, Z2348-2010
Type II
Synthes (Hong Kong)
Ltd
2724 2032
2010/09/16
AMD Picasso/Picasso Lite lasers
FDA
Z-2349-2010
Type II
N.A.
N.A.
2010/09/16
Abiomed Impella 5.0 Circulatory Support System Catalog number: 004840
Serial numbers: 45921, 45922, 45923, 45924
FDA
Z-2382-2010
Type II
N.A.
N.A.
2010/09/16
Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC
FDA
Z-2393-2010
Type II
Direct Health Ltd.
25281109
2010/09/16
Siemens Stratus CS Acute Care Troponin 1 TestPak (Troponin I assay)
FDA
Z-2400-2010
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/09/16
Maquet HLM Tubing Pack; Bioline Coating. Product number BEQ-TOP 14801.
FDA
Z-2401-2010
Type II
Maquet Hong Kong Ltd.
2393 9511
2010/09/16
Invacare CareGuard Mattress Models CG10180 and CG10180A used with IVC
and ValueCare Series of manual, semi-electric and electric beds.
FDA
Z-2402-2010
Type II
Direct Health Ltd.
25281109
2010/09/16
Invacare Mattress Model 5185 and 5185XL - packaged in the IVC Bed Models
BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED121633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.
FDA
Z-2403-2010
Type II
Direct Health Ltd.
25281109
2010/09/16
Stryker Bur Guard REF 2296-301
FDA
Z-2420-2010
Type II
Stryker China Ltd
2518 6915
2010/09/16
Siemens Dimension Vista Chemistry 2 Calibrator, Catalog number KC120.
FDA
Z-2387-2010
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/09/16
Westmed BagEasy Manual Resuscitation Devices
FDA
N.A.
Class I
N.A.
N.A.
2010/09/17
BioMérieux VIDAS HIV Duo Quick Lot 839967401 Expt Date 03/02/2011
MHRA
2010/009/008/601/003
FSCA
bioMerieux China Ltd.
2195 9348
2010/09/17
Leica Biosystems Newcastle Peloris rapid tissue processor with serial numbers
0260018A to 0260312A
MHRA
2010/009/006/081/011
FSCA
Leica Microsystems
Limited
2564 6699
2010/09/17
Kimal K-Flow Access Catheters; Kimal High Flow (HF) Haemodialysis
Catheters; Kimal Right Atrial (KRA) Catheters
2010/09/17
Philips Healthcare Philips M3002 IntelliVue X2 and M8102A IntelliVue MP2.
2010/09/20
MHRA
MDA/2010/072
MDA
N.A.
N.A.
Philips
Electronic Hong
Kong Ltd
FSN86201157
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
B. Braun Safety Air Detector (SAD) with Red Detector for Dialog machine
MHRA
2010/009/014/081/020
FSCA
2010/09/20
Fresenius Av-Set Fmc Paed S; Av-Set Fmc Bvm Btm Paed S; Av-Sn-Set Fmc
Paed./Baby S; Av-Sn-Set Fmc P
MHRA
2010/009/007/081/003
FSCA
2010/09/20
Beckman Coulter AU Clinical Chemistry Analyzer
MHRA
2010/008/020/601/002
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/09/20
Otto Bock Skippi Power Wheelchair
MHRA
2010/009/002/291/001
FSCA
Otto Bock Asia Pacific
Limited
2598 9772
2010/09/21
All brands Intravenous (IV) extension sets with multiple ports
MHRA
MDA/2010/073
MDA
N.A.
N.A.
2010/09/21
GE Aisys Carestation, S/5 Avance Anesthesia Carestation, Amingo Carestation
MHRA
2010/009/016/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/21
Medical Innovations Rotacrush Lithotripter Internal - Lit3-K2-30-35-200
MHRA
2010/009/008/401/003
FSCA
N.A.
N.A.
2010/09/21
GE Lightspeed VCT
MHRA
2010/009/013/081/010
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/21
GE Optima CT660
MHRA
2010/009/016/081/017
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/21
Helapet SY0001 ETO Sterile 1ml Syringe
MHRA
2010/009/013/601/007
FSCA
N.A.
N.A.
2010/09/22
Elekta CMS Software XiO Release 1.0.2 and above
MHRA
2010/009/004/601/001
FSCA
Elekta Ltd.
2891 2208
2010/09/22
Pride Mobility Colt XL8 - Transaxle
MHRA
2010/006/007/301/002
FSCA
N.A.
N.A.
2010/09/22
QIAGEN Therascreen: K-Ras mutation kit
MHRA
2010/009/006/081/002
FSCA
N.A.
N.A.
2010/09/22
Abbott Diagnostics Architect tacrolimus reagent - 01L77-25 (lot number
86599M500)
MHRA
2010/009/014/601/005
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/24
Thoratec Laboratories Heartmate II LVAS System Controller
MHRA
2010/009/006/081/001
FSCA
N.A.
N.A.
2010/09/24
Beckman Coulter Core TDM Multi-Calibrator (Part No. ODC6411)
MHRA
2010/009/013/601/001
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/09/24
Beckman Coulter Access, UniCel, and SYNCHRON Clinical Systems
MHRA
2010/008/024/601/004
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/09/24
Abbott Diagnostics architect iVancomycin - 1P30-25
MHRA
2010/009/014/601/003
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/24
Astra Tech. Extension Line
MHRA
2010/009/015/081/028
FSCA
N.A.
N.A.
B. Braun Medical Hong
Kong
Fresenius Medical
Care Hong Kong
Limited
2529 2009
2583 0813
2010/09/27
Boston FLEXIMA Biliary Stent System (of 20 model numbers)
FDA
Z-1975-2010 thru Z-19942010
Type II
Boston Scientific Hong
Kong Ltd
2960 7136
2010/09/27
Starion The Starion Instruments Thermal Ligating Shears; STLS 23C: Model
numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022 STLS
35C: Model 102-138D, Lot Numbers: 907004 and 907008v
FDA
Z-2239-2010
Type II
N.A.
N.A.
2010/09/27
CIVCO Surgi-Tip Transducer Cover
FDA
Z-2242-2010
Type II
N.A.
N.A.
FDA
Z-2243-2010
Type II
N.A.
N.A.
FDA
Z-2407-2010
Type II
Siemens Healthcare
Diagnostic Limited
2870 7533
FDA
Z-2422-2010
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/09/27
2010/09/27
BioCheck Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA
TEST KIT; Catalog #/Product # BC-1123; Kit lot numbers: RN-27940, 33689,
and 37260
Siemens Dimension Tacrolimus Flex Reagent Cartridge; Lot Numbers:
DC0306 (exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10),
GA0348 (exp 12/14/10)
2010/09/27
Philips DigitalDiagnost X-ray System; Part Number 4512 201 04752 Software
Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2.
2010/09/28
Abbott Diagnostics Cell DYN 3200CS and 3200SL Analysers
MHRA
2010/009/019/601/006
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/28
Cefndy Bariatric Commodes X220 and X221
MHRA
2009/011/017/081/018
FSCA
N.A.
N.A.
Health Canada
56411
Type I
Beckman Coulter Hong
Kong Ltd
2240 6150
Health Canada
56430
Type I
Johnson & Johnson
Medical (HK)
2738 6027
Health Canada
56465
Type I
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
Health Canada
56100
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
Health Canada
55916
Type II
Ortho Clinical
Diagnostics
2737 5504
Health Canada
56348
Type II
N.A.
N.A.
2393 9511
2010/09/29
2010/09/29
2010/09/29
Beckman Coulter, Inc. A) AU5400 Clinical Chemistry Analyzer
B) AU2700 Clinical Chemistry Analyzer
C) AU400/AU400E Clinical Chemistry Analyzers
D) AU600/AU640/AU640E Clinical Chemistry Analyzers
E) AU680 Clinical Chemistry Analyzer
F) AU480 Clinical Chemistry Analyzer
Lifescan Inc.
A) OneTouch DataLink Data Management System
B) OneTouch DataLink Management System
Roche Diagnostics Ltd. Cobas IT 3000 Software
2010/09/29
GE Medical Systems Information Technologies, Inc. A) Transport Pro V2
Patient Monitor
B) Transport Pro Patient Monitor (PDM Compatible)
Ortho-Clinical Diagnostics Inc. A) Vitros 5600 System Software 1.4 & Below
B) Vitros 3600 System Software 1.4 & Below
Sysmex Corporation A) XT-2000I Analyzer - Sysmex Hematology Analyzers
B) Sysmex XT-1800I Analayzer - Sysmex Hematology Analyzers
C) XT-4000I Hematology Analyzer
Maquet Cardiopulmonary AG Straight Connector
Health Canada
56358
Type II
2010/09/29
CaridianBCT, Inc. Cobe Spectra Apheresis System wbc
Health Canada
55784
Type II
2010/09/29
Vascular Solutions, Inc. Langston Dual Lumen Catheter
Medline Industries Inc A) Nygh Dental Pack
B) Nygh Minor and Major Pack
C) C-Section Pack
D) Nygh T & A Pack
E) Nygh Septoplasty Pack
F) Nygh Laparoscopy Pack
G) Grace Total Hip Pack
H) Nygh Vascular Pack
I) Cardiac Pack
Excelsior Medical Corporation Prefilled Flush Syringe
Health Canada
56416
Type II
Maquet Hong Kong Ltd.
CaridianBCT (Asia
Pacific) Ltd.
N.A.
Health Canada
56350
Type II
N.A.
N.A.
Health Canada
56438
Type II
N.A.
N.A.
2010/09/29
2010/09/29
2010/09/29
2010/09/29
2010/09/29
2576 1366
N.A.
2010/09/29
Focus Medical, LLC Naturalase 1064 Laser
Health Canada
55902
Type II
N.A.
N.A.
2010/09/29
Wilson-Cook Medical, Inc. A) Six-Shooter Saeed Multi-Band Ligator
B) Ten-Shooter Saeed Multi-Band Ligator
Health Canada
56462
Type II
N.A.
N.A.
2010/09/29
Trinity Biotech USA Captia EBV VCA IGM
Health Canada
56527
Type II
N.A.
N.A.
2010/09/29
Philips Medical Systems (Cleveland), Inc. Mx8000 IDT Multislice CT Imaging
System
Health Canada
56344
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/09/29
Instrumentation Laboratory Co. A) ACL Top 500 CTS
B) ACL Top, ACL Top 700 LAS, ACL Top CTS
Health Canada
56433
Type II
N.A.
N.A.
2010/09/29
Southmedic Inc. Stainless Safety Scalpel Sterile
Health Canada
56459
Type II
N.A.
N.A.
2010/09/29
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Logiq E9
Ultrasound System-Sector Transducer
Health Canada
56175
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/29
Roche Diagnostics GMBH MagNa Pure LC 2.0 Instrument
Health Canada
56376
Type III
2010/09/29
Metrex Research Corporation Curing Light Sleeves
Baxter Healthcare Corporation
A) Micro-Volume Extension Sets with Filter
B) Micro-Volume Extension Set
Health Canada
56429
Type III
Roche Diagnostics
(Hong Kong) Ltd
N.A.
Health Canada
56507
Type III
Baxter Healthcare Ltd
2807 8555
2010/09/29
Ortho-Clinical Diagnostics Inc. Ortho HTLV-I/II AB-Capture Elisa Test
Health Canada
56514
Type III
Ortho Clinical
Diagnostics
2737 5504
2010/09/29
Sterngold Dental, LLC A) ERA Implant Master Prosthetic Kit
B) ERA Mini Dental Implant System,Complete
Health Canada
56385
Type III
N.A.
N.A.
2010/09/29
Sterngold Dental, LLC Sterngold/Hader Torque Wrench Kit
Health Canada
56387
Type III
N.A.
N.A.
2010/09/29
Smith & Nephew, Inc., Endoscopy Division BIORAPTOR 2.9mm Suture Anchor
Health Canada
56446
Type III
Smith & Nephew LTD
2645 8706
2010/09/29
Abbott Laboratories Diagnostic Division A) Cell-Dyn 3700 Haematology
System-SL Analyser
B) Cell-Dyn 3200SL System
C) Cell-Dyn 3700 Haematology System-CS Analyser
Health Canada
56461
Type III
Abbott Laboratories
LTD.
2593 2211
2010/09/29
Roche Diagnostics GMBH Cobas Integra Glucose HK Gen. 3
Health Canada
56482
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/29
Proctor & Gamble Neutral 40Ml – 217028891 – Uk Only
MHRA
2010/008/025/601/001
FSCA
N.A.
N.A.
2010/09/29
BrainLAB 21210E Planning Software iPlan Stereotaxy versions 3.0.0 and
3.0.1in combination with 21242 iPlan AC/PC planning
MHRA
2010/009/023/081/022
FSCA
BrainLAB Ltd
2417 1881
2010/09/29
BioMérieux VITEK® 2 Piperacillin/Tazobactam Test
MHRA
2010/009/022/601/006
FSCA
bioMerieux China Ltd.
2195 9348
2010/09/30
Medtronic Octopus Nuvo Tissue Stabilizer - TSMICS1
MHRA
2010/009/022/081/007
FSCA
Medtronic International,
Ltd.
2919 1300
2010/09/29
2485 7510
N.A.
Monthly Summary of Medical Device Safety Alerts - August 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of
Description of Product
Issue
(YYYY/MM/D
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Medtronic International,
Ltd.
Siemens Healthcare
Diagnostic Limited
Philips Electronic Hong
Kong Ltd
Solutions Health Care
Products
Schmidt BioMedTech
(H.K.) Limited
N.A.
Zimmer PTE Ltd.
(Hong Kong branch)
Zimmer PTE Ltd.
(Hong Kong branch)
N.A.
Johnson & Johnson
Medical (HK)
Agent Contact
Telephone No.
2010/08/02
Medtronic Sutureless Unipolar Myocardial Lead
Health Canada
53385
Type II
2919 1300
2010/08/02
Siemens Dimension Vista System-Enzymatic Creatinine Assay (ECREA)
Health Canada
55520
Type II
2010/08/02
Philips Heartstart HS1 Onsite Defibrillator, Heartstart HS1 Home Defibrillator
Health Canada
55525
Type II
2010/08/02
Liko Scale Adapters
Health Canada
55601
Type II
2010/08/02
Minntech Endoscope Disinfector
Health Canada
55606
Type II
2010/08/02
Immunotech Estrone Radioimmunoassay (RIA) Kit
Health Canada
55630
Type II
2010/08/02
Zimmer Versys Hip System Femoral Head 12/14
Health Canada
55632
Type II
2010/08/02
Zimmer ITST Fixation Locking Bolt Extractor
Health Canada
55641
Type II
2010/08/02
Teleflex Medical Rusch Care Premium Drain Bag
Health Canada
55666
Type II
2010/08/02
Depuy Summit Broach Handle
Health Canada
55756
Type III
2010/08/02
CaridianBCT A) COBE Spectra White Blood Cell Sets
B) COBE Spectra Therapeutic Plasma Exchange Sets
Health Canada
55784
Type II
CaridianBCT (Asia
Pacific) Ltd.
2576 1366
2010/08/02
Digiterm Comfort 4 Eco
MHRA
2009/009/001/291/028
FSCA
N.A.
N.A.
2010/08/02
Activate Corgi Sprint (size 3 only)
MHRA
2009/012/008/401/004
FSCA
N.A.
N.A.
2010/08/02
Fisher & Paykel Sleepstyle
MHRA
2010/005/019/081/010
FSCA
N.A.
N.A.
2010/08/03
BioMérieux VIDAS RUB IGG II, ref 30221, Lot 837810801
MHRA
2010/007/023/601/003
FSCA
bioMerieux China Ltd.
2195 9348
2010/08/03
Medtronic Everest Inflation device/ survival kit, models AC2200, AC3200 and
AC3205P
MHRA
2010/007/022/081/011
FSCA
Medtronic International,
Ltd.
2919 1300
2010/08/04
DiaSorin Liaison Analyser
MHRA
2010/006/028/401/011
FSCA
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
2870 7533
2870 7533
2821 5480
2688 2933
2620 8329
N.A.
2992 0968
2992 0968
N.A.
2738 6027
2010/08/04
Siemens ADVIA centaur HIV Ag/Ab combo (CHIV) assay
MHRA
2010/007/019/601/003
FSCA
2010/08/04
Stryker Crossfire Consoles
MHRA
2010/007/027/291/013
FSCA
Stryker China Ltd
2518 6915
2240 6150
N.A.
2010/08/04
Beckman Coulter SYNCHRON rheumatoid factor (RF) reagent -- PN 475136
lot numbers M907325
Wescott Sae-Flo MD Extension Set with Y-Connector Product Code
WEPCA200AY
Activate Corgi Sprint (size 2 only)
2010/08/04
Invacare Instructions for use - XLT
MHRA
2009/003/010/301/001
FSCA
2010/08/04
Coloplast Self-Cath Nelaton CH12 Catheter
MHRA
2010/008/002/291/019
FSCA
2010/08/05
Biomet Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle
(REF 904755), Toggleloc Artificial ligament fixation device ZIPLOOP
Technology Implant Kit (REF 909848)
FDA
Z-1952-2010 to Z-1953-2010
Class II
2010/08/04
2010/08/04
MHRA
2010/007/023/601/004
FSCA
Beckman Coulter Hong
Kong Ltd
MHRA
2010/007/029/601/006
FSCA
N.A.
MHRA
2010/003/002/081/007
FSCA
N.A.
N.A.
Direct Health LTD
Coloplast (Hong Kong)
Ltd
2528 1109
N.A.
N.A.
3628 7428
2010/08/05
Terumo Cardiovascular Procedure Kit (P/N 64937, 65246, 65503/70881-02,
70608-01, 71544-01, 71546-01, 71733, 71766PP, 71934, 72642, 72790,
72846, 131351-02, 70608-01, 71032)
FDA
Z-2149-2010 to Z-2163-2010
Class II
TERUMO CHINA
(H.K.) LTD.
2866 0811
2010/08/05
Baxa Exacta-Mix EVA Container, sterile (REF: 137, 138, 139, 140, 141, 142,
143), Halobag EVA Dual-Chamber Bag (REF: 341), Exacta-Mix Calibration
Bag (Recorder No. H938 371 3), Exacta-Mix 2400 Valve Assembly w/
Calibration Bag (REF: 724), Exacta-Mix Valve Set (REF 706, 706D)
FDA
Z-2137-2010 to Z-2148-2010
Class II
N.A.
N.A.
2010/08/05
Siemens Healthcare Diagnostics Dimension Vista LOCI Reaction Vessels,
catalog number KS855.
FDA
Z-2117-2010
Class III
Siemens Healthcare
Diagnostic Limited
2810 7533
MHRA
2009/006/001/081/003
FSCA
Stryker China Ltd
2518 6915
MHRA
2010/007/027/291/010
FSCA
N.A.
N.A.
FSN86201138
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
2010/007/027/291/012
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
CP-01785
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
2010/008/002/291/013
FSCA
N.A.
N.A.
2010/08/05
2010/08/05
2010/08/05
2010/08/06
2010/08/09
Stryker Howmedica Osteonics Exeter Femoral head 26mm diameter standard
neck
Newdeal Forefoot Sterile Cannulated Drill (specific lots)
Philps M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia
Gas Modules with M1657B manifolds shipped from Jan 01, 2009 to May 25,
2010 (M1013A / M1019A) respectively Jun 10, 2010 (M1026B / M1026BT)
Philips
(1) M1013A: Serial Number range ARYE-0014 to ASBC-0013;
Electronic Hong
(2) M1019A: Serial Number range ARZC-0202 to ASBE-0086;
Kong Ltd
(3) M1026B: Serial Number range 4614H27003 to 4614H28158;
(4) M1026BT: Serial Number range 4614H27160 to 4614H28184
Codman Surgical Patties -1/4 X 1/4 and 5/16 round sizes (Model : 80-1396, 80MHRA
1399)
Varian Medical
Varian Eclipse Client software versions with build numbers from 7.3.10
Systems Pacific
through 8.6.15 (i.e. excluding 8.6.17)
Inc.
2010/08/10
Trinity Biotech Captia VZV IgM kit (Product Code : 2325650)
2010/08/10
Karl Storz Calcuson & Endomat LC units used in combination, Karl Storz
Suction Tubing Set, Item No. 20330342
MHRA
2010/008/004/081/013
FSCA
2010/08/10
Fresenius Bloodline for 4008 Dialysis Machine, Product : AV-SET FMC
(FA404E/FV404E), Code : 5016481
MHRA
2010/008/005/081/016
FSCA
2010/08/10
Rocialle InHealth Ophthalmic Procedure Pack (Code: RMT8761-REVE)
MHRA
2010/005/006/291/010
FSCA
2010/08/10
Hospira Gemstar Pump Set (List No. 13261-0401, Lot no. 670695H, 691805H,
760665H; List No. 13261-6102, Lot No. 740545H)
Hospira Limited
N.A.
Firm Initiated
Field Action
Hospira Limited
2898 2886
2010/08/11
Roma Medical Aids All mobility scooters
MHRA
2009/007/003/301/002
FSCA
N.A.
N.A.
2010/08/11
Ikaria INOMAX DS drug-delivery systems
FDA
N.A.
Class I
N.A.
N.A.
2010/08/11
Hospital Metalcraft Bristol Maid Baby Crib Trolleys, BA/3/B and BA/6
MHRA
2010/005/025/081/019
FSCA
N.A.
N.A.
2010/08/11
Karl Storz MTP Rhino Fiberscope Cover (code 041310-50 Lot-no. 0907/05)
MHRA
2010/008/004/081/012
FSCA
KARL STORZ
Endoscopy China Ltd.
2865 2411
Baxter
Healthcare Ltd
N.A.
Firm Initiated
Field Action
Baxter Healthcare Ltd
2807 8555
FDA
Z-1257-2010 to Z-1309-2010
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
FDA
Z-1402-2010 to Z-1403-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/08/11
2010/08/12
2010/08/12
Baxter HomeChoice Automated Peritoneal Dialysis System (Product Code:
5C4474)
Philips AC power cords manufactured by Electri-Cord with tall bridge design.
Used across all Philips product lines, as well as Respironics/Philips products,
Dixtel owned products and Dixtal (formerly Novametrix or
Respironics/Novametrix products.
GE Healthcare GE Centricity PACS-IW software (version 3.7.3), GE Centricity
Web Diagnostic (WebDX) software (version 1.0.0.2)
MHRA
KARL STORZ
Endoscopy China Ltd.
Fresenius Medical
Care Hong Kong
Limited
N.A.
2865 2411
2583 0813
N.A.
2010/08/12
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0
and R4.2.
FDA
Z-1405-2010
Class II
Elekta Ltd.
2891 2208
2010/08/12
Merit Medical Systems Vessel Sizing Angiographic Catheter, REF 7602-2M65,
5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO. (lot no. G775032)
FDA
Z-1731-2010
Class II
King Health Limited
2481 3787
FDA
Z-1756-2010
Class II
N.A.
N.A.
FDA
Z-1784-2010
Class II
N.A.
N.A.
2010/08/12
2010/08/12
Dreamcon Fancy i Color cosmetic lens, Contents: A pair of sterile soft color
contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm
DIA. 14.5mm. a) Includes models Amber, Amethyst, Blueberry Crush,
BumbleBee Yellow, Denim Blue, Envious Green, Honey, Pebble Gray, Marble
Swirl, Royal Blue, Ultraviolet, HA11, HA12, HA13, HA14, HA16, HL21, HL22,
HL23, HL24, HL26, Fierce Fandango and Holiday Green (Lot no. D01704); b)
inlcudes models Copper, Gotham Gray, HJ31, HW21, HW22, Jade and
Natural Hazel (lot no. D01711); c) includes models Aquamist, Artic Blue, Deep
Ocean Blue, HJ35, HJ36 and HW26 (lot no. D01712); d) includes models
HJ33, HJ34, HW23, HW24, Lavender, Lazer Green, Sour Apple Green and
Vibrant Violet (lot no. D01713); and e) includes models 011, 015, 024, 029,
032, 033, 035, 043-1, 044, 046, 047, 049, 055, 063-1, 064, 071, 079, 085 and
088 (lot no. unidentified).
CODE
a) Lot Number D01704; b) Lot Number D01711; c) Lot Number D01712; d) Lot
Number D01713; e) Lot (unidentified)
Orthohelix Surgical Designs Modular Foot System 3.5mm x 22mm Locking
Screw M/N: MFT-021-35-22, Lot no. 0964081
MR Holdings (HK)
Limited
Fresenius Medical
Care Hong Kong
Limited
2010/08/12
Mindray Passport V Monitor, Part Number 6100F.
FDA
Z-1785-2010
Class II
2511 0701
2010/08/12
Fresenius Medical Care Optiflux F180NR Dialyzers, Catalog Number:
0500318E., Lot no. 10AU04011
FDA
Z-1951-2010
Class II
2010/08/12
Microtek Medical Stackhouse Laser Resistant Suction Probe, Size: 1/4" x 9"
(0.64cm x 22.9cm), REF 24014, qty 10 ea, Sterile EO, 2015-05.
FDA
Z-2109-2010
Class II
N.A.
N.A.
2010/08/12
Wright Medical Technology Claw Hex Screw Charlotte " F&A System
Contents: 1 each Foot and Ankle Screw ... Implant Material: Stainless Steel
Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - NonSterile. Item # 40133520
FDA
Z-2188-2010
Class II
N.A.
N.A.
2010/08/12
Ascent Healthcare Solutions Reprocessed Femoral Compression Device,
Model 11165, Lot numbers: 869509, 878402, 878439, 879762, 879990, 880274
FDA
Z-2196-2010
Class III
N.A.
N.A.
2010/08/12
DIMA Incontinence Sling - Contasure Needleless
MHRA
2010/006/021/291/009
FSCA
N.A.
N.A.
2010/08/12
Smith & Nephew Orthopaedics Ltd Peri-Loc 3.5mm Anterolateral Distal Tibial
Plate - Single Lot number 08GM01799
MHRA
2010/005/011/601/002
FSCA
Smith & Nephew LTD
N.A.
2010/08/12
Siemens Medical Solutions e.cam SPECT Camera Systems with Profile AC
option
MHRA
2010/002/003/081/016
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/08/12
Invacare Stability - TDX SP
MHRA
2010/004/030/301/001
FSCA
Direct Health Ltd.
25281109
2010/08/12
Smith & Nephew Healthcare Ltd Dyonics Bonecutter Electroblade - Item code:
7205962 and 72202213 Lot number: All
MHRA
2010/008/010/081/002
FSCA
Smith & Nephew LTD
N.A.
2583 0813
2010/08/14
St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838,
3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3107789, 3107790)
FDA
N.A.
Class I
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
2010/08/16
Drive Medical Walking frame (Model : 10281W-1 to 10287W-1)
MHRA
2010/006/014/301/001
FSCA
N.A.
N.A.
2010/08/16
MIPM TeslaPlus MRI-compatible Patient Monitor with New ECG leads
MHRA
2010/008/003/291/022
FSCA
N.A.
N.A.
2010/08/16
Philips All Bucky Diagnost with Optimus X-ray Generator
MHRA
2010/002/012/401/018
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/08/17
Kimal Extension Set Product No K39/10/100 and K39/10/200
MHRA
2010/006/016/401/005
FSCA
N.A.
N.A.
2010/08/17
Varian BrachyVision (Versions 8.2 through 8.9)
MHRA
2010/008/013/081/003
FSCA
Varian Medical
Systems Pacific Inc.
2724 2836
2010/08/18
Abbot CELL-DYN 4000 and Sapphire vent head assembly
MHRA
2010/008/006/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/08/18
Stryker Scorpio T72 Tibial Insert Trial
MHRA
2010/008/006/081/027
FSCA
Stryker China Ltd
2518 6915
2010/08/19
Ortho-Clinical Diagnostics mALB Reagent, GENs 2, 3, and 4 Cat. No 6801740
MHRA
2010/006/011/401/005
FSCA
Ortho Clinical
Diagnostics
2737 5504
2010/08/19
Swissimplant solysafe septal occluder - all diameters - type 15rRef 010.0001,
type 20 Ref 010.0002, type 25 ref 010.0003, type 30 Ref 010.0004, type 35 ref
010.0005
MHRA
2010/008/006/081/020
FSCA
N.A.
N.A.
2010/08/19
Siemens Medical Solutions AXIOM Luminos TF and Sireskop SD
MHRA
2010/008/010/081/005
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/08/19
BD GasPak EZ Large Incubation Container (Cat No. 260672, Lot No.
7110573)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/08/19
Cardinal Health Medi-Vac® Non-Conductive Suction Tubing (Cat No. N510,
N512, N56A, N610, N612, N66A, N710, N712, N76A, NEX510; NEX512;
NEX56A; NEX610; NEX612, NEX66A; NEX710, NEX712; NEX76A) (All lot
numbers prior to Y10KXXXX)
Solar-Med
Limited
FCA 2010236
Firm Initiated
Field Action
Solar-Med Limited
2425 0926
2010/08/19
Johnson & Johnson Acuvue (Narafilcon A) contact lens 1 Day Acuvue TruEye
(Lot No. 492237, 492238, 492250, 492251, 492287, 492288, 492289, 492268,
492241, 492282, 492283, 492280, 492281, 492252, 492254, 492245)
Johnson &
Johnson Vision
Care, Johnson
& Johnson
(Hong Kong) Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Vision Care, Johnson &
Johnson (Hong Kong)
Ltd.
2737 5718
2010/08/20
Sonosite SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer" Part
number P05813 and P06841.
FDA
Z-2191-2010
Class II
N.A.
N.A.
2010/08/20
ConMed Linvatec REF 87100 87k Arthroscopy Tubing Set (Lot 0904151
through 1005201), for use with the 87k Arthroscopy Pump (87000)
FDA
Z-2192-2010
Class II
ConMed Limited
N.A.
2010/08/20
Wright Medical Technology Dynasty A-Class Poly Liner, REF DLXP-LD36
FDA
Z-2212-2010
Class II
N.A.
N.A.
2010/08/20
Minntech DSD Application Guide (MG04-0001 revision M) for the Pentax
Universal Video Scope Hookup (DSD-110-HU0109) only when used with the
DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U
endoscope.
FDA
Z-2213-2010
Class II
Schmidt BioMedTech
(H.K.) Limited
2620 8329
2010/08/20
Beckman Coulter Access Immunoassay Systems AFP QC, Part Number:
33219, Lot Numbers: 911158, 911581, and 917631
FDA
Z-2208-2010
Class III
N.A.
N.A.
2010/08/20
St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838,
3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3110892,
3118797, 3107789, 3107790)
FDA
Z-2178-2010 to Z-2182-2010
Class I
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
2010/08/21
Immuncor Panoscreen I, II & III
Health Canada
55873
Type I
Uninet Technology LTD
2838 8423
2010/08/23
GE Healthcare CARESCAPE™ Monitor B850
MHRA
2010/007/007/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/08/23
Fujirebio Mesomark Kits
Health Canada
55955
Type II
N.A.
N.A.
2010/08/23
Teleflex IMA / ENT Blade Electrode
Health Canada
55952
Type II
N.A.
N.A.
2010/08/23
Immucor Galileo Blood Bank Analyzer
Health Canada
55949
Type II
Uninet Technology LTD
2838 8423
2010/08/23
Siemens Syngo Dynamics
Health Canada
55938
Type III
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/08/23
Gyrus Dissector PlasmaKnife (DPK)
Health Canada
55925
Type II
Olympus Hong Kong
and China Ltd
2170 5678
2010/08/23
Heine Optotechnik XP Laryngoscope Blabe Mac 3
Health Canada
55909
Type III
N.A.
N.A.
2010/08/23
Sybron Endo K3 Gutta Percha
Health Canada
55901
Type III
N.A.
N.A.
2010/08/23
Roche Anti-CCP for Elecsys and Cobas E
Health Canada
55874
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/08/23
Toshiba Aquilion One System - Main Unit
Health Canada
55835
Type II
Sanko Medical
Systems (HK) LTD
23840688
2010/08/23
Stryker Sonopet Ultrasonic Aspirator Console
Health Canada
55828
Type II
Stryker China Ltd
2518 6915
2010/08/23
Medtronic Polestar N-20 - Magnetic Resonance Diagnostic Device
Health Canada
55746
Type II
Medtronic International,
Ltd.
2919 1300
2010/08/23
Roche (Tina Quant IgG Gen.2)
Health Canada
55734
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/08/23
AGFA A) NX8000 workstations used in combination with 19'' Barco monitor
and mounting stand, B) NX8200 workstations used in combination with 19''
Barco monitor and mounting stand
Health Canada
55730
Type II
AGFA Hong Kong
Limited
2555 9421
2010/08/23
GE HiSpeed DX/I LX/I CT System
Health Canada
55695
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/08/23
Siemens Immulite 2500 System-Human Chorionic Gonadotropin (HCG) Assay
Health Canada
55581
Type III
N.A.
N.A.
2010/08/23
OridionA) Filterline Set
B) Smart Capnoline Plus ADU/INT 25/100 UN
C) Smart Capnoline Plus O2 ADU/INT 25UN
D) Smart Capnoline H Plus O2 ADU/INT 25UN
E) Niv-Line Adult 25UN
Health Canada
55493
Type II
N.A.
N.A.
2010/08/23
Varian
A) Clinac Linear Accelerator
B) Trilogy Radiotherapy Delivery System
C) Clinac IX Radio Therapy Delivery System
D) Novalis TX Linear Accelerator
Health Canada
55377
Type II
Varian Medical
Systems Pacific Inc.
2724 2836
2010/08/23
Biomerieux O-F Dextrose Tubed Media
Health Canada
55201
Type III
bioMerieux China Ltd.
2195 9348
2010/08/24
Draeger Oxylog 3000 emergency / transport ventilators
MHRA
2010/008/016/081/002
FSCA
Draeger Medical Hong
Kong Ltd.
2877 3077
2010/08/24
Varian Optical Guidance Platform used for Clinac or Novalis TX
Varian Medical
Systems Pacific
Inc.
CP-00356
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
2010/08/25
BrainLAB 19506B, 19506C KOLIBRI NAVIGATION STATION 2.0 (WITH
MOBILE CAMERA STAND 2.0); 19801A KOLIBRI MOBILE CAMERA STAND
2.0
BrainLAB Ltd
10-06-02.SEL.3 (III)
Firm Initiated
Field Action
BrainLAB Ltd
2417 1881
2010/08/25
Allergan UK Easyband - Version 2 and Version 3
MHRA
2010/003/026/081/004
FSCA
Allergan Asia Limited
2610 2525
2010/08/25
Allergan UK Easyband - Gen0
MHRA
2010/003/026/081/004
FSCA
Allergan Asia Limited
2610 2525
2010/08/25
Aesculap AG Tibia Offset Cemented Stem (Model Number: NR196K)
MHRA
2010/008/006/081/005
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/08/25
Aesculap AG Hydrolift instrumentation
MHRA
2010/008/006/081/006
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/08/25
Smith & Nephew VLP Compression Plate 7 Hole 56mm (Product code
72824014S Lot Number: all batches)
MHRA
2010/008/016/081/007
FSCA
Smith & Nephew LTD
2645 8706
2010/08/25
Beckman Synchron® Systems LX® 20 & UniCel® DxC Systems
MHRA
2010/008/006/601/004
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/08/26
Abbott Point of Care i-STAT Level 2 Control Value Assignment Sheets & iSTAT CLEW A20 Software/System Manual Update Compact Disc
MHRA
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/008/009/291/003
2010/08/26
ThermoFisher PB0226A, Oxoid G.C. Selective Agar with Lysed Blood and
LCAT, lot numbers 1140346, 1140347
MHRA
2010/008/017/601/001
FSCA
N.A.
N.A.
2010/08/26
SonoSite NanoMaxx Ultrasound system
MHRA
2010/008/020/601/005
FSCA
N.A.
N.A.
2010/08/26
BD BACTEC FX - Top Unit (Cat. No. 441385, All sequential serial numbers
between and including FT001 to FT0906 and FT0922), BD BACTEC FX Software (Cat. No. 441398, Serial No. V100E, V101F, V200B, V210A, V220B,
V221A, V230B, V300A; Cat. No. 441750, Serial No. V100A)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/08/27
Boston Scientific Wingspan Stent System 3.0x15mm (Cat. No. WE030015,
Lot 13192372, 13215033)
Boston
Scientific Hong
Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
2010/08/27
AGFA 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack
with LCD Arm Agfa's Computed Radiography Systems with NX2.X software
(Lot: LU8QJ000)
FDA
Z-2100-2010
Class II
AGFA Hong Kong
Limited
2555 9421
2010/08/27
International Technidyne Corporation (ITC) RQCHRT HRT Control Level 1 &
2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test
Tubes. (Test kit lot numbers: H9KHR002, Exp 07/2010 and BOKHR001, Exp
1/2011; RAF 10-016)
FDA
Z-2110-2010
Class II
Vastec Medical Ltd.
2897 1912
2010/08/27
Cardinal Health Temno Coaxial Chiba Fine Needle Aspiration; a coaxial
introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm)
(REF CCH2220, Lot D09121745)
FDA
Z-2111-2010
Class II
CareFusion Hong Kong
Ltd.
2891 8730
2010/08/27
International Technidyne Corporation (ITC) directCheck Whole Blood Quality
Controls Plasma, Coagulation Control. (Catalog number: DCJLR-N; Lot
number: M9DNL055, exp. 9/2010)
FDA
Z-2200-2010
Class II
Vastec Medical Ltd.
2897 1912
2010/08/27
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, Knee prosthesis
component. (REF 183022, Lot: M402080)
FDA
Z-2204-2010
Class II
N.A.
N.A.
2010/08/27
CareFusion Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O
PEEP 15 FT 5/Pkg. (Units: Y09D1922 Y09H0564 Y09H0565 Y09K0491
Y09K0492 Y09S1283 Y09S1284 Y10A1230)
FDA
Z-2205-2010
Class II
CareFusion Hong Kong
Ltd.
2891 8730
2010/08/27
Zimmer Trabecular Metal acetabular revision system buttress augment (004898-001-54, 00-4898-001-58, 00-4894-300-00, 00-4894-400-00)
FDA
Z-2214-2010 to Z-2217-2010
Class II
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
2010/08/27
Pride Electric rise and recline chair - models C1, C5, C6, C11, C15, LC101,
D30, 560, 660, 670 & T3
MHRA
2009/009/021/261/001
FSCA
N.A.
N.A.
2010/08/27
Seca 955 & 959
MHRA
2009/009/014/401/010
FSCA
N.A.
N.A.
2010/08/30
Beckman COULTER® AC•T™ 5diff, COULTER® AC•T™ 5diff Cap Pierce,
and COULTER® AC•T™ 5diff Autoloader Hematology Analyzers
MHRA
2010/008/009/601/003
FSCA
N.A.
N.A.
2010/08/30
Beckman SYNCHRON® System(s) Modular Creatinine Reagent Kit (472525)
Buffer lot M911427 and M911518
MHRA
2010/008/009/601/004
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/08/30
Aesculap Targon Tx Access Reamer, part no. KH451R
MHRA
2010/008/016/081/015
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/08/30
Schulke Thermosept Alka Clean Forte/Thermosept Nkz
MHRA
2010/008/016/291/011
FSCA
N.A.
N.A.
2010/08/30
Hill-Rom TotalCare Duo2 Therapy System
MHRA
2009/008/017/261/003
FSCA
Solar-Med Limited
2425 0926
2010/08/30
Joerns Oxford Hoist Weigh-scales OP97000 models
MHRA
2010/007/009/401/005
FSCA
N.A.
N.A.
Monthly Summary of Medical Device Safety Alerts -July 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/07/02
Medtronic Orthopedic Dovetail Clamp, REF 9730289.
FDA
Z-0923-2010
Class II
N.A.
N.A.
2010/07/02
Pointe Scientific Creatinine Reagent Set (Catalog # C7539-150, C7539-625,
C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R11000, and 7-C7539-R1-500), Creatinine Reagent R2 (Catalog # 3-C7539-L, 7C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539R2-125 and 8-7539-R2-250). All lots numbers containing the numbers 923202;
exp. 2011-08.
FDA
Z-1035-2010 to Z-1036-2010
Class II
N.A.
N.A.
2010/07/02
FHC Micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog #
MT-GL4K. Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583,
17589, 17588, and 17581.
FDA
Z-1143-2010
Class II
N.A.
N.A.
2010/07/02
Lockheed-Martin Aculight Corporation Perseus Pulsed Fiber Laser, Model
number: ML36L-1541. Additional Model numbers with non-defective type"A"
fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Serial
Numbers: 00001, 00002, and 00003
FDA
Z-1170-2010
Class II
N.A.
N.A.
2010/07/02
ev3 Protg EverFlex Self-Expanding Biliary Stent System (REF: PRB35-06-150080, REF PRB35-06-120-120 and PRB35-06-150-120, Lot Numbers: 7857377,
7856788 and 7858698)
FDA
Z-1598-2010
Class II
Sinomed Company Ltd.
28877640
2010/07/02
Advanced Neuromodulation Systems (St. Jude Medical) Eon Mini Implantable
Pulse Generator (IPG) (Code: 65-3788-01, Serial Numbers: 703271, 703287,
703050, 703051, 704169, 704476 and 704520)
FDA
Z-1599-2010
Class II
N.A.
N.A.
2010/07/02
Cardinal Health Disposable Skin Stapler (catalog number FS-35W, Lot
Numbers: 090203-SH and 091008-SH)
FDA
Z-1610-2010
Class II
CareFusion Hong
Kong Ltd.
2891 8730
2010/07/02
Orthofix 4.5MM, 5.5MM, 6.5MM, 7.5MM, 8.5MM Bone Tap, Modular (Part
Number 52-1024, 52-1025, 52-1026, 52-1027, 52-1028)
FDA
Z-1611-2010 to Z-1615-2010
Class II
N.A.
N.A.
2010/07/02
Wright Medical Technology Advance Duramer Tibial Insert (REF: Kimp-312L,
Kimp-312R, Lot Number: 679391, 681644)
FDA
Z-16356-2010 to Z-1637-2010
Class II
N.A.
N.A.
FDA
Z-1639-2010
Class II
N.A.
N.A.
FDA
Z-1665-2010 to Z-1679-2010
Class II
N.A.
N.A.
FDA
Z-1651-2010 to Z-1652-2010
Class III
N.A.
N.A.
FDA
Z-1203-2010 to Z-1204-2010
Class III
N.A.
N.A.
2010/07/02
2010/07/02
2010/07/02
2010/07/02
Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection
Site, Sterile, Non pyrogenic, Latex Free (Product Code: KSA-140. Lot Numbers:
903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091,
906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018,
909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037)
Biomet Mallory Head Calcar Provisional replacement stem (REF 104773,
104986, 11-104902, 11-104904, 11-104905, 11-104939, 11-104947, 11104953, 11-104954, 11-104971, 11-104972, CP154591, CP154593, CP154599,
CP154604.)
Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot
Numbers: 00401, 00502, 00701, 00702, 00501)
Churchill Medical Systems Vycon Nutrisafe 2 syringe 5 ml (Product Code:
1015.062M, Lot Numbers: 910118), 10 ml (Product Code: 1015.122M, Lot
Numbers: 910107, 911165)
2010/07/02
Ferring Pharmaceuticals Euflexxa (1% sodium hyaluronate). Pre-filled syringe
(Lot Numbers: RC0101A, RC0102A, RC0107A, RC0114A, RC0118A,
RC0122A, RC0123A, RC0127A, and RC0131A)
FDA
Z-1635-2010
Class III
N.A.
N.A.
2010/07/02
Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide
(Scorpio Anterior Skim Cut Guide, product code 7650-5003; Distal Femoral
Resection Guide Stand, product code 7650-5005; Punch Thru Tibial
Baseplates, product codes 3750-0003, 3750-0004, 3750-0005, 3750-0006,
3750-0007, 3750-0009, 3750-0011 and 3750-0013)
MHRA
2010/004/013/081/013
FSCA
Stryker China Ltd
2518 6915
2010/07/02
Nova Biomedical Ionized Calcium and Ionized Magnesium Sensors (27813,
37272, 42458) on Nova Stat Profile pHOx, Stat Profile Critical Care Xpress,
Nova 8 and BioProfile FLEX analyzers
MHRA
2010/006/028/601/002
FSCA
N.A.
N.A.
2010/07/02
Beckman Coulter IOTest 3 CD5- FITC / CD-10 PE / CD-19 ECD (Part number:
A07707, Lot number: 27)
MHRA
2010/006/029/601/001
FSCA
Beckman Coulter
Hong Kong Ltd.
2240 6150
2010/07/02
Gebrueder Martin Molina Pin Driver (Reference number: 51-600-85)
MHRA
2010/006/028/081/014
FSCA
N.A.
N.A.
2010/07/02
Kapitex Trachidress (Model: Trachidress TR DRE 0001; Lot number: WO 25700
– WO 25702)
MHRA
2010/002/010/401/021
FSCA
N.A.
N.A.
2010/07/02
BD Beaver Xstar Slit Blade 3.0mm Straight Blades (REF 375521, Lot 9138996)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/07/02
BD Vacutainer ACD Solution A tube (Cat No. 364606, Lot 0077189)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/07/03
Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot
Numbers: 00401, 00502, 00701, 00702, 00501)
FDA
N.A.
Class I
N.A.
N.A.
2010/07/05
Elekta CMS Software XiO Patient Scan Position and Treatment Orientation
Designation in XiO
MHRA
2010/006/003/081/003
FSCA
Elekta Ltd.
2891 2208
2010/07/05
Karl Storz Cart Trolley (Model : 29003xxx)
MHRA
2010/002/002/401/007
FSCA
KARL STORZ
Endoscopy China Ltd.
2865 2411
2010/07/05
Volcano pcFM Software Kit (Model 6830 ComboMap System pcFM)
MHRA
2010/006/025/081/001
FSCA
N.A.
N.A.
2010/07/05
Zimmer Trabecular Metal Acetabular Revision System Buttress Augments And
Trabecular Metal
MHRA
2010/004/009/081/007
FSCA
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
2010/07/05
Draeger Blood Pressure Monitors Cuff, Neonatal ; Sizes 1 to 5 (Model :
MP00901, MP00902, MP00903, MP00904, MP00905)
MHRA
2010/006/028/081/023
FSCA
Draeger Medical Hong
Kong Ltd.
2877 3077
2010/07/06
GE A) Prospeed Scanner System, B) Sytec 6000 (Model : a)B7970YZ,
b)P9183AH)
Health Canada
47109
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/07/06
Technidata TD-Synergy Software (Model : TD-SYN-01)
Health Canada
52751
Type III
N.A.
N.A.
2010/07/06
Biomet Sports Medicine Artificial Ligament Fixation Device (Model : 904755 )
Health Canada
53910
Type II
Swedish Trading Co.,
Ltd
2953 5111
2010/07/06
Mizuho America Mizuha Doppler Probe (Model : 07-150-10)
Health Canada
53996
Type III
Keymax Technology
(HK) Ltd.
3150 8413
2010/07/06
Hill-Rom 100 Low Bed
Health Canada
54548
Type II
N.A.
N.A.
2010/07/06
2010/07/06
Hill-Rom A) Hill-Rom 1000 Beds, B) Care Assist P1170
GE Medical Systems Innova 2000 Cardiovascular System
Health Canada
Health Canada
54567
54810
Type II
N.A.
N.A.
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/07/06
Ohmeda Giraffe In-Bed Scales
Health Canada
55120
Type II
2010/07/06
Stryker Instruments A) Commandf II Microelectric System, B) Core Drills
Health Canada
55206
Type II
Stryker China Ltd
2518 6915
2821 5480
2010/07/06
Philips Medical Systems 1.5T Edge Eclipse system - Main Unit
Health Canada
55221
Type II
Philips Electronic Hong
Kong Ltd
2010/07/06
Bio-Rad Strep B Select (Model: 63750)
Health Canada
55233
Type II
Bio-Rad Pacific Ltd.
N.A.
2010/07/06
Elekta Focal Software (Release 4.40.00 & Up)
Health Canada
55234
Type II
Elekta Ltd.
2891 2208
2010/07/06
Haemonetics Plasma Bowl (Model : 0625B-00)
Health Canada
55256
Type II
Haemonetics (Hong
Kong) Limited
2116 3166
2010/07/06
Tyco Hydra Vision DR60/80 System, Generators
Health Canada
55273
Type II
Tyco Healthcare
(HKSAR) Ltd.
2574 3251
2010/07/06
Beckman Coulter
A) P3, P4 Plates for the PK7200 Automated Microplate System-Microplate
Reader
B) P3, P4 Plates for the PK7200 Automated Microplate System-Analyzer Class 3
C) P3, P4 Plates for the PK7300 Automated Microplate System-Instrument
Class 3
Health Canada
55300
Type II
Beckman Coulter
Hong Kong Ltd
2240 6150
2010/07/06
Smith & Nephew Gigli Saw Blade, 12 Inch (Model ; 210482)
Health Canada
55302
Type II
Smith & Nephew LTD
2010/07/06
Siemens Dimension Tacrolimus Flex Reagent Cartridge, DF107
Health Canada
55304
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/07/06
International Technidyne Corporation (ITC) Hemochron Response Insrtument,
IDMS
Health Canada
55307
Type III
N.A.
N.A.
2010/07/06
Siemens Syngo Imaging PACS
MHRA
2010/004/019/081/011
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/07/07
Stryker Epic, Epic II, and Epic II+ Critical Care Bed Models 2030 and 2031 and
Zoom II Critical Care Bed Model 2040
MHRA
2010/006/007/081/016
FSCA
Stryker China Ltd
2518 6915
2010/07/07
Oxford Midi 150A Electrical Hoist
MHRA
2010/001/013/401/006
FSCA
N.A.
N.A.
2010/07/08
DePuy (a JnJ company) P.F.C. Sigma Modular Tibial Tray SZ-4 N-8 (Model :
866024)
MHRA
2010/006/022/291/008
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/07/08
Bausch & Lomb Boston ES Rigid Gas Permeable Contact lens manufactured
with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material (Lot
no. 156PTC05)
FDA
Z-1705-2010
Class II
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
2010/07/08
Ciba Vision AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. (Lot
Number: 8717082, Exp. 10/2013 and Lot Number: 8717066, Exp. 10/2013)
FDA
Z-1706-2010
Class II
Ciba Vision (Hong
Kong) Ltd.
3972 7300
2010/07/08
Angiodynamics PulseSpray Infusion System, 90 cm x 20 cm infusion length
(Catalog No./Ref 12500402, Lot no. 991437)
FDA
Z-1707-2010
Class II
N.A.
N.A.
2010/07/08
Siemens Axiom Artis systems with Motor Controller Unit (Model Numbers:
10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959,
7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and
7728392)
FDA
Z-1732-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/08
Angiodynamics BENEPHIT(TM) XT Infusion System, (Model/REF Number
70035, Batch Numbers: P909081, P909291, P910092, P910262, P911053,
P911163, P911243, P912083, P912293 and P001203), ANGIODYNAMICS
BENEPHIT(TM) CV Infusion System, 35 cm (Catalog/Model/REF Number
60035, Batch Number: P909231)
FDA
Z-1733-2010 to Z-1734-2010
Class II
N.A.
N.A.
2010/07/08
Argon Medical Devices ARTERIAL LINE KIT (REF/REORDER NO. 194284,
496185, 496413Y, 498104, 498410B, 498411B, 498412B, 498439, 498447; Lot
No. 99737820, 99738261, 99737884, 99737777, 99737665, 99736745,
99716572, 99734514, 99738189)
FDA
Z-1737-2010 to Z-1745-2010
Class II
N.A.
N.A.
2010/07/08
Medtronic Hospital Grade Power Cord, UL, Part # 66319, 055476,
manufactured by Electri-Cord Manufacturing Co. beginning in February 2003.
(The cords are a detachable unit, supplied with the instruments listed below:
Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue
# 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump
consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic
autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R.
Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000,
SEQ1000E, SEQ1000R.)
FDA
Z-1939-2010
Class II
Medtronic International
Ltd.
2919 1300
2010/07/08
STERIS 4085, 5085 & 5085SRT Surgical Tables (Model #: 4085, 5085 &
5085SRT).
FDA
Z-1941-2010
Class II
Swedish Trading Co.
Ltd.
6199 0634
2010/07/08
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune
Complex EIA Kit, Part#: MK021.
FDA
Z-1942-2010
Class III
N.A.
N.A.
2010/07/08
Biomet Microfixation "1.5MM" System High Torque (HT), SD, X-DR, Screw
1.5MM X 3.5MM (WXL) Titanium, Non Sterile Product. (Ref: 91-6103, Lot no.
829760)
FDA
Z-1943-2010
Class III
Swedish Trading Co.,
Ltd
2953 5111
2010/07/09
Merit Medical Systems Laureate Hydrophilic Guide Wire - LWSTDA35180,
LWSTFA35180, LWSTFS35180, LWSTDA35260EX, LWSTFA35260EX,
LWSTFS35260EX
MHRA
2010/007/005/291/021
FSCA
King Health Limited
2481 3787
2010/07/09
BrainLAB Digital Lightbox
MHRA
2010/006/030/081/022
FSCA
BrainLAB Ltd
2417 1881
Accuray Asia
Ltd.
N.A.
Firm Initiated
Field Action
Accuray Asia Ltd
2247 8628
FDA
N.A.
News Release
N.A.
N.A.
2010/07/12
Accuray CyberKnife System (securing the LINAC Cover)
2010/07/12
Various FDA Safety Notification: Risk of Air or Gas Embolism When Using Airor Gas- Pressurized Spray Devices
2010/07/13
Siemens Immunlite 2000/2500 Chemiluminenscent Substract (Lots No. lots
L2SUBX 253, 254, 255, 256A, 257A, 258, 259S)
MHRA
2010/005/027/081/013
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7827
2010/07/13
Boots All In One Contact Lens Solution
MHRA
2010/007/006/291/001
FSCA
N.A.
N.A.
2010/07/13
HAAG-STREIT Tonometer Measuring Prism
HAAG-STREIT
Field Safety Notice No. 201001/01
FSCA
The Vita Company Ltd.
2548 7483
2010/07/14
Integra Lifesciences Integra Neuroballoon Catheters (Model:7CBD10)
MHRA
2010/007/006/291/021
FSCA
N.A.
N.A.
2010/07/14
Terumo Destination Carotid Guiding Sheath
MHRA
2010/007/006/291/006
FSCA
TERUMO CHINA
(H.K.) LTD.
2866 0811
2010/07/14
ArjoHuntleigh Atlas Skull Traction Unit (Model : SA9085)
MHRA
2010/003/030/601/001
FSCA
Arjo Huntleigh (Hong
Kong) Ltd.
2508 1416
2010/07/14
Roma Medical Aids All models of mobility scooter and powered wheelchair
MHRA
2009/011/004/301/001
FSCA
N.A.
N.A.
2010/07/14
Spectranetics QuickCat Extraction Catheter (Model : 60090-01)
MHRA
2010/006/017/401/013
FSCA
N.A.
N.A.
2010/07/14
Single Use Surgical (SUS) Vein Hook/Phlebectomy Hook Codes - S090, S106,
S134, and S135 Sterile -Single Use Devices
MHRA
2010/006/030/601/003
FSCA
N.A.
N.A.
2010/07/15
Merivaara Promerix Operating Table (product code 100060000)
MHRA
2010/007/008/291/002
FSCA
N.A.
N.A.
2108 4005
2010/07/15
Cardiac Science Powerheart 9390A automated external defibrillator
FDA
Z-1810-2010
Class II
Pacific Medical
Systems Limited
2010/07/15
Cardiac Science Treadmill models TM55, TM65, and CR60 (brand names
include Quinton, Burdick, and Cardiac Science).
FDA
Z-0985-2005 & Z-1757-2010
Class II
Shun On Healthcare
Limited
N.A.
2010/07/15
Romedic EVA 450 Patient Lift Battery Charger. (Serial numbers:
373317696102209, 373317696102210, 373317696102224, 373317696102227,
373317696102228, 373317696102232, 373317696102235, 373317696102242,
and 373317696102244)
FDA
Z-1736-2010
Class II
N.A.
N.A.
2010/07/15
DiaDexus PLAC Test Reagent Kit, immuno-turbidimetric method (part no.
90107, 90110, 90112, 90115, 90116, 10-112, 10-0113, 10-115)
FDA
Z-1748-2010 to Z-1753-2010
Class II
N.A.
N.A.
2010/07/15
International Technidyne Corporation (ITC) directCHECK Whole Blood Control
for Hemochron J. Microcoagulation Systems (Catalog number: DCJPT-A, Lot
no. G9DPA005).
FDA
Z-1786-2010
Class II
N.A.
N.A.
2010/07/15
Inviro Medical Devices InviroSnap Retractable Safety Syringes, Single use,
Sterile. (Catalog number: 100002, 100017, 100018, 100019, 100032, 100034,
100019, 100032, 100038, 100047, 100055).
FDA
Z-1800-2010
Class II
N.A.
N.A.
2010/07/15
Maquet (Datascope) CS100 Intra-Aortic Balloon Pump (Product number 099800-3023-XX), CS300 Intra-Aortic Balloon Pump (Product number 0998-00-3013XX), System 98XT/98 Intra-Aortic Balloon Pump (Product number 0998-00-0446XX and 0998-00-0479-XX).
FDA
Z-1811-2010 to Z-1813-2010
Class II
N.A.
N.A.
2010/07/15
Biomet 3i GS300 Gold Slotted Screw-3mm (Lot no. 868517, 865348, 868515)
FDA
Z-1956-2010
Class II
Ositek (HK), Inc. Ltd
3157 1757
2010/07/15
Biokit biokit HSV-2 Rapid test (Catalogue Number: 3000-28001), Sure-Vue
HSV-2 Rapid Test (Catalogue No: 23-046395) In Vitro Diagnostic test for
Herpes Simplex Virus 2.
FDA
Z-1970-2010 to Z-1971-2010
Class II
N.A.
N.A.
2010/07/16
Stryker Model 6200 M1 Ambulance Cot (Model : 6100-xxx-xxx)
MHRA
2010/006/029/081/009
FSCA
Stryker China Ltd
2518 6915
2010/07/16
SMS O2 Hose Assembly BS5682/NIST 3m Part No SMS0062386, Air-4 Hose
Assembly BS5682/NIST 3m Part No SMS0062387 and O2 Hose Assembly
BS5682/NIST 30" Part No SMS0062388
MHRA
2010/007/008/081/007
FSCA
N.A.
N.A.
2010/07/16
Philips Respironics V60 Ventilator
MHRA
2010/007/008/291/009
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/07/16
Volcano s5 Family Software Version 3.2 Intravascular Ultrasound Scanner
MHRA
2010/007/008/291/008
FSCA
N.A.
N.A.
2010/07/16
Osypka Pace 203H/300 Model 3085 in the range from S/N 0706101 to S/N
1001210
Pace 203H/300 Model 3085 in the range from S/N 0706101 to S/N
1001210
MHRA
2010/006/029/081/001
FSCA
N.A.
N.A.
2010/07/19
Beckman Coulter SYNCHRON Immunoglobulin A (Ig-A) Reagent
MHRA
2010/007/002/601/003
FSCA
Beckman Coulter
Hong Kong Ltd
2240 6150
2010/07/19
Drive Medical Mercury M36 Powered Scooter (Batch : WU-4726)
MHRA
2009/006/008/261/001
FSCA
N.A.
N.A.
2010/07/19
Siemens E-CAM Patient Handling System
MHRA
2010/007/007/291/008
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
Boston
Scientific Hong
Kong Ltd
NA
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
MHRA
2010/007/021/081/011
Philips
Electronic Hong
Kong Ltd
FSN86201147 (FSN dated
24 Jun 2010)
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5364
2010/07/19
Boston Scientific Ultraflex Esophageal Stent System, Ultraflex
Tracheobronchial Stent System and Ultraflex Precision Colonic Stent System
2010/07/19
Philips IntelliVue Patient Monitors MP60 (M8005A) (Serial no. DE22701289 –
DE84316576), MP70 (M8007A) (Serial No. DE22702728 – DE84399581)
2010/07/21
Cory Bros Purple Surgical Ultimate Endo Retrieval Pouch
MHRA
2010/006/014/401/012
FSCA
N.A.
N.A.
2010/07/21
CIBA VISION Softperm (synergicon A) contact lenses
MHRA
2010/006/008/081/004
FSCA
Ciba Vision (Hong
Kong) Ltd.
3972 7300
2010/07/21
Siemens Healthcare Diagnostics ADVIA Centaur Hepatitis B core Total (HBcT)
Assay (Cat. No. 07566733, Lot No. 49471033, 50694033, 51071033, 51628033,
52260033, 52809033, 53674033)
MHRA
2010/007/009/081/008
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/21
Ethicon Endo-Surgery (EES) (a J & J Company) PROXIMATE® PPH
Procedure for Prolapse and Hemorrhoids Set (product code PPH03, lot number
F4N12N)
MHRA
2010/007/007/291/006
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/07/21
BD BBL Staphyloslide Latex Test Kit (Cat no. 240952, 240953)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/07/21
Liko Viking M Patient Lift
Health Canada
54859
Type II
N.A.
N.A.
2783 1838
2010/07/21
GE Centricity Ultra Laboratory Information System
Health Canada
55072
Type II
GE Medical Systems
Hong Kong Ltd.
2010/07/21
Roche MagNa Pure Compact Instrument
Health Canada
55083
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/07/21
Brentwood IQManager Diagnostic Workstation
Health Canada
55107
Type III
N.A.
N.A.
2919 1300
2010/07/21
Medtronic Carelink - Monitor
Health Canada
55207
Type II
Medtronic
International, Ltd.
2010/07/21
Hill-Rom A) Hill-Rom 1000 Beds, B) Careassist Hospital Bed
Health Canada
55218
Type II
Solar-Med Limited
2425 0926
2010/07/21
Boston Scientific A) Synchro 2 Soft Guidewire, B) Synchro 2 Standard
Guidewire, C) Synchro PVS 1300 Neuro Guidewire
Health Canada
55223
Type II
Boston Scientific Hong
Kong Ltd
2960 7136
2010/07/21
Remel TB Potassium Permanganate Counterstain
Health Canada
55303
Type II
Hong Kong South East
Chemicals &
Instruments Ltd
2802 6333
2010/07/21
Smiths Medical A) Medfusion Syringe Infusion Pump, 3010, B) Medfusion
Syringe Infusion Pump, 3010A
Health Canada
55335
Type II
Goodman Medical
Supplies Ltd
2332 4455
2010/07/21
Immucor Anti-FY Blood Grouping Reagent
Health Canada
55381
Type III
Uninet Technology LTD
2838 8423
2010/07/21
Tomotherapy HI-ART System
Health Canada
55439
Type II
Transmedic Pte Ltd
(608) 824 2867
2010/07/21
Toshiba Kalare
Health Canada
55449
Type II
Sanko Medical
Systems (HK) LTD
23840688
2010/07/21
Medtronic Sofamor Danek Nim-Eclipse System - Module, Surface Preamp
Health Canada
55529
Type II
Medtronic
International, Ltd.
2919 1300
2010/07/21
Beckman Coulter Access Thyroglobulin Antibody II Reagent
Health Canada
55500
Type II
Beckman Coulter
Hong Kong Ltd
2240 6150
2010/07/22
DiaSorin Liaison VZV (Varicella Zoster Virus) IgG;Liaison VZV IgM
MHRA
2010/007/014/081/002
FSCA
N.A.
N.A.
2010/07/22
Invitrogen 7500Fast Dx Real-Time PCR Instrument With Sds V1.4 Software
MHRA
2010/007/013/081/001
FSCA
Invitrogen Hong Kong
Limited
N.A.
Boston
Scientific Hong
Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
MHRA
2010/007/022/081/006
Varian Medical
Systems Pacific
Inc.
CP-02334
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
2010/07/22
Boston Scientific CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE
implantable defibrillators manufactured between Jan 2006 and Nov 2007
2010/07/22
Varian Clinac 2100 (All C series Clinacs Equipped for Rapid Arc Treatment
delivery)
2010/07/22
Biosite Triage Total Controls 5, Level 1 (Model 88753), Level 2 (Model 88754),
Triage Total Controls Calibration Verification 5 (Model 88755)
FDA
Z-1788-2010 to Z-1790-2010
Class II
N.A.
N.A.
2010/07/22
Medtrol CaviBleach Wipes (Reorder No. 10-1155, Lot number: F29, Exp June
2010)
FDA
Z-1815-2010
Class II
N.A.
N.A.
2010/07/22
Respironics Trilogy 100 Ventilator, Model/Catalog Number 1054260
FDA
Z-1896-2010
Class II
Celki Medical Company
2332 3366
2010/07/22
Haag-Streit Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered.
FDA
Z-1897-2010
Class II
The Vita Company Ltd.
N.A.
2010/07/22
Smith & Nephew Genesis II Tibial Drill Guide, REF 71440238
FDA
Z-1900-2010
Class II
Smith & Nephew LTD
N.A.
2010/07/22
Bio-Rad VARIANT II Hemoglobin Testing System with CDM 3.5 Software
Version 3.5 (Model Number: 270-2000), VARIANT II TURBO Hemoglobin
Testing System with CDM 3.6T Software Version 3.5 (Model Number: 270-2600)
FDA
Z-1901-2010 to Z-1902-2010
Class II
Bio-Rad Pacific Ltd.
N.A.
2010/07/22
Sedecal Hydradjust IV DR Urological Table Sedecal Generator ( a) p/n 750732 64W generator & b) p/n 750733 80W generator).
FDA
Z-1904-2010
Class II
N.A.
N.A.
2010/07/22
DiaSorin GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100
test kit), CA-1553 (500 test kit).
FDA
Z-1914-2010
Class II
N.A.
N.A.
2010/07/22
Philips HeartStart FRx AED (Model number 861304), HeartStart HS1 OnSite"
(Model number M5066A), HeartStart HS1 Home (Model Number M5068A)
FDA
Z-1915-2010 to Z-1917-2010
Class II
Philips Electronic Hong
Kong Ltd
2821 5364
2010/07/22
MIRA CR4050 12mm Finger Probe, CR4055 25mm Finger Probe, CR4060 68
mm Finger Probe
FDA
Z-1918-2010 to Z-1920-2010
Class II
N.A.
N.A.
2010/07/22
SpineMatrix Lumbar Matrix Scan, Diagnostic Electromyography System
consisting of the CERSR Electromyography System and Electrode Array
FDA
Z-1935-2010
Class II
N.A.
N.A.
2010/07/22
Centurion Medical Products Dialysis On/Off Kit (DT11300), C.A.P.D. Tubing
Exchange Tray (HT80), Dialysis Tray (SP560)
FDA
Z-1936-2010 to Z-1938-2010
Class II
N.A.
N.A.
2010/07/22
Stanley Security Solutions Tabs Professional Monitor (Model 25022, 25023,
25223)
FDA
Z-1944-2010 to Z-1947-2010
Class II
N.A.
N.A.
2010/07/22
Bio-Rad Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM AntiHBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219.
FDA
Z-1620-2010
Class III
Bio-Rad Pacific Ltd.
N.A.
2010/07/22
Wilden Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR (erythrocyte sedimentation rate) Tubes. (Product Number: EXI0552).
FDA
Z-1816-2010
Class III
N.A.
N.A.
2010/07/23
Siemens ACUSON and SONOLINE Antares™ Ultrasound Systems versions
4.0, 5.0 and Acuson S2000
MHRA
2010/007/012/081/003
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/23
Fresenius 5008/5008S Bloodlines, 4008 E-Beam Bloodlines, 4008 ETO
Bloodlines, Genius Bloodlines and MultiFiltrate Bloodlines
MHRA
2010/007/020/081/015
FSCA
Fresenius Medical
Care Hong Kong
Limited
2583 0813
2010/07/23
Heraeus PALAMIX uno 1x80 Vacuum mixing system (Ref. no. 66036743; lot
no. 200177, 200178, 200179, 200180, 200181, 200182, 200183, 200184,
200185); PALAMIX duo 2x80 (Ref. no. 66036746; lot no. 500040); PALAMIX
Hip Set (Ref. no. 66044411; lot no. 800011, 800012)
MHRA
2010/007/021/291/019
FSCA
N.A.
N.A.
2010/07/26
Zimmer Trabecular Metal Femoral Cone Augment, Left & Right
MHRA
2010/007/012/081/006
FSCA
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
2010/07/26
Synovis PSD Gel with Peri-Strips Dry Staple Line Reinforcement with Apex
Processing & Peri-Strips Dry with Veritas Collagen Matrix Staple line
Reinforcement Replacement Fel 3-packs
MHRA
2010/007/020/081/007
FSCA
N.A.
N.A.
2010/07/26
Scan Mobility ScanBeta Cot Velcro
MHRA
2010/002/012/401/001
FSCA
N.A.
N.A.
2010/07/27
Beckman Coulter UniCel DxI 600 and 800 Systems Running System Software
Version 4.3
MHRA
2010/007/016/601/006
FSCA
Beckman Coulter
Hong Kong Ltd
2240 6150
2010/07/27
Beckman Coulter Active® I-PTH ELISA, DSL-10-8000 & Active® Intact PTH
DSL-8000
MHRA
2010/007/009/601/003
FSCA
Beckman Coulter
Hong Kong Ltd
2240 6150
2010/07/27
LeMaitre Vascular The Unballoon Non-Occlusive Modeling Catheter
MHRA
2010/007/020/081/017
FSCA
N.A.
N.A.
2010/07/28
Permobil Instructions for use for all Permobil wheelchairs
MHRA
2010/003/002/401/015
FSCA
N.A.
N.A.
2010/07/28
Siemens VARTA Microbattery rechargeable battery type p312 and charger,
used in hearing aid applications with the family name Siemens Pure and its
derivates
MHRA
2010/005/006/081/020
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/28
B.R.A.H.M.S. fBhCG KRYPTOR lot 09045 (reagent unit) in combination with
calibrator B.R.A.H.M.S. fBhCG KRYPTOR CAL lot 09033
MHRA
2010/007/021/291/018
FSCA
N.A.
N.A.
2010/07/28
Abbott Medical Optics (AMO) AMO WaveScan WaveFront Systems and Offline
Programming Module (OPM), software versions 3.67 and 3.671
AMO Asia
Limited
N.A.
Firm Initiated
Field Action
AMO Asia Limited
2401 5711
2010/07/29
CU Medical Paramedic CU-ER1, CU-ER2, CU-ER3, CU-ER5 Non-implantable
Defibrillator
MHRA
2010/007/022/081/004
FSCA
N.A.
N.A.
2010/07/30
2010/07/30
2010/07/30
Multi-Med 22ga x 1" Straight Huber Needle (Model number 10600218, Lot
9B020M), 22ga x 1" Right Angle Huber Needle (Model number 10600219, Lot
9B017M).
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx
System. Medical device (Product codes: GXMRSA/SA-BC-10, Lot 00601,
00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101,
01102, 01301, 01302; Product code: GXMRSA/SA-BC-CE-10, Lot 01001,
01101, 01301)
Orthopediatrics Orthopediatrics IM Femoral Nail (Part # 10-1500-021, 10-1500022, 10-1500-023, 10-1500-024, 10-1500-025, 10-1500-026, 10-1500-031, 101500-032, 10-1500-033, 10-1500-034, 10-1500-035, 10-1500-036, 10-1500037, 10-1500-071, 10-1500-072, 10-1500-073, 10-1500-074, 10-1500-075, 101500-076, 10-1500-081, 10-1500-082, 10-1500-083, 10-1500-084, 10-1500085, 10-1500-086, 10-1500-087)
FDA
Z-1888-2010 to Z-1889-2010
Class I
N.A.
N.A.
FDA
Z-1898-2010
Class I
N.A.
N.A.
FDA
Z-0339-2010 to Z-0364-2010
Class II
N.A.
N.A.
2010/07/30
BD BD FACSCount Controls Kit, An Automated Differential Cell Counter,
Model/Catalog Number: P/N: 340166, Lot Number: 89031721
FDA
Z-1007-2010
Class III
BD
2575 8668
2010/07/30
AGFA DT2 Mammo, Size 8 x 10 inch (Ref No. E2RN6, Lot Number: 36810031,
36750062)
FDA
Z-1799-2010
Class III
AGFA Hong Kong
Limited
2555 9421
2010/07/30
BD BD Difco Salmonella O Group A Antigen, packaged in 5 mL glass vials.
(Catalog #240731, Lot 9126057, Exp May 04, 2012)
FDA
Z-2025-2010
Class III
BD
2575 8668
2010/007/005/291/002
FSCA
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
FSN 86100096A
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
2010/07/30
2010/07/30
Bausch & Lomb ReNU Multi-Purpose Solution and ReNu MultPlus Solution
(Lot: CA128.4,, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5,
CA025.5, CA025.5, CA025.5, CA025.5, CA025.5, BA184.2, BA184.2, BA184.2,
BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2,
BA184.2, BA184.2, BA184.2, BA117.5, BA184.2, BA184.2, BA184.2, BA184.2,
MHRA
BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2,
BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, E1ELC91390,
E1ELC91393, E1ELC91390, E1ELC91291, E1ELC91294, E1ELC91330,
E1ELC91338, E1ELC91291, E1ELC91294, E1ELC91330E1ELC91338,
E1ELC91393, E1ELC91390, E1ELC91393, DA031, CA142)
Philips HeartStart MRx monitor/defibrillator, models M3535A, M3536A, M3536J,
Philips
and M3536MC (All HeartStart MRx units with serial numbers less than
Electronic Hong
US00542779)
Kong Ltd
2010/07/30
Merz Novabel Dermal Filler
MHRA
2010/007/023/081/016
FSCA
N.A.
N.A.
2010/07/30
VEXIM Spine Jack Preparation Kit
MHRA
2010/007/013/291/031
FSCA
N.A.
N.A.
2010/07/30
Sterimedix (Altomed) Ophthalmic handpieces. used for irrigation/ aspiration
during ophthalmic procedures (Model : M5510, M5513, M5514, M5519, A3402,
A3404, A3405, A3406)
MHRA
2010/001/029/081/009
FSCA
N.A.
N.A.
2010/07/30
Gordon Ellis Ashby - part numbers 6312/6314/6316 Raised Toilet Seats
MHRA
2010/007/013/601/002
FSCA
N.A.
N.A.
2010/07/30
Linet Eleganza 3 with split siderails
MHRA
2010/007/022/601/001
FSCA
N.A.
N.A.
2010/07/30
AMO (Abbott) Complete Multi-Purpose Solution and Total Care Lens Care
Solution
MHRA
2010/007/023/081/008
FSCA
AMO Asia Limited
2401 5711
2529 2009
N.A.
2010/07/31
B. Braun AddEase Binary Connector
Health Canada
55733
Type I
B. Braun Medical Hong
Kong
2010/07/31
Rehabilitation Centre for Children Tilt Standing Frame
Health Canada
55699
Type I
N.A.
Monthly Summary of Medical Device Safety Alerts - June 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/06/01
Vital Images Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the
licensing of CT lung or CT Colon
FDA
Z-1600-2010
Class II
N.A.
N.A.
2010/06/01
Endotec Prosthesis Knee, Prosthesis Shoulder, Prothesis Hip, Prothesis Ankle,
TMJ Components
FDA
Z-1621-2010 to Z-1627-2010
Class II
N.A.
N.A.
2010/06/01
Philips HeartStart FR2+ Automated External Defibrillator
Philips
Electronic Hong
Kong Ltd
N.A.
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
2010/06/02
Centurion Medical Products Basic Core Pack # OR1805, Sterile (Lots:
2009100590, 2009110990, 2009121490, 2010011190 and 2010031590)
FDA
Z-1595-2010
Class II
N.A.
N.A.
2010/06/02
Stryker Accolade Distal Centralizers 14 mm Large (Catalog No.: 1059-6714) &
13 mm Medium (Catalog No.: 1059-4513) (Lot no. WDYMLE & WDXMLE)
FDA
Z-1593-2010 to Z-1594-2010
Class II
Stryker China Ltd
2518 6915
2010/06/02
Animas (JNJ) One Touch Ping Insulin Pump using ezManager Max diabetes
management software.
FDA
Z-1560-2010
Class III
Johnson & Johnson
Medical (HK)
2738 6027
2010/06/03
Cutera Titan XL handpieces (Serial no. TX2183)
MHRA
2010/005/011/081/003
FSCA
N.A.
N.A.
2010/06/03
Beckman Coulter IMMAGE Systems Buffer 1 (BUF 1) (REF: 447650, Lot:
T908069, T908104, T909110, T001036)
MHRA
2010/005/024/061/002
FSCA
Beckman Coulter
Hong Kong Ltd
2240 6150
2010/06/04
DJO Surgical (Encore Medical) MIKA (Minimally Invasive Knee Arthroplasty)
Instrumentation System - MIKA Speedblocks Size 8-12 (Cat no. 8000-01-368,
800-01-369-, 800-01-370, 800-02-343, 800-02-344, 800-02-345)
MHRA
2010/005/017/291/025
FSCA
N.A.
N.A.
2010/06/04
Sanofi-Aventis Sculptra Apyrogenic Suspension (Poly–L–lactic Acid) - batch
number 1A9032
MHRA
2010/005/026/081/017
FSCA
Sanofi-Aventis HK
2506 8333
2010/06/04
Hospira Receptal PVC Liner (List no. OL2129701, OL21297W1, OF8079701,
OG6619701, OG9159701, OE0989701, OF8069701)
MHRA
2010/005/028/081/037
FSCA
Hospira Limited
2898 2886
2010/06/04
Elekta Linear Accelerator Software - XVI R4.5
MHRA
2010/005/027/081/004
FSCA
Elekta Ltd.
2891 2208
2010/06/04
Elekta XiO Release 4.50.00 and higher
MHRA
2010/005/027/601/001
FSCA
Elekta Ltd.
2891 2208
2010/06/05
NERL Diagnostics Lifesign Staph Latex Kits / Wampole Staph Latex Test
FDA
Z-1111-2010
Class II
N.A.
N.A.
2010/06/05
Galt Medical Micro Introducer Kit 5F, Model number: KIT-014-29
FDA
Z-1592-2010
Class II
N.A.
N.A.
2010/06/05
Stryker Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920
FDA
Z-1601-2010
Class II
Stryker China Ltd
2518 6915
2010/06/05
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part
numbers: MR-FC-2EO, MR-FC-3EO
FDA
Z-1616-2010
Class II
N.A.
N.A.
2010/06/05
Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light); 2) Stryker
Equipment Delivery System (EDS), Ceiling Mounted Equipment Booms, the
booms are ceiling mounted devices; 3) Stryker VISUM Halogen Surgical Lights
(Ceiling Mounted Surgical Lights); 4) SwitchPoint Element (SPE) Control
System. Control System for audio/video, surgical, and room equipment; 5)
SwitchPoint Infinity (SPI) Control System; 6) Ceiling Suspensions (Surgical
Light and Flat Panel Suspensions);
FDA
Z-1640-2010
Class II
Stryker China Ltd
2518 6915
2010/06/05
Blackstone Medical Orthofix Spinal Implants, Hallmark Anterior Cervical Plate
System; Plate Bender Part number 62-0070. Non Sterile. Part number 62-0070
FDA
Z-1653-2010
Class II
N.A.
N.A.
2010/06/05
GE Innova 4100 IQ: 4100 / 4100 IQ, Innova 3100 IQ: Innova 3100 / 3100 IQ,
Innova 2100IQ
FDA
Z-1659-2010 to Z-1661-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/05
InSound Medical Lyric in-canal hearing aid
FDA
Z-1681-2010
Class II
N.A.
N.A.
2010/06/05
Circaid Juxta-Lite compression wrap (various sizes)
FDA
Z-1684-2010 to Z-1702-2010
Class II
N.A.
N.A.
2010/06/05
3m Imtec Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
FDA
Z-1703-2010
Class II
2010/06/05
Imaxeon Avidia Angiograph Contrast Injector
MHRA
2010/005/028/081/031
FSCA
N.A.
N.A.
2010/06/05
DeRoyal Custom Procedure Trays (CPT) Angio Pack (Code: 55-012953, Lot
no. 195336, 191453, 191454, 191455, 195335)
MHRA
2010/005/028/081/032
FSCA
N.A.
N.A.
2010/06/07
Draeger Delta and Gamma XXL
Draeger Medical
Hong Kong Ltd.
N.A.
Firm Initiated
Field Action
Draeger Medical Hong
Kong Ltd.
2877 3077
2010/06/07
Siemens 550 TXT Table (Model: 07346534, Lot: 1108, 1109, 1110, 1121,
1122, 1123, 1216, 1345, 1354, 1421, 1481)
Health Canada
54154
Type III
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/06/07
Stryker A) Autoclavable Camera Tray (0233-410-000), B) 45cm Laparoscopic
Tray (0250-015-704), C) 23 Instrument Tray (0242-000-024), D) Dilator Tray
(0234-020-124), E) Bio-Absorbable Tray (0234-020-123)
Health Canada
54622
Type II
Stryker China Ltd
2518 6915
2010/06/07
Oridion Medical A) Capnostream 20 (US) N with Printer (CS08657, CS08659),
B) Capnostream 20 (US) N (CS08651), C) Capnostream 20 (US) M (CS08653)
Health Canada
54790
Type II
N.A.
N.A.
2010/06/07
Coopersurgical INCA Infant Nasal Cannulae Assembly for CPAP (continuous
positive airway pressure) 9F, 10.5F, 12F, 15F and 7.5F (Model: AL-44-2709,
AL-44-2710, AL-44-2712, AL-44-2715, AL-44-2707)
Health Canada
54701
Type II
N.A.
N.A.
2010/06/07
Stryker Small Joint Handpiece (275-601-500) and Hand Control Shaver
Health Canada
54355
Type II
Stryker China Ltd
2518 6915
2010/06/07
Stryker Switchpoint Infinity 2 Standard With DVI With PIP Control System
(0678-000-537), Stryker Switchpoint Infinity 2 Standard With Hi-Res With DVI
(0678-000-536)
Health Canada
54569
Type II
Stryker China Ltd
2518 6915
2010/06/07
Hospira Symbiq One Channel Infuser (16026), Symbiq Two Channel Infuser
(16027)
Health Canada
54403
Type II
Hospira Limited
2898 2886
2010/06/07
Baxter 1550 Hemodialysis Instruments (Model: 5M5538, 6001238147,
6001238148, 6001238149, 6001238218)
Health Canada
54625
Type III
Baxter Healthcare Ltd
2807 8555
2010/06/07
Bioplate Bioplate Titanium Fixation System, Sterile Kits
Health Canada
54690
Type II
N.A.
N.A.
2010/06/07
Teleflex Medical Blade Electrode (Model: 809315)
Health Canada
53866
Type II
N.A.
N.A.
2010/06/07
Siemens Healthcare Diagnostics Dimension Vista System-1500 Analyzer
(Model: 1000035896)
Health Canada
54568
Type III
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/06/07
Roche Diagnostics Elecsys-Antibodies to Thyroid Peroxidas (Model:
11820818191)
Health Canada
54002
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/07
Rochester Medical Femsoft Insert (Model: 71201, 71202, 71203, 72201,
72202, 72203)
Health Canada
54707
Type II
N.A.
N.A.
2010/06/07
Restorative Therapies FES Leg / Arm Cycle Ergometer, RT300 (Model:
FA100052, FA102011, FA104581)
Health Canada
54668
Type II
N.A.
N.A.
2010/06/07
Thermo Anatomical Pathology Microm HM355S Microtome (Model: 36 101
6409)
Health Canada
54338
Type II
N.A.
N.A.
2593 2211
2010/06/07
Abbott IMX Sirolimus Reagent (List No. 5C91-21)
Health Canada
54481
Type III
Abbott Laboratories
LTD.
2010/06/07
Stryker Infravision Esophageal Kit (Model: 0220-180-548)
Health Canada
54720
Type II
Stryker China Ltd
2518 6915
2010/06/07
Integra Lifesciences Mayfield Infinity XR2 radiolucent Base Unit (Model: A2079)
Health Canada
54531
Type III
N.A.
N.A.
2010/06/07
Micro Typing Systems Ortho Provue (Model: MTS213784)
Health Canada
36665
Type III
N.A.
N.A.
2010/06/07
Roche Diagnostics PSM Software Version 2.01.05b and above (Model:
04944607001)
Health Canada
54207
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/07
Philips QCPR - CPR Meter Upgrade Kit (Model: 861444)
Health Canada
54745
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/06/07
Stryker Video Carts With Isolation Transformers (Model: 240-099-001, 240-099Health Canada
011, 240-099-011K, 240-099-020, 240-099-020K)
54347
Type II
Stryker China Ltd
2518 6915
2010/06/07
Leica Microsystems Surgical Microscope Footswitch (Model: 10445599,
10446000, 10448164, 10448406, 10448407)
Health Canada
54029
Type II
Leica Microsystems
Limited
2564 6699
2010/06/07
GE Healthcare, Bio-Sciences Corp. Whatman 903 Newborn Screening Card
(Model: 10534567, 10534678, 10534732, 10534751, 10534784, 10534785,
10534804)
Health Canada
54741
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/07
Varian Ximatron (Model: CX)
Health Canada
54560
Type II
Varian Medical
Systems Pacific Inc.
2724 2836
2010/06/07
Navilyst Vaxcel Port and Vaxcel Port with PASV Valve
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
2010/06/08
Abbott ARCHITECT Sirolimus Reagent (List no. 01L76-25, Lot 80162M100)
MHRA
2010/006/001/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/06/09
Roche Cobas Amplicor HIV-1 Monitor Test, v1.5, CE-IVD (Material No.
21118390123, Lot No. M04255)
MHRA
2010/006/003/081/004
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/09
Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, Version 2.0 (Material No.
04894570190)
MHRA
2010/006/003/081/005
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/09
C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh labeled
with C.R. Bard/Davol brand names (product no. 0112650, 0112660, 0112680,
0112720 Bard Flat Mesh with lot no. 48HVS036, 43APD007, HUSD0629,
HURL0336, 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027,
HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43FQD327) are not
Bard-manufactured products
FDA
N.A.
Class I
N.A.
N.A.
2010/06/09
Boston Scientific Fathom - 14 Steerable Guidewire (Lot No. B17404, B18118,
B18485, B18595, B18702, B18746, B18596, B18747, B19308, B18947,
B17847 & B18948)
Boston Scientific
Hong Kong Ltd
90599507FA
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
2010/06/09
Sorin Paradym DR, CRT-D & CRT-D sonR ICD (Models:8550, 8750 & 8770)
Innotronik Hong
Kong Limited
N.A.
Firm Initiated
Field Action
Innotronik Hong Kong
Limited
2877 6787
2010/06/09
BD Hypromellose Ophthalmic Solution USP 2% w/v BD HPMC, 2ml Sterile
Solution (REF 585306, Lot: 9A005BD, 9A006BD, 9J237BD, 0A019BD, and
0A021BD)
MHRA
2010/005/028/081/017
FSCA
BD
2575 8668
2010/06/09
DePuy (JNJ) Corail Hip Cemented Femoral Stem Without Collar Size 11
(Product code: L96411, Lot No. 3028743) and Size 9 (Product code: L96409,
Lot No. 3028308)
MHRA
2010/006/004/081/005
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/06/10
Philips Intera and Achieva systems with “Basic T1 Perfusion Package”
(Software Releases R1.8.1, R2.1.5, R2.5, R2.6, R11.8.1, R12.1.5 and R12.6)
MHRA
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/06/10
Roche LightCycler MRSA Advanced Test (P/N: 05352894190)
MHRA
2010/005/028/081/036
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/10
Wright Medical Technology Rayhack Drill Guide Angled, Ref 4010-0206
FDA
Z-1779-2010
Class II
N.A.
N.A.
2010/06/10
Ohio Medical MoblVac Portable Wound Care Pump (Models 769600, 759600,
769600, 769601, 769602, and 769610); NPWT Small Mobile Bag (Model
769709)
FDA
Z-1777-2010 to Z-1778-2010
Class II
N.A.
N.A.
2010/06/10
Angiodynamics DURAMAX Hemodialysis Catheters (Cat. no. 10302802,
10302803, 10302804, 10302805, 10302806, 10302807, 10302809, 10302812,
10302813, 10302814, 10302815)
FDA
Z-1761-2010 to Z-1771-2010
Class II
N.A.
N.A.
2010/06/10
Baylis LumbarCool Pain Management Kit (Model/Catalogue Number: LUK-17150-4, Lot No. LKFA160310)
FDA
Z-1755-2010
Class II
N.A.
N.A.
2010/06/10
Continental Medical Labs Xenon Diagnostic Circuit Kits labeled as "Xenon
Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit"
Manufactured for RAF MEDICAL, INC. or Medico-Mart, Inc.
FDA
Z-1754-2010
Class II
N.A.
N.A.
2010/06/10
GE Healthcare Seno Advantage 2.2 workstations with software version 22_01
and 22_02
FDA
Z-1747-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/10
Terumo Sarns Cardioplegia Set with MP-4 Module (Catalog Nos. 6375,
165720, 15501 and 16010)
Terumo China
(Hong Kong)
Limited
MD-2010-002-C
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/06/10
Boston Scientific Synchro-14 and Synchro2 Guidewire
Boston Scientific
Hong Kong Ltd
90599507FA
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
2010/06/11
Patterson Medical Liftmaster 160 (AA8974) and Liftmaster 190 (AA8943)
MHRA
2009/011/012/301/001
FSCA
N.A.
N.A.
2010/003/005/081/024
2010/06/11
DePuy (JNJ) Mitek VAPR Integrated Handpiece Electrode (Product Code:
225370, 227355, 227504, 227204, 227301, 227312, 227302, 227305, 227211,
227202, 227203, 227213 and 227252)
Johnson &
Johnson (Hong
Kong) Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
(Hong Kong) Ltd.
2738 6027
2010/06/11
Stryker SwitchPoint Infinity 2 & SwitchPoint Element DOM Cards, Product
Reference: 0100224307 (SPI2 DOM Card), 0100224592 (SPE DOM Card)
MHRA
2010/006/003/081/014
FSCA
Stryker China Ltd
2518 6915
2010/06/11
Varian DIC / Fiches de traitement version 1.54.09d and ARIA Standard version
1.1
MHRA
2010/006/008/081/006 (CP01953)
FSCA
Varian Medical
Systems Pacific Inc.
2724 2836
2010/06/11
Park House Healthcare Atlantic Bed Rails, Product code EBA013
MHRA
2010/005/019/301/002
FSCA
N.A.
N.A.
2010/06/14
Thermo Fisher Scientific Eb0212E Oxoid Cooked Meat Medium (Lot Number:
1084871)
MHRA
FSCA
N.A.
N.A.
2010/06/15
Elekta XiO Release 4.50.00
MHRA
2010/005/028/081/038
FSCA
Elekta Ltd.
2891 2208
2010/06/15
Elekta XiO Release 4.0.2
MHRA
2010/006/003/081/019
FSCA
Elekta Ltd.
2891 2208
2010/06/15
Codan Argus Infusion pumps A707 and A708 (Article numbers: 18.0110, 18.0111, 19.0110
and 19.0111)2010/003/022/081/024
MHRA
FSCA
N.A.
N.A.
2010/06/15
Oxoid Giolitti-Cantoni Broth CM0523 (Lot: 793642)
2010/06/15
Medtronic StealthStation S7 System Retractable Power Cable
2010/06/17
Activate Corgi Power Hi-Lo
2010/06/18
Abbott i-STAT ACT Celite Cartridges (Catalog No. 07G01-1), i-STAT ACT
Kaolin Cartridges (Catalog No. 07G81-01)
FDA
2010/06/18
Oxoid dry Spot Staphytect Plus (Catalog #DR0100M, DR0850M, DR0850B, Lot
No. J055610, J539110, J591710, J577920, J610620)
2010/06/18
2009/010/014/601/004
MHRA
2010/005/018/601/002
FSCA
N.A.
N.A.
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International
Ltd.
2919 1300
FSCA
N.A.
N.A.
Z-0813-2010 to Z-0814-2010
Class II
Bio-Asia Diagnostics
Co. Ltd.
N.A.
FDA
Z-0817-2010 to Z-0818-2010
Class II
N.A.
N.A.
Ortho Development 10 degree Tibial Augment Wedge and 5mm Tibial
Augment Block, component of Balanced Knee Modular Tibial System
FDA
Z-1228-2010 to Z-1229-2010
Class II
N.A.
N.A.
2010/06/18
Vital Diagnostics Envoy 500 Serum Control Kit and ATAC Serum Control Kit
FDA
Z-1233-2010 to Z-1234-2010
Class II
N.A.
N.A.
2010/06/18
Abbott ARCHITECT System Software v5.00 and v5.10 (List Number 5F48-22
and 5F48-23)
FDA
Z-1316-2010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/06/18
Endocare Cryo V Probe (Model # Cryo 206V, CVA2400)
FDA
Z-1400-2010 to Z-1401-2010
Class II
N.A.
N.A.
MHRA
2009/010/029/081/001
2010/06/18
Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN
1700CS (Closed Sampler) (list numbers 03H57-01, 03H57-03), CELL-DYN
1800 (list numbers 07H77-01, 07H77-03)
FDA
Z-1628-2010 to Z-1630-2010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/06/18
Mckesson Medical Imaging Voiceware clip software update to certain Horizon
Medical Imaging Systems.
FDA
Z-1735-2010
Class II
N.A.
N.A.
2010/06/18
Diagnostic Hybrids Rabbit Kidney Culture with brand name 'FreshCells'
(Catalog No. 48-0600, Lot no. 480109)
FDA
Z-0822-2010
Class III
N.A.
N.A.
2010/06/19
Boston Scientific Hong
Cardiac Pacemakers Altrua 20, 40, 50 and 60 Implantable Pulse Generator (S201, S206,
54496
S503, S504, S508, S601,
Type IIS602, S603 and S606)
Health S208,
CanadaS209, S403, S404,
Kong Ltd
2010/06/19
Ace Surgical Supply Calcium Sulfate Hemihydrate Kit, 1g (Model or Catalog#505-2001)
and
Calcium Sulfate Hemihydrate
54873
Kit, 0.5g (Model
Type
or Catalog#505-2002)
I
N.A.
Health
Canada
2010/06/19
Philips Heartstart FRX AED (Model No. 861304) and Heartstart HS1 Onsite Defibrillator
Health(Model
CanadaNo. M5066A)
54809
Type II
Philips Electronic Hong
Kong Ltd
9101 3077
2010/06/19
Siemens Immulite 2000 System and Immulite 2500 System (Model/Catalog# L2SUBM;
LotCanada
or Serial# 282, 283) 54811
Health
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/06/19
Navilyst Vaxcel Port/Mini/T/PU/6F/1.1/1.9 (Model or Catalog # 45-303, 45-305, 45-310,
45-315,
45-360), Vaxcel Port w PASV/Mini/T/PU/6F/1.1/1.9
Type II
# 45-213, 45-215, 45-220) and Vaxcel Port w PASV/Standard/T/PU/8F/1.6/2.6 (M
N.A. (Model or Catalog
N.A
Health
Canada45-320, 45-340,54921
2010/06/19
Toshiba Aplio XG Ultrasound System (Model# SSA-790A)
55073
Type II
Sanko Medical
Systems (HK) LTD
2010/06/19
Datascope CS300 Intra-Aortic Balloon Pump (Model or Catalog# 0998-00-3023-XX,Health
Lot orCanada
Serial# SI135828G8)54614
Type III
N.A.
N.A
2010/06/19
Remington Disposable Surgical Extension Cable (Model or Catalog#
FL-601-97, Lot or Serial# 100701)
Health Canada
54899
Type I
N.A.
N.A
2010/06/19
Varian Flexible Probe with Blocking Washer (part of the Segmented Cylinder
Set) (Model or Catalog# GM11002420, Lot or Serial# Y01 to E19)
Health Canada
54886
Type II
Varian Medical
Systems Pacific Inc.
2724 2836
2010/06/19
Boston Scientific Flexima Biliary Stent System (Model or Catalog# 3922, 3925, 3926,
3927,Canada
3930, 3931, 3932, 3933,
54480
3935, 3936)
Health
Type III
Boston Scientific Hong
Kong Ltd
2960 7136
2010/06/19
Voco Futurabond NR Single Dose (Model or Catalog# 1153, Lot or Serial# 1006320,Health
1012481)
Canada
54852
Type II
N.A.
N.A
2010/06/19
Smith & Nephew Genesis II Resection Cutting Blocks (Model or Catalog # 71440116,
71440118)
Health
Canada
54935
Type I
Smith & Nephew LTD
2648 7700
2010/06/19
Abbott Laboratories
Abbott i-STAT PT/INR Cartridges (Model or Catalog # 04J50-01, 04J50-02, Lot or Serial#
N09315, N09323, N09323A,
54626 N09346A, S09347,
Type
S09354,
III
T10009, T10011)
Health Canada
LTD.
2593 2211
2010/06/19
Medrad Stellant CT Dual Syringe Kits (Model or Catalog# SDS-CTP-QFT, SDS-CTP-SPK)
Health Canada
Type II
Prism Technologies
Ltd.
2786 3233
2738 6027
Health Canada
55065
2960 7136
N.A
2010/06/19
Micro Typing Systems Ortho Provue Analyzer Software V. 3.1 (Model or Catalog# MTS213784)
Health Canada
55074
Type II
Johnson & Johnson
Medical (HK)
2010/06/19
Micro Typing Systems Ortho Provue Analyzer Software V. 3.1 (Model or Catalog# MTS213784)
Health Canada
55075
Type II
Johnson & Johnson
Medical (HK)
2738 6027
2010/06/19
Escalon PD Access 18 Gauge Vascular Access Device (Model or Catalog # 78050)Health Canada
54858
Type II
N.A.
N.A.
2010/06/19
Medrad Sterile Disposable Syringe Kit (Model or Catalog # 150-FT-Q, Lot or Serial #Health
96501,
96502)
Canada
54929
Type II
Prism Technologies
Ltd.
2786 3233
Health Canada
54897
Type II
N.A.
N.A
Siemens Healthcare Diagnostics VERSANT Sample Preparation 1.0 Reagent Lot number B005X, Box 1 and Box 2 (Ref 04801677 and 04801685)
MHRA
2010/006/009/081/002
FSCA
Siemens Healthcare
Diagnostic Limited
28707827
2010/06/23
St. Jude Medical Exclaim (Model no. 3224) and Lamitrode Paddle Leads
(Model no. 3243, 3246, 3266, 3267, 3268, 3269, 3283, 3286, 3208, 3210,
3219, 3214, 3240, 3254, 3255, 3244, 3262, 3263, 3245, 3264, 3265, 3280,
3288, 3289 and 3228)
MHRA
2010/006/015/081/011
FSCA
St. Jude Medical
(Hong Kong) Ltd.
2996 7651
2010/06/24
Medela Symphony Double Pumping Kit; the instructions were packaged with
the following non-sterile single user accessory kits for use with Symphony
breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b)
Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099,
Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits;
e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts.
FDA
Z-1442-2010
Class II
N.A.
N.A.
2010/06/24
Leica Peloris Rapid Tissue Processor; catalog number 26.0001 and 26.0005.
FDA
Z-1551-2010
Class II
Leica Microsystems
Limited
2564 6699
2010/06/24
Acumed Intramedullary Fixation Rod, common name Fibula Rod, labeled IM
Rod System: a) Model # 40-0028-S; b) Model # 40-0029-S; and c) Model # 400031-S.
FDA
Z-1552-2010
Class II
N.A.
N.A.
2010/06/24
Acumed Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical
Screw, Ref: HCO3250-S.
FDA
Z-1602-2010
Class II
N.A.
N.A.
2010/06/24
Maquet EXXCEL Soft Standard Wall EPTFE Vascular Graft (UPN
M002004810260), EXXCEL Soft Thin Wall EPTFE Vascular Graft (UPN
M002004948580).
FDA
Z-1606-2010 to Z-1607-2010
Class II
Maquet Hong Kong Ltd.
2393 9511
2010/06/24
PerMedics Odyssey treatment planning system version 4.4 through 4.6.
FDA
Z-1609-2010
Class II
N.A.
N.A.
2010/06/24
Newport e360 Ventilator (All serial numbers beginning with N093609XXXXX,
N093610XXXXX, N093611XXXXX, and N093612XXXXX)
FDA
Z-1617-2010
Class II
N.A.
N.A.
2010/06/24
I2s Micro Implantable Systems Inserter Wand Holder (Serial # 4273-0001
through 4273-0061)
FDA
Z-1619-2010
Class II
N.A.
N.A.
2010/06/24
Cardiac Science Responder 2000 Defibrillator/Monitor Models: 2025653,
2026109, and 2026114.
FDA
Z-1683-2010
Class II
Pacific Medical
Systems Limited
2108 4005
2010/06/24
DATEX-Ohmeda TruSat Oximeter and Accessories, Model 3500
FDA
Z-1814-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/24
Bausch & Lomb Millennium Microsurgical System Vit Enhancer (MVE), Stellaris
Vision Enhancement System
FDA
Z-1662-2010 to Z-1664-2010
Class II
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
2010/06/24
Cambridge Heart Alternans Sensor Kit Assembly
FDA
Z-1776-2010
Class II
N.A.
N.A.
2010/06/24
Pelton & Crane Spirit 3000 Dental Chair, Catalog number: 3003, Model
number: SP30.
FDA
Z-1311-2010
Class III
N.A.
N.A.
2010/06/25
Tosoh Bioscience G8 Hemoglobin F&A2 Control Set (lots: 8BKITP3, level 1
and 8BKITP4, level 1)
MHRA
2010/006/008/081/002
FSCA
N.A.
N.A.
2010/06/25
Innogenetics LiRAS for Infectious Diseases v2.01 (lot: 2009090901) and all
previous versions of the software
MHRA
2010/006/014/291/009
FSCA
N.A.
N.A.
2010/06/19
Elekta XiO Radiation Treatment Planning System (Release 2.1.0 & Higher)
2010/06/22
2010/06/29
Fresenius 5008 and 5008S Haemodialysis Machines
MHRA
MDA/2010/053
MDA
2010/06/29
Innogenetics Innotest Beta-Amyloid(1-42) (Product codes: 80324 & 80177,
Batchnumbers: 196524, 204108, 206189, 196526, 201230, 204109 & 206205)
MHRA
2010/006/015/081/001
FSCA
Fresenius Medical
Care Hong Kong
Limited
2583 0813
N.A.
N.A.
Fresenius Medical
Care Hong Kong
Limited
B. Braun Medical
(Hong Kong) Ltd.
2010/06/29
Fresenius 5008 Dialysis Machines
MHRA
2010/001/011/081/013
FSCA
2010/06/29
B. Braun Online Substitution Line for Dialog 7210558 and 721055A
MHRA
2010/006/003/081/023
FSCA
2010/06/29
Siemens Dimension Tacr Flex Reagent Cartridges (DF107) (lots: DC0306,
CA0320, DA0334 and GA0348)
MHRA
2010/006/018/291/014
FSCA
Siemens Healthcare
Diagnostics Limited
2870 7888
2010/06/29
Peacocks Skylux C4VS Theatre Operating Light
MHRA
2009/011/016/401/004
FSCA
N.A.
N.A.
2010/06/29
Ultimate T-Bag Oxygen Enrichment Device (Code: 7000T)
MHRA
2010/002/025/401/009
FSCA
N.A.
N.A.
2010/06/29
Bard DORADO PTA Balloon Dilatation Catheter (Product code# DR135412,
DR135415, DR135417, DR135420, DR135512, DR135515, DR135517,
DR135520, DR135612, DR135615, DR135620, DR135712, DR135715,
DR135717 and DR135720)
MHRA
2010/005/026/081/030
FSCA
N.A.
N.A.
2010/06/29
Olympus KeyMed Lens Cleaning Sheath - MAJ 1537
MHRA
2010/005/004/401/017
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/06/29
Fresenius Orchestra Base Primea Infusion System
MHRA
2010/006/009/081/013
FSCA
N.A.
N.A.
2010/06/30
2009/007/009/401/011
Arjo Huntleigh (Hong
ArjoHuntleigh / Huntleigh Healthcare Contoura 800 series beds (Model nos. 200800, C880,
C881, C882, C885, C886, C888 all followed by
FSCA
/L or /N; Serial nos.: 184234 to 364832)
2508 1416
MHRA
Kong) Ltd.
2010/06/30
Acumed Ulnar Shortening Saw Blade - Hub Style S (Part No. 80-0499-S) (Lot no. 214436,
215637, 215638,
215639, 215640, 215641, 219931,
FSCA 220909)
2010/004/020/291/009
MHRA
2010/06/30
Roche Diagnostics AMPLILINK Software v 3.1.x and v 3.2.x for COBAS AmpliPrep/COBAS
2010/006/023/291/003
MHRATaqMan assays
2010/06/30
Siemens Dimension Enzymatic Creatinine (EZCR) Flex reagent cartridges, DF270B
MHRA
2010/006/022/081/002
2583 0813
2529 2009
N.A.
N.A.
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2724 2836
2170 5678
2010/06/30
Varian C-Series Clinacs
MHRA
2010/006/018/291/009
FSCA
Varian Medical
Systems Pacific Inc.
2010/06/30
Olympus KeyMed 5.5mm TroQ Trocar Spike (Product Codes: A5816, A5821,
A5948, A5949, A5968, A5979, WA58341L and WA58343L)
MHRA
2010/006/021/291/021
FSCA
Olympus Hong Kong
and China Ltd
2010/06/30
CIVCO Universal Couchtop Rectangular Extension (Part number: MTIL6600; Lot numbers:
M131280, M135840,
2010/006/024/291/003
M161440, M161450, M161460,
FSCA M161470, M163620
N.A. and M179980) N.A.
MHRA
2010/06/30
TomoTherapy Hi-Art Treatment System Software (Versions 4.0.0, 4.0.1 and 4.0.2)
MHRA
2010/006/023/291/002
2010/06/30
Fresenius AV-SET FMC (FA404E/FV404E) Bloodline (Product Code: 5016481; Batch Number:
2010/006/024/291/021
MHRA QMU123)
2010/06/30
Stryker Pkg. Disposable Scope Warmer (Part No. 502-360-000)
Stryker China
Limited
N.A.
FSCA
N.A.
N.A.
FSCA
Fresenius Medical
Care Hong Kong
Limited
2583 0813
Firm Initiated
Field Action
Stryker China Limited
2518 6915
Monthly Summary of Medical Device Safety Alerts - May 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
2010/05/04
Description of Product
Diopsys Enfant Pediatric VEP Vision Testing System, Product number: 85100001-00 Rev 1
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
Z-1437-2010
Class III
N.A.
N.A.
2891 8730
2010/05/04
CareFusion NicoletOne vEEG System.
FDA
Z-1256-2010
Class II
CareFusion Hong
Kong Ltd.
2010/05/04
Novasys Medical Renessa RF System, model PR0918.
FDA
Z-1404-2010
Class II
N.A.
N.A.
2010/05/04
3M Micropore Single Use Rolls (REF 1530S-1), 3M Micropore Paper Tape
(Cat. No. 1530-118, 1530-136, 1530-154, 1530-12Y, 1530-15Y, 1530-254,
1530-336)
FDA
Z-1413-2010 to Z-1420-2010
Class II
3M Hong Kong Ltd
2806 6111
2738 6027
2010/05/04
Cordis AVANTI+ Introducer (Catalog # 402656X, 504606X, 504656X).
FDA
Z-1421-2010
Class II
Johnson & Johnson
Medical (HK)
2010/05/04
Integra LifeSciences Integra Licox Ref 1P2.P; 1P2; CC1/P1.
FDA
Z-1422-2010
Class II
N.A.
N.A.
2010/05/04
Advanced Neuromodulation Systems Swift-Lock (TM) Anchor Accessory Kit,
Directions For Use Model 1192.
FDA
Z-1425-2010
Class II
St. Jude Medical
(Hong Kong) Ltd.
2996 7688
2010/05/04
American Diagnostica REF 822 IMUBIND(R) Plasma PAI-1 ELISA.
FDA
Z-1426-2010
Class II
N.A.
N.A.
2010/05/04
Elekta iView GT Electronic Portal Imaging Device
FDA
Z-1436-2010
Class II
Elekta Ltd.
2891 2208
FDA
N.A.
Press Release
Baxter Healthcare Ltd
2807 8555
Baxter Colleague Volumetric Infusion Pump
2010/05/05
Remark : FDA has further issued Questions and Answers about the Baxter
Colleague Infusion Pump Recall on 5 May 2010. According to FDA's
recommendations, users may continue to use the Colleague pumps during the
transition period. In view of the numerous software and hardware defects
reported since 2005, users are advised to seek replacement for their
Colleague Pumps.
Questions and Answers issued by FDA
2010/05/05
Philips Heartstart MRx Defibrillator Monitors
MHRA
2010/004/029/081/009
FSCA
Philips Electronic Hong
Kong Ltd
2821 5480
2010/05/05
Smith & Nephew Dyonics II Shaver Controller (Item code: 7220873, lot no.
AAX2448)
MHRA
2010/004/029/081/018
FSCA
Smith & Nephew LTD
2648 7700
2010/05/05
Medtronic Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG,
D234VRC), Maximo II CRT-D (D284TRK), Maximo II DR/VR (D284DRC,
D284VRC)
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Medtronic
International, Ltd.
2919 1300
2010/05/06
B. Braun Infusomat space lines Cyto-Set (REF 8250910SP), Neutrapur (REF
8700110SP, 8250731SP, 8700095SP), Original Infusomat Line type Neutrapur
(REF 8250731T)
MHRA
2010/001/026/601/001
FSCA
B. Braun Medical
(Hong Kong) Ltd.
2529 2009
2010/05/06
DePuy Corail AMT HA Femoral Stem Std With Collar S11 and Without Collar
S8 (Model: 3L92501, 3L92507)
MHRA
2010/004/027/081/022
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/05/06
Codman & Shurtleff (JNJ) Medstream Implantable Drug Pump (Model: 914200, 91-4201)
MHRA
2010/004/012/291/014
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/05/06
Beckman Coulter Synchron Systems Modular Glucose (GLUCm) Reagent
(Model 472500)
2010/05/06
St. Jude Medical Convert+ Model V-195 Implantable Cardioverter-Defibrillator
2010/05/07
2010/05/07
Cook Medical Ciaglia Blue Dolphin and Ciaglia Blue Rhino Balloon
Percutaneous Tracheostomy Introducer Set (with Shiley Percutaneous
Tracheostomy Tube)
Newdeal LARGE QWIX screws (diameter 7.5mm, lg 65mm) (Cat: 111765S
and 121765S; Batches EGH5 and EGJK)
MHRA
2010/004/023/601/003
FSCA
Beckman Coulter
Hong Kong Ltd
2240 6150
St Jude Medical
(Hong Kong) Ltd.
N.A.
Firm Initiated
Field Action
St. Jude Medical
(Hong Kong) Ltd.
2996 7651
AR Burkill & Sons (HK)
Ltd
2541 1041
MHRA
2010/004/028/081/022
FSCA
MHRA
2010/004/022/081/005
FSCA
N.A.
N.A.
2724 2836
MHRA
2010/003/031/081/002
FSCA
Varian Medical
Systems Pacific Inc.
FDA
N.A.
Press Release
N.A.
N.A.
MHRA
2010/003/031/401/002
FSCA
N.A.
N.A.
FDA
Z-1434-2010 to Z-1435-2010
Class II
N.A.
N.A.
Elekta Synergy
FDA
Z-1441-2010
Class II
Elekta Ltd.
2891 2208
2010/05/10
Elekta Leksell Gamma Knife C.
FDA
Z-1533-2010
Class II
Elekta Ltd.
2891 2208
2010/05/10
Stryker Literature for Implant Extraction Set - Implant Extraction Guide Module
One & Two.
FDA
Z-1443-2010
Class II
Stryker China Ltd.
2814 7463
2010/05/10
Baxter RenAmin (Amino Acid) Injection (product code 2A6222); Baxter
Evacuated Containers (product code 1A8502, 1A8503).
FDA
Z-1528-2010 to Z-1530-2010
Class II
Baxter Healthcare Ltd
2807 8555
2010/05/10
Medtronic HMS PLUS Hemostasis Management System (Catalog Number:
30514).
FDA
Z-1537-2010
Class II
Medtronic International
Ltd.
2919 1362
2010/05/10
Arrow International Percutaneous Sheath Introducer (PSI) Kit with Integral
Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters (Catalog
number: ASK-09903-CMC).
FDA
Z-1538-2010
Class II
N.A.
N.A.
2010/05/10
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products CA 125 II
Reagent Packs, Lot 1060 (CAT No. 6800038)
MHRA
2010/004/022/081/004
FSCA
Ortho Clinical
Diagnostics
2737 5504
2010/05/10
Boston Scientific Radial Jaw 4 Large Capacity w/ Needle Biopsy Forceps (Cat.
No. M00513331, M00513334, M00513330, Lot No. 13244654, 13361332,
13361334, 13244654)
Boston
Scientific Hong
Kong Ltd
90596143FA
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
2010/05/11
Zimmer Nexgen Complete Knee Solution, Mis Total Knee Procedure,
Stemmed Tibial Component, Fixed Bearing (Part no. 00-5950-027-01/02, 005950-037-01/02, 00-5950-037-12, 00-5950-047-01/02, 00-5950-057-01/02, 005950-057-03-04)
MHRA
2010/004/029/081/010
FSCA
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
2010/05/11
Smith & Nephew Aimer endofemoral (Item code: 72201714, 72201715,
72201716, 72201717, 72201713)
MHRA
2010/005/006/081/014
FSCA
Smith & Nephew Ltd.
2648 7700
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2783 1838
2870 7888
2010/05/07
Varian Varisource iX Console
2010/05/07
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog
Number 1570)
2010/05/10
The Helping Hand Company Acheeva Learning Station
2010/05/10
Orthofix US XCaliber Meta-Diaphyseal Complete Kit, 99-91600; Orthofix US
XCaliber Ankle Complete Kit, 99-91647.
2010/05/10
2010/05/11
GE Healthcare CARESCAPE Monitor B850 version 1.0.1.13 and 1.0.2.1
MHRA
2010/004/030/601/002
2010/05/11
GE Centricity Laboratory; Software Versions: v4.1
MHRA
2010/004/028/081/013
FSCA
GE Medical Systems
Hong Kong Ltd.
2010/05/11
Siemens MicroScan Gram Negative MIC Type 37 (B1016-147) Panels
MHRA
2010/005/005/081/025
FSCA
Siemens Healthcare
Diagnostics Limited
2010/05/11
Abbott CELL-DYN Sapphire System, List Number 08H00-01 and 08H00-03
MHRA
2010/004/014/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/05/11
Caledonian Medical CalMed custom procedure packs - various
MHRA
2010/004/028/601/001
FSCA
N.A.
N.A.
2010/05/11
Zimmer Nexgen complete knee solution stemmed & rotating hinge knee tibial
broach impactor
MHRA
2010/004/019/081/007
FSCA
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
2010/05/11
Hill-Rom Totalcare Bed System (Model : P1900)
Health Canada
52322
Type II
N.A.
N.A.
2010/05/11
Cardinal Health DIS/NIC1 VEEG 32CHNL ETHNT (Model : V EEG)
Health Canada
53613
Type II
CareFusion Hong
Kong Ltd.
2891 8730
2783 1838
2010/05/11
GE Datex Ohmeda Network and iCentral
Health Canada
53807
Type II
GE Medical Systems
Hong Kong Ltd.
2010/05/11
Therakos Cellex Procedural Kits (Model : CLXECP)
Health Canada
53868
Type II
N.A.
N.A.
Health Canada
53937
Type II
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
Health Canada
54000
Type II
CareFusion Hong
Kong Ltd.
2891 8730
N.A.
N.A.
2010/05/11
2010/05/11
Zimmer
A) TMARS - Buttress Augments
B) TMARS - Column Butress Augments
Cardinal Health
A) Sterile CABG Pack
B) Ensemble Sterile Total Hip
C) Sterile Pacemaker Pack
D) Urology Vaginal With Champs
E) Sterile Thoracic Pack
F) Sterile Plastic Extremity Pack
G) Ensemble Total Knee
H) Ensemble Sterile Plastics
I) Sterile Cesarean Section Pack
J) Sterile Major Laparotomy Pack
K) Sterile Vascular Pack
L) Sterile Minor Set Up Pack
M) Sterile Major ABD Pack
2010/05/11
Medibo Ministrel Patient Lift (Model : HMA0001, HMA0011)
Health Canada
54019
Type II
2010/05/11
Medline Cardiac Sternal Pack (Model : DYNJ32436X)
Health Canada
54033
Type II
N.A.
N.A.
2010/05/11
Advanced Sterilization Products Automatic Endoscope Reprocessor (Model :
20300, 20301)
Health Canada
54046
Type II
Johnson & Johnson
Medical (HK)
2738 6027
2010/05/11
Elekta XIO Radiation Treatment Planning System (Model : 9200)
Health Canada
54227
Type II
Elekta Ltd.
2891 2208
2010/05/11
A) Stryker Smart-Pump Dual Channel
B) Stryker Smart-Pump Printer
Health Canada
54263
Type II
Stryker China Ltd
2518 6915
2010/05/11
Medtronic O-ARM Imaging System (Part # 9732719, 9733346, BI-700-00027100, BI-700-00027-120, BI-700-00027-230)
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International
Ltd.
2919 1300
2010/05/12
Heartware Ventricular Assist System Controller
MHRA
2010/005/004/291/011
FSCA
N.A.
N.A.
2010/05/12
Arrow International (Teleflex Medical) Arrow 4 Fr Peripherally Inserted Central
Catheter (PICCs) Kits
MHRA
2010/005/007/081/014
FSCA
N.A.
N.A.
2010/05/12
Edwards Lifesciences Swan Ganz Continuous Cardiac Output (CCO)
Catheters (Models 744HF75 and 746HF8)
MHRA
2010/005/006/081/004
FSCA
N.A.
N.A.
2010/05/13
Baxter All Aquarius Haemofiltration Machines
MHRA
MDA/2010/039
MDA
Baxter Healthcare Ltd
2807 8555
2010/05/13
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100
FDA
Z-1131-2010
Class II
N.A.
N.A.
2010/05/13
Elekta Leksell GammaPlan
FDA
Z-1134-2010
Class II
Elekta Ltd.
2891 2208
2010/05/13
Leica Microsystems Shutter HX SP5, a component of the Leica Point Scanning
Confocal Microscope Models TCS SP5 and TCS SP5 X. Material No:
1531160006 Spare Part No: 15000904000093
FDA
Z-1221-2010
Class II
Leica Microsystems
Limited
2564 6699
2010/05/13
Stryker Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S,
0788100001, and 0788100001S.
FDA
Z-1238-2010
Class II
Stryker China Ltd.
2814 7463
2953 5111
2010/05/13
Biomet Microfixation Patient Distractor Driver 10.87cm (Part Number SP-1918).
FDA
Z-1319-2010
Class II
Swedish Trading Co.,
Ltd
2010/05/13
Orthohelix Surgical Designs Mini Max Torque 2.6 mm diameter Drill Bit, Model
#HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38.
FDA
Z-1430-2010
Class II
N.A.
N.A.
2010/05/13
Philips Heartstart FRx AED (Model 861304), Heartstart (HS1) Onsite AED
(Model M5066A), Heartstart (HS1) Laerdal brand onsite AED (Model
M5067A), HeartStart HS1 Defibrillator (Model M5068A).
FDA
Z-1193-2010 to Z-1196-2010
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/05/14
Immucor Gamma Antibody identification cell panel Panocell-10, Cat. No.
0003032 Lot: 13083
MHRA
2010/005/007/081/011
FSCA
Uninet Technology LTD
2838 8423
2010/05/14
Zimmer Cannulated modular screwdriver (part no. 1160-2)
MHRA
2010/004/028/081/010
FSCA
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
2992 0968
2010/05/14
Zimmer End screw extender sleeve (Part no. 1165-10)
MHRA
2010/004/028/081/011
FSCA
Zimmer PTE Ltd.
(Hong Kong branch)
2010/05/18
Defibtech DBP-2800 Battery Packs used with DDU-100 series AEDs sold
under the brand names Lifeline AED and ReviveR AED (serial no.: between
202001005 and 202005916, or between 206001001 and 206009871.)
MHRA
2010/005/010/291/011
FSCA
Defib China
3750 7464
MHRA
2010/004/013/291/006
FSCA
Stryker China Ltd.
2814 7463
MHRA
2009/007/017/401/007
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
MHRA
2010/004/030/291/003
FSCA
N.A.
N.A.
2783 1838
2010/05/18
2010/05/18
Stryker
a) HMRS Curved Anchorage Stems 12 mm to 19mm (6365-5-012 to 6365-5019),
b) HMRS Straight Anchorage Stems 11mm to 15mm (6367-4-011 to 6367-4015),
c) GMRS/HMRS PLUS Curved Anchorage Stems 12mm to 19mm (6365-5-112
to 6365-5-119),
GE Aespire 100/7100 (S/N: AMXL00100-AMXN01192), Aespire 7900
(ANCL00100-ANCN01565), Aespire View (APHN00100-APHN00179), Avance
(ANBL00100-ANBN01719), Amingo (AMNM0100-AMNN00164), ADS 180
(AMXL01114, AMXL01115, AMXM00476, AMXM01233, AMXN00302)
Anesthesia Machines
2010/05/18
KaVo ESTETICA E70 and E80 units
2010/05/18
GE Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ cardiovascular X-ray
imaging systems with InnovaIQ Table distributed from February 2008 to April
2010.
MHRA
2010/005/010/081/021
FSCA
GE Medical Systems
Hong Kong Ltd.
2010/05/18
Varian Eclipse Version 7.310 (Multiple Workstations) or VARiS Vision system
7.x
Varian Medical
Systems Pacific
Inc.
CP-00648
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
2010/05/19
Biomet Stanmore Total Knee (Right & Left) (Part 3 125510 and 123511)
MHRA
2010/004/027/081/006
FSCA
N.A.
N.A.
2010/05/19
DWA (Dialyse Wasser Aufbereitungsanlagen) Central Concentrate Supply
Systems CeCon 3000
MHRA
2010/004/022/081/003
FSCA
N.A.
N.A.
2010/05/19
Pronefro Therapy chair (supplied by Hemotion UK Ltd.)
MHRA
MDA/2010/042
MDA
N.A.
N.A.
FSCA
BrainLAB Ltd
2417 1881
FSCA
CareFusion Hong
Kong Ltd.
2891 8730
2010/05/19
Brainlab Digital Lightbox 2.0 with data export
MHRA
2010/005/012/291/003 (1004-09.DWI.1)
2010/05/19
CareFusion NicoletOne System vEEG/ nEEG/ LTM/ Sleep/ ICU Monitor/
Ambulatory Software Version 5.3, 5.4 & 5.7
MHRA
2010/005/010/081/027
(RA2010-04)
MHRA
2010/004/028/081/014
FSCA
Schmidt Bio Med Tech
(H.K.)
2620 8329
Abbott Freestyle Navigator Continuous Glucose Monitor System (Item no.
70684-01, 70684-02, 70684-03, 70791-01, 70791-02, 70791-20, 70965-01,
70965-02, 70965-03, 70966-01, 70966-02, 70966-03, 70966-04, 71036-01,
71036-02, PRT: 03415-001, 03831-001, 03831-002, 03831-091)
FDA
Z-0820-2010 to Z-1461-2010
Class II
Abbott Laboratories
Ltd.
2593 2211
2010/05/20
Elekta Precise Treatment Table
FDA
Z-1432-2010
Class II
Elekta Ltd.
2891 2208
2010/05/20
Encore Medical 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM (Cat. no. 39211-604)
FDA
Z-1433-2010
Class II
N.A.
N.A.
2010/05/20
Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P,
30P and 40P.
FDA
Z-1524-2010
Class II
N.A.
N.A.
2010/05/20
Bard Access Systems PowerPort isp M.R.I Implanted Port without Suture
Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen
Venous Catheter REF#1806061.
FDA
Z-1525-2010
Class II
Senrex International
Ltd.
2311 8938
2010/05/20
Siemens Dimension Vista CHEM 3 calibrator, Catalog number KC130.
FDA
Z-1535-2010
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/05/20
Davol Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"),
Product Code: 0010211.
FDA
Z-1536-2010
Class II
N.A.
N.A.
2010/05/20
Encision AEM Disposable Electrode (REF ES0301, ES0301-45, ES0309,
ES0310, ES0310-45, ES0311, ES0312, ES0312-45)
FDA
Z-1539-2010 to Z-1546-2010
Class II
N.A.
N.A.
2010/05/20
Synthes 7.5mm Ti Solid Humeral Nail 230 mm and 250 mm, Catalog number
462.723S and 462.725S
FDA
Z-1548-2010 to Z-1549-2010
Class II
Synthes (Hong Kong)
Ltd
2724 2032
2010/05/20
Alcon Constellation Vision System
MHRA
2010/005/017/291/007
FSCA
Alcon Hong Kong, Ltd.
2568 0636
2010/05/20
Olympus Electrosurgical Snare Tube Models: MAJ-13, MAJ-15, SD-9L/U-1,
SD-11 L/U -1, SD-12 L/U -1, SD-13 L/U -1, SD-16 L/U -1, SD-17 L/U -1.
MHRA
2010/005/017/291/016
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/05/20
Terumo Sarns Disposable Centrifugal Pump (Cat. Nos. 164275 & 16427X) and
Cardiovascular Procedure Kits containing pumps from affected lots
Terumo China
(Hong Kong)
Limited
MD-2010-001-R-E
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/05/24
Acumed Trial Gage (Part number TR-TG01, Lots : 211365, 214346, 220365,
222678, & 224183)
MHRA
2010/005/018/081/016
FSCA
N.A.
N.A.
2010/05/24
Abbott Diagnostics Clinical Chemistry Phosphorus (List no. 7D71-21, all lots)
MHRA
2010/005/011/601/004
FSCA
Abbott Laboratories
Ltd.
2566 8711
2010/05/24
Smith & Nephew Reflection Liner Adapter (Product code: 71323144,
71323145)
MHRA
2010/005/011/601/003
FSCA
Smith & Nephew LTD
2648 7700
2010/05/24
Siemens ADVIA Centaur Systems Calibrator A Lot 068 and 069 for FT4 Value
Assignment
MHRA
2010/005/011/081/007
(078D0959-01)
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/05/24
Possum Nickel Metal Hydride Battery Pack HC2000B/HC1800A/B Model 131214 (Used in the Freeway and Companion A and B Environmental Aids)
MHRA
2010/005/010/301/001
FSCA
N.A.
N.A.
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/05/19
Spacelabs Healthcare Vital Signs Monitor Model 91220
2010/05/20
2010/05/24
BD Phoenix PMIC/ID Panels, PMIC/ID-107 (Cat# 448607, Lot# 0083198)
2010/05/24
AliMed IQ Cupid Pull Cord Alarm
Health Canada
54333
Type II
N.A.
N.A.
2010/05/24
Stryker Universal Flat Panel Yoke
Health Canada
54351
Type II
Stryker China Ltd
2518 6915
2010/05/24
USA Instruments Breast Biopsy Plates
Health Canada
54354
Type II
N.A.
N.A.
Health Canada
2010/05/24
Zimmer Spine Nexlink Polyaxial Screw Driver
2010/05/24
Johnson & Johnson Coated Vicryl Rapide Suture (Model : VR416, VR417,
VR917, VR935, VR944 )
Health Canada
2010/05/24
Stryker Zoom Stretcher-SM-304
Health Canada
Type II
Zimmer PTE Ltd.
(Hong Kong branch)
2992 0968
54468
Type II
Johnson & Johnson
Medical (HK)
2738 6027
54479
Type II
Stryker China Ltd
2518 6915
3628 7428
54444
2010/05/24
Coloplast Saline Filled Testicular Prosthesis
Health Canada
54489
Type II
Coloplast (Hong Kong)
Ltd
2010/05/25
GS Elektromedizinische Geräte G. Stemple GmbH Corpuls3 Defibrillator /
Monitoring System pertaining to software 1.4.0, 1.5.0 and 1.6.0
MHRA
2010/004/009/081/009
FSCA
N.A.
N.A.
2010/05/25
James Spencer Ventnor shower chairs
MHRA
2009/007/029/401/005
FSCA
N.A.
N.A.
MHRA
2010/005/018/081/005 (RA
2010-016)
FSCA
Stryker China Ltd.
2814 7463
2737 5504
2010/05/27
Stryker OIC PEEK Cage (Product Ref: 6731304S, Lot Ref: 52952)
2010/05/28
Novartis Chiron RIBA HCV 3.0 SIA (Product code: 930600, Lot YA1209,
YA1691, YA1758, YA1804, 98290, 98743)
2010/05/28
Veridex (JNJ) CellTracks AutoPrep System (Product code: 9541)
MHRA
2010/005/018/081/021
FSCA
Ortho Clinical
Diagnostics
MHRA
2010/005/025/081/001 (CL10156_EU)
FSCA
Ortho Clinical
Diagnostics
2737 5504
FSCA
Stryker China Ltd.
2814 7463
2010/05/28
Stryker AVS (Adaptive Vertebral PEEK Spacer) TL Spacer Trial 7-18 (Product
Ref: from 48389407 to 48389418)
MHRA
2010/005/021/081/021 &
2010/005/010/291/002 (RA
2009-224)
2010/05/31
Talley G3 Quattro Plus mattresses, 99-01-05-306 (from April 2006) fitted to
Linet Eleganza Smart bed frames with 3/4 (three quarter) side rails.
MHRA
2009/006/004/401/010
FSCA
N.A.
N.A.
2010/05/31
Medtronic LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitors
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International
Ltd.
2919 1300
Monthly Summary of Medical Device Safety Alerts - April 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
Description of Product
Source of
Information*
Reference No. by
Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/04/07
Covidien Auto Suture ProTack Fixation 5 mm Product Catalogue #
174006.
FDA
Z-1157-2010
Class II
Covidien
3157 7220
2010/04/07
Elekta Leksell Gamma Knife Perfexion, Article #715000.
FDA
Z-1158-2010
Class II
Elekta Ltd.
2891 2208
2010/04/07
Toshiba Aplio 50 (SSA-700A; software version 5.5r002); Aplio 80 (SSA770A; software version 5.5r002), Xario (SSA-660A; software version 1.0
and later).
FDA
Z-1171-2010 to Z-1173-2010
Class II
Sanko Medical Systems
(HK) LTD
23840688
2010/04/07
Advanced Orthopaedic Solutions (AOS) Trochanteric Nail (Product Part
Number: 1034-170, 1034-200, 1036-170, 1036-200, 1037-200, 1038200, 1040-170, 1040-200, 1041-170, 1041-200, 1042-200, 1043-200).
FDA
Z-1181-2010 to Z-1192-2010
Class II
N.A.
N.A.
2010/04/07
Medrad Avanta Fluid Management Injection System, Avanta MultiPatient Disposable Set (MPAT) High Pressure Check Valve, Catalog
number AVA 500 MPAT, Material number 3018231.
FDA
Z-1199-2010
Class II
Prism Technologies Ltd.
2786 3233
2010/04/08
Intuitive Surgical Da Vinci S Surgical System IS2000
FDA
Z-1161-2010
Class II
Chindex
N.A.
2010/04/08
Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949,
WA58341L, and WA58343L
2170 5678
2010/04/08
2010/04/08
2010/04/08
2010/04/08
2010/04/08
2010/04/08
UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm),
CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance"
Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU
Plus Handle
Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000 and
Spirit 3000 Dental Chairs with magnetic headrests. (Model # L5, SP15,
SP18, SP20, SP30)
Encompass Therapeutic Support Systems AccuMax Quantum Complete
(Model CU3/CU4)
Ulti Med Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe
short needle
K C Pharmaceuticals Publix Sterile Preserved Saline Solution
SKU#041415-003767, Top Care Sterile Preserved Saline Solution
SKU#0036800-16040, Safeway Sterile Preserved Saline Solution
SKU#321130-700707, Hannaford Sterile Preserved Saline Solution
SKU#041268-029297, Kroger Sterile Preserved Saline Solution
SKU#011110-385956, CVS Sterile Preserved Saline Solution
SKU#050428-253793.
Trinity Biotech Auto D-Dimer control, level 2 (Product code: A8096, Lot
no: T159027, T090006)
FDA
Z-1163-2010
Class II
Olympus Hong Kong and
China Ltd
FDA
Z-1174-2010
Class II
N.A.
N.A.
FDA
Z-1179-2010 to Z-1180-2010
Class II
N.A.
N.A.
FDA
Z-1216-2010
Class II
N.A.
N.A.
FDA
Z-1217-2010
Class II
N.A.
N.A.
FDA
Z-1222-2010 to Z-1227-2010
Class II
N.A.
N.A.
MHRA
2010/003/026/081/017
FSCA
N.A.
N.A.
2010/04/08
Beckman Coulter Access Estradiol Reagent Kit (REF 33540, Lot
913016, 915171, 917766)
MHRA
2010/003/025/601/006
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/04/08
Zimmer Trauma Ti - interference screws and dymanic hip screw plates
MHRA
2010/003/018/291/003
FSCA
Zimmer PTE Ltd. (Hong
Kong branch)
2992 0968
2010/04/08
2010/04/08
2010/04/08
2010/04/09
Zimmer Continuum Acetabular Systems Shell Inserter Adapter with and
without rotational control (part no. 00-8790-003-00, 00-8790-003-10)
Zimmer Universal clamp instrument (part no. SN2027-1-02200, SN20271-02201)
Siemens Healthcare Diagnostics Chloride electrode (REF 07097504, PN
073-0049-01) used with ADVIA Chemistry Systems 1200, 1650, 1800,
2400
Marshall Visionary Single Use Laryngeal Airway Device Size 1.5, Size 2,
Size 3, Size 4 and Size 5 (product code: 707150, 707200, 707300,
707400, 707500)
MHRA
2010/003/023/081/005
FSCA
Zimmer PTE Ltd. (Hong
Kong branch)
2992 0968
2992 0968
MHRA
2010/002/005/081/010
FSCA
Zimmer PTE Ltd. (Hong
Kong branch)
MHRA
2010/003/016/291/017
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
MHRA
2010/003/026/081/016
FSCA
N.A.
N.A.
2010/04/09
ConMed Goldline Rocker Switch Pencil (Cat. # 130301A, 130304A,
130307A, 130319A, 130327A, 130337A, 130339A, 131307A, 131319A,
131327A, 60-6829-001A, 60-6829-005A)
MHRA
2010/003/031/291/009
FSCA
N.A.
N.A.
2010/04/12
ArjoHuntleigh Minstrel patient hoist (non scale type)
MHRA
2009/011/003/401/001
FSCA
Arjo Huntleigh (Hong
Kong) Ltd.
2508 1416
2010/04/12
Smith & Nephew IV Cap/Obturator (Product code: 72201846, lot
50282872 & 50304125)
MHRA
2010/003/030/291/007
FSCA
N.A.
N.A.
2010/04/12
Madrimed (W&H) VINCI 600Ss (Ref: 17306010)
MHRA
2010/003/030/291/013
FSCA
N.A.
N.A.
2010/04/13
BrainLAB iPlan RT Dose software versions 4.0, 4.1.0 and 4.1.1 (Model
No. 21213C, 21213D and 21213E) used with Monte Carlo Dose
Algorithm 23071
BrainLAB Ltd.
10-03-01.ALV.2
Firm Initiated Field Action
BrainLAB Ltd
2417 1881
2010/04/14
Stryker Crossfire Consoles (Product Ref: 0475000000)
MHRA
2010/004/008/081/018
FSCA
Stryker China Ltd
2518 6915
2010/04/14
Abbott CELL-DYN Emerald System (List no. 09H39-01)
MHRA
2010/004/002/601/002
FSCA
Abbott Laboratories LTD.
2593 2211
2010/04/15
Stryker Dual Irrigation Adaptor (Product Ref: 250-070-419)
MHRA
2010/003/024/081/021
FSCA
Stryker China Ltd
2518 6915
2010/04/15
Kimal Long Term Haemodialysis Catheters
MHRA
2010/002/010/401/007
FSCA
N.A.
N.A.
2010/04/15
American Medical Systems GreenLight PV Fiber Guard Assembly 01267300
MHRA
2010/003/024/081/005
FSCA
N.A.
N.A.
2010/04/15
Fresenius Medical Care Disinfection block (spare part) for 5008 & 5008S
dialysis system
MHRA
2010/004/008/081/015
FSCA
Fresenius Medical Care
Hong Kong Limited
2583 0813
2010/04/15
Respironics
A) Model 860 Transcutaneous CO2/O2 Monitor System
B) Capnogard Model 1265 End Tidal Monitor
C) End Tidal Monitor System Cosmo 7100
D) Cosmo Plus Model 8100
(Model : A) 6590-00, U6590-00
B) 5555-00, U5555-00
C) 5758-00
D) 6758-00)
Health Canada
52213
Type II
Celki Medical Company
2332 3366
2010/04/15
Newport Medical Instruments e360 Ventilator
Health Canada
52740
Type II
N.A.
N.A.
2010/04/15
Hospira
A) Symbiq One-Channel Infuser
B) Symbiq Two-Channel Infuser
(Model : A) 16026, B) 16027)
Health Canada
53355
Type II
Hospira Limited
2898 2886
2010/04/15
Bomimed Reusable Fiber Optic LED Medium Laryngoscope
Handle
Health Canada
53524
Type II
N.A.
N.A.
2010/04/15
HILL-ROM Excel Care ES Bariatric Bed (Model : P610B)
Health Canada
53527
Type II
N.A.
N.A.
2010/04/15
Linvatec Corporation Video Carts & Replacement Cord Reel (Model :
VP6501, VP6502, VP6504, VP6547, VP8500)
Health Canada
53530
Type II
N.A.
N.A.
2010/04/15
Vital Images Vitrea 5.1 (Model : VPMC-11725)
Health Canada
53571
Type II
N.A.
N.A.
Health Canada
53582
Type II
Sanko Medical Systems
(HK) LTD
23840688
Health Canada
53616
Type II
Baxter Healthcare Ltd
2807 8555
2010/04/15
2010/04/15
Toshiba Aquilion 64 System With Optional Software (Model : TSX101A/H )
Baxter
A) Colleague Volumetric Infusion Pump
B) Colleague 3 Volumetric Infusion Pump
C) Colleague Guardian CXE Color Pump
D) Colleague Guardian 3 CXE Color Pump
E) French Colleague CXE Volumetric Pump
F) French Colleague 3 CXE Volumetric Pump
(Model : A) 2M8151, 2M8151KL, 2M8161, 2M8161L, 2M8161LU,
DNM8151, DNM8151L
B) 2M8153, 2M8163, 2M8163LU, DNM8153, DNM8153L
C) 2M9161, 2M9161L
D) 2M9163, 2M9163L, 2M9163LU
E) DNM9161, DNM9161L
F) DNM9163, DNM9163L)
2010/04/15
Biomet Microfixation 1.5mm Bone Screw (Model : 91-1504, 95-1504)
Health Canada
53651
Type II
Swedish Trading Co., Ltd
2953 5111
2010/04/15
Precision Medical Flow Selector (Model : PM1000)
Health Canada
53663
Type I
N.A.
N.A.
2010/04/15
Picis
A) Caresuite Anesthesia Manager
B) Caresuite PACU Manager
C) Caresuite Critical Care Manager
(Model : A) 4220, B) 4245, C) 1110)
Health Canada
53683
Type II
N.A.
N.A.
2010/04/15
Animas
A) Animas 2020 Insulin Pump
B) OneTouch Ping Insulin Pump (Model : A) 100-380-51, 100-381-51,
100-382-51, 100-384-51, 100-385-51, 200-260-51, 200-261-51, 200-26251, 200-263-51, 200-264-51, 200-265-51, 200-370-00, 200-371-00, 200372-00, 200-374-00, 200-375-00
B) 100-420-51, 100-421-51, 100-422-51, 100-424-51, 100-425-51, 100430-51, 100-431-51, 100-432-51, 100-434-51, 100-435-51)
Health Canada
53695
Type I
Johnson & Johnson
Medical (HK)
2738 6027
2010/04/16
Philips DigitalDiagnost General radiographic examinations,
BuckyDiagnost General Radiography and Tomography, EasyDiagnost
Multi-functional R/F systems
FDA
Z-0847-2010 to Z-0849-2010
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/04/16
CareFusion Cardinal Health EnVe Ventilator Cat # 19250-001.
FDA
Z-0857-2010
Class II
CareFusion Hong Kong Ltd.
2891 8730
2010/04/16
Bard Access Systems Huber Plus Non-Coring Needle Safety Infusion
Set, REF 011901NY, 011901
FDA
Z-0861-2010 to Z-0862-2010
Class II
Senrex International Ltd.
2311 8938
2010/04/16
Integra LifeSciences Qwix 4.3mm Stabilization Screws (Part Number:
111432SND, 111434SND)
FDA
Z-1253-2010 to Z-1254-2010
Class II
N.A.
N.A.
2010/04/16
Encore Medical Foundation Knee System, Patella Trial, 26 mm, part
number 802-01-019.
FDA
Z-1255-2010
Class II
N.A.
N.A.
2010/04/16
Siemens Axiom Artis Systems Operating with VB22, VB23, VB30, and
VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357,
7555365, 7555373, and 7728392.
FDA
Z-1312-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/16
Mindray Datascope AS3000 Anesthesia System (Product numbers 099800-3024-01).
FDA
Z-1313-2010
Class II
MR Holdings (HK) Limited
2010/04/16
Orthofix Xcaliber meta-diaphyseal kit with dynamic compressiondistraction unit
2010/04/16
Philips Diagnost 76, EasyDiagnost and EasyDiagnost Digital Systems
2010/04/16
Medtronic U-CLIP V100D Approximation Device
MHRA
2010/002/023/081/021
FSCA
N.A.
N.A.
Philips
Electronic Hong
Kong Ltd
FSN-70600049
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
Medtronic
N.A.
Firm Initiated
Field Action
Medtronic International, Ltd.
2919 1300
2810 7533
2010/04/10
Siemens AXIOM Artis
MHRA
2010/003/026/081/006
FSCA
Siemens Healthcare
Diagnostic Limited
2010/04/10
Randox Laboratories CH203 RX Monza
MHRA
2009/011/009/601/001
FSCA
Randox Laboratories Hong
Kong
3595 0515
2010/04/10
Edwards Lifesciences Ascendra Balloon Catheter Loader Assembly
(Model No. 9100BCL23 and Model No. 9100BCL26)
MHRA
2010/004/008/081/007
FSCA
N.A.
N.A.
2010/04/10
Smith & Nephew PERI-LOC 3.5mm X14mm Self Tapping Non Locking
Cortex Screw - Product Code 71804014
MHRA
2010/004/001/601/003
FSCA
Smith & Nephew LTD
2648 7700
2010/04/20
Edwards Lifesciences NovaFlex Delivery System (Models 9350FS23 &
9350FS26)
MHRA
2010/004/013/291/019
FSCA
N.A.
N.A.
2010/04/20
Immunodiagnostic Systems IDS ostase BAP ELISA, cat AC-20F1, lot
5117
MHRA
2010/004/012/291/005
FSCA
N.A.
N.A.
2010/04/20
Cyberonics VNS Therapy Model 250 Programming Software (version
7.1) for demipulse and demipulse duo generators
MHRA
2010/004/008/081/020
FSCA
N.A.
N.A.
2010/04/20
Draeger Sola 300 examination lights installed between 2001 and 2003
Draeger
Medical Hong
Kong Ltd.
N.A.
2010/04/21
Covidien Shiley tracheostomy products (lot no. in the range of
0810XXXXXX to 0908XXXXXX)
MHRA
2010/04/21
Boston Scientific Back-up Meier Steerable Guidewire RVTF
2010/04/21
Inion CPS Biodegradable Fixation System and CPS Baby Biodegradable
Fixation System (Model Nos. PLT-1000 to PLT-1062, SCR-1200 to SCR2225, PCK-6001 to PCK-6101)
2010/04/22
International Technidyne Corporation (ITC) Hemochron Signature Elite
(serial no.: SE2830 to SE2854 and SE2880 to SE4789
Draeger Medical Hong
Firm Initiated Field Action
Kong Ltd.
2877 3077
2009/009/023/401/009
FSCA
Tyco Healthcare (HKSAR)
Ltd.
2574 3251
Boston
Scientific Hong
Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
Inion Oy
N.A.
Firm Initiated
Field Action
Minton Supplies Company
2271 7709
MHRA
2010/004/015/291/003
FSCA
N.A.
N.A.
2010/04/22
Beckman Coulter Integrated UniCel DxC 600i/660i/680i/860i/880i
Synchron Systems (with serial numbers <2760) Software version 4.9
build 01 (REF: A84500, A86646)
MHRA
2010/003/002/601/008
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/04/23
William Cook Wayne Pneumothorax Sets or Trays (Global product no.
G09922, G44035, G11183, G07910, G11182, G12032)
MHRA
2010/003/017/291/020
FSCA
AR Burkill & Sons (HK) Ltd
2541 1041
2010/04/23
Welch Allyn CP200 (Electrocardiograph with optional Spirometry)
MHRA
2010/004/020/291/002
FSCA
N.A.
N.A.
2010/04/23
Stryker Howmedica Restoration ADM Trial Cup Holder (Catalog number:
1235-0-000).
FDA
Z-1201-2010
Class II
N.A.
N.A.
2010/04/23
Elekta Leksell Gamma Knife Perfexion, Product Number: 715000.
(Reason: Frame Adaptor)
FDA
Z-1232-2010
Class II
Elekta Ltd.
2891 2208
2010/04/23
Elekta Leksell Gamma Knife (code: LGK 4203, LGK 4309, LGK 4333,
LGK 4343 and LGK 4354)
FDA
Z-1236-2010
Class II
Elekta Ltd.
2891 2208
2010/04/23
Agendia MammaPrint, Catalog Numbers MP01, MP US version 03.
FDA
Z-1321-2010
Class II
N.A.
N.A.
2010/04/23
Baxter 1550 Single Patient System Hemodialysis Machines; product
codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
FDA
Z-1322-2010
Class II
Baxter Healthcare Ltd.
2807 8555
2010/04/23
Circulatory Technology Bigger Better-Bladder, Catalog Number BBB38
(with 3/8 inch ID tubing).
FDA
Z-1323-2010
Class II
N.A.
N.A.
2010/04/23
GE Centricity PACS-IW software & GE Centricity Web Diagnostic 1.0
(WebDX) software (version 3.x & 3.7.7.x)
FDA
Z-1394-2010 to Z-1395-2010
Class II
GE Medical Systems Hong
Kong Ltd.
2783 1838
2010/04/23
Mindray SmarTemp Probe Covers for use with the Accutorr V Monitor,
DPM3 Monitor, VS-800 Monitor (model ST010)
FDA
Z-1396-2010 to Z-1398-2010
Class II
MR Holdings (HK) Limited
N.A.
2010/04/23
Orthohelix Surgical Designs Quick Connect Adapter Model #CSS-QAAdapter MaxTorque(R) Maxtorque Quick, Mat: 17-4PH.
FDA
Z-1399-2010
Class II
N.A.
N.A.
2010/04/23
Boston Scientific Bionic NAVIGATOR Clinician Programmer Model
Number SC-7150-4.
FDA
Z-1409-2010
Class II
Boston Scientific Hong
Kong Ltd
2960 7136
2010/04/23
Siemens Syngo Imaging XS model number 10496279. The intended
use: image processing radiological.
FDA
Z-1423-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/26
Covidien Shiley tracheostomy products (lot no. in the range of
0810XXXXXX to 0908XXXXXX); Custom/Specialty Shiley tracheostomy
tubes (lot no. in the range of 0904XXXXXX to 0912XXXXXX)
FDA
N.A.
Press Release
Tyco Healthcare (HKSAR)
Ltd.
2574 3251
2010/04/26
Ethicon Vicryl Rapide* (Polyglactin 910) Suture
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Medical (HK)
2738 6027
2010/04/26
Welch Allyn Illuminated sigmoidoscope and anoscope systems and
accessories
Johnson &
Johnson
Medical (HK)
MHRA
2009/012/008/081/012
FSCA
N.A.
N.A.
2010/04/26
Siemens Stratus CS STAT Fluorometric Analyzer
MHRA
2010/004/021/081/010
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/27
Medtronic Vascular Cannula and Catheters : Catheter Introducer - Input
TS and PS Introducer Sets with Puncture Needle (Model : 070A11)
MHRA
2010/003/015/291/001
FSCA
Medtronic International, Ltd.
2919 1300
2010/04/27
Invitrogen IVDs, genetic testing : Nucleic Acid - Res Unitray, B High Res
ASG, B22 Unitray and B22 ASG
MHRA
2010/004/013/291/010
FSCA
Invitrogen Hong Kong
Limited
2407 8450
2010/04/27
Abbott IVDs, Clinical Chemistry : Murex HIV 1.2.O - 9E25-02, batches
L325710 and L325810
MHRA
2010/004/020/601/001
FSCA
Abbott Laboratories LTD.
2593 2211
2010/04/28
BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, Lot
9202221
MHRA
2010/004/021/081/006
FSCA
BD
2575 8668
2010/04/28
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
9390A, 9390E; CardioVive 92531, 92532, 92533; Nihon Kohden 9200G,
9231; and GE Responder 2019198, 2023440 External Defibrillators
2010/04/28
FDA
N.A.
News Release
N.A.
N.A.
Medtronic A) HMS System - Instrument, B) HMS System - Test
Cartridges & Controls
Health Canada
52320
Type II
Medtronic International, Ltd.
2919 1300
2010/04/28
Arrow International A) Stopcocks, B) Stopcock With Male Luer Lock, C)
Stopcock 4-Gang 4-Way Luer Lock, D) 4-Gang Stopcock Manifold, E) 5Gang Stopcock Manifold, F) Triple Hi Flo 4-way Stopcock With Manifold,
G) Double 4-Way Stopcock With Male Luer Lock, H) Hi Flo 3-Way
Stopcock With Male Luer Lock, I) 3-Gang 4-Way Hi Flo 9 FR Stockcock,
J) Stopcock With Extension, K) Stopcock With Monitoring Line, L)
Stopcock Extension With Anesthesia Induction, M) T-Connector With
Microbore Extension, N) Microbore IV Extension Set, O) Entension With
Anti-Siphon Valve For Syringe, P) IV Set With Double H-F Stopcock 72
HR, Q) Hi-Flo Y Type Blood Pump Set, R) Y Type Positive Pressure
Blood Set, S) Triple Anesthesia Induction Valve, T) Monitoring Line Male
Extension, U) Hi-Flo Stopcock With Luer-Lock Extension, V) Y Type
Positive Pressure Pump Set, W) 4-Gang 4-Way H-F Stopcock Manifold
Health Canada
53437
Type II
Cemma Enterprise Co., Ltd
2412 2310
2010/04/28
Bio-Rad MRSA Select (Model : 63747, 63749)
Health Canada
53591
Type II
Bio-Rad Pacific Ltd.
2789 3300
2010/04/28
Medline Cardiac Procedure Pack (Model : DYNJ31903X)
Health Canada
53612
Type II
N.A.
N.A.
2010/04/28
Stryker Heated Insufflators (Model : 0620-030-407)
Health Canada
53729
Type II
Stryker China Ltd
2518 6915
2010/04/28
Stryker Disposable Strykerprobe (Model : 0250-070-550)
Health Canada
53731
Type II
Stryker China Ltd
2518 6915
2010/04/28
Beckman Coulter A) Access System - Free T4 Assay, B) Unicel DXI 600
Access Immunoassay System -Free T-4 Assay, C) Unicel DXI 800
Access Immunoassay System Free T-4 Assay
Health Canada
53734
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/04/28
Carestream Health A) T MAT L Film, B) T MAT G Film
Health Canada
53792
Type II
Carestream Health Hong
Kong Limited
2564 9759
2780 9421
2010/04/28
Zoll E Series BLS Defibrillator
Health Canada
53801
Type II
Suburfarm Investment &
Trading Co.
2010/04/28
Synthes Medullary Tube Part (Model : 355.01)
Health Canada
53804
Type II
Synthes (Hong Kong) Ltd
2724 2032
2010/04/28
Stryker Endoscopy Infravision IR Illuminator (Model : 220-180-521)
Health Canada
53805
Type II
Stryker China Ltd
2518 6915
2010/04/28
Howmedica Osteonics Anterior Skim Cutting Guide
Health Canada
53876
Type II
Stryker China Ltd
2518 6915
2010/04/28
Howmedica Osteonics Distal Femoral Resection Guide (Model : 76505005)
Health Canada
53907
Type II
Stryker China Ltd
2518 6915
2010/04/28
Howmedica Osteonics Scorpio Punch Thru Tibial Base-Plates
Health Canada
53909
Type II
Stryker China Ltd
2518 6915
2010/04/29
Johnson & Johnson Bioplate Cranial Fixation Sterile Kits
MHRA
2010/003/031/291/008
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/04/29
Siemens Medical Solutions 3gAllergy Specific IgE Universal Kit (Model :
IMMULITE 2000)
MHRA
2010/004/023/081/019
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/29
2010/04/29
Edwards Lifesciences NovaFlex Delivery System (Models 9350FS23 &
9350FS26)
Boston Scientific FleximaR Biliary Stent System
MHRA
Boston
Scientific Hong
Kong Ltd
2010/004/013/291/018
FSCA
N.A.
N.A.
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
Monthly Summary of Medical Device Safety Alerts - March 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
N.A.
Class I
Vastec Medical Ltd.
2897 1912
2010/03/01
StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges
(Model #510)
2010/03/02
Beckman Coulter Olympus PK7200 Blood Grouping System
MHRA
2010/002/023/081/005
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/02
Siemens Versacell Connectivity With Advia 1800 Systems
MHRA
2010/002/024/081/001
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/03/03
Hill-Rom ROLKO Monkey Pole equipped with a roller, Type: TGNR100GR
MHRA
2010/001/005/291/006
FSCA
N.A.
N.A.
MHRA
2010/002/025/081/004
FSCA
N.A.
N.A.
Health Canada
49997
Type II
N.A.
N.A.
2010/03/03
2010/03/03
Wassenburg WD440 and Wassenburg WD440-PT endoscope washer
disinfectors
PML Micrologicals A) Campylobacter CVA Agar B) Campylobacter
CCDA-Preston Agar, C) Campylobacter Agar, Blood-Free, D) PEA Agar
+ 5% Sheep Blood (SB), E) Columbia CNA/Macconkey, F) Sabouraud
Liquid (Broth)
2010/03/03
Technidata TD-Synergy software (TD-SYN-01)
Health Canada
52749
Type II
N.A.
N.A.
2010/03/03
Philips Medical Systems A) HeartStart MRx Monitor/Defibrillator, B)
HeartStart MRx AC Power Module Kit
Health Canada
52858
Type II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/03/03
Wallac OY Lifecycle For Prenatal Screening
Health Canada
52863
Type II
N.A.
N.A.
2010/03/03
Medline Industries Medline Self Sealing Sterilization Pouches
Health Canada
52864
Type II
N.A.
N.A.
2010/03/03
Drive Medical Design A) Economy Dual Channel Tens B) Self-Adhesive
Electrodes, C) Neb to Go, D) Deluxe Dual Channel Tens, E) APP Pad,
F) Fingertip Pulse Oximeter
Health Canada
52943
Type II
N.A.
N.A.
2010/03/03
Zimmer Nexgen Complete Knee, Stemmed Tibial
Health Canada
52954
Type II
Zimmer PTE Ltd. (Hong
Kong branch)
2992 0968
2010/03/03
Smiths Medical Cadd-Solis Infusion Pump-AC Power Cord
Health Canada
52967
Type II
N.A.
N.A.
2010/03/03
Smith & Nephew Wound Management Division EZCARE Negative
Pressure Wound Therapy System
Health Canada
53008
Type II
Smith & Nephew LTD
2648 7700
2010/03/03
Whatman 903 Newborn Screening Card
Health Canada
53017
Type II
N.A.
N.A.
2010/03/03
Linvatec A) C-Reamer Cannulated, 9 and 10 mm B) Digit Trap Finger
Grasping Device, C) Arthro-Knife Banana Serrated, Straight, D) ArthroKnife Banana Serrated, Left, E) Arthro-Knife Hook, Straight, F) ArthroKnife Retro, Straight, G) Arthro-Knife Serrated, Straight Rosette, H)
Arthro-Knife Mini Meniscus, Straight, I) Arthro-Knife Serrated, Straight 2Sided, J) Arthro-Knife Serrated, Straight, Round
Health Canada
53019
Type II
N.A.
N.A.
2010/03/03
Tyco Healthcare Handi-Fil Disposable Syringe Fill Tube
Health Canada
53027
Type II
Tyco Healthcare (HKSAR)
LTD
3157 7220
2010/03/03
Olympus A) Olympus Trocar Spikes (Conical Tip), B) Olympus Trocar
Spikes (Triangular Tip)
Health Canada
53040
Type II
Medical Systems Division,
Olympus Hong Kong and
China Limited
2170 5603
2010/03/03
The Laryngeal Mask Company Limited A) LMA Pain Care 3000, B) LMA
Pain Care 4200
Health Canada
53106
Type II
N.A.
N.A.
2010/03/03
Wright Medical Technology Advance Tibial Wedge Augment
Health Canada
53128
Type II
N.A.
N.A.
2010/03/04
Merit Medical Systems Endotek Alimaxx-B Uncovered Biliary Stent for
Endoscopic Delivery, REF 70129-204, 70129-205, 70129-206, 70129208, 70129-209, 70129-210
FDA
Z-0801-2010 to Z-0806-2010
Class II
King Health Limited
2481 3787
2010/03/04
Hospira LifeShield Latex-Free Primary SYMBIQ Set, list number 1609628, LifeShield Latex-free Primary I.V. Set, list number 19689-01
FDA
Z-0808-2010 to Z-0809-2010
Class II
Hospira Limited
2898 2886
2010/03/04
Biomet 3i Locator Restorative Abutment, ILOA002
FDA
Z-0810-2010
Class II
Ositek (HK), Inc. Ltd
3157 1757
2010/03/04
Encore Medical Foundation Knee Revision Baseplate, Part Number 32101-106
FDA
Z-0826-2010
Class II
N.A.
N.A.
2010/03/04
Gibson Laboratories RambaChrom KPC M/N 11500, RambaChrom VRE
M/N 11600
FDA
Z-0827-2010 to Z-0828-2010
Class II
N.A.
N.A.
2010/03/04
Cybernet Systems MedStar Telemedicine System Model 533-210, 533380, 533-386, 533-381
FDA
Z-0852-2010 to Z-0855-2010
Class II
N.A.
N.A.
2010/03/04
Maquet Cardiovascular EXXCEL Soft Standard Wall EPTFE Vascular
Graft, Product Code: M002004910580
FDA
Z-0866-2010
Class II
Maquet Hong Kong Ltd.
2393 9511
2010/03/04
Beckman Coulter Access progesterone reagent kit (REF 33550) and
Access cortisol reagent kits (REF 33600)
MHRA
2010/002/022/601/001
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/04
Novacare Alternating pressure mattress overlay (ASX)
MHRA
2009/011/012/081/004
FSCA
N.A.
N.A.
2010/03/05
Synthes compression connecting screw (Part number: 358.610)
MHRA
2010/003/001/081/015
FSCA
Synthes (Hong Kong) Ltd
2724 2032
2010/03/05
Emergo (Abbott) i-STAT EC8+ cartridges 06F04-02, i-STAT 6+
cartridges 06F05-02, i-STAT EC4+ cartridges 06F07-02, i-STAT E3+
cartridges 06F08-02, i-STAT CHEM8+ cartridges 03M88-02, i-STAT
CG8+ cartridges 03M86-02, i-STAT EG7+ cartridges 06F01-02, i-STAT
EG6+ cartridges 06F02-02
MHRA
2010/002/017/081/005
FSCA
Bio-Asia Diagnostics Co.
Ltd.
2787 0906
2010/03/05
Sysmex CA-1500 coagulation analyser (art. No. 97347516, 98306210,
99324211, 99324815)
MHRA
2010/002/009/081/005
FSCA
N.A.
N.A.
2010/03/05
Newdeal Right Hallu-C plates size 1-40 mm non sterile, Ref no. 117340,
Lot no. EF44
MHRA
2010/002/023/081/013
FSCA
N.A.
N.A.
2010/03/05
Newdeal QWIX screws 4.3mm diameter, Cat. no. 111432S and 111434S
MHRA
2010/002/008/081/016
FSCA
N.A.
N.A.
2010/03/05
Physio-Control LIFEPAK 15
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2919 1300
Philips
Electronic Hong
Kong Ltd
FSN86100090A
Firm Initiated
Field Action
Philips Electronic Hong
Kong Ltd
2821 5480
FDA
N.A.
Class I
GE Medical Systems
Hong Kong Ltd.
2783 1838
Eurovema Alvema ITO pushchair
MHRA
2010/001/005/081/002
FSCA
N.A.
N.A.
2010/03/08
SmitCare Ringwood Bathseat, Product code SNE343
MHRA
2009/008/026/401/002
FSCA
N.A.
N.A.
2010/03/08
Invitrogen All set gold and SSP unitray low resolution kits (product code:
7800010, 7800110, 54340D, 7810010, 7810110, 54350D, 7850010,
7850110, 54360D, 7870010, 7870110, 54320D)
MHRA
2010/003/001/081/006
FSCA
Invitrogen Hong Kong
Limited
2407 8450
2010/03/08
Stryker Implant Extraction Set Brochure / Guide B1000057 (Extraction
Hook Large)
MHRA
2010/002/009/081/002
FSCA
Stryker China Ltd
2522 6915
2010/03/09
Unipath Clearview hCG Combo pregnancy test for professional use
(Product code: 506760)
MHRA
MDA/2010/016
MDA
N.A.
N.A.
2010/03/09
Steris Harmony LA, LC 500 and LA 700 Surgical Lighting and Media
System
MHRA
2010/003/002/081/008
FSCA
Swedish Trading Co. Ltd.
6199 0634
2010/03/09
Naniwa Rubber Tubing Set for Blood Purification (Model: DFPP-SGL,
Lot: 980425, 992624)
MHRA
2010/003/005/081/021
FSCA
N.A.
N.A.
2010/03/09
Aidapt VR231 Lenham adjustable height commode (manufactured in
November 2008)
MHRA
2010/002/001/401/017
FSCA
N.A.
N.A.
2010/03/09
Farla Medical Disposable Long Scissors (Product code: 4003201, batch
no. 091003)
MHRA
2010/003/001/081/002
FSCA
N.A.
N.A.
2010/03/09
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
9390A, 9390E; CardioVive 92531, 92532, 92533; NK 9200G, 9231;
Responder 2019198 and 2023440
FDA
N.A.
Class I
Pacific Medical Systems
Limited
2108 4005
2010/03/10
Balt Extrusion Silk intracranial stent
MHRA
2009/012/003/401/010
FSCA
N.A.
N.A.
2010/03/10
Biomet M2A-magnum modular heads - size 44mm part #157444 (batch
#1793089)
MHRA
2010/003/004/081/017
FSCA
N.A.
N.A.
2010/03/10
Biodiagnostics MPO QuickCard lot # M683
MHRA
2010/002/024/601/002
FSCA
N.A.
N.A.
2010/03/10
Abbott Diagnostics ARCHITECT HAVAb IgM reagent (List no. 6C30-20
and 6C30-25)
MHRA
2010/003/002/601/007
FSCA
Abbott Laboratories LTD.
2593 2211
2010/03/05
Philips Healthcare HeartStart MRx Monitor/Defibrillator
2010/03/08
Thomas Medical Products Transseptal Sheath Introducer Kit (also under
the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding
Introducer Kit)
2010/03/08
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
Stryker Eye Surgery Stretcher 1069 / Stryker Eye Surgery Stretcher
1079 (Product No. 1069000000 & 1079000000)
MHRA
2010/003/004/081/010
FSCA
Stryker China Ltd
2522 6915
2010/03/11
BHM Medical Cricket-3, Cypress-2, Ergolift, Ergolift 600, Ergostand,
Explorer, Explorer 600, Graduate, Junior, Medilifter-IV, Mezzo, Ministand,
ML-4, Primo, Sherpa, SSL-2, Standup, Trekker and Xtreme hoists and
standing aids
MHRA
MDA/2010/022
MDA
Arjo Huntleigh (Hong
Kong) Ltd.
2508 1416
2010/03/11
Abiomed AB5000 Circulatory Support System (Cat. No. 0015-0000,
Serial No. AD5001 through AD5496 except AD5006 & AD5018)
FDA
N.A.
Class I
N.A.
N.A.
2010/03/11
Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective
Electrode (ISE) Flow Cell. UniCel DxC 600 (PN No. A10405), 600 PRO
(A11810), 600i (A27318), 800 (A11816), 800 PRO (A11812), 880i
(A59102), 680i (A64903), 660i (A64871), 860i (A64935)
FDA
N.A.
Class I
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/12
Newdeal IPP on interphalangeal implant (Ref no. 230 001S, 230 002S)
MHRA
2009/012/004/081/003
FSCA
N.A.
N.A.
2010/03/12
Beckman Coulter LH 500 Analyzer, LH 750 Analyzer, LH 780 Analyzer,
GENS Analyzer, UniCel DxH 800 Coulter Cellular Analysis System
MHRA
2010/002/018/601/001
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/12
Biodiagnostics PR3 ANCA Serine proteinase 3 QuickCard, Part no.
CS014, CS014A, Batch no. M695
MHRA
2010/001/028/601/002
FSCA
N.A.
N.A.
2010/03/12
Baylis Medical Torflex Transseptal Guiding Sheath (Model no. TF8-38-62S, Lot no. S21244, S21903, S21940, S22739, and S22739X1)
FDA
N.A.
Class I
N.A.
N.A.
2010/03/15
Radiometer ABL505/555, EML105, ABL600, ABL700 Series, ABL800
Flex And ABL800 Basic Blood Gas Analyser
MHRA
2010/002/002/081/018
FSCA
N.A.
N.A.
2010/03/15
ThermoFisher Scientific Oxoid Ready Poured Plate, Yersinia Agar (CIN
Medium), PO0287A, lot number 1118247
MHRA
2010/003/005/601/002
FSCA
N.A.
N.A.
2010/03/15
DePuy (JNJ) ASR Articular Surface Replacement and ASR Xl
Monoblock Metal-On-Metal System
MHRA
2010/003/009/081/036
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/03/16
Micromedical Technologies Aquastar Water Caloric Irrigator
Health Canada
52635
Type II
N.A.
N.A.
2010/03/16
Advanced Meditech International A) CH-HI Ultrafyn Reusable Thermal
Cautery, B) CT-2121 Disposable Thermal Cautery Tips
Health Canada
52942
Type II
N.A.
N.A.
2010/03/16
Siemens Medical Solutions Artiste MV System
Health Canada
53047
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/03/16
Diagnostica Stago A) Staclot LA 20, B) Start 4 NG DSI 115V
Health Canada
53133
Type II
Healthpro Technology Co.
Ltd
2575 2028
2010/03/11
BD GeneOhm Cdiff Assay, Cat. No. 441401
2010/03/11
2010/03/16
Teleflex Arrow Select IV Tubing Sets, Accessories, and Certain
Embolectomy Catheters
FDA
N.A.
Press Release
N.A.
N.A.
2010/03/16
Zimmer NextGen Knee Gender Solutions CR-Flex Femoral Component
(00-5750-014-01)
FDA
Z-0915-2010
Class II
Zimmer PTE Ltd. (Hong
Kong branch)
2992 0968
2010/03/16
Smith & Nephew JOURNEY " UNI TIBIAL BASEPLATE (REF 71422221
through 71422226, 71422231 through 71422248, 71422251 through
71422258, 71422261 through 71422268, 71933296 through 71933303)
FDA
Z-0924-2010 to Z-0967-2010
Class II
Smith & Nephew LTD
2648 7700
2010/03/16
Siemens Healthcare Diagnostics Dimension Vista System BUN Flex
Reagent Cartridge, Catalog number K1021
FDA
Z-1017-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
FDA
Z-1021-2010 to Z-1022-2010
Class II
N.A.
N.A.
FDA
Z-1030-2010 to Z-1032-2010
Class II
N.A.
N.A.
2010/03/16
2010/03/16
Smartinfuser (Hsmg, Inc.) PainPump, part numbers P49230, P49220,
P49224-D, P49224N, P49230-D and P49234; SmartBlock Pain
Management System, Part numbers P49524, P49534, P49624, and
P49634.
Baxa Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 739,
740
2010/03/16
GE Healthcare 1011-9000-000 Aisys Anesthesia Machine and Monitor,
1009-9002-000 Avance Anesthesia Machine and Monitor
MHRA
2010/003/009/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/03/16
GE Healthcare Centricity PACS-IW, software version 3.7.3
MHRA
2010/003/009/081/010
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/03/16
BrainLAB IMRI OR Power Management / Uninterruptible Power Supply
MHRA
2010/003/009/081/035
FSCA
BrainLAB Ltd
2417 1881
2010/03/16
Invitrogen A High Res SSP Unitray (item code: 4729010, 4729110),
AllSet Gold A High Res SSP Kit (item code: 54010D)
MHRA
2010/003/005/081/015
FSCA
Invitrogen Hong Kong
Limited
2407 8450
2010/03/16
C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh
labeled with C.R. Bard/Davol brand names (product no. 0112650,
0112660, 0112680, 0112720 Bard Flat Mesh with lot no. 48HVS036,
43APD007, HUSD0629, HURL0336, 43HPD027, 43HPD032,
HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763,
43IOD011, 43IPD038, 43FQD327) are not Bard-manufactured products
FDA
N.A.
Safety Notice
N.A.
N.A.
2010/03/17
Convatec (Unomedical) Unilect ECG Electrodes
MHRA
2010/003/010/291/001
FSCA
N.A.
N.A.
2010/03/17
Nova Biomedical Nova Statstrip Glucose Test Strips (lot no.
0309019249)
MHRA
2010/002/019/601/003
FSCA
N.A.
N.A.
2010/03/17
Newdeal Hallu-C Plate - Size 3-50 mm, Non-Sterile, reference number
117 350 (Lots EF4A and EF4B)
MHRA
2010/002/018/081/015
FSCA
N.A.
N.A.
2010/03/18
Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm, Catalog (REF)
Number 145281-ENT, Lot Number MH136952
FDA
N.A.
Class I
Olympus Hong Kong and
China Ltd
2170 5678
2010/03/18
Medical Action Bundle Kit, using MPS Acacia with Q-Syte BD#385151
(Cat. no. 69946B), Venous Access Tray, using BD Q-Syte Luer Access
Split Septum BD #385100 (Cat. no. 69498), Dialysis Kit, using BD QSyte Luer Access Split Septum BD #385100 (Cat. no. 57977)
FDA
N.A.
Class I
N.A.
N.A.
2010/03/18
2010/03/19
Arrow International (Teleflex Medical) MAC Two Lumen Central Venous
Access Kit with ARROWg+ard Blue (R) Access Device (Catalog/Part #
ASK-21242-UVA2), Percutaneous Sheath Introducer Kit with
ARROWg+ard Blue (R) Sheath (Catalog/Part # ASK-29803-SJH), MultiLumen Central Venous Catheterization Kit with Blue Flex- Tip(R),
ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42703SJH), Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK42802-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue
Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part #
ASK-45703-SHB), Multi-Lumen Central Venous Catheterization Kit with
Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part
Stryker Xia 3 Polyaxial Screw, 8.5mm x 65mm (Catalog number:
482318565)
FDA
N.A.
Class I
N.A.
N.A.
FDA
Z-0823-2010
Class II
Stryker China Ltd
2519 6915
2010/03/19
Synthes in situ bender / Cutter kit-wide-sterile (Cat. number: 530.512S)
FDA
Z-0825-2010
Class II
Synthes (Hong Kong) Ltd
2724 2032
2010/03/19
Beckman Coulter LH SlideMaker (Part Number 6605633), GEN*S
SlideMaker (Part Numbers 6605360)
FDA
Z-0850-2010 to Z-0851-2010
Class II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/19
Pointe Scientific Liquid HDL (PEG) Cholesterol Reagent Set (Catalog #
H7511-60, H7511-SAM, 7-H7511-30, 8-H7511-30, 3-H-7511-L)
FDA
Z-0859-2010 to Z-0860-2010
Class II
N.A.
N.A.
2010/03/19
Bio-Rad Variant II Turbo Hemoglobin A1c Program, model number 270
2417
FDA
Z-0867-2010
Class II
Bio-Rad Pacific Ltd.
2789 3300
2010/03/19
Polymer Technology Systems Panels Cholesterol test strips for selftesting or professional use with CardioChek analyzers, Catalog # 1711.
FDA
Z-0871-2010
Class II
Ultronics Enterprise
Limited
2764 5208
FDA
Z-0909-2010 to Z-0911-2010
Class II
Stryker China Ltd
2519 6915
FDA
Z-0912-2010 to Z-0913-2010
Class II
N.A.
N.A.
2010/03/19
2010/03/19
Stryker Trident Acetabular Hip System Polyethylene Inserts, Triathlon
X3 UHMWPE Tibial Inserts and Patellar Components, Scorpio X3
UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components
Pointe Scientific Uric Acid (Liquid) Reagent Set (Catalog # HU782-246
and HU982-615), Liquid Uric Acid (R1) Reagent Set (Catalog # HU482R1)
2010/03/19
Beckman Coulter Access Peristaltic Pump component of: UniCel DxI
800, UniCel DxI 600 and UniCel DxC 880i SYNCHRON Access Clinical
Systems. (Pump Part Numbers A62712, A62839, A62840, A62841, and
A63124) (Instrument Part Numbers: 973100, A30260, and A59102)
FDA
Z-0914-2010
Class II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/19
Sybron Dental Specialties Sealapex Express, Part Number: 33639
FDA
Z-0917-2010
Class II
N.A.
N.A.
2010/03/19
Kamiya Biomedical "K-ASSAY CRP (3) Calibrator E". (Catalog number:
"KAI-084C")
FDA
Z-0973-2010
Class II
N.A.
N.A.
2010/03/19
Sigma-Aldrich Histopaque-1077 (Ref. 10771), Histopaque-1119 (Ref.
11191)
FDA
Z-0976-2010 to Z-0977-2010
Class II
N.A.
N.A.
N.A.
N.A.
Firm Initiated
Field Action
Boston Scientific Hong
Kong Ltd
2960 7136
MHRA
2010/001/029/081/007
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
FDA
Z-1140-2010
Class I
N.A.
N.A.
Class II
Hong Kong South East
Chemicals & Instruments
Ltd
2802 6333
2010/03/22
Boston Scientific Clinician Programmer M400 (SC-7150-4) Battery Pack
2010/03/22
Lifescan (Johnson & Johnson) Onetouch Ultrasmart Meter (Catalogue
number 020-890, Lot number V0903003X)
2010/03/25
Centurion Medical Products Pump Fill Kit DT10175
2010/03/25
Remel Oxoid CM0225 Brain Heart Infusion IVD
FDA
Z-0979-2010
2010/03/25
Pointe Scientific Calcium Reagent, Calcium (CPC) R1 and (CPC) R2
Reagent Set (Cat.# HC902-576, HC902-1000, HC902-SAM-911,
HC402-R1, 3-HC902-R1, HC402-R2, 3-HC902-R2
FDA
Z-1041-2010 to Z-1043-2010
Class II
2010/03/25
Elekta PrecisePLAN 2.15 Treatment Planning System
FDA
Z-1109-2010
Class II
2010/03/25
Cook Modified Novy Cornual Cannulation Set with clear tip, G17558,
REF J-NCS-504070
FDA
Z-1137-2010 to Z-1138-2010
Class II
2010/03/25
Remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref
12402
FDA
Z-1139-2010
Class II
2010/03/25
ConvaTec (Unomedical) Neutralect Diathermy Cable, Ref code 3508M
and 3405M.
FDA
Z-1142-2010
Class II
N.A.
N.A.
2010/03/25
Sybron Dental Specialties Bond-1 Primer/Adhesive
FDA
Z-1150-2010
Class II
N.A.
N.A.
2010/03/25
R.O. Gulden Image Consultant (IC) Software
FDA
Z-1176-2010-2010
Class II
N.A.
N.A.
2010/03/25
Stryker Femoral Sponge REF 206-715, 206-730, 306-563S10, 306-705000S8, 0306-708-000S4
FDA
Z-1104-2010 to Z-1108-2010
Class II
N.A.
N.A.
N.A.
N.A.
Elekta Ltd.
2891 2208
A.R. Burkill & Sons (Hong
Kong) Ltd
Hong Kong South East
Chemicals & Instruments
Ltd
2541 1041
2802 6333
2010/03/26
Nucletron Oncentra Brachy
MHRA
2010/003/015/081/003
FSCA
Nucletron Asia Pacific Ltd.
2311 2683 /
2311 2684 /
2311 3025
2010/03/26
Animas (JNJ) 2020 Insulin Pumps
MHRA
2010/003/022/081/014
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/03/26
Synthes Awl 2,5 mm with Trocar tip Article Number: 324.111 All Batches
MHRA
2010/003/016/291/010
FSCA
Synthes (Hong Kong) Ltd
2724 2032
2010/03/26
Biotest Medical Diagnostics Seraclone Anti-k (KEL2)
MHRA
2010/003/017/291/018
FSCA
Chong Lap (HK) Co. Ltd.
2736 3078
2010/03/26
Biosite Triage TOX Drug Screen, PN 94400
MHRA
2010/003/015/081/006
FSCA
N.A.
N.A.
2010/03/26
GE Healthcare Innova 2100IQ, 3100IQ and 4100IQ
MHRA
2010/003/019/291/008
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/03/26
Trinity Biotech Captia Mumps IgM Kit (product code: 2325950 and
2325960)
MHRA
2010/003/024/081/020
FSCA
N.A.
N.A.
2010/03/26
Fresenius Kabi C.A.T.S. Auto Transfusion System (AT-1 disposables
9005101 and C.A.T.S. machine)
FSCA
Fresenius Kabi Hong
Kong Ltd.
2116 2683
2010/03/29
Siemens Healthcare Diagnostics ADVIA Centaur System version 4.0
(078-A002R02) / ADVIA Centaur XP System version 6.0 (078-A011-03)
MHRA
2010/003/016/291/018
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/03/29
Beckman Coulter UniCel DxH 800 system
MHRA
2010/003/015/601/001
FSCA
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/29
Siemens Healthcare Diagnostics Dimension clinical chemistry system
Open Well Instability with Lipase (LIP) Flex reagent cartridges (DF55A)
MHRA
2010/003/011/291/009
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2407 8450
2010/03/29
2010/03/29
2010/03/29
2010/03/29
Invitrogen Unitray B*52 SSP (472602 and 472612) and AllSet Gold
B*51/52 Hi Res SSP (54180D)
Becton Dickinson CD7 (M-T701) PE, CD7 (M-T701) FITC, CD7 (MT701) V450, and CD7 (M-T701) PE-Cy7 (Part no. 332773, 332774,
642916, 342899)
Abbott Diagnostics ARCHITECT Anti-HCV Reagents List numbers:
6C37-20, 6C37-25 and 6C37-30
Varian FastPlan Conical Collimator Plans
MHRA
2010/003/012/601/004
MHRA
2010/003/012/291/012
FSCA
Invitrogen Hong Kong
Limited
MHRA
2010/003/025/081/018
FSCA
Becton Dickinson Asia Ltd.
2575 8668
MHRA
2010/003/023/601/001
FSCA
Abbott Laboratories LTD.
2593 2211
Varian Medical
Systems Pacific
Inc.
CP-02191
Firm Initiated
Field Action
Varian Medical Systems
Pacific Inc.
2724 2836
2010/03/30
Oxoid Antimicrobial Susceptibility Testing Discs Ciprofloxacin 1ug, code
CT0623B, lot 843801
MHRA
2010/003/024/601/001
FSCA
Hong Kong South East
Chemicals & Instruments
Ltd
2802 6333
2010/03/30
Lancer Fibro Cleaner Automatic Endoscope Reprocessors FC4
MHRA
2009/009/002/291/012
FSCA
N.A.
N.A.
2010/03/30
Bayer Healthcare 5-second CONTOUR and CONTOUR TS Blood
Glucose Monitoring System
MHRA
2010/003/024/601/002
FSCA
Bayer HealthCare Ltd.
28144815/
28145220
2010/03/30
Abbott Diagnostics Clinical Chemistry Albumin BCG (AlbG), List No.
7D53-21, lot no. 77056HW00, 80051HW00, 83030HW00
MHRA
2010/003/017/601/003
FSCA
Abbott Laboratories LTD.
2593 2211
2010/03/30
DÜ RR DENTAL CA 4 Amalgam Separator (Ref: 7805-100-50, 7805-10050E, 7805-08)
MHRA
2010/003/016/291/015
FSCA
N.A.
N.A.
2010/03/31
Baxter Healthcare Coseal Surgical Sealant (certain serial numbers)
MHRA
2010/001/013/081/014
FSCA
Baxter Healthcare Ltd
2807 8555
2010/03/31
Applied Medical Resources Corporation Surgical Trocars - Separator
(Model : C0R36, C0R37)
Health Canada
52934
Type II
N.A.
N.A.
2010/03/31
Stryker Trauma Implant Extraction Set
Health Canada
53127
Type II
Stryker China Ltd
2518 6915
2010/03/31
Beckman Coulter A) Access System - Cortisol Assay B) Access System Progesterone Assay, C) Unicel DXI600 Acc.Immuno.Sys.-Cortisol, D)
Health Canada
Unicel DXI600 Acc.Imm.Sys.-Progesterone, E) Unicel DXI800
Acc.Imm.Sys.-Cortisol, F) Unicel DXI800 Acc.Imm.Sys.-Progesterone
53210
Type II
Beckman Coulter Hong
Kong Ltd
2240 6150
2010/03/31
Intersurgical Clear-Guard II Breathing Filter
Health Canada
53292
Type II
Shun On Healthcare
Limited
3123 8000
2010/03/31
Smith & Nephew Dyonics 25 Fluid Management System-Patient Tube
Set
Health Canada
53313
Type II
Smith & Nephew LTD
2648 7700
Health Canada
53326
Type I
GE Medical Systems
Hong Kong Ltd.
2783 1838
Health Canada
53348
Type II
N.A.
N.A.
2010/03/31
2010/03/31
GE Healthcare Finland OY A) Trusat Oximeter, B) Trusat Oximeter With Expension Option
Maddak A) Bath Safe Adjustable Shower Seat w/o Back and Arms, B)
Bath Safe Adjustable Shower Seat with Back, C) Bath Safe Shower Seat
w/Back and Arms, Blue, D) Bath Safe Adjustable Transfer Bench, Brown
Box
2010/03/31
Immucor Galileo Echo Blood Bank Analyzer (Model : 0087000)
Health Canada
53353
Type II
Uninet Technology LTD
2838 8423
2010/03/31
Conmed Endoscopic Technologies Entake Tri-Funnel G-Tube
Health Canada
53424
Type II
N.A.
N.A.
2010/03/31
Tomotherapy Hi-Art System (S/N: 10169, 10037)
Health Canada
53493
Type II
N.A.
N.A.
2010/03/31
Poly Implant Prothese IMGHC-TX, IMGHC-MX, IMGHC-LS
N.A.
FR-2010-03-007
FSCA
N.A.
N.A.
Monthly Summary of Medical Device Safety Alerts - February 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/02/01
Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069)
MHRA
2010/001/015/081/006
FSCA
N.A.
N.A.
2010/02/01
Trinity Biotech Captia Measles IgM Kit (Product Code: 2326050)
MHRA
2010/001/025/291/009
FSCA
N.A.
N.A.
2010/02/01
Beckman Coulter Closed tube aliquotter (CTA) for synchron LXi725 (REF: 388982,
389695) and UniCel DxC600i (REF: A25637, A25633)
MHRA
2010/001/025/601/001
FSCA
Beckman Coulter Hong Kong
Ltd
2240 6150
2010/02/01
Stryker Xcelerate ceramic 4:1 cutting blocks (Scorpio: 8000-0003, 8000-0004,
8000-0005, 8000-0006, 8000-0007, 8000-0008, 8000-0009, 8000-0011, 8000-0013
; Duracon: 8000-7005, 8000-7010, 8000-7020, 8000-7030, 8000-7040, 8000-7050,
8000-7060)
MHRA
2009/012/015/081/011
FSCA
Stryker China Ltd
2518 6915
2010/02/02
Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers
M4741A, M4742A, M4743A and M4744A)
Philips
Electronic Hong
Kong Ltd
FSN86100088A
Firm Initiated
Field Action
Philips Electronic Hong Kong
Ltd
2821 5480
2010/02/04
Centurion Healthcare Products (code no. LM110, LM115)
FDA
Z-0105-2010 to Z-01062010
Class I
N.A.
N.A.
2010/02/04
GE OEC 9900 Elite ESP, GE OEC 9900 Elite GSP Fluoroscopes
FDA
Z-0004-2010 to Z-00052010
Class II
GE Medical Systems Hong
Kong Ltd.
2783 1838
2010/02/04
Richard Wolf Hulka Clip, item 4986.90
FDA
Z-0272-2010
Class II
N.A.
N.A.
2010/02/04
GE Infinia with Hawkeye 1 (model no.: H2508PW, H2508PY, H3000WN,
H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS), Infinia
with Hawkeye 4 (model no.: H3000WC and H3000WD), Millenium VG with
Hawkeye/Discovery VH with Hawkeye (model no.: BR321000008)
FDA
Z-0494-2010 to Z-04962010
Class II
GE Medical Systems Hong
Kong Ltd.
2783 1838
2010/02/04
Ellex Motorized Safety Filter, Zeiss; (Model no. 6339585), Motorized Safety Filter,
Wild (Model no. 6339590).
FDA
Z-0577-2010 to Z-05782010
Class II
N.A.
N.A.
2010/02/04
Zap Lasers SoftLase Pro Dental Lasers
FDA
Z-0587-2010
Class II
N.A.
N.A.
2010/02/04
GE iDXA, Prodigy 1-8 series, DPX-NT series, DPX-MD series, DPX-Bravo/Duo, GE
Lunar DEXA bone densitometers operating with enCORE software versions 12.0,
12.1, 12.2,13.0, & 13.1.
FDA
Z-0600-2010 to Z-06042010
Class II
GE Medical Systems Hong
Kong Ltd.
2783 1838
2010/02/04
GE MAC 800 RESTING ECG ANALYSIS SYSTEM.
FDA
Z-0645-2010
Class II
GE Medical Systems Hong
Kong Ltd.
2784 1838
2010/02/04
KCI AC Power Cords (#4100079, 4102204, M4268840, 340225, M4268882,
M426884).
FDA
Z-0662-2010 to Z-06672010
Class II
N.A.
N.A.
2010/02/04
B. Braun Outlook Pump IV Set w/Universal Spike, Outlook Pump Add On Set,
Outlook Pump Set, Drop Universal IV Admin Set, Safeline Y Type Blood Set for
Outlook Pump, Outlook Pump Syringe Add On Set, Outlook Pump Nitroglycerin
FDA
Z-0670-2010 to Z-07182010
Class II
N.A.
N.A.
2010/02/04
Stryker CBCII ConstaVac Blood conservation system (REF 225-28E), CBCII
collection only (REF 225-28-S20), CBC Blood Conservation Kit (REF 225-28-85),
CBCII (REF225-28-85S1, 225-28-85S4, REF 225-28-S5), CBCII Blood
Conservation Kit (REF 225-28-514, 225-28-516, 225-28-526), CBCII Double
Trocar Kit (REF 225-28-614, 225-28-616, 225-28-626, 225-28-626S1, CBCII
ConstaVac Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm)
PVC Drain (REF 225-28-914, 225-28-916, 225-28-926), CBCII ConstaVac Blood
Collection Only (REF 225-29), CBCII ConstaVAc Blood Conservatin Kit (REF 225414, 225-414S2, 225-414-W, 225-416, 225-426, 225-426-W), CBCII with 3/16 in.
Silicone Drain, (REF 0225-028-S16), CBCII Collection (REF 0225-028-S21)
2010/02/04
FDA
Z-0719-2010 to Z-07432010
Class II
N.A.
N.A.
Merivaara Merilux X3, Merilux X5, Merilux Duo 320, Merilux Trio 360
MHRA
2009/009/023/081/001
FSCA
N.A.
N.A.
2010/02/04
ev3 Silverhawk cutter driver (Catalogue number FG 02550)
MHRA
2010/001/029/081/008
FSCA
Sinomed Company Ltd.
28877640
2010/02/04
Hospira A) Lifeshield Nonvented Primary IV Set, B) Lifeshield Microdrip Primary
Piggyback
Health Canada
52078
Type II
Hospira Limited
2898 2886
2010/02/04
Dana Douglas Nexus 3 Model : 4500185F, 4500225F, 4500245F
Health Canada
52174
Type II
N.A.
N.A.
2010/02/04
Howmedica Osteonics Scorpio 4:1 Ceramic Blocks
Health Canada
52242
Type II
N.A.
N.A.
2010/02/04
Abaxis Piccolo Comprehensive Metabolic Panel
Health Canada
52289
Type II
N.A.
N.A.
2010/02/04
Toshiba Aquilion One TSX-301A/2
Health Canada
52445
Type II
Sanko Medical Systems (HK)
LTD
2384 0688
2010/02/04
Stryker Spine Jam Shidi Needles
Health Canada
52532
Type II
N.A.
N.A.
2010/02/04
Dana Douglas A) Nexus 1, B) Nexus 2
Health Canada
52535
Type I
N.A.
N.A.
2010/02/04
Baxter Y-Type Blood Solution Sets
Health Canada
52558
Type II
Baxter Healthcare Ltd
2807 8516
2010/02/04
Howmedica Osteonics Restoration Modular Plasma Distal Stem
Health Canada
52681
Type II
N.A.
N.A.
2010/02/04
Dorel Juvenile Ear Thermometer Model 49531
Health Canada
49531
Type II
N.A.
N.A.
2010/02/04
Fimet F1 Dental Chair
MHRA
2009/001/014/291/002
FSCA
N.A.
N.A.
FDA
N.A.
News Release
N.A.
N.A.
MHRA
2009/009/010/401/001
FSCA
N.A.
N.A.
Pacific Medical
Systems Limited
N.A.
Firm Initiated
Field Action
Pacific Medical Systems
Limited
2108 4005
2010/02/05
2010/02/05
Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic
Introducer System with Infusion Sideport
Bound Tree Economy vacuum splints (Product code: SP040, SP041, SP042,
SP043)
2010/02/08
Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive
92532, CardioLife 9200G and 9231 (manufactured/serviced between Oct 19, 2009
and Jan 15, 2010)
2010/02/08
Reva Elegance, Excalibur ,Appollo and Highgrove baths
MHRA
2008/011/013/301/002
FSCA
N.A.
N.A.
2010/02/08
GE Instatrak button probe, debrider attachments, biopsy and shunt guides,
articulating arm and transmitter arms used with InstaTrak 3500, ENTrak 2500 and
other GE Healthcare Surgery Navigation Systems
MHRA
2010/002/002/081/019
FSCA
GE Medical Systems Hong
Kong Ltd.
2783 1838
2010/02/08
BD Shigella poly Group D Antiserum S. sonnei; types I,II, 241031 (Lot # 8032036 &
9110319)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/02/09
Covidien Moltech/Accutronics Battery (Rev. D & E) used in Legendair and
Supportair ventilators and Associated Accessory-Open Pack
MHRA
2010/001/020/081/001
FSCA
Covidien
3157 7220
MHRA
2010/002/001/081/028
FSCA
Philips Electronic Hong Kong
Ltd
2821 5480
Accuray Asia Ltd.
N.A.
Firm Initiated
Field Action
Accuray Asia Ltd
2247 8628
BD Q-Syte Luer Access (Cat no. 380510, 385100, 385101) and BD Nexiva Closed
IV Catheter Systems (Cat. No. 383530, 383531, 383532, 383533, 383534, 383536,
383537, 383538, 383539,383540,383647,383649)
FDA
N.A.
Press Release
BD
2575 8668
2010/02/10
Acacia IV Extension Sets with BD Q-Syte Luer Access Device (REF: 385150,
385151, 385164, 385165, 385166)
FDA
N.A.
Press Release
N.A.
N.A.
2010/02/12
Elekta IMPAC Medical Systems SEQUENCER for MOSAIQ
MHRA
2010/002/001/081/029
FSCA
N.A.
N.A.
2010/02/12
Cook Novy Cornual Cannulation Set
MHRA
2010/001/020/081/002
FSCA
N.A.
N.A.
2010/02/12
diaDexus PLAC Test Reagent Kit (10-0112, 10-0113, 10-0115)
MHRA
2010/001/025/081/001
FSCA
N.A.
N.A.
Medtronic
N.A.
Firm Initiated
Field Action
Medtronic International, Ltd.
2919 1300
Johnson &
Johnson Medical
(HK)
N.A.
Firm Initiated
Field Action
Johnson & Johnson Medical
(HK)
2738 6027
2010/02/09
Philips Panorama HFO systems on software release R2.5.3 and higher
2010/02/09
Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning
System Version 3.0, 3.1, 3.5.0, 3.5.1)
2010/02/10
2010/02/12
Medtronic EnRhythm & EnRhythm MRI pacemakers
2010/02/12
Johnson & Johnson LIfeScan OneTOuch SUreStep and OneTouch SUreStep
Hospital Test Strips
2010/02/17
Invitrogen DRB1*11 SSP Unitray, DRB1*11 SSP niTray with Taq, DRB1*11 AllSet
Gold SSP
MHRA
2010/001/025/291/002
FSCA
Invitrogen Hong Kong Limited
2407 8450
2010/02/17
Beckman Coulter PrepPlus (PN 286600) Coulter Preplus
MHRA
2010/002/004/601/002
FSCA
N.A.
N.A.
2010/02/17
Smith & Nephew Orthopaedics Promos Standard Inclination Set - Model Numbers
75006722, 75006723, 75006724, 75006725, 75006722
MHRA
2010/002/008/601/002
FSCA
N.A.
N.A.
2010/02/17
Stryker Femoral Sponges
MHRA
2010/002/004/291/016
FSCA
N.A.
N.A.
2010/02/17
Beckman Coulter Clinical Chemistry Instrumentation A10405, A11810, A27318,
A11816, A11812, A59102, A64903, A64871, A64935
MHRA
2010/001/012/601/001
FSCA
N.A.
N.A.
2010/02/17
GE Centricity PACS RA1000 Workstation
MHRA
2010/002/004/291/013
FSCA
N.A.
N.A.
2010/02/17
Roche Diagnostics Accu-Chek Inform II meter
MHRA
2010/002/011/081/004
FSCA
N.A.
N.A.
2010/02/17
ConMed Linvatec TS8850 concept grafix tendon stripper
MHRA
2010/002/008/081/018
FSCA
N.A.
N.A.
2010/02/17
Invacare Scanbed 750 Hospital Bed
MHRA
2008/002/011/061/019
FSCA
N.A.
N.A.
2010/02/17
Beckman Coulter Access AccuTnI Reagent Kit
MHRA
2010/002/010/601/003
FSCA
N.A.
N.A.
2010/02/17
Baxter HomeChoice Automated PD System / HomeChoice PRO Automated PD
N.A.
Firm Initiated
Field Action
Baxter Healthcare Ltd
2807 8516
2010/02/17
Philips Allura Xper Systems / Allura Integris Systems with Velara Generator
N.A.
Firm Initiated
Field Action
Philips Electronic Hong Kong
Ltd
2821 5480
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
Baxter
Healthcare Ltd.
Philips
Electronic Hong
Kong Ltd
2010/02/17
BD 10ml LS Plastipak Syringe, 302188
2010/02/18
Eden Medical Portable IV Infusion Pumps
MHRA
2009/012/031/081/014
FSCA
N.A.
N.A.
2010/02/18
Jointmedica Birmingham Knee Replacement bearing insert re. 300003-10
MHRA
2010/001/019/081/006
FSCA
N.A.
N.A.
2010/02/18
Stryker Tessier Osseous Microtome (TOM) bone mill
MHRA
2010/002/011/081/015
FSCA
N.A.
N.A.
2010/02/18
Cincinnati Sub-Zero Products Warmair Cardiac Blanket
Health Canada
52127
Type II
N.A.
N.A.
2010/02/18
Beckman Coulter Unicel DXC 600, 800, 600I, 880I, 660I, 680I, 860I
Health Canada
52600
Type II
N.A.
N.A.
2010/02/18
Smiths Medical AC Power Cords used with 9200 Advisor / 8400 Capnocheck / BCI
3180 Pulse
Health Canada
52815
Type II
N.A.
N.A.
2010/02/18
EMCM Artesense (PMMA Collagen Dermal Implant)
Health Canada
52836
Type II
N.A.
N.A.
2010/02/18
Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901,
826801, 829401, 814301, 820502, 831502
FDA
Z-0104-2010
Class I
N.A.
N.A.
Class I
N.A.
N.A.
2010/02/18
Stryker Instruments Navigation System II CART / PC SPC-1
FDA
Z-0123-2010 to Z-01232010
2010/02/18
Stryker Imaging Guradian Services Software 0240-009-430, 0240-020-013, 0240020-022
FDA
Z-0134-2010
Class II
N.A.
N.A.
2010/02/18
Medcomp 10F Bioflex Tesio Kit with cutting trocar, BFR-6CTT
FDA
Z-0161-2010
Class II
N.A.
N.A.
2010/02/18
STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm
FDA
Z-0414-2010
Class II
Swedish Trading Co. Ltd.
6199 0634
2010/02/18
Biomet bone mulch screw, 10.5mm x 20mm, TI-6AL-4V alloy, steril, Ref. 907320
FDA
Z-0779-2010
Class II
N.A.
N.A.
2010/02/18
Cincinnati Sub-Zero Products FilteredFlo Cardiac Blanket / TempPad Cold
Therapy Pad
FDA
Z-0781-2010 to Z-07822010
Class II
N.A.
N.A.
2010/02/18
Edwards Lifesciences Fogaty Occulsion Catheter Ref. 6208022F
FDA
Z-0002-2010
Class II
N.A.
N.A.
2010/02/18
Philips HeartStart MRx(M3535A/M3536A) Defibrillator / Monitor Serial No.
US00533518 to US00535118
FDA
Z-0003-2010
Class II
Philips Electronic Hong Kong
Ltd
2821 5480
2010/02/18
Synthes 2.0mm Screw Manipulation Forceps, Bending Pliers-straight for
Craniofacial/Orthognathic, Plate Holding Forceps, TI Matrixmanible Saggittal,
2.0mm Drill bit Stryker J-latch
FDA
Z-0075-2010 to Z-00822010
Class II
N.A.
N.A.
2010/02/19
SapiMed SMA 4545FP Sterile Rectoscopy Kit - Lot no. 9A010I
MHRA
2010/001/026/401/023
FSCA
N.A.
N.A.
2010/02/19
GlaxoSmithKline (GSK) Polident Dentrue Adhesives (Zn)
GlaxoSmithKline
Limited
N.A.
Firm Initiated
Field Action
GlaxoSmithKline Limited
31898904
2010/02/22
Bredent Medical Dental Implant SKYFF002
MHRA
2010/002/008/081/012
FSCA
N.A.
N.A.
2010/02/22
Leica Biosystems Peloris Rapid Tissue Processor Part Number 26.001
TGA
RC-2010-RN-00122-3
Class II
Leica Microsystems Limited
2564 6699
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong Kong
Ltd
2960 7136
2010/02/22
Boston Scientific BLUE MAX and Ultra-thin Diamond Balloon Dilatation Catheters
2010/02/24
American Medical Systems GreenLight HPS Fibre
MHRA
2010/001/026/081/006
FSCA
N.A.
N.A.
2010/02/24
Maquet Cardiopulmonary Vasoview Hemopro Endoscopic Vessel Harvesting
System
MHRA
2010/002/001/081/024
FSCA
Maquet Hong Kong Ltd.
2393 9511
2010/02/25
Solafeet Model ST-400 Solafeet Foot portable tanners
FDA
Z-0608-2010
Class II
N.A.
N.A.
FDA
Z-0744-2010 to Z-07482010
Class II
King Health Limited
2481 3787
FDA
Z-0749-2010
Class II
Abbott Laboratories LTD.
2593 2211
2010/02/25
2010/02/25
Merit Medical Systems University Health System Custom Cardiac Cath Pack, K09T02178, Custom Cardiac Cath Pack Kit, K09-08945, Custom Angiographic Kit, K09MS3084, Jeanes Hospital Custom Cath Procedure Tray, K09T-08945.
Abbott Vascular (Guidant) RX ACCULINK Carotid Stent System, 10x40 mm,
Product Number: 1011344-40.
2010/02/25
2010/02/25
2010/02/25
2010/02/25
2010/02/25
2010/02/25
Stryker Triathlon Total Stabilizer Femoral Component (Catalog number: 5512-F201, 5512-F-301, 5512-F-402, 5512-F-501, 5512-F-502).
Stryker Xia Precision System (Catalog number: 48237110, 48237105, 48237115,
FDA
Z-0757-2010 to Z-07612010
Z-0789-2010 to Z-0792-
Class II
Stryker China Ltd
2518 6915
Class II
Stryker China Ltd
2519 6915
Class II
Stryker China Ltd
2520 6915
48237135).
Stryker Reamer T-Handle (Catalog Number: 1101-2100), Navigation Reamer Thandle (Catalog Number: 2124-2100).
FDA
Stryker Scorpio PS Femoral Waffle (No post) with LFIT, Product code 72-4107-L.
FDA
Z-0795-2010
Class II
Stryker China Ltd
2521 6915
FDA
Z-0796-2010
Class II
Stryker China Ltd
2522 6915
FDA
Z-0798-2010
Class II
N.A.
N.A.
Stryker Depth Gauge (Catalog Number: 703707). This product is sold separately or
as part of Kit # 990256.
Neurovision Medical Products 2-Channel Laryngeal Surface Electrode (Model
LSE500DCS and LSE500DCL)
FDA
2010
Z-0793-2010 to Z-07942010
2010/02/25
Wescor Hematology reagent C eosin stain SS-035C
MHRA
2010/002/015/081/003
FSCA
N.A.
N.A.
2010/02/25
Medartis A-2723.01 APTUS Radius 2.5 Drill Block, Left; A-2723.02 APTUS Radius
2.5 Drill Block, Right
MHRA
2010/002/019/081/003
FSCA
N.A.
N.A.
2010/02/25
Zimmer Reconstruction System Tenaculum Insturments
Zimmer PTE Ltd.
(Hong Kong
branch)
N.A.
Firm Initiated
Field Action
Zimmer PTE Ltd. (Hong Kong
branch)
2992 0968
2010/02/26
BD FACS SAMPLE PREP ASSISTANT II SPA II Catalog No. 337170, Sample
Probes Lot Numbers 92035 and 92036
MHRA
2010/002/015/081/016
FSCA
BD
2575 8668
2010/02/26
Trumpf Ondal spring arm AC2000 in Helicon and Xenion surgical lights
MHRA
2010/002/018/081/007
FSCA
N.A.
N.A.
2010/02/26
Abbott Paraffin Pretreatment Reagent Kit II (List No. 7J02-02) & Paraffin
Pretreatment Reagent Kit III (List No. 7J02-03)
MHRA
2010/002/004/601/004
FSCA
Abbott Laboratories LTD.
2593 2211
Monthly Summary of Medical Device Safety Alerts - January 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by
Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
2010/01/04
GE Healthcare Revolution XR/d system control room PC model 5117866-2 with
Software collector 5115434
FDA
Z-0002-2009
Class II
2010/01/04
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/04
Flir MilCAM Recon III Model Family of IR Imagers that incorporates a Class I
infrared laser for Laser Range Finding
FDA
Z-0937-2009
Class II
2010/01/04
FLIR Systems Co., Ltd.
2792 8955
2010/01/04
Flir MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared
laser pointer
FDA
Z-1223-2009
Class II
2010/01/04
FLIR Systems Co., Ltd.
2792 8955
2010/01/04
GE Healthcare CT Systems Table Model Number 2225283, 227124, 22269165
FDA
Z-1257-2009 to Z-1259-2009
Class II
2010/01/04
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/04
NRT - Nordisk Rontgen Teknik A/S Celex / GE Precision MPi, REF no.: 02980000
FDA
Z-1658-2009
Class II
2010/01/04
N.A.
N.A.
2010/01/04
GE Healthcare Innova 2100IQ, Innova 3100, Innova 3100-IQ, Innova 4100, Innova
4100-IQ (Recall# Z-1687-2009 to Z-1691-2009)
FDA
Z-1687-2009 to Z-1691-2009
Class II
2010/01/04
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/04
Cook Endoscopy Jejunal Feeding Set, Product Order number FLOWJ-9-20
FDA
Z-1910-2009
Class II
2010/01/04
A.R. Burkill & Sons (Hong Kong) Ltd.
2298 1125
2010/01/04
Abiomed iPulse Circulatory Support System (Catalog number: 0036-0010)
FDA
Z-1931-2009
Class II
2010/01/04
N.A.
N.A.
2010/01/04
BioTek Gen5CL Microplate Data Collection and Analysis Software
FDA
Z-2223-2009
Class II
2010/01/04
N.A.
N.A.
2010/01/04
St. Jude Medical (SJM) FAST-CATH Hemostasis Introducer (REF 406702, 406709)
FDA
Z-2228-200 to Z-2229-2009
Class II
2010/01/04
St. Jude Medical (Hong Kong) Ltd.
2996 7688
2010/01/04
Beckman Coulter Enhanced Access AccuTnI Reagent Kit (Part number A78803)
MHRA
2009/012/023/601/004
FSCA
2010/01/04
Beckman Coulter Hong Kong Ltd
2240 6150
2010/01/04
Abbott Architect HIV Ag/Ab Combo Calibrator, list number 4J27-01, lot 73507HN00
MHRA
2009/012/022/601/001
FSCA
2010/01/04
Abbott Laboratories LTD.
2593 2211
2010/01/04
Intersurgical T-pieces sized 22F, 22M and 22M/15F for various breathing systems
MHRA
2009/010/028/401/002
FSCA
2010/01/04
Shun On Healthcare Limited
N.A.
2010/01/04
AGA Medical Corporation Amplatzer TorqVue 45° Delivery System
MHRA
2009/012/022/081/005
FSCA
2010/01/04
N.A.
N.A.
2010/01/04
bioMérieux chromID Salmonella agar
MHRA
2009/012/001/601/002
FSCA
2010/01/04
bioMerieux China Ltd.
2195 9348
2010/01/04
bioMérieux Vidas TPSA
MHRA
2009/012/001/601/001
FSCA
2010/01/04
bioMerieux China Ltd.
2195 9348
2010/01/06
ev3 Trailblazer Support Catheter (Model no. SC-014-135, SC-018-090, SC-035065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150)
FDA
N.A.
Class I
2010/01/06
Sinomed Company Ltd.
2887 7640
2010/01/06
Agfa Mamoray HDR-C Plus DLF1 - 37780023
MHRA
2009/011/017/401/013
FSCA
2010/01/06
AGFA Hong Kong Limited
2555 9421
2010/01/06
Siemens Healthcare Diagnostics Dade Hepzyme B4240-10, lot 528752
MHRA
2009/012/023/291/011
FSCA
2010/01/06
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/07
Philips Healthcare HeartStart Vehicle Wall Mount (Model M5528A) and DC Power
Module (Model M5529A)
MHRA
2009/012/022/081/007
FSCA
2010/01/07
Philips Electronic Hong Kong Ltd
2821 5480
2010/01/07
Siemens Biograph mCt-X, model number 10248670, 10248671, 10248672
FDA
Z-0162-2010 to Z-0164-2010
Class II
2010/01/07
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/07
Biomet Microfixation LactoSorb Self Drilling Adjustable Tap Model Numbers 9152075 Lot # 064350 and 915-2185 Lot # 885580
FDA
Z-0489-2010 to Z-0490-2010
Class II
2010/01/07
Swedish Trading Co., Ltd
2953 5111
2010/01/07
Terumo Sarns Centrifugal Pump (Cat. no. 164275, 164275X)
FDA
Z-0544-2010 to Z-0545-2010
Class II
2010/01/07
TERUMO CHINA (H.K.) LTD.
2866 0811
2010/01/07
Hill-Rom Affinity Four Birthing Bed (Model P3700B)
FDA
Z-0548-2010
Class II
2010/01/07
N.A.
N.A.
2010/01/07
Siemens Symbia S Series SPECT System (Part: 8717741), Symbia T Series
SPECT-CT (Part: 8717733, 10275007, 10275008, 10275009, 10275010)
FDA
Z-0583-2010 to Z-0584-2010
Class II
2010/01/07
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/11
Philips Healthcare GXR Systems with SCP Generator and tube grid switch
functionality
MHRA
2009/012/030/081/001
FSCA
2010/01/11
Philips Electronic Hong Kong Ltd
2821 5480
2010/01/11
BD
2575 8668
2010/01/11
BD CD103 PE, BD CD103 FITC, and BD Oncomark CD103/CD22/CD20, 340944
N.A.
N.A.
Firm Initiated
Field Action
2010/01/12
General Medical Merate Opera, Precision RXi, Meratel, BRT-20, Clinodigit,
Compact, Futura 2000 and Arkiton 90/20M systems
MHRA
2009/012/015/081/016
FSCA
2010/01/12
N.A.
N.A.
2010/01/12
Cardia Atriasept II ASD and PFO devices
MHRA
2010/001/007/291/004
FSCA
2010/01/12
N.A.
N.A.
2010/01/12
Invacare Action 3 and Action 4 manual wheelchairs
MHRA
MDA/2010/004
MDA
2010/01/12
Direct Health Ltd.
N.A.
2010/01/13
Stryker Endoscopic Digital Image Storage System SDC HD (0240050888), SDC
HDI (0240050888i) and SDC Pro 2 (0240050800, 0240050810)
MHRA
2009/012/016/081/010
FSCA
2010/01/13
Stryker China Ltd
2518 6915
2010/01/14
GE Healthcare Solar 8000I System - Patient Monitor
Health Canada
43880
Type II
2010/01/14
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/14
Ossur Total Knee Prosthetic Device (Model : TK1100)
Health Canada
50746
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Siemens Medical Solutions Acuson X300 (Model : 10037409)
Health Canada
50794
Type II
2010/01/14
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/14
Beckman Coulter Immage Alpha2-Macroglobulin AMG Reagent
Health Canada
50959
Type II
2010/01/14
Beckman Coulter Hong Kong Ltd
2240 6150
2010/01/14
Baxter Syndeo PCA Syringe Pump (Model : 2L3113, 2L3113R)
Health Canada
50978
Type II
2010/01/14
Baxter Healthcare Ltd
2807 8555
2010/01/14
GE Medical Systems A) Omega 1V Table, B) Omega V Table
Health Canada
51642
Type II
2010/01/14
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/14
Siemens Healthcare Diagnostics Rapidpoint 405 System Cartridges (Models :
10283221, 130520, 130521)
Health Canada
51667
Type II
2010/01/14
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/14
Sorin Clearguide Precision Bipolar Devices (Model : KTV15, PBD01)
Health Canada
51914
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Toshiba Aplio Artida Ultrsound System (Model : SSH-880CV)
Health Canada
51965
Type II
2010/01/14
Sanko Medical Systems (HK) LTD
23840688
2010/01/14
Dixtal Pulse Oximetry Products (Model : A) 2001, B) 515B, 520A
Health Canada
52058
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Millipore Millex 33 Syringe Filter Unit (Model : SLGVM33RS)
Health Canada
52075
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Lumenis One (Model : GAL 150000)
Health Canada
52100
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Siemens Healthcare Diagnostics Crotor
Health Canada
52101
Type II
2010/01/14
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/14
Zimmer Trabecular Metal Reverse Shoulder System (Model : 00-4309-037-09, 004309-037-12)
Health Canada
52106
Type II
2010/01/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
2010/01/14
Respironics Novametrix A) Tidal Wave Model 610, B) Tidal Wave SP Model 710,
C) Tidal Wave SP Model 715, D) NICO Model 7300, E) Tidal Wave Model 615
Health Canada
52112
Type II
2010/01/14
Philips Health Care (Great China)
2821 5480
2010/01/14
Wallac OY A) Defia Neonatal Thyroid Stimulating Hormone Assay, B) Defia
Neonatal IRT Assay, C) 1235 Auto Delfia System Plate Processor Class 2
Health Canada
52122
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Teleflex Medical One Way Valve (Model : 1665)
Health Canada
52132
Type II
2010/01/14
N.A.
N.A.
2010/01/14
B. Braun Medical A) Horizon Pump Blood Set NF/US3120,V7490, B) Horizon Pump
Set V7453 AND V7402, C) Horizon Pump Nitroglycerin Sets V7450, D) Horizon
Pump IV Sets Numerous Cat.#, E) Outlook Pump Set NF3115M, F) Outlook Pump
IV SET W/Univer.Spike V7416F
Health Canada
52133
Type II
2010/01/14
B Braun Medical Hong Kong
2277 6125
2010/01/14
Zimmer Nexgen Complete Knee Solution, MIS (Model : 00-5954-057-02)
Health Canada
52161
Type II
2010/01/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
2010/01/14
Baxa Exactamix Empty Eva Container (Model : 738, 739, 740)
Health Canada
52180
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Stryker Trauma A) T2 Ankle System-Arthrodesis Nails,Left, B) T2 Ankle SystemArthrodesis Nails,Right
Health Canada
52186
Type II
2010/01/14
Stryker China Ltd
2518 6988
2010/01/14
Howmedica Osteonics Triathlon Total Stabilizer Femur (Model : 5512-F-301, 5512F-501)
Health Canada
52187
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Arizant A) Bair Hugger Warming Unit, B) Bair Paws Patient Adj. Warming System,
C) Ranger Irrigation Fluid Warming System, D) Bair Paws Model 875 Warming
Unit, E) Ranger Blood/Fluid Warming System
Health Canada
52223
Type II
2010/01/14
N.A.
N.A.
Health Canada
51949
Type II
2010/01/14
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
Health Canada
51949
Type II
2010/01/14
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
2010/01/14
2010/01/14
Bausch & Lomb A) Arnold-Bruening Intracordal Injection, B) Trach Tube Jackson,
C) Trocar Needle & Stylet, D) Speaking Tube, E) Visco-Expression Cannula, F)
Terry IRR Scapper, G) Can FNT SNUS Van Alyea, H) Can Antrum Van Alyea, I)
Arnold-Bruen Laryngeal Injection Set, J) Laryngeal Injection Set Needle Rubin, K)
Lyrngeal Injector Set Arnold Adaptor, L) ENT Trocar Antrum Coakley, M) TracheaSpeaking Tube Sterling, N) Jackson Lacrimal Intubation Set, O) X-BLD F/N/N-250
DISP STORZ, P) Surgilens Corneal Shield, Q) Cannula Angled Graether
Bausch & Lomb A) Opthalmic Cannula, B) I/A Handpiece, C) Opthalmic Surgical
Cannulas-Reusable, D) Excellus Hanstome Microkeratome, E) Sharpoint Ultra
Plug, F) Millenium Microsurgical System, G) Millenium Microsurgical SystemConnecto, H) Ryan 90 Degree Pick, I) Antrum Killian Sterling, J) Can Antrum
Killian Chrome Cannula, K) Needle Fascia Wright, L) Sceral Plugs, M) Suct TB
Guilford-Wright, N) TB Silastic, O) Silicone Tubing, P) Suction Tube Tonsil
Yankauer, Q) Suct TB Tonsil Goodhil-Pynchon, R) Suct TB Baron W/Cut-Off, S)
TB Suct Ferg-Frazier, T) Suction Tube Rosen, U) Needle House, V) Needle Utility
Rosen Type House, W) Needle Perforating McGee, X) Needle Schuknech Straight
Rigid, Y) Algerbrush Rust Ring Cornea Burrs, Z) Tonsil Needle Luer-LK
2010/01/14
Biedermann Motech Ext Tandem Connector (Product code: 1725-197-17, 1725197-18)
MHRA
2009/012/014/081/010
FSCA
2010/01/14
N.A.
N.A.
2010/01/14
Thermo Fisher Scientific PB0378A Oxoid Ready Poured Plate, Iso-Sensitest Agar
+ 5% Blood + 20mg/l N.A.D., 4mm depth
MHRA
2010/001/006/601/006
FSCA
2010/01/14
N.A.
N.A.
2010/01/14
Thermo Fisher Scientific PO0152A Mueller Hinton Agar, 4mm depth
MHRA
2010/001/006/601/005
FSCA
2010/01/14
N.A.
N.A.
2010/01/14
Beckman Coulter Access Free T3 Calibrators A13430
MHRA
2010/001/005/601/001
FSCA
2010/01/14
Beckman Coulter Hong Kong Ltd
2240 6150
2010/01/14
Merit Medical Systems Mistique Infusion Catheters
MHRA
2009/012/030/081/016
FSCA
2010/01/14
King Health Limited
2481 3787
2010/01/15
Rocialle InHealth RML122-044 10cm × 7.5cm 32ply XRD swab sterile
Spire Biomedical Decathalon (Model: DE19SH24 and DE19SH24-K, DE23SH28
and DE23SH28-K, DE27SH32 and DE27SH32-K, DE31SH36 and DE31SH36-K,
DE35SH40 and DE35SH40-K, DE50SH55 and DE50SH55-K, DF19SH24,
DF23SH28, DF27SH32, DF31SH36, DF35SH40, DF50SH55, DF19SH24-100,
DF23SH28-100, DF27SH32-100, DM19SH24, DM23SH28, DM27SH32,
DX19SH24-XP, DX23SH28-XP, DX27SH32-XP, DEC19SH24 and DEC19SH24-K,
DEC23SH28 and DEC23SH28-K, DEC27SH32 and DEC27SH32-K, DEC31SH36
and DEC31SH36-K, DEC35SH40 and DEC35SH40-K, DEC50SH55 and
DEC50SH55-K, DFC19SH24 and DFC19SH24-K, DFC23SH28 and DFC23SH28K, DFC27SH32), ALTA (Model: AL19SH24, AL23SH28, AL27SH32, AL31SH36,
AL35SH40, AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL19SH24-XP,
AL23SH28XP, AL27SH32XP, ALC19SH24, AL27SH32XP, ALC19SH24,
ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55)
Covidien Staplers, cutters and various products (product code: CART; SRVM;
Surg200; Surg300; OPMA, CS21; CS25; CS29; CS33 RALC30; RALC30V;
RALC45; RCW100; SLC55B; SLC55G; SLCR55B; SLCR55G; SLS55B4; .FS14;
FS214; FS312; FS3SCG; FS214RC; MR14; PLC75; PLCR75B; PLCR75G;
PES100; PES100RC; PEC200RC; PES200RC; PLCR45B; PLCR45G; PLC60;
PLCR60B; PLCR60G; PLCR60GT; PLC60RC; PCS21; PCS29; PC100; PC100S;
PC100RC. SS01; MCV1A; iR45B; iR45G; iR45MB; iR45MG; iR45V; iR60B;
iR60G; iR60MB; iR60MG; iR60B4; iDriveS; iDriveC; iDriveF. i60S; i60SRC; i60;
i60XXL; i45; i45V; iB100; iB1C1; iBIG-1; iBIT-1. RCP; RCPOR. T300; PSP; PWCD)
MHRA
2010/001/007/291/005
FSCA
2010/01/15
N.A.
N.A.
FDA
Z-0288-2010 to Z-0335-2010
Class II
2010/01/18
N.A.
N.A.
FDA
Z-0392-2010 to Z-0412-2010
Class II
2010/01/18
Covidien
3157 7220
2010/01/18
2010/01/18
2010/01/18
Numed IMPACT Catheters (Model No. 307)
FDA
Z-0509-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
Medtronic Repose G2 Bone Screw System (REF 76353200), Repose G2 Bone
Screw (REF 76310200)
FDA
Z-0535-2010 to Z-0536-2010
Class II
2010/01/18
Medtronic International, Ltd.
2919 1300
2010/01/18
Luxottica Polycarbonate prescription lenses (single vision, progressive, and trifocal)
FDA
Z-0542-2010
Class II
2010/01/18
N.A.
N.A.
FDA
Z-0579-2010
Class II
2010/01/18
Direct Health LTD
N.A.
FDA
Z-0580-2010 to Z-0581-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
2010/01/18
Invacare Storm TDX SR Power Wheelchair with Stability Lock, Model numbers:
TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCGHD, TDXSRV-HD.
Greatbatch Medical Enpath Lead Adaptor (Ref: 501214), Enpath Myopore
Sutureless Myocardial Pacing Lead (Ref: 511211)
2010/01/18
Teleflex Medical Oxygen Sensor (Cat. no: 5804, Lot no. 906018 and 906003)
FDA
Z-0585-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
BD 30 ml Syringe Luer-Lok Tip (Catalog # 309650)
FDA
Z-0586-2010
Class II
2010/01/18
BD
2575 8668
2010/01/18
Endologix Powerlink System with IntuiTrak Delivery System (Endovascular Graft)
(Model Number 34-34-80L, 34-34-80LE)
FDA
Z-0593-2010 to Z-0594-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
Stryker MIS Bur (REF 8420-107-120, 8420-107-125, 8420-107-130, 8420-107-135,
8420-107-230)
FDA
Z-0595-2010 to Z-0599-2010
Class II
2010/01/18
Stryker China Ltd
2518 6915
2010/01/18
Invitrogen DRB1*04 Locus High Res SSP UniTray (Code: 450404, 450414) and
DRB1*04 Locus High Res AllSet Gold SSP (Code: 54230D)
FDA
2009/012/015/081/026
FSCA
2010/01/18
Invitrogen Hong Kong Limited
N.A.
2010/01/18
Bausch & Lomb Phacoemulsification Needle Wrench in Stellaris or Millennium
phacoemulsification units including DP4305 & DP4305E, DP4310 & DP4310E,
CX5310, CX4320, BL5110, BL5111, BL5112, BL5120, BL5121, BL5122, BL5113,
BL5113A, BL5114, BL5114A, BL5123, BL5123A, DP8130S, DP8145S, DP8230S,
DP8245S, DP8330S, DP8345S, DP8430S, DP8430AS, DP8730S
FDA
N.A.
Firm Initiated
Field Action
2010/01/18
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
2010/01/19
B. Braun All pole clamps for Infusomat Space and Perfusor Space infusion pumps
MHRA
MDA/2010/007
MDA
2010/01/19
B Braun Medical Hong Kong
2277 6125
2010/01/20
Thermo Fisher Scientific PB0146A Iso-Sensitest agar + horse blood, 4mm depth
(lot no. 1115822)
MHRA
2010/001/014/601/001
FSCA
2010/01/20
N.A.
N.A.
2010/01/20
Siemens Axiom Iconos R200
MHRA
2009/012/009/081/013
FSCA
2010/01/20
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/20
Abbott CELL-DYN 4000 vent head spring assembly (List no. 07H95-01)
MHRA
2010/001/012/601/002
FSCA
2010/01/20
Abbott Laboratories LTD.
2593 2211
2010/01/21
GE Healthcare LightSpeed VCT 7.2 Vision and Discovery CT750 HD Computed
Tomography X-ray systems
MHRA
2010/001/015/081/004
FSCA
2010/01/21
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/21
Unomedical Diathermy cables 3405M and 3508M
MHRA
2010/001/012/081/001
FSCA
2010/01/21
N.A.
N.A.
2010/01/21
Karl Storz MTP fluid irrigation filter MTP 031125 and CO2 gas filter 0311231-1
MHRA
2009/012/004/081/004
FSCA
2010/01/21
N.A.
N.A.
2010/01/21
Berchtold A) Chromophare Surgical Lighting System (C200, C300, C450,
C450/452, C570, C571, C571/572, C950, D500, D530, D530LED, D540, D650,
D660, E520, E550, E650, E655, E800, E805, LED 558, LED 668, LED 778, X65,
X66)
B) Chromoview Flat Panel Arm (224, 224 FP, FP, TRAGARM)
Health Canada
52179
Type II
2010/01/21
N.A.
N.A.
2010/01/21
Philips A) Heartstart FRx AED (861304)
B) Heartstart HS1 Onsite Defrillator (M5066A)
Health Canada
51902
Type II
2010/01/21
Philips Electronic Hong Kong Ltd
2821 5480
2010/01/21
Abbott A) i-Stat EG7+ Cartridges (06F01-01, 06F01-02)
B) i-Stat EG6+ Cartridges (06F02-01, 06F02-02)
C) i-Stat CG8+ Cartridges (3M86-01, 03M86-02)
D) i-Stat CHEM8+ Cartridges (03M88-01, 03M88-02)
Health Canada
Type II
2010/01/21
Abbott Laboratories LTD.
2593 2211
2010/01/21
Draeger A) Radiant Warmer (RW82, RW82-1)
B) Birthing Room Warmer (WBR82, WBR82-1)
Health Canada
50181
Type II
2010/01/21
N.A.
N.A.
2010/01/21
Hospira A) Symbiq Set Backcheck Valve Clave Port (16000, 16008, 16013, 16019,
16021, 16022)
B) Lifeshield Latexfree Primary Symbiq (16089, 16090, 16093)
Health Canada
51955
Type II
2010/01/21
Hospira Limited
2898 2886
2010/01/21
Nipro Blood Tubing Set for Hemodialysis (A231TR/V811TR)
Health Canada
52178
Type II
2010/01/21
N.A.
N.A.
2802 2900
2010/01/21
Fresenius 2008H Hemodialysis Machine (150254, 501228, 507115)
Health Canada
49355
Type II
2010/01/21
Fresenius Medical Care Asia Pacific
Ltd.
2010/01/21
Abbott i-Stat 1 Analyzer (06F16-10)
Health Canada
52261
Type II
2010/01/21
Abbott Laboratories LTD.
2593 2211
2010/01/21
GE OEC 9800 Plus Mobile Digital Imaging (00-870632-05, 2274023)
Health Canada
51836
Type II
2010/01/21
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/21
Bio-Rad Variant II Turbo Hemoglobin A1C Program (70291500, 70292239,
70292240)
Health Canada
52177
Type II
2010/01/21
Bio-Rad Pacific Ltd.
N.A.
2010/01/21
Spiegelberg ICP probe 3 PN [SND 13.1.53/FV534P], serial numbers 12835 to
13393, and probe 3 PS [SND 13.1.63/FV535P], serial numbers 6937 to 7122
MHRA
2009/012/022/081/001
FSCA
2010/01/21
N.A.
N.A.
2010/01/22
Medtronic Sofamor Danek Extended Length Trocar (Item No.: 7578013, 7578014)
FDA
Z-0606-2010 to Z-0607-201
Class II
2010/01/22
Medtronic International, Ltd.
2919 1300
2010/01/22
Cordis Aquatrack Hydrophilic Nitinol Guidewire, REF C3526-SSA
FDA
Z-0623-2010
Class II
2010/01/22
Johnson & Johnson Medical (HK)
2738 6027
2010/01/22
Sorin Clearglide EVH (REF: KTV15, KTV16, KTV17, KTV18, KTV22, KTV23),
Clearglide Precision Bipolar (REF: PBD01)
FDA
Z-0624-2010 to Z-0630-2010
Class II
2010/01/22
N.A.
N.A.
2010/01/22
Orthofix Pillar SA PEEK Spacer System Instrument Case (REF: 49-0021) (Pillar SA
Insertion Instrument 49-1100)
FDA
Z-0641-2010
2010/01/22
Remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin (Ref R01626)
FDA
Z-0644-2010
2010/01/22
Telefelx Medical Hudson RCI One Way Valve (REF 1665)
FDA
2010/01/22
Welch Allyn A) Vital Signs 300 Monitor w/Pulse Rate
B) Vital Signs 300 Monitor w/Pulse Rate/Printer
C) Vital Signs 300 w/Pulse Rate/Map/Printer
D) Vital Signs 300 w/Temperature and Printer
E) Vital Signs 300 Monitor/Nellcor SPO2
F) Vital Signs 300 Monitor/Nellcor SPO2 Printer
G) Vital Signs 300 Monitor/Nellcor SPO2/Temp
H) Vital Signs 300 Monitor/SPO2/Temp/Printer
2010/01/22
Mindray SmarTemp Probe for use with VS-800 Vital SIgns Monitor
2010/01/22
2010/01/25
2010/01/25
Varian Ximatron, all C-Series models
Hettich Plastic Hematocrit Rotors (201424-01 Haematokrit 20 with 2050
haematocrit rotor, 2004-01 Mikro 20 with 2076 haematocrit rotor, 2070 Mikro 12-24
with 2050 haematocrit rotor, 2075 Haematokrit 24 with 2050 haematocrit rotor)
Nipro All GlucoPro Insulin Syringes (JD+01U3008-5C, JD+01U3013-5C,
JD+01U3013-5C, JD+01U3108-5C, JD+01U3108-5C, JD+03U3008-5C,
JD+03U3013-5C, JD+03U3013-5C, JD+03U3108-5C, JD+03U3108-5C,
JD+05U3008-5C, JD+05U3013-5C, JD+05U3013-5C, JD+05U3108-5C,
Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning
System Version 3.5)
2010/01/22
N.A.
N.A.
Class II
2010/01/22
Hong Kong South East Chemicals &
Instruments Ltd
2802 6333
Z-0652-2010
Class II
2010/01/22
N.A.
N.A.
Health Canada
52292
Type II
2010/01/22
N.A.
N.A.
Mindray
N.A.
Firm Initiated
Field Action
2010/01/22
N.A.
N.A.
Varian Medical
Systems Pacific
Inc.
CP-01842
Firm Initiated
Field Action
2010/01/22
Varian Medical Systems Pacific Inc.
2724 2836
FDA
N.A.
Press Release
2010/01/25
N.A.
N.A.
FDA
N.A.
Press Release
2010/01/25
N.A.
N.A.
MHRA
2010/001/019/291/012
FSCA
2010/01/25
Accuray Asia Ltd
2247 8628
2010/01/25
ThermoFisher Scientific Oxoid Ready Poured Plate, Pseudomonas CFC Selective
Agar, PO0291A, lot number 1113977
MHRA
2010/001/019/601/001
FSCA
2010/01/25
N.A.
N.A.
2010/01/26
Invitrogen DRB3,4,5 SSP UniTray (451806D), DRB4 AllSet Gold SSP (542110D),
DRB3,4,5 AllSet Gold SSP (54080D), Cw High Resolution SSP UniTray (4719010),
Cw AllSet Gold SSP (54030D)
MHRA
2009/012/031/081/007
FSCA
2010/01/26
Invitrogen Hong Kong Limited
N.A.
2010/01/26
Roche Elecsys Folate III (Material No. 04476433190)
MHRA
2010/001/021/081/009
FSCA
2010/01/26
Roche Diagnostics (Hong Kong) Ltd
2485 7510
2010/01/26
Invitrogen SSP UniTray and AllSet Gold HLA typing kits (450303, 450504D,
450514, 450904, 450202D, 450212D, 54230D, 54240D, 54250D, 54260D, 54290D)
MHRA
2009/012/022/081/019
FSCA
2010/01/26
Invitrogen Hong Kong Limited
N.A.
2010/01/27
Exelint Exel/Exelint Huber needles (Code: 26901, 26902, 26904, 26906, 26907,
26908, 26909, 26911, 26921, 26922, 26923, 26924, 26925), Exel/Exelint Huber
Infusion Sets (Code: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R,
27949R, 27950R, 27954R, 27955R, 27958R, 27959R) and Exel/Exelint
“Securetouch+” Safety Huber Infusion Sets (Code: 37854S, 37855S, 37858S)
FDA
N.A.
Press Release
2010/01/27
N.A.
N.A.
2010/01/28
Medtronic Pressure Products SafeSheath CSG Sheath Introducers
Medtronic
International, Ltd.
N.A.
Firm Initiated
Field Action
2010/01/28
Medtronic International, Ltd.
2919 1300
2010/01/29
Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200,
GEF09500, GEF09600, GEF09700, and GEF09800, using Software version
6.00.04)
FDA
N.A.
News Release
2010/01/29
N.A.
N.A.
2010/01/29
Stelkast Unicondylar Knee Femoral Component SC2462-1, Lot no. 20210-100108
FDA
Z-0371-2010
Class II
2010/01/29
N.A.
N.A.
2010/01/29
Biomet 2.9 Micromax L-15 suture anchor (REF 905456. Lot no. 695710)
FDA
Z-0611-2010
Class II
2010/01/29
N.A.
N.A.
2010/01/29
Tornier Arthro Tunneler (Cat. No. SMB000101, Lot No. 09K1, 09J5, 09J6, 09K3,
09K4, & 09K5)
FDA
Z-0656-2010
Class II
2010/01/29
N.A.
N.A.
2001/01/29
Boston Scientific FasTrackerR-325 Infusion Catheter
Boston Scientific
Hong Kong Ltd.
N.A.
Firm Initiated
Field Action
2001/01/29
Boston Scientific Hong Kong Ltd
2960 7136
2010/01/25
Major Safety Alerts in December 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Information*
Reference No. by
Source
Alert Type
by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent
Contact
Telephone
BD
N.A.
Firm Initiated
Field Action
2009/12/02
BD
2575 8668
Firm Initiated
Philips SureSigns Patient Monitors, Vital Signs Monitors and Vital Signs Viewers (Model
Philips
No. VM3, VM4, VM6,
VM8, VS3, VSV)
N.A.
Field Action
2009/12/03
Philips Electronic Hong Kong Ltd
2821 5364
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
Description of Product
BD CD45 APC-H7, Cat. No 641408
Bausch & Lomb ReNu Multi-Purpose Solution (Lot# GA8028)
FDA
Z-0159-2010
Class II
2009/12/04
ConMed Electrosurgery
FDA
Z-0165-2010
Class II
2009/12/04
N.A.
N.A.
2810 7533
Siemens Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM licenseFDA
(Model No. 7502029,
10496279)
Z-0174-2010
Class II
2009/12/04
Siemens Healthcare Diagnostic
Limited
Baxter System 1000 family of Hemodialysis Instruments with 4.B.09, 4.B.1.1 and 4.B.1.3FDA
software
Z-0179-2010
Class II
2009/12/04
Baxter Healthcare Ltd
2807 8516
Boston Scientific Guidant LATITUDE communicator (Model: 6481)
FDA
Z-0180-2010
Class II
2009/12/04
Boston Scientific Hong Kong Ltd
2960 7136
Stryker 2.1mm Cross-Cut Fissure Bur (Ref: 2296-101-621)
FDA
Z-0263-2010
Class II
2009/12/04
Stryker China Ltd
2518 6915
MHRA
2009/011/025/291/008
FSCA
2009/12/04
N.A.
N.A.
Corin Uniglide unicondylar knee, femoral component (Part no. 514-0400, Lot no. NKZT)
MHRA
2009/011/030/081/004
FSCA
2009/12/04
N.A.
N.A.
MHRA
2009/011/030/081/007
FSCA
2009/12/04
N.A.
N.A.
ThermoFisher Scientific Oxoid Ready Poured Plate, F.A.A. + Nalidixic acid + Tween™MHRA
( H.P.A) (PB1065A)
2009/011/027/601/001
FSCA
2009/12/04
N.A.
N.A.
Cyberonics VNS Therapy Demipulse and Demipulse Duo (Models 103 and 104)
Trinity Biotech Trinicheck Control Level 3 (Product code: T4103)
Fresenius Kabi Agilia Volumat Administration Sets VLON90
MHRA
2009/011/025/291/010
FSCA
2009/12/04
Fresenius Kabi Hong Kong Ltd.
2116 2683
St Jude Medical Epicor Ultrawand LP
MHRA
2009/011/012/081/010
FSCA
2009/12/04
St. Jude Medical (Hong Kong)
Ltd.
2996 7688
Nipro Europe Pureflux Dialyser (PF-210L)
MHRA
2009/005/007/061/011
FSCA
2009/12/04
N.A.
N.A.
WFR-Aquaplast/Q-Fix Systems kVue Couchtop
MHRA
2009/010/030/401/006
FSCA
2009/12/04
N.A.
N.A.
FDA
N.A.
Safety Notice
2009/12/07
Swedish Trading Co. Ltd.
2953 5192
MHRA
2009/012/002/081/007
FSCA
2009/12/08
Medtronic International Ltd.
2919 1362
STERIS System Processor (SS1)
Medtronic Legend AF01 Footed Attachment
GE Medical Systems Hong Kong
GE Medical Systems Dynamic MRI imaging using CADstream with "pure" software -Health
SignaCanada
1.5TExcite HD, 3.0T
Signa HDX , 1.5T
Signa
Discovery MR750, 1.5T Signa Infinity Twinspped Excite,
2783 1838
Signa 1.5T Infinity Excite, Signa Excite 3.0T, Signa HDXT 1.5T
50777
Type
II HDX,2009/12/08
Ltd.
Getinge Steam Sterilizer 422HC, 433HC, 522HC, 533HC, 633HC, 733HC, 833HC Health Canada
50976
Type II
2009/12/08
N.A.
N.A.
Elekta Instruments Leksell gamma Knife Perfexion 715000
Health Canada
51437
Type II
2009/12/08
Elekta Limited, HK
2891 2208
Derma Sciences Dupaque X-Ray Detectable Sponges
Health Canada
51464
Type II
2009/12/08
N.A.
N.A.
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
51706
Type I
2009/12/08
Uninet Technology LTD
2838 8423
ConMed Linvatec Advantage, 2-Button Turbo Handpiece D9924
Health Canada
51507
Type II
2009/12/08
Anaheim Medical Products
N.A.
Elekta Instruments Leksell gamma Knife Perfexion 715000
Health Canada
51522
Type II
2009/12/08
Elekta Limited, HK
2891 2208
Stryker Endoscopy SDC HD Capture Recorder / SDC HD Capture Device 240050-888 / 240-050-890
Health Canada
51583
Type II
2009/12/08
Stryker China Ltd
2518 6915
Zimmer Dental Advent 4.5mmd Platform Tapered Abutment AVACT
Health Canada
51588
Type II
2009/12/08 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Sysmex Reagents RET-Search II RED-700A
Health Canada
51623
Type II
2009/12/08
N.A.
N.A.
Baxter Healthcare Buretrol IV Solution Adm. Sets Clearlink 2C8864
Health Canada
51663
Type II
2009/12/08
Baxter Healthcare Ltd
2807 8516
Stryker Communications Vertical Surgical Table 0788-100-000, 0788-100-001, 0788-100-0015
Health Canada
51664
Type II
2009/12/08
Stryker China Ltd
2518 6915
Smith & Nephew BHR Streamline Cup Introducers 90128285
Health Canada
51665
Type II
2009/12/08
Smiths & Nephew Ltd
9651 5523
Medxl Intravenous Infusion Accessory IVMED20 / IVMED60
Health Canada
51696
Type II
2009/12/08
N.A.
N.A.
Nonin Medical Model 7600 - Oximeter Pod
Health Canada
51731
Type II
2009/12/08
Celki Medical Company
2332 3366
Stryker Instrumentsb CBC II Blood Conservation Kit 225-414-000
Health Canada
51764
Type II
2009/12/08
Stryker China Ltd
2518 6915
2783 1838
Health Canada
51766
Type II
2009/12/08
GE Medical Systems Hong Kong
Ltd.
Boston Scientific
N.A.
Firm Initiated
Field Action
2009/12/08
Boston Scientific Hong Kong Ltd
2960 7136
BD
N.A.
Firm Initiated
Field Action
2009/12/08
BD
2575 8668
Celki Medical
Company
N.A.
Firm Initiated
Field Action
2009/12/08
Celki Medical Company
2268 9201
Tepnel Diagnostics Elucigene CF30 (Lot: CF030B19838)
MHRA
2009/008/014/601/001
FSCA
2009/12/09
N.A.
N.A.
Immucor Anti-Co(b) (Item number 0008307, Lot number 6081004300)
MHRA
2009/012/001/081/003
FSCA
2009/12/10
Uninet Technology LTD
2838 8423
Biosense Webster (a JNJ company) Carto 3 System
MHRA
2009/011/030/081/018
FSCA
2009/12/10
Johnson & Johnson Medical (HK)
2738 6027
Quotient Diagnostics Quo-Test A1c reagents, catalogue reference 0031, lot 010018
MHRA
2009/011/030/081/026
FSCA
2009/12/10
N.A.
N.A.
FDA
Z-0286-2010 to Z0287-2010
Class II
2009/12/11
Philips Electronic Hong Kong Ltd
2821 5480
Z-0390-2010 to ZStryker Taper V40 Femoral Head (Cat. no. 6260-5-326) & LFIT V40 Femoral Head (Cat.FDA
no. 6260-9-132)
0391-2010
Class II
2009/12/11
Stryker China Ltd
2518 6915
GE Healthcare Signa HDE 1.5T MRI System - Magnet M3335SE
Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs
BD BD Sterile BBL Trypticase Soy Agar with Lecithin and Polysorbate 80,
299896, 221961 & 292480
SeQual Eclipse Oxygen System Model 1000 (Distributed bet Jun06 & Jan 08)
Philips Respiratory Gating System (Catalog #NPTA540)
Merit Medical Systems Convenience Trays
Stryker Thor Anterior Plating System Non Sterile Thor Standard Screws
FDA
Z-0413-2010
Class II
2009/12/11
King Health Limited
2481 3787
FDA
Z-0423-2010 to Z0454-2010
Class II
2009/12/11
Stryker China Ltd
2518 6915
Z-0479-2010
Class II
2009/12/11
N.A.
N.A.
FDA
Z-0481-2010
Class II
2009/12/11
Johnson & Johnson Medical (HK)
2738 6027
MHRA
2009/012/003/081/005
FSCA
2009/12/11
N.A.
N.A.
Cargille Laboratories Modified Kingsbury-Clark Albumin Standards (Catalog number: 52064)
FDA
Animas (JNJ) ezManager Max Diabetes Management System version 2.0.9.
Altomed Aspiration Handpieces Style Curved: Style 45, Style 60 And Style 90 Tips
MHRA
2009/012/003/081/004
FSCA
2009/12/11
Olympus Hong Kong and China
Ltd
2170 5678
Varian Medical
Systems Pacific
Inc.
CP-01117
Firm Initiated
Field Action
2009/12/11
Varian Medical Systems Pacific
Inc.
2722 8122
FSCA
2009/12/15
N.A.
N.A.
Olympus Keymed CelonLab POWER (Ref. WB991029, 991.029)
Varian Clinac C-series and Novalis Tx
B&H Surgical Instrument Makers Single use bayonet bipolar/monopolar forceps (Lots:14092303,14093206,14093205)
MHRA
2009/012/002/081/002
MHRA
2009/012/003/081/003
FSCA
2009/12/16
N.A.
N.A.
Aesculap AG & Co. KG (a divison of B. Braun) Orthopilot Active Transmitter Hip FS605MHRA
2009/011/030/081/022
FSCA
2009/12/16
B. Braun Medical (Hong Kong)
Ltd.
2529 2009
MHRA
2009/012/007/601/001
FSCA
2009/12/18
N.A.
N.A.
Trinity Biotech Trinicheck Control Level 1; Trinicheck Control Level 2 (T4101 and T4102)
MHRA
2009/012/009/081/008
FSCA
2009/12/18
N.A.
N.A.
Gebrüder Martin Genos MC/MT MINI Internal Distractor
MHRA
2009/012/010/081/003
FSCA
2009/12/18
N.A.
N.A.
Bakare Kleerside Adjustable Nursing Bed
MHRA
2009/010/021/081/006
FSCA
2009/12/18
N.A.
N.A.
BD
N.A.
Firm Initiated
Field Action
2009/12/21
BD
2575 8668
Class II
2009/12/21
Coloplast (HK) LTD
3628 7427
Z-0190-2010
Class II
2009/12/21
Milverton Ltd.
2367 8123
N.A.
N.A.
NeoVista Vidion Reusable Delivery Module (Cat. No. ASY-1419-EN)
Biomet Vanguard lock-on femoral impactor (32-486206)
BD Difco Decarboxylase Base Moeller 289020
Coloplast Titan OTR Inflatable Penile Prosthesis, 18cm scrotal Bioflex cylinder set w/OTR
FDAPump (Lot: 1919244)
Z-0171-2010
Alphatec Spine NOVEL SPINAL SPACER SYSTEM
FDA
Organogenesis Apligraf (draftskin) packaging
FDA
Z-0181-2010
Class II
2009/12/21
FDA
Z-0199-2010 to Z0258-2010
Class II
2009/12/21 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Zimmer Gender Solutions Natural-Knee Flex System
Z-0260-2010 to ZPhilips GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL (Cat: 882390
and 882410) and the GEMINI TF (Cat:
882470,
882473) Philips Electronic Hong Kong Ltd
FDA
Class
II 882471,
2009/12/21
0261-2010
2821 5480
Synthes Norian CRS Rotary Mixer Cement 10cc (Cat. 614.10.01S)
FDA
Z-0269-2010
Class II
2009/12/21
Synthes (Hong Kong) Ltd
2724 2032
Biomet K-Wire/Trocar Point (REF 35-351534)
FDA
Z-0367-2010
Class II
2009/12/21
N.A.
N.A.
Z-0368-2010 to Z0369-2010
Class II
2009/12/21
Johnson & Johnson Medical (HK)
2738 6027
Biosense Webster (a JNJ company) NaviStar RMT Diagnostic/Ablation Steerable Tip Catheters
FDA
Smith & Nephew Oxinium Femoral Head (REF 71343603)
FDA
Z-0389-2010
Class II
2009/12/21
Smiths & Nephew Ltd
9651 5523
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style
FDA
Z-0419-2010
Class II
2009/12/21
Philips Electronic Hong Kong Ltd
2821 5480
Tornier LMP-50 (Lesser Metatarsal Phalangeal Implant)
FDA
Z-0455-2010
Class II
2009/12/21
N.A.
N.A.
FDA
Z-0459-2010 to Z0465-2010
Class II
2009/12/21
N.A.
N.A.
Pentron TempSpan Dual-Cure Temporary Crown and Bridge Material, Part number N69AD
FDA
Z-0482-2010
Class II
2009/12/21
N.A.
N.A.
FDA
Z-0491-2010
Class II
2009/12/21
N.A.
N.A.
Nutech Bath Safe Adjustable Shower Seat, Adjustable Transfer Bench, Shower Seat
Alphatec Spine Zodiac Polyaxial Spinal Fixation System, Part Number: 62665-50
FDA
Z-1091-2010
Class II
2009/12/21
N.A.
N.A.
Alphatec Spine ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520FDA
Z-0498-2010
Class II
2009/12/21
N.A.
N.A.
Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, REF 904842P
Zimmer Nexgen MIS procedures TM tibial tray size 8, Part No. 005954-057-02
BD BACTEC Blood Culture media, 442192 442260 442265 442193 442206
Intervascular Vascular Prothesis IGK1608, IGK2010
MHRA
BD
Maquet Hong
Kong Ltd.
2009/12/21 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
2009/012/014/081/003
FSCA
N.A.
Firm Initiated
Field Action
2009/12/21
BD
2575 8668
N.A.
Firm Initiated
Field Action
2009/12/21
Maquet Hong Kong Ltd.
2393 9511
GE Medical Systems Hong Kong
GE Healthcare OEC IT3000, IT2500 (EnTrak), IT2500 Plus (EnTrak Plus), IT3500 (InstaTrak),
Plus (InstaTrak Plus), ConneCTstat,
ConneCTstat
MHRA IT3500
2009/012/014/081/024
FSCA
2009/12/22 Plus
Ltd.
2783 1838
N.A.
Firm Initiated
Field Action
2009/12/22
Boston Scientific Hong Kong Ltd
2960 7136
New Deal Hintegra Talar Cutting Guides, Left Cutting Guide, Right Cutting Guide Health Canada
51435
Type II
2009/12/23
N.A.
N.A.
Bio-Rad MRSA Select Reference 63747 Coffret 20 Plaque
Health Canada
51525
Type II
2009/12/23
Bio-Rad Pacific Ltd.
2789 3300
Remel Rapid Eric Electronic Compendium RE8323600
Health Canada
51669
Type I
2009/12/23
Hong Kong South East
Chemicals & Instruments Ltd
2802 6333
Berlin Heart Excor System-Connecting Set for Cannula
Health Canada
51703
Type I
2009/12/23
N.A.
N.A.
Getinge Washer Disinfectors 9027, 9100, 9120, 9125, 9218
Health Canada
51707
Type II
2009/12/23
N.A.
N.A.
Imaging Sciences International i-CAT 3D Dental Imaging System
Health Canada
51709
Type II
2009/12/23
N.A.
N.A.
Vascular Solutions Pronto-Short Extraction Catheter
Health Canada
51819
Type II
2009/12/23
N.A.
N.A.
Roche Molecular Systems Amplicor STD Specimen & Transport Kit
Health Canada
51858
Type II
2009/12/23 Roche Diagnostics (Hong Kong) Ltd
Boston Scientific Guider Softip Guide Catheter
Boston Scientific
Hong Kong Ltd
2485 7510
Toshiba Medical Systems Diagnositc Ultrasound Transducers / Probe PVT-681MV Health Canada
51870
Type II
2009/12/23
Sanko Medical Systems (HK)
LTD
Becton Dickinson Canada BD 30ml Luer-Lok Syringes 309650
Health Canada
51921
Type II
2009/12/23
BD
2575 8668
Imaging Sciences International i-CAT 3D Dental Imaging System
Health Canada
51944
Type II
2009/12/23
N.A.
N.A.
MHRA
2009/012/015/601/001
FSCA
2009/12/24
N.A.
N.A.
ThermoFisher Scientific Oxoid Bottled Media, Brain Heart Infusion Broth BO0366M (lotMHRA
numbers 1106667
and 1106916)
2009/012/010/601/003
FSCA
2009/12/24
N.A.
N.A.
Biomet 19mm diameter Oxford Revision Stems (Ref# 650-0735, 650-0736, 650-0737, 650-0755,
650-0756
and 650-0757)
MHRA
2009/012/016/081/009
FSCA
2009/12/24
N.A.
N.A.
Stryker Ankle Arthrodesis Nail (Cat. no. 18181030S, 18181130S, 18181230S, 18191030S,
18191230S,
18191230S)
MHRA
2009/012/015/081/027
FSCA
2009/12/24
Stryker China Ltd
2518 6915
Class III
2009/12/28
N.A.
N.A.
Stryker China Ltd
2518 6915
Oxoid Brain Heart Infusion CM0225
Megadyne Medical Products E-Z CLEAN Non Stick Cautery Tip (Lot no. 91469)
FDA
Z-0486-2010
Z-0556-2010 to ZStryker Super SecurFit HA Hip Stem (Cat. no. J6051-0425, J0651-0525, J6051-0625) and
no. J6054-XXXX)
FDAPrimary Super SecurFit Stems (Cat.Class
II
2009/12/28
0557-2010
Zimmer Spine Abbott Spine Sequoia dorsal height & revision tool (REF 3367-1)
FDA
Z-0554-2010
Class II
2384 0688
2009/12/28 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Z-0510-2010 to ZMerit Medical Systems Connecting Tube (K10-04129, K10-04131), Monarch (IN2130, IN2230),
Majestik Series Angiographic Needles
Transfer Set (TS120,
TS220),
Prelude Short2481
Sheath
Introducer (PSS-6F-4-018MT, PRO-6F-11-035), Medallion Syringe (MSS111-LB), StayFIX Fixa
FDA
Class II (AN20T52C),
2009/12/28
King Health
Limited
3787
0524-2010
Alphatec Spine Solanas Titanium Pedicle Screw (Part No. 63035-12, 63035-14)
FDA
Z-0502-2010 to Z0503-2010
Class II
2009/12/28
Zimmer Gender Solutions Nexgen Complete Knee Solution (REF 00-5764-013-52)
FDA
Z-0501-2010
Class II
2009/12/28 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Milverton Ltd.
2367 8123
Z-0466-2010 to ZStryker Scorpio Femoral Components (70-3007R, 70-4107R, 71-3003L, 71-3005R, 71-4505L,
80-4407R,
80-4408L,
81-4403L, 81-4404L,
81-4407L,
FDA 71-4505R, 80-4405L, 80-4405R,Class
II
2009/12/28
Stryker 81-4404R,
China Ltd 81-4405L,2518
6915 81-4407R, 81-4409L)
0477-2010
Z-0375-2010 to ZZimmer Natural Nail System (REF 00-2490-001-00, 00-2490-001-05, 00-2490-001-10, 00-2490-005-00,
00-2490-005-03, 00-2490-008-00,
00-2490-008-10,
00-2490-001-03,
PTE Ltd. (Hong
00-2490-001-08,
Kong branch)00-2490-001-53,
2992 0968
00-2490-008-03, 00-2490-008-08, 00-2490-005-04, 00-2490-000-11)
FDA
Class II
2009/12/28 Zimmer
0388-2010
Encompass Group Thermoflect Product Line
Siemens Glucose Biosensor (Lot no. 2809)
Roche Diagnostics Accu-Chek Inform II (Mat. No. 05060303001, 05060311001)
Siemens Dimension IBCT Flex reagent cartridge DF84
FDA
N.A.
Press
Release
2009/12/29
N.A.
N.A.
MHRA
2009/012/017/081/003
FSCA
2009/12/30
Siemens Healthcare Diagnostic
Limited
2810 7533
2009/12/30
Roche Diagnostics (Hong Kong)
Ltd
2481 3387
2810 7533
MHRA
MHRA
Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System (product number 629029)
MHRA
2009/012/016/081/031
FSCA
2009/012/022/081/014
FSCA
2009/12/30
Siemens Healthcare Diagnostic
Limited
2009/012/018/601/003
FSCA
2009/12/30
Beckman Coulter Hong Kong Ltd
2240 6150
Firm Initiated
Field Action
2009/12/30
Varian Medical Systems Pacific
Inc.
2724 2836
Varian Medical
Varian Eclipse Client versions 7.3 (build 7.3.10), 8.0 (builds 7.5x), 8.1 (builds 8.1.x),
and 8.5
(builds 8.2.x)
Systems
Pacific
Inc.
N.A.
Major Safety Alerts in November 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Information*
Reference No. by
Source
Alert Type by
Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
Terumo Sarns Disposable Centrifugal Pump (Model# 164275)
Health Canada
51040
Type II
3-Nov-09
TERUMO CHINA (H.K.)
LTD.
2866 0811
Sorin Revolution Centrifugal Blood Pump (Model no. 50300700)
Health Canada
51015
Type II
3-Nov-09
N.A.
N.A.
Stryker Neptune 2 Ultra Rover (Model 0702-001-00)
Health Canada
51120
Type II
3-Nov-09
Stryker China Ltd
2518 6915
Type II
3-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
Description of Product
GE Giraffe & Panda T-Piece Resuscitation System (Model # M1091316,
M1091335, M1091365)
Maquet Connection Bracket 1180.36AO
Health Canada
51025
Health Canada
51053
Type II
3-Nov-09
Maquet Hong Kong LTD.
2393 9511
Boston Scientific Imager II Urology Torque Catheters
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
3-Nov-09
Boston Scientific Hong
Kong Ltd
2960 7136
Medtronic Titan Anchor (Model 3550-39)
Medtronic
International Ltd.
N.A.
Firm Initiated Field
Action
3-Nov-09
Medtronic International,
Ltd.
2919 1362
MHRA
N.A.
MDA
6-Nov-09
N.A.
N.A.
Boston Scientific IMAGERT II Angiographic Catheter (Peripheral
Intervention)
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
9-Nov-09
Boston Scientific Hong
Kong Ltd
2960 7136
Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor
FDA
Z-2030-2009
Class I
9-Nov-09
Medtronic International,
Ltd.
2919 1362
Covidien Pedi-Cap CO2 Detector
FDA
Z-2047-2009
Class I
9-Nov-09
Covidien
3157 7220
Penumbra Neuron 5F Select Catheter
FDA
Z-2049-2009
Class I
9-Nov-09
Synapse Therapeutics
Limited
9106 1836
Roche/Hitachi Preciset TDM I (Cat. no. 03375790 190); Roche/Hitachi
Preciset TDM II (Cat. no. 03375781 190)
FDA
Z-2000-2009 to Z2001-2009
Class II
9-Nov-09
Roche Diagnostics (Hong
Kong) Ltd
2485 7510
BD Diagnostics GeneOhm (BDDG) (Cat no. 441242; 441244)
FDA
Z-2000-2009 to Z2001-2009
Class II
9-Nov-09
BD
2575 8668
Accuracy CyberKnife Treatment Delivery System
FDA
Z-1810-2009
Class II
9-Nov-09
Accuray Asia Ltd
2247 8628
Oak Tree International EASYMax N self-Monitoring Blood Glucose
System (Recall# Z-1937-2009)
FDA
Z-1937-2009
Class II
9-Nov-09
N.A.
N.A.
Teleflex Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Hudson RICA
Sheridan, ET Tube, Sher-I-Bronch LS & Sher-I-Bronch RS, Sher-I-Bronch
Accessory Pack
FDA
Z-1940-2009 to Z1944-2009
Class II
9-Nov-09
N.A.
N.A.
BD Q-Syte Luer Access Split-Septum (Cat no. 385100) and Q-Syte
Extension Set (Cat. No. 385102)
BD
N.A.
Firm Initiated Field
Action
9-Nov-09
BD
2575 8668
AMO Asia Limited
N.A.
Firm Initiated Field
Action
9-Nov-09
AMO Asia Limited
2401 5711
Beckman Coulter PK7300 automated pre-transfusion analyser and consumables MHRA
2009/011/002/081/016
FSCA
9-Nov-09
Beckman Coulter Hong
Kong Ltd
2240 6150
Joerns Healthcare OXFORD Mobile Hoists, Ceiling Hoists and Bathing Products MHRA
2009/007/022/401/003
FSCA
9-Nov-09
N.A.
N.A.
Smith & Nephew Trigen internal hex screw, model 71642220
MHRA
2009/011/002/601/002
FSCA
9-Nov-09
Smith & Nephew LTD
2648 7700
Swann-Morton Blade shape no. 27
MHRA
2009/010/021/601/002
FSCA
9-Nov-09
N.A.
N.A.
Health Canada
50934
Type II
9-Nov-09
N.A.
N.A.
URIT Medical Electronic Uritest 13G urine test strips
AMO Vitrax II Opthalmic Viscosurgical Device (Sodium Hyaluronate 3%)
Orthofab Triporteur Star 4 and Quadriporteur Star 4
Medical Device Control Office
Department of Health
The Government of HKSAR
Smith & Nephew Endo Femoral Aimers
Health Canada
50942
Type I
9-Nov-09
Smith & Nephew LTD
9651 5523
Diasorin Gammacoat Plasma Renin Activity 123I RIA Kit
Health Canada
51278
Type II
9-Nov-09
N.A.
N.A.
Olsen Medical Midas Touch Needle Electrode
Health Canada
51204
Type II
9-Nov-09
N.A.
N.A.
Draeger Medical
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
10-Nov-09
Draeger Medical Hong
Kong Ltd
2877 3077
MHRA
MDA/2009/072
MDA
10-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
BD
N.A.
Firm Initiated Field
Action
10-Nov-09
BD
2575 8668
AMO Asia Limited
N.A.
Firm Initiated Field
Action
11-Nov-09
AMO Asia Limited
2401 5711
FSCA
11-Nov-09
Siemens Healthcare
Diagnostic Limited
2810 7533
Dragermedical Omega or Omega S package which may include
SC7000/SC8000/SC9000XL, Kappa, Delta/Delta XL (Delta Family) and
Infinity Explorer, in combination with the Trident NMT and / or PiCCO
SmartPod
GE Healthcare Tec 6 Plus Desflurane vaporiser
BD Hettich Centrifuge for PREPStain System (SAP# 490664, 490663)
AMO Tecnis 1-Piece Intraocular Lens (Model# ZCB00)
Siemens Mammomat Inspiration [system: 10140000; biopsy Unit: 10501300]
MHRA
Medical Devices Group XiO, releases 4.3.0 to 4.50.00
MHRA
2009/010/023/601/007
FSCA
11-Nov-09
N.A.
N.A.
Cardiac Science Powerheart AED G3, Cardio Vive, Responder
MHRA
2009/010/026/081/004
FSCA
11-Nov-09
N.A.
N.A.
FDA
N.A.
Class I
12-Nov-09
N.A.
N.A.
Bausch & Lomb
(Hong Kong ) Ltd
N.A.
Firm Initiated Field
Action
12-Nov-09
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
MHRA
MDA/2009/074
MDA
13-Nov-09
Maquet Hong Kong Ltd.
2393 9511
Whatman Body Fluid Collection Paper 903
FDA
Z-1871-2009
Class II
13-Nov-09
N.A.
N.A.
Abiomed AB5000 Portable Driver (Catalog number: 0025-0000)
FDA
Z-1914-2009
Class II
13-Nov-09
N.A.
N.A.
Remington Medical Chiba Needle Marked Model: CNM-2308
FDA
Z-1935-2009
Class II
13-Nov-09
N.A.
N.A.
Verathon BladderScan BVI 9400
FDA
Z-1939-2009
Class II
13-Nov-09
N.A.
N.A.
Abbott AxSYM Cancer Assay Disk Version 5.0
FDA
Z-2222-2009
Class II
13-Nov-09
Abbott Laboratories LTD.
2593 2211
Biomet 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, Osseotite Custom,FDA
Micromini Implant,
Lot # 470258
Z-2227-2009
Class II
13-Nov-09
Ositek (HK), Inc. Ltd
3157 1757
Leonhard Lang SKINTACT Electrodes for Defibrillation, S&W Electrodes
for Defibrillation
FDA
Z-2233-2009 to Z2234-2009
Class II
13-Nov-09
N.A.
N.A.
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT
100-48 and LT 60-24
FDA
Z-2249-2009 to Z2250-2009
Class II
13-Nov-09
B. Braun Medical Hong
Kong
25292009
Abbott Martel Printer Accessory to i-STAT Portable Clinical Analyzer,
rechargeable battery pack (Cat. No. 06723-91, 06F21-35)
FDA
Z-2328-2009
Class II
13-Nov-09
Abbott Laboratories LTD.
2593 2211
ConMed Linvatec PowerPro, PowerProMax and Mpower handpieces
FDA
Z-1950-2009 to Z1952-2009
Class I
13-Nov-09
N.A.
N.A.
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter (Model
No. EC1001 and EC65)
Bausch & Lomb Boston Conditioning Solution Original
Maquet Servo 300 and 900 ventilators (SV300 and SV900)
Medical Device Control Office
2009/010/020/081/010
Department of Health
The Government of HKSAR
ConMed Linvatec MC5057 Universal Cable
FDA
Z-2007-2009
Class I
13-Nov-09
N.A.
N.A.
Synthes Ti Synex II Vertebral Body Replacement (VBR)
FDA
N.A.
Class I
13-Nov-09
Synthes (Hong Kong) Ltd.
2724 2032
Stryker Navigation PC SPC-1
MHRA
2009/011/006/081/003
FSCA
16-Nov-09
Stryker China Ltd.
2518 6915
Joerns Healthcare OXFORD Battery Charger for Mermaid & Historic
Oxford Hoists
MHRA
2008/001/024/401/005
FSCA
16-Nov-09
N.A.
N.A.
Invacare User manual of Rea Azalea wheelchair range
MHRA
2008/011/020/061/008
FSCA
16-Nov-09
Direct Health LTD
N.A.
FDA
N.A.
Press Release
16-Nov-09
N.A.
N.A.
Joerns Healthcare OXFORD slings, all types
MHRA
2008/011/006/401/013
FSCA
17-Nov-09
N.A.
N.A.
Beckman Coulter UniCel DxI system software, versions 4.2 or 4.2.1 (used
on UniCel DxI 800 and 600 Access immunoassay systems and UniCel
DxC 880i, 860i, 680i and 660i SYNCHRON Access clinical systems)
MHRA
2009/011/002/601/003
FSCA
17-Nov-09
Beckman Coulter Hong
Kong Ltd
2240 6150
Smiths Medical
2183502-11/16/09003-R
Firm Initiated Field
Action
17-Nov-09
Goodman Medical
Supplies Ltd
2332 4455
FDA
N.A.
Press Release
18-Nov-09
N.A.
N.A.
2783 1838
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices
Smiths Medical Medfusion Syringe Pumps (Models: 3010A, 3500)
Cardiovascular Systems ViperSheath Sheath Introducer
GE Healthcare Voluson E6 and Voluson E8 Diagnostic Ultrasound
Systems using software versions 9.0.0, 9.0.1, and 9.0.2
MHRA
2009/011/005/601/001
FSCA
19-Nov-09
GE Medical Systems
Hong Kong Ltd.
Lindare Medical Kryptonite Bone Cement (Product code: KRYP-Z-10,
KRYP-X-10, KRYP-Z-03, KRYP-X-03)
MHRA
2009/010/023/081/004
FSCA
19-Nov-09
N.A.
N.A.
Thermo Fisher Scientific Oxoid ready-poured plate, Mueller Hinton agar,
4mm depth (PO0152A)
MHRA
2009/011/004/601/002
FSCA
19-Nov-09
N.A.
N.A.
Stryker Flat foot resorbable implant
MHRA
2009/011/002/081/007
FSCA
19-Nov-09
Stryker China Ltd
2518 6915
2919 1362
Elmdown C01A KyphX HV-R Bone Cement, C01B KyphX HV-R Bone
Cement with Mixer
MHRA
2009/011/011/081/002
FSCA
19-Nov-09
Medtronic International
Ltd.
Invacare Meteor Scooter
MHRA
2009/001/007/401/013
FSCA
19-Nov-09
Direct Health LTD
N.A.
FDA
Z-1706-2009 to Z1709-2009
Class II
19-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
2529 2009
GE Vascular Drape, Drape, Disposable Pack
B. Braun Celsite Access Port Model ST305P
FDA
Z-1961-2009
Class II
19-Nov-09
B. Braun Medical Hong
Kong
Theken Spine iLink Bone Void Filler (Model Number: 50-05-0010)
FDA
Z-1965-2009
Class II
19-Nov-09
N.A.
N.A.
GE Healthcare Datex-Ohmeda S/5 Critical Care Monitor and S/5
Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & LICUO5A software
FDA
Z-1994-2009 to Z1995-2009
Class II
19-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
Lumitex Ultra-Thin LightMat Surgical Illuminator (Model Number: UA2550)
FDA
Z-1998-2009
Class II
19-Nov-09
N.A.
N.A.
Roche Coaguchek XS System (04837975001), Coaguchek XS PST Kit
(04837738001), Coaguchek XS Plus Care Kit (05021537001)
FDA
Z-2002-2009 to Z2004-2009
Class II
19-Nov-09
Roche Diagnostics (Hong
Kong) Ltd
2485 7510
2770 6877
Vbm Medizintechnik Vertriebs Gmbh Transtracheal (Jet Ventilation)
Catheter ACU 1060.1
FDA
Z-2010-2009
Class II
19-Nov-09
Foxwood Medical
Supplies
HACH SteriChek Residual Peroxide Reagent Strips
FDA
Z-2016-2009
Class II
19-Nov-09
EuroTech (Far East) Ltd.
281 40 311
Siemens AXIOM Artis MP, AXIOM Artis dMP and AXIOM Artis Zee
Multipurpose
MHRA
2009/011/006/081/020
FSCA
19-Nov-09
Siemens Healthcare
Diagnostic Limited
2810 7533
ev3 Protégé EverFlex Biliary Stent System (Model no. PRP35-06-100080, Lot 7821736)
MHRA
2009/011/013/081/002
FSCA
20-Nov-09
Sinomed Company Ltd.
2887 7640
Siemens Syngo Imaging XS VA60 and VA70 in combination with "JPEG
Compression" license
MHRA
2009/009/022/081/017
FSCA
20-Nov-09
Siemens Healthcare
Diagnostic Limited
2810 7533
Medical Device Control Office
Department of Health
The Government of HKSAR
ZOLL R Series defibrillators
MHRA
2009/009/014/291/004
FSCA
20-Nov-09
Suburfarm Investment &
Trading Co.
2780 9421
Roche Diagnostics Elecsys Thyroglobulin
MHRA
2009/011/010/081/005
FSCA
20-Nov-09
Roche Diagnostics (Hong
Kong) Ltd
2485 7510
Abbott SCC Bar Code Scanner used with m2000rt, m2000sp and m24sp instruments
MHRA
2009/011/015/601/001
FSCA
23-Nov-09
Abbott Laboratories LTD.
2593 2211
Thoratec HeartMate II and HeartMate XVE LVAS, 12-volt sealed lead
acid battery clips (Model no. 1237)
MHRA
2009/011/012/081/003
FSCA
23-Nov-09
N.A.
N.A.
GE Healthcare Innova 2121IQ and 3131IQ
MHRA
2009/011/013/081/017
FSCA
23-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
Mediplus Low Mix Dual Infusion Set with Gravity IV Valve (product code:
6604)
MHRA
2009/011/012/601/006
FSCA
23-Nov-09
N.A.
N.A.
Medtronic
International Ltd.
N.A.
Firm Initiated Field
Action
23-Nov-09
Medtronic International,
Ltd./Pacific Medical (HK)
Ltd
2919 1362/ 2343
8009
Zimmer Sesamoid Plasty Workstation Power Cord (part number 200.304)
MHRA
2009/011/010/081/009
FSCA
24-Nov-09
Zimmer PTE Ltd. (Hong
Kong branch)
2992 0968
Respironics V60 Ventilator (Part No. 1053614)
MHRA
2009/010/023/081/002
FSCA
25-Nov-09
Celki Medical Company
2268 9201
BD
N.A.
Firm Initiated Field
Action
25-Nov-09
BD
2575 8668
Newdeal Panta support device (Cat. No. 519110)
MHRA
2009/011/023/081/004
FSCA
26-Nov-09
N.A.
N.A.
Thermo Fisher Scientific Oxoid ready-poured plate, DCA (Hynes),
PO0126A
MHRA
2009/011/019/601/005
FSCA
26-Nov-09
N.A.
N.A.
2738 6027
Medtronic CryoCath Arctic Front System
BD BBL Prepared Sterile Pack Plates Trypticase Soy Agar, Sterile Pack,
221236 (Lot No. 9266717)
Cordis CROSSOVER Sheath Introducer (Cat. No. 403545S, 403585S,
403645S, 403685S, 403745S, 403785S)
FDA
Z-0087-2010
Class I
26-Nov-09
Johnson & Johnson
Medical (HK)
Ortho Development Pivot BiPolar Head (Part no. 133-2846, 133-2847,
133-2848, 133-2851, 133-2852)
FDA
Z-0086-2010
Class II
26-Nov-09
N.A.
N.A.
GF Health Products John Bunn 1392 Series Jackson Tracheostomy
Stainless Steel Tube
FDA
Z-0139-2009
Class II
26-Nov-09
N.A.
N.A.
Cardinal Health Craig Calibrated Cannula (Cat. No. OS5000-005)
FDA
Z-0141-2010
Class II
26-Nov-09
N.A.
N.A.
Stryker Stair-PRO Stair Chair (Model 6251 and 6252)
FDA
Z-0148-2010 to Z0149-2010
Class II
26-Nov-09
Stryker China Ltd
2518 6915
Wallace OY Trinest Microplate Incubator and Shaker (Model : 1296-0050)
Health Canada
51375
Class II
26-Nov-09
N.A.
N.A.
GE Apexpro Telemetry System - Clinical Info
Health Canada
48250
Type II
26-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
Bausch & Lomb
(Hong Kong ) Ltd
N.A.
Firm Initiated Field
Action
26-Nov-09
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
Hospira Limited
N.A.
Firm Initiated Field
Action
26-Nov-09
Hospira Limited
2898 2886
Immucor Galileo Echo (Cat. no. 0087000)
MHRA
2009/011/023/081/026
FSCA
27-Nov-09
Uninet Technology LTD
2838 8423
Sybron Dental Specialities Elements Gutta Percha and Elements
RealSeal cartridge kits (Part no. 972-1002, 972-1003, 972-2001, 9722002)
MHRA
2009/011/017/081/014
FSCA
30-Nov-09
N.A.
N.A.
Bausch & Lomb SoFlex SE Silicone Posterior Chamber Intraocular Lens
(Model L161SE, Lot 4916928 (23.5D))
Hospira IV Administration Sets with Borla clamp
Medical Device Control Office
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - October 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of
Source of
Alert Type by
Description of Product
Reference No. by Source
Issue
Local Agent
Agent Contact Telephone No
Information*
Source
(YYYY/MM/D
2009/009/025/081/014
02-十月-09
Sorin Revolution sterile ventricular pump
N.A.
N.A.
FSCA
MHRA
Maquet Hong
2009/009/014/291/024
02-十月-09
MAQUET Hanaulux 2004, 2005, 3004, 3005 & Blue 130 and ALM XTEN
2393 9511
FSCA
MHRA
Kong LTD.
Siemens
Siemens Axiom Artis – US Terason 2000 with Terason 2000 SW version
Healthcare
2009/008/025/081/023
02-十月-09
2810 7533
FSCA
MHRA
3.1.9 or earlier
Diagnostic
Limited
Olympus Hong
ALOKA (Olympus) ultrasound system SSD-ALPHA10
2009/009/015/291/004
02-十月-09 Kong and China
2170 5678
FSCA
MHRA
Ltd
Direct Health
Invacare Duo Range Wheelchairs
2007/002/005/081/015
02-十月-09
2528 1109
FSCA
MHRA
LTD
GE Medical
GE Centricity Laboratory, software version 3.3AImp
2009/006/001/291/012
02-十月-09 Systems Hong
2783 1838
FSCA
MHRA
Kong Ltd.
ArthroCare ArthroWand Saber 30 with Integrated Cable (Cat No. AC4330Z-1900-2009
05-十月-09
N.A.
N.A.
Class II
FDA
01)
GE Medical
GE Healthcare Signa Ovation 0.35T and Signa Openspeed 0.7T MR
Z-1722-2009 to Z-1723-2009
05-十月-09 Systems Hong
2783 1838
Class II
FDA
Systems
Kong Ltd.
Hill-Rom Clinitron Cll Air Fluidized Therapy Units and Clinitron Up-Lift Air
Z-1902-2009 to Z-1903-2009
05-十月-09
N.A.
N.A.
Class II
FDA
Fluidized Therapy Units
Perkin Elmer Specimen Gate Laboratory (Product Code: 5002-0180,
Z-1905-2009
05-十月-09
N.A.
N.A.
software version 1.2 and 1.3) and Specimen Gate Lab - MSMS Data Suite
Class II
FDA
(Product code 5002-03 10)
Allied Healthcare Products Empty M9, Empty D, Empty Jumbo D aluminum
Z-2031-2009 to Z-2038-2009
05-十月-09
oxygen cylinders and First Responder Kit containing a 240-liter aluminum
N.A.
N.A.
Class II
FDA
oxygen cylinder
Hitachi EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners and
Z-2054-2009 to Z-2055-2009
05-十月-09
N.A.
N.A.
Class II
FDA
EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners
2009/10/06
Unomedical Manual Pulmonary Resuscitators
N.A.
Press Release
N.A.
N.A.
FDA
Stryker Triathlon AR 4:1 Cutting Blocks - Size 1-8 (Cat. no. 6541-0-701 Z-1916-2009 to Z-1917Stryker China
08-十月-09
2518 6915
6541-0-708) and Triathlon MIS 4:1 Cutting Blocks - Size 1-8 (Cat no.: 6541Class II
FDA
2009
Ltd
5-701 - 6541-5-708)
AGFA Hong
Z-1889-2009
08-十月-09
2555 9421
AGFA NX 2008 Central Monitoring System (CMS) (Product Code: E2FB6)
Class II
FDA
Kong Limited
Teleflex Sheridan Preformed Cuffed Tracheal Tube Nasal 6.5 (CAT. NO. 5Z-1890-2009 to Z-1891-2009
08-十月-09
N.A.
N.A.
22313) and Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0 (Cat no.
Class II
FDA
5-22314)
Sanko Medical
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with
Z-0005-2009
08-十月-09
238400688
Class II
Systems (HK)
FDA
version 3.40 or higher software
LTD
Z-1898-2009
08-十月-09
Angiodynamics SmartPort CT Port Access System (Cat no. CT80STPD)
N.A.
N.A.
Class II
FDA
GE Medical
GE Healthcare Centricity CARDDAS V3.1: 2D Echo Form
2009/009/028/081/009
08-十月-09 Systems Hong
2783 1838
FSCA
FDA
Kong Ltd.
Cochlear (HK)
Firm Initiated
Cochlear (HK)
N.A.
08-十月-09
Cochlear Non-Magnetic Plug, Z50100, Implant Magnet Z50101
2530 5773
Ltd
Field Action
Ltd
Boston
Firm Initiated
Boston Scientific
Boston Scientific Guider Softip Guide Catheter
N.A.
09-十月-09
2960 7136
Scientific Hong
Field Action
Hong Kong Ltd
Kong Ltd
Medical Device Control Office
170
Department of Health
The Government of HKSAR
Johnson and Johnson (Ortho Clinical Diagnostics) enGen Laboratory
Automation System / TCAutomation Products (Software version 2.8.2 and
below)
Newdeal BBOP Lock Plantar Basal Plates
Medtronic BRYAN Cervical Disc System 6470114, 6470115, 6470116,
6470117, 6470118
Angiotech (Medical Device Technologies, Inc.) Various pouches
Richardson Healthcare SwabX X-ray Detectable Gauze Swabs
Unomedical Manual Pulmonary Resuscitators
Merck Serono pH Indicator Strips
Astra Tech Medena Tapered Tip (Product Ref. No. 68104)
Natus neoBLUE mini LED Phototherapy System
Haemonetics MCS+9000 Devices (Hardware Safety System update)
Huntleigh Healthcare Dopplex Centrale DC11 patient monitor central unit
Arcoma ArcoTable NT (Product Ref. 0055)
Bard Magnum Disposable Biopsy Core Needle 16 gauge (Catalog
numbers: MN1610, MN1613, MN1616 and MN1620)
Sybaritic NannoLight MP50 (Model No.: 304207-MP, 404207, 404207-MP,
404207-B, 404208-B, 404208-MP)
Bard Peripheral Plastic Radiolucent Coaxial (VC10118P, VC10140P) and
MR Coaxial (VC10140MR, VC10118MR)
Apheresis Technologies PlasmaPro Plasma Pump (Model PP-05) (Owner
Manual Modifications)
Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp
(5C4482) and Minicap Extended Life PD Transfer Set Extra Short (4") with
Twist Clamp (5C4483)
Stryker Vertier Surgical Table (Part no 0788100000, 0788100001,
0788100000S and 0788100001S)
Johnson and
Johnson
(Ortho Clinical
Diagnostics)
MHRA
N.A.
Firm Initiated
Field Action
09-十月-09
2009/010/005/081/006
FSCA
12-十月-09
MHRA
2009/009/018/081/014
FSCA
12-十月-09
MHRA
MHRA
FDA
MHRA
MHRA
MHRA
Haemonetics
(Hong Kong)
Limited
MHRA
MHRA
Bard Pacific
Health Care
Co. Ltd
2009/009/011/291/002
2009/009/029/081/014
N.A.
2009/006/024/291/003
2009/010/002/081/003
2009/009/029/081/017
FSCA
FSCA
Press Release
FSCA
FSCA
FSCA
12-十月-09
12-十月-09
13-十月-09
13-十月-09
13-十月-09
14-十月-09
N.A.
Firm Initiated
Field Action
14-十月-09
2008/012/019/401/005
2009/009/028/081/020
FSCA
FSCA
15-十月-09
15-十月-09
Johnson and
Johnson (Ortho
Clinical
Diagnostics)
N.A.
Medtronic
International, Ltd.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Haemonetics
(Hong Kong)
Limited
N.A.
N.A.
N.A.
Firm Initiated
Field Action
15-十月-09
Conmed Limited
2854 4413
FDA
Z-1444-2009
Class II
16-十月-09
N.A.
N.A.
FDA
Z-1879-2009 to Z-1882-2009
Class II
16-十月-09
N.A.
N.A.
FDA
Z-1897-2009
Class II
16-十月-09
N.A.
N.A.
FDA
Z-1893-2009 to Z-1894-2009
Class II
16-十月-09
Baxter
Healthcare Ltd
2807 8516
FDA
Z-1899-2009
Class II
16-十月-09
MHRA
2009/010/008/081/016
FSCA
16-十月-09
Stryker Surgical protocols for hip implants: Cutting Edge Calcar Planer and
Accolade TMZF
Fisher and Paykel Healthcare Heater Wire Adaptors (Model# 900MR800)
MHRA
2009/009/014/291/021
FSCA
16-十月-09
Health Canada
50850
Type II
19-十月-09
Siemens Acuson S2000 (Model no. 10041461)
Heath Canada
50793
Type II
19-十月-09
GE AW Volumeshare (Model no S30321ZK) and AW Volumeshare2
(Model no. 5183859-3, 5183859-4, 5183859-5)
Health Canada
49927
Type II
19-十月-09
Ethicon (JNJ) Gynecare Morcellex Tissue Morcellator (product code:
MX0100, MX0100R)
MHRA
2009/010/012/081/001
FSCA
19-十月-09
MHRA
2009/010/012/081/002
FSCA
19-十月-09
Stryker China
Ltd
Baxter
Healthcare Ltd
Stryker China
Ltd
N.A.
Siemens
Healthcare
Diagnostic
Limited
GE Medical
Systems Hong
Kong Ltd.
Johnson &
Johnson
Medical (HK)
N.A.
MHRA
2009/007/006/081/014
FSCA
19-十月-09
N.A.
Baxter Healthcare Tisseel and Duploject Spray Sets
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter
ESTECH COBRA® Adhere XL Surgical System, Magnetic Introducer,
Introducer and Introducer Set
Zimmer Durom Acetabular Cup
MHRA
2009/009/022/081/016
FSCA
19-十月-09
Roche Diagnostics ONLINE TDM Gentamicin Assay, used with cobas c
501 and Modular Analytics <P> analysers
MHRA
2009/010/001/081/007
FSCA
19-十月-09
Medical Device Control Office
171
Zimmer PTE
Ltd. (Hong Kong
branch)
Roche
Diagnostics
(Hong Kong) Ltd
2737 6162
N.A.
2919 1300
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2116 3166
N.A.
N.A.
2518 6915
2807 8516
2518 6915
N.A.
2810 7533
2783 1838
2738 6027
N.A.
N.A.
2992 0968
2485 7510
Department of Health
The Government of HKSAR
Roche Diagnostics cobas b 221 MSS cassette (Product ref. 03261085184)
Baxter COLLEAGUE Triple Channel Mono, CX and CXE Volumetric
infusion Pumps (Product Codes: 2M8153, 2M8153K, 2M8163)
Varian VARiS Vision version 6.2, 6.1 and 6.0
Varian Clinac, Trilogy and Novalis Tx
Varian Various products (Stereotactic Radiosurgery Treatments)
MHRA
Baxter
Healthcare Ltd
Varian Medical
Systems
Pacific Inc.
Varian Medical
Systems
Pacific Inc.
Varian Medical
Systems
Pacific Inc.
2009/009/015/291/021
FSCA
19-十月-09
N.A.
Firm Initiated
Field Action
20-十月-09
N.A.
Firm Initiated
Field Action
20-十月-09
N.A.
Firm Initiated
Field Action
20-十月-09
N.A.
Firm Initiated
Field Action
22-十月-09
Roche
Diagnostics
(Hong Kong) Ltd
Baxter
Healthcare Ltd
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Viking Group
HK Ltd
Philips
Electronic Hong
2486 7510
2807 8516
2722 8122
2722 8122
2722 8122
AAT (GB) Ltd C-max U/2
MHRA
2009/006/003/291/015
FSCA
22-十月-09
Philips Avalon Fetal Monitors, Models FM20, FM30, FM40 and FM50
MHRA
2009/010/015/081/013
FSCA
23-十月-09
Wallach Surgical Devices LL100 CO2 Cryosurgical System and accessories
MHRA
2009/010/002/081/008
FSCA
23-十月-09
GE Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT 02
FDA
Z-1558-2009
Class II
27-十月-09
GE CIC Pro Clinical Information Center Central Station (CIC Pro version
5.1, MP100 Hardware)
FDA
Z-1600-2009
Class II
27-十月-09
Cardinal Health Pyxis Anesthesia System 3500
Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile
(Cat no. 48906075)
FDA
Z-1883-2009
Class II
27-十月-09
FDA
Z-1886-2009
Class II
27-十月-09
Abbott FreeStyle Lite Blood Gluose Test Strips (Part no 70822-02)
FDA
Z-1936-2009
Class II
27-十月-09
FDA
Z-1948-2009
Class II
27-十月-09
N.A.
N.A.
FDA
Z-1997-2009
Class II
27-十月-09
N.A.
N.A.
FDA
Z-2017-2009 to Z-2021-2009
Class II
27-十月-09
N.A.
N.A.
FDA
Z-2079-2009 to Z-2108-2009
Class II
27-十月-09
N.A.
N.A.
FDA
Z-2232-2009
Class II
27-十月-09
N.A.
N.A.
FDA
Z-2236-2009 to Z-2237-2009
Class II
27-十月-09
FDA
Z-2238-2009
Class II
27-十月-09
GE Innova 2000, Innova 3100/3100IQ, Innova 4100/4100IQ
FDA
Z-2240-2009 to Z-2242-2009
Class II
27-十月-09
N.A.
Beckman
Coulter Hong
GE Medical
Systems Hong
Kong Ltd.
BrainLab Radiotherapy Treatment Planning Software (Cat no 20610,
20620, 20630)
FDA
Z-2251-2009
Class II
27-十月-09
BARD Simpulse SOLO System with Soft Splash Shield Tip (Product Code:
0067590)
IMTEC MDI Hybrid Implant O-Ball abutment (Product Code: MII-0B13, MIIOB15)
BARD Button Device Continuous Feeding Tube (REF: 000256, 000292,
000282, 000283, 000284)
Integra Life Sciences Nerve Block Tray, Single Shot Epidural Tray, Hand
Drill-Sterile, Universal Block Tray, Block Tray, Biopsy Tray, Tuohy Needle,
Custom Procedure Tray
Oridion Medical Capnostream20 capnograph pulse oximeter monitor and
monitor with printer
Action Products Bol-X-II (item no 32052 and 32102)
Beckman Coulter SYNCHRON Systems Salicylate (SALY) Reagent (Part
no 378194)
Abbott Flexiflo Quantum Enteral Pump (Model # 50596, 50598 and 59322)
FDA
Z-2252-2009
Class II
27-十月-09
Wright Medical ADVANCE Canal Filling Stem Extension (Item No.
KSP10140, KSP12140)
Orthofix ISKD Intramedullary Skeletal Kinetic Distractor
Stryker Reflex Hybrid Screw Extractor (Cat. No. 48511905B, 48511905D)
Oxoid Antimicrobial Susceptibility Testing Discs Moxifloxacin 5ug (code
CT1633B)
MHRA
2009/010/014/081/008
FSCA
27-十月-09
MHRA
MHRA
2009/010/014/081/017
2009/010/013/081/008
FSCA
FSCA
27-十月-09
28-十月-09
MHRA
2009/010/016/601/003
FSCA
28-十月-09
Medical Device Control Office
172
GE Medical
Systems Hong
Kong Ltd.
GE Medical
Systems Hong
Kong Ltd.
N.A.
Stryker China
Ltd
Abbott Diabetes
Care
BrainLAB Ltd
Abbott
Laboratories
Starry Medical
Technology, Ltd
Stryker China
Ltd
2395 6339
2783 1838
2783 1838
N.A.
2518 6915
2806 4204
N.A.
2240 6150
2783 1838
2417 1881
2961 4503
2518 6915
Department of Health
The Government of HKSAR
Vairan 4D Integrated Treatment Console
BD Vactainer Urine Kit (364954, 364956, 364957, 364988)
Varian Medical
Systems
Pacific Inc.
N.A.
Firm Initiated
Field Action
28-十月-09
Varian Medical
Systems Pacific
Inc.
2722 8122
BD
N.A.
Firm Initiated
Field Action
28-十月-09
BD
2575 8668
GE Medical
Systems Hong
Kong Ltd.
2783 1838
N.A.
N.A.
GE Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software
FDA
Z-2316-2009
Class II
29-十月-09
Posey Key Lock Belt, Fifth Point Restraint, Connecting Strap/Belt, Locking
Twice-As Tough Cuffs, Locking Twice-As Tough Ambulatory Belt, Swedish
FDA
Z-2254-2009 to Z-2275-2009
Class II
29-十月-09
Siemens EasyLink Informatics System included with the Dimension Vista
System (Part No. 1000046623)
FDA
Z-1991-2009
Class II
29-十月-09
Qualitest Pharmaceuticals Accusure Insulin Syringes
Ergolet Luna track lift spreader bar
ThermoFisher Brain Heart Infusion Broth, EB0366E, lot number 1090463
FDA
MHRA
MHRA
N.A.
2009/009/029/081/024
2009/010/020/601/002
Press Release
FSCA
FSCA
29-十月-09
29-十月-09
29-十月-09
Medtronic MiniMed Paradigm Veo Insulin Pumps MMT-554 and MMT-754
MHRA
2009/009/030/291/008
FSCA
29-十月-09
Horiba ABX Pentra 400
MHRA
2009/010/021/081/016
FSCA
29-十月-09
Medical Device Control Office
173
Siemens
Healthcare
Diagnostic
Limited
N.A.
Medtronic
International, Ltd.
2810 7533
N.A.
2919 1300
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - September 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Reference No. by
Date of Issue
Agent Contact
Description of Product
Alert Type by Source
Local Agent
Information*
Source
(YYYY/MM/DD)
Telephone No
GE Healthcare Innova 2000, 3100 and 4100
MHRA
2009/008/026/291/006
FSCA
03-九月-09
GE Medical Systems Hong Kong Ltd.
2783 1838
Medi-Plinth Equipment GY02E GP Gynae Examination Couch
MHRA
2009/008/026/291/019
FSCA
03-九月-09
N.A.
N.A.
Smiths Medical Omnifuse GB/EN with Lockable Cover (product code:
0157-0001)
MHRA
2009/008/024/291/008
FSCA
03-九月-09
N.A.
N.A.
AMO Asia
Limited
N.A.
Firm Initiated Field Action
03-九月-09
AMO Asia Limited
2401 5711
2821 5226
2518 6915
AMO (Abbott Medical Optics, Inc.) WaveScan Offline Programming
Module (OPM) Software, Version 3.67
Philips Healthcare HeartStart MRx M3536A
Stryker Transport Stretcher 737, Stryker SM104 M-Series Stretcher
1007, Stryker Trauma Stretcher 1027, Stryker Eye Surgery Stretcher
1079
GE Healthcare Innova 2100IQ, 2121IQ, 3100IQ, 3131IQ and 4100IQ
with GE Fluoro UPS 20KVA
MHRA
2009/008/024/081/013
FCSA
04-九月-09
Philips Health
Care (Great
China)
MHRA
2009/008/026/291/007
FSCA
04-九月-09
Stryker China Ltd
GE Medical
Systems Hong
Kong Ltd.
Celki Medical
Company
MHRA
2009/008/026/291/012
FSCA
04-九月-09
Philips Respironics Esprit Ventilator System, Model no V1000 (Product
no 1001456)
FDA
Z-1813-2009
Class II
04-九月-09
Hospira Phoenix Infusion System with MedNet Software
FDA
Z-1815-2009
Class II
04-九月-09
Hospira Limited
2898 2886
Stryker Reflex Hybrid Level Anterior Cervical Plate, Reflex Hybrid
variable self-drilling screw and Reflex Hybrid Variable Self-Tapping
Screw
FDA
Z-1958-2009 to Z-1960-2009
Class II
04-九月-09
Stryker China Ltd
2518 6915
Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management
Protection system)
FDA
Z-1934-2009
Class II
04-九月-09
N.A.
N.A.
Teleflex Medical Sheri-I-Bronch Endobronchial Tube Kit and Sher-ISWIV Double Swivel Tracheal Tube
Health Canada
50274
Type I
07-九月-09
N.A.
N.A.
Teleflex Medical Surgical Scissors
Health Canada
49787
Type II
07-九月-09
N.A.
N.A.
Stryker Pain Pimp Catheters, Infusion Sets and Pain Pump2 Kits
Health Canada
49458
Type II
07-九月-09
Health Canada
50168
Type II
07-九月-09
Toshiba Aquillion One (Model # TSX-301A/2)
Health Canada
50342
Type II
07-九月-09
Stryker China Ltd
Roche
Diagnostics
(Hong Kong) Ltd
Sanko Medical
Systems (HK) LTD
2518 6915
Roche CoaguChek XS Instrument (Model# 3666794) and CoaguChek
XS Plus Monitor (Model # 04800842190)
Zimmer Versys Hip System Femoral Head (Model # 801802802)
Health Canada
50277
Type II
07-九月-09
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Bio-Rad Laboratories Anti-Cardiolipin IGM Test Kit (Model# 425-2020)
Health Canada
50175
Type II
07-九月-09
Diagnostic Systems Laboratories (DSL) Active Cortisol Enzyme
Immunoassay Kit (Model# DSL-10-2000)
Health Canada
50075
Type II
07-九月-09
Beckman Coulter Hong Kong Ltd2240 6150
Technidata TDWorkstation Working With Sebia Hyris (Model# TD-WST01)
Health Canada
50203
Type II
07-九月-09
N.A.
N.A.
Accuray CyberKnife Robotic Radiosurgery System (Model#28000)
Health Canada
50252
Type II
07-九月-09
Accuray Asia Ltd
2247 8628
Invacare Action 3 Comfort
MHRA
2009/001/020/301/002
FSCA
07-九月-09
Direct Health LTD
N.A.
Invacare Birdie, Birdie Compact, Birdie Plus and Birdie Electrical Mobile
Hoists
MHRA
2009/008/017/261/004
FSCA
07-九月-09
Direct Health LTD
N.A.
Medical Device Control Office
174
Bio-Rad Pacific
Ltd.
2783 1838
2268 9201
2485 7510
238400688
N.A.
Department of Health
The Government of HKSAR
IMTEC (a 3M company) ILUMAVision software, version 2.1.0
MHRA
2009/008/020/081/001
FSCA
07-九月-09
N.A.
N.A.
Karma Mobility Karma 20" Self Propel Wheelchair
MHRA
2009/004/023/401/007
FSCA
08-九月-09
N.A.
N.A.
Siemens Immulite 2000 Androstenedione (L2KAO) kit, Immulite 2500
Androstenedione (L5KAO) kit
MHRA
2009/008/028/081/007
FSCA
07-九月-09
Siemens Healthcare Diagnostic Limited
2810 7533
Corin Uniglide Unicondylar Knee System, Zenith Total Ankle System
and Modular Femoral Head
MHRA
2009/008/006/081/015
FSCA
07-九月-09
N.A.
N.A.
2919 1362
Medtronic Enterra Therapy System
MHRA
2009/008/025/081/001
FSCA
07-九月-09
Medtronic
International Ltd.
Trinity Biotech Multichannel Discrete Analyzer (MDA) II coiled axis
tubing (Product Number BX34138-901, BX45612568)
MHRA
2009/007/006/081/015
FSCA
07-九月-09
N.A.
N.A.
Medrronic
International Ltd
N.A.
Firm Initiated Field Action
08-九月-09
Medrronic
International Ltd
2919 1362
FDA
N.A.
Press Release
10-九月-09
Anaheim Medical
2527 9929
MHRA
2009/008/028/081/002
FSCA
10-九月-09
N.A.
N.A.
BD
N.A.
Firm Initiated Field Action
10-九月-09
BD
2803 5320
Draeger Stabilet Infant Warming System (Model # 200, 300, 1250,
1500, 200/3000, 2000, 2200/3200, 3000 and 3200)
FDA
Z-1955-2009
Class I
10-九月-09
N.A.
N.A.
Luv N' Care Gel Filled Teethers - Nuby, Cottontails and Playskool
FDA
Z-1878-2009
Class I
10-九月-09
N.A.
N.A.
Dreager Heater Elements for Resuscitaire Infant Radiant Warmers
(Model # RW82, RW82 VHA, WBR82 and WMRW82)
FDA
Z-1693-2009
Class II
10-九月-09
N.A.
N.A.
International Technidyne (ITC) Hemochron Jr. ACT-LR Assay (JACTLR) (Recall#: Z-1732-2009)
FDA
Z-1732-2009
Class II
10-九月-09
N.A.
N.A.
Amvex Integrated Flowmeter
FDA
Z-1724-2009
Class II
10-九月-09
N.A.
N.A.
MHRA
2009/008/028/081/009
FSCA
17-九月-09
N.A.
N.A.
Medtronic Concerto CRT-D and Virtuoso ICD
Conmed PRO5 and PRO6 series handpieces and MC5057 Universal
cable
Biomet Kent Hip Twist Drills (Item No. 31-401478 & 31-401479)
BD Difco Trypsin 250 (Cat No: 215240 & 215250)
CardioChek PTS panels CHOL+HDL+GLU, panel test strips
Siemens Immulite 1000 / 2000 / 2500 hsCRP (high sensitivity CRP)
MHRA
2009/009/009/291/005
FSCA
17-九月-09
Siemens Immulite 1000 Total T4, LKT4 kit
MHRA
2009/009/003/291/009
FSCA
17-九月-09
Baxter System 1000 with 4.B.0.9, 4.B.1.1 and 4.B.1.3 software
MHRA
2009/009/007/291/017
FSCA
17-九月-09
Siemens
Healthcare
Diagnostic Limited
Siemens
Healthcare
Diagnostic Limited
Baxter Healthcare Ltd
2810 7533
2810 7533
2807 8516
GE Healthcare Seno Advantage 1.x, 2.0 & 2.1
MHRA
2009/009/004/291/015
FSCA
17-九月-09
GE Medical
Systems Hong
Kong Ltd.
IMPAC Medical Systems (Elekta) SEQUENCER for MOSAIQ
MHRA
2009/009/001/291/012
FSCA
17-九月-09
N.A.
Maquet Harness Safety System for transport of CS300 Intra-Aortic
Balloon Pump
MHRA
2009/009/001/291/021
FSCA
17-九月-09
GE Healthcare Image Diagnost MammoWorkstation
MHRA
2009/009/004/291/016
FSCA
17-九月-09
GE Healthcare Uni-Circuit Kit, Adult, Disposable
FDA
Z-1870-2009
Class II
18-九月-09
Stryker 100ml Autofuser PainPump
FDA
Z-1823-2009 to Z-1868-2009
Class II
18-九月-09
Stryker China Ltd
2518 6915
Bard Access System Gauderer Genie II, Ponsky, Bard, FASTRAC
FDA
Z-2179-2009 to Z-2207-2009
Class II
18-九月-09
N.A.
N.A.
Medical Device Control Office
175
Maquet Hong
Kong LTD.
GE Medical
Systems Hong
Kong Ltd.
GE Medical
Systems Hong
Kong Ltd.
2783 1838
N.A.
2393 9511
2783 1838
2783 1838
Department of Health
The Government of HKSAR
Smith & Nephew Orthopaedics PIP Fixation Hinge Kit (Ref 101638)
FDA
Z-2027-2009
Class II
18-九月-09
American Optisurgical Horizon Phacoemulsification System (Model
HZN-2030)
FDA
Z-1808-2009
Class II
18-九月-09
Smith & Nephew
LTD
9651 5523
N.A.
N.A.
Olympus Hong
Kong and China
Ltd
Boston Scientific
Hong Kong Ltd
Gyrus Acmi (Olympus) PKS SEAL Open Forceps, product codes
3103PK, 3104PK, 3105PK, 915000PK, 915005PK & 915010PK
MHRA
2009/008/019/601/002
FSCA
18-九月-09
Boston Scientific LATITUDE communicator (model: 6468, 6476)
MHRA
2009/009/009/291/009
FSCA
18-九月-09
Beckman Coulter SYNCHRON Systems Phenobarbital (PHE) Reagent
MHRA
2009/009/001/601/001
FSCA
18-九月-09
Beckman Coulter Hong Kong Ltd2240 6150
Ventana Medical Systems (Roche) PATHWAY HER-2/neu (4B5) Rabbit
Monoclonal Primary Antibody
MHRA
2009/009/010/291/005
FSCA
18-九月-09
Roche Diagnostics (Hong Kong) Ltd
2485 7510
2170 5678
2960 7136
MHRA
2009/009/007/291/015
FSCA
18-九月-09
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field Action
18-九月-09
Boston Scientific
Hong Kong Ltd
2960 7136
Picis Anesthesia Manager (Model# 4220), PACU Manager (Model #
4245) and Critical Care Manager
Health Canada
50507
Type II
21-九月-09
N.A.
N.A.
Beckman Coulter Synchron CX Immuno-Protein Calibrator (Model#
442840)
Health Canada
50657
Type II
21-九月-09
Beckman Coulter Hong Kong Ltd2240 6150
Carl Zeiss Meditec Stratus OCT Tomographer Vers. 6.0 Software
(Model# Stratus OCT, Software Version 6.0.0)
Health Canada
50625
Type II
21-九月-09
Carl Zeiss Far
East Co. Ltd
2332 0402
Coloplast InterDry Ag (Model# 7910, lot# 1789435)
Health Canada
50228
Type II
21-九月-09
Coloplast (HK)
LTD
3628 7427
Hurricane Medical Hydrodissector Cannulas (Model# 4027, lot# 90402)
Health Canada
50440
Type II
21-九月-09
N.A.
N.A.
21-九月-09
Philips Health
Care (Great
China)
2821 5226
Fenwal AMICUS Separator
Boston Scientific Swiss LithoClast Pneumatic Probes
Philips Medical HeartStart MRx, Defibrillator/Monitor (Model# M3535A,
M3536A)
Health Canada
50623
Type II
Immucor Galileo 500ul Syringes (Model# 64999, 65050)
Health Canada
50526
Type II
21-九月-09
GE Healthcare Datex Ohmeda Carestations Interface
Health Canada
47422
Type II
21-九月-09
Boston Scientific Cobra Electrosurgical System (Model# M00448100,
M00448110, M0048400)
Philips Gyroscan Intera ACS 1.5 Tesla MR System and Intera 1.5 T MR
Systems-Coils
Health Canada
50601
Type II
21-九月-09
Uninet
Technology LTD
GE Medical
Systems Hong
Kong Ltd.
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great
China)
2838 8423
2783 1838
2960 7136
Health Canada
50623
Type II
21-九月-09
Implant Direct Screwplant Implants, Screwplant Healing Collars, Legacy
Healing Collars, Screwindirect implants, Screwplus implants,
Screwdirect implants, replant implants and replus implants
Health Canada
50598
Type II
21-九月-09
N.A.
N.A.
Biomimed Aquesure Disposable Filters (Lot# 042709, 042309, 042209)
Health Canada
50420
Type II
21-九月-09
N.A.
N.A.
Cook Sydney IVF Culture Oil (Model# K-SICO-200)
Health Canada
47702
Type II
21-九月-09
N.A.
N.A.
Immucor Capture-R Ready Screen (4) (Model# 0066802, 0066812, lot#
K226)
Health Canada
50618
Type II
21-九月-09
N.A.
N.A.
The Anspach Effort Emax 2 Plus System - Foot Pedal (Model# EPLUSFP, Lot# SN C08301701901)
Health Canada
50456
Type II
21-九月-09
N.A.
N.A.
MHRA
2009/009/014/291/019
FSCA
21-九月-09
Tyco Healthcare (HKSAR) LTD3157 7220
BrainLAB Ltd
N.A.
Firm Initiated Field Action
22-九月-09
BrainLAB Ltd
2417 1881
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field Action
23-九月-09
Boston Scientific
Hong Kong Ltd
2960 7136
Tyco CT9000ADV
BrainLAB Navigation Software Knee (version 2.1.1 and all previous
versions) and/or BrainLAB Planning Software knee (all versions) in
combination with Zimmer INNEX Implants
Boston Scientific Liberte Bare-Metal Coronary Stents
Medical Device Control Office
176
2821 5226
Department of Health
The Government of HKSAR
ConMed Livatec PowerPro, PowerProMax and Mpower I handpieces
MHRA
2009/008/024/081/010
FSCA
23-九月-09
N.A.
N.A.
ConMed Linvatec Universal Cable (3.6 metres / 12 feet)
MHRA
2009/008/024/081/009
FSCA
23-九月-09
N.A.
N.A.
GE Healthcare Proteus XR/a, Revolution XR/d, and Definium 8000
systems with Fixed Table Models # 2259988, 2259988-2, 2351505 and
5131070
MHRA
2009/009/014/291/022
FSCA
23-九月-09
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field Action
23-九月-09
Boston Scientific
Hong Kong Ltd
2960 7136
FDA
Z-1715-2009 to Z-1716-2009
Class II
24-九月-09
N.A.
N.A.
N.A.
Varian Medical
Systems Pacific
Inc.
N.A.
2724 2836
N.A.
N.A.
Boston Scientific CircuCool Fluid Circulation Pump
Wright Medical CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH.
(Ref 38AM-3604, 38AM-3635)
FDA
Z-1721-2009
Class II
24-九月-09
Varian VARiS LINK
MHRA
2009/009/011/291/003
FSCA
24-九月-09
Mölnlycke ProcedurePak (Lap Chole Pack)
MHRA
2009/009/015/291/010
FSCA
24-九月-09
MHRA
2009/009/015/291/003
FSCA
24-九月-09
Med Tec Foot Lok Cushion (Part no. MTAFS01)
Arcoma OrbixTop, ArcoSphere
Zimmer Magna -FX Cannulated Screw Fixation
Penumbra Neuron Delivery Catheter 070
BD Probetec ET CT/GC Endocervical Speciment Collection and Dry
Transport System-Pink (Cat no. 440476)
Zimmer PTE Ltd
(Hong Kong
branch)
Synapse
Therapeutics
Limited
BD
Firm Initiated Field Action
24-九月-09
N.A.
Firm Initiated Field Action
24-九月-09
N.A.
Firm Initiated Field Action
24-九月-09
BD
2575 8668
Draeger Medical
Hong Kong Ltd
28773077
N.A.
N.A.
MHRA
2009/006/017/291/019
FSCA
25-九月-09
Mölnlycke ProcedurePak (Lap Chole Pack)
MHRA
2009/009/021/081/012
FSCA
25-九月-09
MHRA
2009/008/007/081/016
FSCA
29-九月-09
Philips
Electronic Hong
Kong Ltd
N.A.
Firm Initiated Field Action
29-九月-09
Immucor Echo Blood Grouping Analyser
MHRA
2009/009/022/081/019
FSCA
30-九月-09
Sigma-Aldrich Histopaque 1077-1 reagent
MHRA
2009/009/021/081/010
FSCA
30-九月-09
Trinity Biotech MDA Auto Dimer (Product code: T3103)
MHRA
2009/009/023/081/015
FSCA
30-九月-09
BD
N.A.
Firm Initiated Field Action
Philips HeartStart FR2 M3860A/M3861A, M3840A/M3841A
BD BBL Lactophenol Cotton Blue Stain Droppers (Cat no 26118)
Boston Scientific Equalizer Occlusion Balloon Catheter
Medical Device Control Office
Boston Scientific
Hong Kong Ltd
N.A.
N.A.
Draeger Medical Sola 500, Sola 500 Mobil, Sola 700 and Stella
Phadia Varelisa U1RNP Antibodies, 17096
Zimmer PTE Ltd.
(Hong Kong
branch)
Synapse
Therapeutics
Limited
N.A.
N.A.
Firm Initiated Field Action
177
Science
International
Corporation
Philips Electronic
Hong Kong Ltd
Uninet
Technology LTD
Sigma-Aldrich
China Inc.
2992 0968
9106 1836
2543 7442
2821 5364
2838 8423
N.A.
N.A.
N.A.
30-九月-09
BD
2575 8668
30-九月-09
Boston Scientific
Hong Kong Ltd
2960 7136
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - August 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Information*
Reference No. by Source
Alert Type by
Source
Date of Issue
(YYYY/MM/DD)
Boston Scientific Guidant Contak Renewal 3 CRT-D, 3HE CRT-D, 4CRT-D,
4HE CRT-D, 4AVT CRT-D, 4AVT HE CRT-D and Vitality DS VR
FDA
Z-1620-2009 to Z-1621-2009
Class II
2009/08/03
Philips TumorLoc software application (software versions: 23.1.1, 20.7.13 and
20.8.15) and TumorLoc Software Application for the EBW
FDA
Z-1578-2009 to Z-1580-2009
Class II
2009/08/03
Stryker Triathlon Revision Instruments (1,2,7,8 TGC Upper Tray and 3-6 TGC
Upper Tray)
FDA
Z-1618-2009 to Z-1619-2009
Class II
2009/08/03
Stryker China Ltd
2518 6915
Stryker Amico E-Cylinder Canister Holder (Catalog/Product Number: 0682-001111 & 0682-000-449)
FDA
Z-1569-2009
Class II
2009/08/03
Stryker China Ltd
2518 6915
Sybaritic DERMALIFE Spa jet 2G System, Feng Shui 2G, Oceana 2G System,
Takara
FDA
Z-1602-2009 to Z-1605-2009
Class II
2009/08/03
N.A.
N.A.
N.A.
Description of Product
Local Agent
Agent Contact Telephone
No
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great
China)
Steris ACS2000 Ambulatory Surgical Table (Model # MTS110003)
FDA
Z-1597-2009
Class II
2009/08/03
Swedish Trading
Co., Ltd
XoranConnect Software version 4.1.0.6
2960 7136
2821 5480
FDA
Z-1577-2009
Class II
2009/08/03
N.A.
N.A.
Stryker PainPump Catheters packaged with PainPump2 (Product code:
0525050000 & 0525158000)
MHRA
2009/003/018/401/006
FSCA
2009/08/03
Stryker China Ltd
2518 6915
B. Braun AV-Set Dialog (R) GB, AV-Set Dialog Standard (R), AV-Set Dialog
(R) Fr & AV-Set Dialog (R) Fr Modified
MHRA
2009/007/021/081/010
FSCA
2009/08/03
B. Braun Medical
Hong Kong
N.A.
Barrington Healthcare (supplied by Hill-Rom) Thermo contour mattress for
hospital beds
MHRA
MDA/2009/051
MDA
2009/08/04
N.A.
N.A.
Siemens Diagnostic Ultrasound System Acuson S2000 (software VA10A,
VA10B, VA10C, VA15 & VA15A)
MHRA
2009/007/008/291/002
FSCA
2009/08/04
Siemens Healthcare Diagnostic Limited 2810 7533
Unomedical Careline Easi-MT Urine Bag (Product code: 47-60 LBH)
MHRA
2009/005/019/401/007
FSCA
2009/08/04
N.A.
N.A.
Invacare REA Assist wheelchairs
MHRA
2009/001/020/401/015
FSCA
2009/08/04
N.A.
N.A.
Days Healthcare 338 Escape Lite Manual Wheelchair (Model No. 338S/SN)
MHRA
2009/005/005/061/005
FSCA
2009/08/04
N.A.
N.A.
BD
N.A.
Firm Initiated Field
Action
2009/08/04
BD
3575 8668
Newdeal Large Qwix Measurer (Ref./Cat. no. 119150)
MHRA
2009/007/029/081/006
FSCA
2009/08/05
N.A.
N.A.
Minerva Dental Silverfil
MHRA
2009/004/029/061/012
FSCA
2009/08/05
N.A.
N.A.
Roche Diagnostics Lightcycler Capillaries (100μL, M-Grade, ID/Cat No.
03612066001)
MHRA
2009/007/009/081/002
FSCA
2009/08/05
Roche Diagnostics (Hong Kong) Ltd
ThermoFisher PO0794A Brilliance U.T.I. Medium
MHRA
2009/007/024/601/001
FSCA
2009/08/05
Siemens Immulite 2000 & 2500 AlaTOP Allergy Screen (Cat.No. L2KAT2 &
L5KAT2 resp.)
MHRA
2009/007/021/081/002
FSCA
2009/08/05
Siemens Healthcare Diagnostic Limited 2810 7533
Beckman Coulter Tube Assembly #142, V2, V12 Wash
MHRA
2009/007/030/601/003
FSCA
2009/08/05
Beckman Coulter Hong Kong Ltd
FDA
N.A.
Press Release
BD Beaver Optimum Blade, 15 Straight
Cardinal Health Alaris System
GE Datex-Ohmeda ADU Carestation, Datex-Ohmeda AS/3 Anesthesia
Delivery Unit and Datex-Ohmeda S/5 Anesthesia Delivery Unit
Medical Device Control Office
FDA
Z-1633-2009 to Z-1635-2009
178
Class II
N.A.
2485 7510
N.A.
2240 6150
2009/08/05
N.A.
N.A.
2009/08/06
GE Medical
Systems Hong
Kong Ltd.
2783 1838
Department of Health
The Government of HKSAR
Abbott StarClose Vascular Closure System (Part no 14677-01)
FDA
Z-1657-2009
Class II
2009/08/06
Philips IntelliVue Clinical Information Portfolio Software Version D.0
FDA
Z-1654-2009
Class II
2009/08/06
Hitachi CXR4 Computed Tomography (CT) Scanners(version 1.51 or less)
and Hitachii ECLOS Computed Tomography (CT) Scanners (Software version
2.11 or less)
FDA
Z-1651-2009 to Z-1652-2009
Class II
2009/08/06
Siemens Somatom Definition Model AS/AS+ (Model no. 8098027)
FDA
Z-1675-2009
Class II
2009/08/06
FDA
Z-1650-2009
Class II
2009/08/06
FDA
Siemens Syngo Imaging Version V31 Picture Archiving and Communication
System (Model no 10014063)
Blackstone Medical (Orthofix Spinal Implants) ICON Modular Pedicle Screw
System (P/N's 54-90 II, 54-9020, 549030)
Abbott
Laboratories LTD.
Philips Health
Care (Great
N.A.
Siemens
Healthcare
Siemens
Healthcare
2593 2211
2821 5480
N.A.
2810 7533
2810 7533
Z-1655-2009
Class II
2009/08/06
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
2009/08/06
Boston Scientific
Hong Kong Ltd
2960 7136
Dynex Technologies DS2 automated microplate processing system
MHRA
MDA/2009/052
MDA
2009/08/06
N.A.
N.A.
GE AdvantageSim MD versions 7.4 through 7.6 inclusive
MHRA
2009/004/016/061/001
FSCA
2009/08/06
GE Medical Systems Hong Kong Ltd. 2783 1838
Penumbra Separator for Neuron Intracranial Access System PSS032 and
PSS041
MHRA
2009/007/031/081/003
FSCA
2009/08/06
MHRA
2009/08/06
Boston Scientific HTA Procedure Set
Accuray Cyberknife Robotic Radiosurgery System (Systems SN#128 and
higher with 2005 Edition Robot Controller)
N.A.
N.A.
Accuray Asia Ltd
2247 8628
2009/007/028/081/004
FSCA
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
2009/08/07
Varian Clinac IX Radio Therapy Delivery System (Model / Catalog# 2100C,
21EXS, CLINAC IX H27, CLINAC IX H29)
Health Canada
50003
Type II
2009/08/10
Beckman Coulter Synchron Rheumatoid Factor (RF) Reagent (Model/Catalog
# 475136)
Health Canada
49912
Type II
2009/08/10
Beckman Coulter Hong Kong Ltd
2240 6150
Health Canada
49712
Type II
2009/08/10
Stryker China Ltd
2518 6915
Health Canada
49713
Type II
2009/08/10
Stryker China Ltd
2518 6915
Philips PCR AC-500/PCR AC-5000 Basic System (model/catalog# MCR1511)
Health Canada
46769
Type II
2009/08/10
Philips Health Care (Great China)
2821 5480
Philips Brilliance 40/64 Slice CT System (Model no 4550 110 02031) & Gemini
TF PET/CT System (Model# 4550 110 09021)
Health Canada
46654
Type II
2009/08/10
Philips Health Care (Great China)
2821 5480
GE AW Volumeshare -CT Perfusion 4 (Model # 5189396)
Health Canada
48164
Type II
2009/08/10
GE Medical Systems Hong Kong Ltd. 2783 1838
GE CIC Pro Clinical Information Centre
Health Canada
46547
Type II
2009/08/10
GE Medical Systems Hong Kong Ltd. 2783 1838
Cardinal Health Bypass TGH Kit and Valve TGH Kit
Health Canada
49952
Type II
2009/08/10
N.A.
N.A.
Medrad Stellant CT Dual Injector Systems P3T (Model/Catalog # 3007301,
3010432, 3014849)
Health Canada
49618
Type II
2009/08/10
N.A.
N.A.
Health Canada
49896
Type II
2009/08/10
N.A.
N.A.
Health Canada
48476
Type II
2009/08/10
N.A.
N.A.
Boston Scientific Neurovascular Spinnaker Elite Flow Directed Microcatheter
Stryker (Howmedical Osteonics) Cancellous Bone Screws and Gap Plate
Screw
Stryker (Howmedical Osteonics) Restoration Modular Calcar Bodies, Moduar
Hip Body/ Bolt STD, Hip Body/Blot, Mod. Hip Broach Body/Bolt, Mod. Conical
Distal Stem and Mod. Conical Bowed Stem
Trinity Biotech Trinclot APTT HS (Product Code: T1204, Lot no R324001)
Arrow (Teleflex Medical) Central Venous Catheterization Set (Model # CS12123-E, CS-15123-E) and Central Venous Catheter (Model # MC-12123, MC15123)
Medical Device Control Office
179
Boston Scientific
Hong Kong Ltd
Varian Medical
Systems Pacific
Inc.
2960 7136
2724 2836
Department of Health
The Government of HKSAR
Posey Soft Belt With Crotch Strap (Model# 4125C) and Breezeline Pelvi
Holder (Model#4411)
Health Canada
49840
Type II
2009/08/10
N.A.
N.A.
Kuschall K-Junior Manual Wheelchair (Model # K-Junior, Lot# 806135534)
Health Canada
49293
Type II
2009/08/10
N.A.
N.A.
Breg Kodiak Power Supply (Lot # 3508, 3908, 4308, 4808)
Health Canada
49511
Type II
2009/08/10
N.A.
N.A.
Uninet
Technology LTD
Smith & Nephew
LTD
Boston Scientific
Hong Kong Ltd
Health Canada
49726
Smith & Nephew LTD
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
Aesculap Targon PFT Depth Stop KH535R for Drill KH536R
MHRA
2009/008/004/081/015
FSCA
2009/08/10
N.A.
N.A.
Disc Motion Technologies InLign ARC (TrueDyne PDS) (part no. TDF-0044-20)
MHRA
2009/007/021/291/008
FSCA
2009/08/10
N.A.
N.A.
Uninet
Technology LTD
2838 8423
Immucor Fetal Bleed Screening Test (Model # 7892, Lot # 17411)
Smith & Nephew Disposable Blade
Boston Scientific Wiseguide Guide Catheter, Impulse Angiographic
(Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter
Type II
Firm Initiated Field
Action
Firm Initiated Field
Action
2009/08/10
2009/08/10
2009/08/10
2838 8423
9651 5523
2960 7136
Immucor Gamma Benelux Gamma ELU-KIT II Buffering Solution
MHRA
2009/007/030/081/002
FSCA
2009/08/10
Wyeth ReFacto AF
MHRA
2009/006/002/081/001
FSCA
2009/08/10
N.A.
N.A.
2593 2211
N.A.
Abbott ARCHITECT i2000 & i2000SR Analyser (List numbers 8C89, 1G17 &
3M74)
Teleflex Medical Multifit Nebulizer and Multifit Nebulizer with BOC Adapter
(Cat.No.922800 & 922820)
MHRA
2009/007/030/601/004
FSCA
2009/08/10
Abbott
Laboratories LTD.
MHRA
2009/008/003/291/016
FSCA
2009/08/11
N.A.
GE Ventri
MHRA
2009/008/011/291/005
FSCA
Toshiba Multi-plane transoesophageal transducer, model PET-511BTM
MHRA
2008/012/003/291/010
FSCA
Stryker Accolade TMZF Hip Stem
FDA
Z-1354-2009 to Z-1684-2009
Class II
2009/08/13
GE Medical Systems Hong Kong Ltd. 2783 1838
Sanko Medical
2009/08/13
Systems (HK)
238400688
LTD
2009/08/14
Stryker China Ltd
2518 6915
Stryker Offset Adaptor Trial 2MM, 4MM, 6MM and 8MM
FDA
Z-1607-2009 to Z-1610-2009
Class II
2009/08/14
Zimmer Pulsavac Wound Debridement System , Allen medullary cement plugs
and Coonrad/ morrey total elbow cement
FDA
Z-1698-2009 to Z-1700-2009
Class II
2009/08/14
Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Medtronic INTREPID Spinal System and Coverplate
FDA
Z-1796-2009 to Z-1802-2009
Class II
2009/08/14
Steris Cmax 110v Surgical Table Hand Control
FDA
Z-1599-2009
Class II
2009/08/14
Raytec Yan X-Ray Detectable Gauze
HA
N.A.
N.A.
2009/08/14
Roche Diagnostics cobas e 411
MHRA
2009/008/005/081/010
FSCA
2009/08/17
Roche Diagnostics (Hong Kong) Ltd
2485 7510
Stryker MIS Diamond Burs
MHRA
2009/008/010/291/001
FSCA
2009/08/17
Stryker China Ltd
2518 6915
ConMed Linvatec UltraPower Diamond Wheel Burs
MHRA
2009/008/011/291/001
FSCA
2009/08/17
ConMed Limited
N.A.
Linet Eleganza 3 and Latera bedframes
MHRA
2009/007/020/601/004
FSCA
2009/08/17
N.A.
N.A.
Fresenius Kabi Ambix activ Set ambulatory (refs. E4302 & 2892095) and
Ambix activ Set stationary (refs. E4529 & 2892098)
MHRA
2009/008/007/601/002
FSCA
2009/08/17
N.A.
N.A.
Zimmer Various targeting components for the Zimmer Natural Nail
MHRA
2009/008/007/081/015
FSCA
2009/08/17
Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Aesculap NN340 Columbus RP Gliding Surface T4/4+ 10mm (lot 51405551)
NN222 Columbus DD Tibial Insert SZ 2/2+ 14mm (lot 51400343)
MHRA
2009/008/006/081/004
FSCA
2009/08/17
Medical Device Control Office
180
Stryker China Ltd
Medronic
International Ltd
Swedish Trading
Co., Ltd
Winner Medical
(Hong Kong) Ltd
B. Braun Medical
Hong Kong
2518 6915
2919 1300
N.A.
3170 7000
N.A.
Department of Health
The Government of HKSAR
Stryker Scorpio femoral components (Cat.No. 70-3007R, 80-4405L, 80-4407R)
Medtronic LIFEPAK 15 Defibrillator/Monitor
MHRA
2009/007/029/081/004
FSCA
2009/08/17
Stryker China Ltd
2518 6915
Medtronic
International Ltd.
N.A.
Firm Initiated Field
Action
2009/08/17
Medtronic
International Ltd.
2919 1362
MHRA
2009/001/007/401/001
FSCA
2009/08/19
Direct Health LTD
N.A.
Hospira AC Power Cords
FDA
N.A.
Press Release
2009/08/20
Hospira Limited
2898 2886
Stryker Trident Hemispherical Acetabular Shell (Part no 508-11-72J)
FDA
Z-1685-2009
Class II
2009/08/20
Stryker China Ltd
2518 6915
Invacare REA Azalea base
Boston Scientific
Hong Kong Ltd
Arjo Huntleigh
(Hong Kong) Ltd.
Johnson &
Johnson Medical
(HK)
Siemens
Healthcare
Diagnostic
Boston Scientific EndoVive Safety PEG Kit and Standard PEG Kit
FDA
Z-1625-2009 to Z-1632-2009
Class II
2009/08/20
Arjo Huntleigh Passive Clip Slings and Flite Clip Slings
FDA
Z-1636-2009 to Z-1637-2009
Class II
2009/08/20
Johnson & Johnson Spine Expedium SFX Cross Connector System Torque
Driver Shaft (REF: 2894-10-300)
FDA
Z-1670-2009
Class II
2009/08/20
Siemens Symbia S Series SPECT System (Part 8717741) and Symbia T
Series SPECT-CT System (Part 10275010)
FDA
Z-1676-2009 to Z-1677-2009
Class II
2009/08/20
Zimmer ITST Intertorchanteric/Subtrochanteric fixation tapered reamer (REF
2258-50-00)
FDA
Z-1701-2009 to Z-1702-2009
Class II
2009/08/20
Zimmer PTE Ltd. (Hong Kong branch) 2992 0968
Smith & Nephew IMHS CP, 3.2mm, Tip Threaded Guide Pin (Ref 71687000)
FDA
Z-1704-2009
Class II
2009/08/20
Smith & Nephew
LTD
9651 5523
Stat Super-Fine Pen Needles and Allison Medical Sure Comfort Pen Needles
with Silicon Tip
FDA
Z-1596-2009
Class II
2009/08/20
N.A.
N.A.
Arrow Large-Bore Central Venous Catheters
FDA
Z-1671-2009 to Z-1672-2009
Class II
2009/08/20
N.A.
N.A.
TomoTherapy Hi-Art system
MHRA
2009/008/013/081/025
FSCA
2009/08/20
N.A.
N.A.
Teleflex Medical Sher-I-Swiv, Sher-I-Bronch
MHRA
2009/008/013/081/024
FSCA
2009/08/20
N.A.
N.A.
AMO (Abbott Medical Optics, Inc.) WaveScan WaveFront System Offline
Programming Module, international version
MHRA
2009/008/012/291/010
FSCA
2009/08/20
N.A.
N.A.
ConMed Linvatec Lightwave Suction Ablator
MHRA
2009/008/010/291/012
FSCA
2009/08/20
ConMed Ltd
N.A.
2960 7136
2508 1416
2738 6027
2810 7533
Gyrus Acmi (Olympus) PlasmaKinetic SuperSect / PK SuperSect Instrument
MHRA
2009/007/013/601/001
FSCA
2009/08/20
Maquet Servo 300 ventilator (SV300)
MHRA
MDA/2009/056
MDA
2009/08/20
Olympus Hong
Kong and China
Ltd
N.A.
Pride Riser Recliner
MHRA
2008/006/024/401/014
FSCA
2009/08/21
N.A.
N.A.
ConMed Linvatec Arthro-Knife Sheathed Knife
MHRA
2009/008/012/291/012
FSCA
2009/08/21
N.A.
N.A.
Spacelabs Healthcare ECG cable with integrated leadwires (PNs: 700-000822, 700-0008-23, 700-0008-24, and 700-0008-25)
MHRA
2009/008/004/291/002
FSCA
2009/08/21
N.A.
N.A.
2783 1838
2417 1881
MHRA
2009/008/011/601/003
FSCA
2009/08/21
GE Medical
Systems Hong
Kong Ltd.
BrainSCAN iPlan RT Dose (Model no 20140 BrainScan Platform SW (all
versions), 21213C iPlan RT Dose Platform SW 4.0, 21213D iPlan Dose
Platform SW 4.1)
BrainLAB Ltd
N.A.
Firm Initiated Field
Action
2009/08/21
BrainLAB Ltd
GE Instatrak 3500 System (Model # 1006236-001)
Health Canada
49926
Type II
GE N-DISVENT-02
Medical Device Control Office
181
2170 5678
N.A.
2009/08/24
GE Medical Systems Hong Kong Ltd. 2783 1838
Department of Health
The Government of HKSAR
GE Compax 40E Table (Model # 2208203, 2225864, 2225881)
Health Canada
49649
Type II
2009/08/24
GE Medical Systems Hong Kong Ltd. 2783 1838
GE Innova 4100 IQ - Main Unit (Model # 2335129) & Innova 2000
Cardiovascular System (Model no S1872LC)
Health Canada
50099
Type II
2009/08/24
GE Medical Systems Hong Kong Ltd. 2783 1838
GE Innova 4100 IQ - Main Unit (Model # 2335129) & Innova 2000
Cardiovascular System (Model no S1872LC)
Health Canada
49983
Type II
2009/08/24
GE Medical Systems Hong Kong Ltd. 2783 1838
GE Reusable Metal Needle Guides & Bushings
Health Canada
48986
Type I
2009/08/24
GE Medical Systems Hong Kong Ltd. 2783 1838
Stryker (Howmedica Osteonics) Delta Ceramic Ball Heads (Model # 18-3200)
Health Canada
50100
Type II
2009/08/24
Smith & Nephew 4.0mm Direct Measuring Gauge (Model # 71117083)
Health Canada
49969
Type II
2009/08/24
Siemens Easylink Informatics System (Model# 100034941)
Health Canada
49974
Type II
2009/08/24
Welch Allyn Vital-Signs Monitor
Health Canada
49917
Type II
2009/08/24
Vascular Solutions Twin-Pass Access Catheter (Model# 5200)
Health Canada
Celki Medical
Company
49872
Type I
Philips Respironics M Series Humidifier
Tyco (Nellcor, Puritan Bennett) PediCap End-Tidal CO2 Detectors
Firm Initiated Field
Action
Firm Initiated Field
Action
N.A.
Stryker China Ltd
Smith & Nephew
LTD
Siemens
Healthcare
2518 6915
2648 7700
2810 7533
N.A.
N.A.
2009/08/24
N.A.
N.A.
2009/08/24
Celki Medical
Company
2268 9201
Tyco Healthcare (HKSAR) LTD
N.A.
Gebrüder MARTIN Acrobat 2000 Spring Arm
MHRA
2009/008/017/081/011
FSCA
2009/08/24
N.A.
N.A.
Cellestis QuantiFERON-TB Gold TB-Antigen Tubes
MHRA
2009/008/017/081/021
FSCA
2009/08/24
N.A.
N.A.
One Lambda HLA B27 FITC Conjugated Monoclonal Antibody
MHRA
2009/008/014/081/012
FSCA
2009/08/24
N.A.
N.A.
Trinity Biotech Auto D Dimer Kit (Product Number CRS126B)
MHRA
2009/008/017/081/026
FSCA
2009/08/24
N.A.
N.A.
Arjo Maxi Move Scoop Stretcher (model # KRA2210-20)
MHRA
2009/007/022/291/009
FSCA
2009/08/24
Arjo Huntleigh
(Hong Kong) Ltd.
2508 1416
Ö ssur Hiptric Frame (Item # 980121, 980122, 980123)
MHRA
2009/007/029/401/003
FSCA
2009/08/24
N.A.
N.A.
Ö ssur Total Knee Junior (Serial numbers: 8573-8792)
MHRA
2009/007/022/301/001
FSCA
2009/08/24
N.A.
N.A.
BD
N.A.
Firm Initiated Field
Action
2009/08/25
BD
2575 8668
Medtronic
International Ltd.
N.A.
Firm Initiated Field
Action
2009/08/25
Medtronic
International Ltd.
2919 1362
MHRA
2009/008/019/081/011
FSCA
2009/08/26
N.A.
N.A.
Roche ACCU-Chek Softclix Lancing Device, Active Meter Kit, Voicemate
Meter, Aviva Meter Kit, Compact Plus Meter Kit and Coaguchex XS Systems
for Patient Self-testing
FDA
Z-1590-2009 to Z-1595-2009
Class II
2009/08/27
Roche
Diagnostics
(Hong Kong) Ltd
2485 7510
SJM (St. Jude Medical) Peel Away Introducer (REF 405116, 405153)
FDA
Z-1713-2009 to Z-1714-2009
Class II
2009/08/27
GE Drapes and Sterile Covers
FDA
Z-1730-2009
Class II
2009/08/27
2783 1838
Siemens Dimension Cardiac Tropnin I Flex Reagent cartridge (CTNI)
FDA
Z-1731-2009
Class II
2009/08/27
N.A.
GE Medical
Systems Hong
Siemens
Healthcare
X Spine Systems Capless Li Pedicle Screw System
FDA
Z-1694-2009
Class II
2009/08/27
BD CLAY ADAMS Dynac III Centrifuge 120V (Cat/Model no.: 420104)
Medtronic LIFEPAK CR Plus Defibrillator
Ortho-Clinical Diagnostics Veridex LLC CellSearch Circulating Tumor Cell
(CTC) Kit (product code 7900001)
Medical Device Control Office
182
2009/08/24
Tyco Healthcare (HKSAR) LTD
N.A.
3157 7220
N.A.
2810 7533
N.A.
Department of Health
The Government of HKSAR
Source Production & Equipment M-19 (Iridium 192): Brachytherapy source
Suarez Foot Choice Therapeutic Foot Massager (Model no YS-322)
Johnson & Johnson STERRAD CYCLESURE and CYCLESURE 24 Biological
Indicator(s)
Medtronic Sutureless Connector (SC) Intrathecal Catheters Cot Compatible
with IsoMed Constant - Flow Infusion Pumps
FDA
Z-1717-2009
Class II
2009/08/27
N.A.
N.A.
FDA
Johnson & Johnson
Medical (HK)
Z-1697-2009
Class II
Firm Initiated Field
Action
2009/08/27
N.A.
Johnson &
Johnson Medical
(HK)
Medtronic
International Ltd.
N.A.
Medtronic
International Ltd.
Smith Medical Portex Tracheal Tube and Portex Paediatric Tracheal Tube
Biomerica EZ PSA and Fortel PSA (Part number 1081)
2009/08/27
2738 6027
N.A.
Firm Initiated Field
Action
2009/08/28
MHRA
2009/008/013/081/007
FSCA
2009/08/28
N.A.
N.A.
MHRA
2009/008/024/081/014
FSCA
2009/08/28
N.A.
N.A.
Boston Scientific Renegade Fiber Braided Microcatheters and Renegade HiFlo Microcatheter
Boston Scientific Renegade Fiber Braided Microcatheters, Renegade Hi-Flo
Microcatheter and Renegade Hi-Flo Microcatheter Kits
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific Contour SE Microspheres
Boston Scientific
Hong Kong Ltd
Medical Device Control Office
N.A.
Firm Initiated Field
Action
Firm Initiated Field
Action
N.A.
N.A.
Firm Initiated Field
Action
N.A.
183
2009/08/31
2009/08/31
2009/08/31
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
2919 1362
2960 7136
2960 7136
2960 7136
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - July 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada,
Canada
Source of
Date of Issue
Description of Product
Reference No. by Source Alert Type by Source
Local Agent
Information*
(YYYY/MM/DD)
Siemens E.CAM Patient Handling System (PHS) Field of View (FOV)
Siemens Healthcare
Z-1505-2009
2009/07/02
Class II
FDA
indicator bars (Part no 43 66 618 and 43 81 088)
Diagnostic Limited
Z-1471-2009 to Z-1473-2009
2009/07/02
Arrow Embolectomy Catheters
Class II
Cemma Enterprise Co., Ltd
FDA
Z-1506-2009
2009/07/02
Inverness Medical BioSrar Strep A OIA MAX (Product Code 90003)
Class II
N.A.
FDA
2009/006/018/081/010
FSCA
2009/07/02
Edwards LifeSciences BM25
N.A.
MHRA
GE Medical Systems Hong
2009/003/019/061/005
FSCA
2009/07/02
GE CT Perfusion 4
MHRA
Kong Ltd.
Cardinal Health Alaris GP volumetric pump and Alaris GP Guardrails
2009/006/017/291/018
FSCA
2009/07/02
Cardinal Health
MHRA
volumetric pump
Bausch & Lomb
Firm Initiated Field
Bausch & Lomb (Hong
N.A.
2009/07/02
Bausch & Lomb Boston Conditioning Solution Original Formula
(Hong Kong ) Ltd
Action
Kong ) Ltd
2009/006/029/081/013
FSCA
2009/07/06
Agfa NX software
AGFA Hong Kong Limited
MHRA
2009/006/026/081/006
FSCA
2009/07/06
Edwards Lifesciences Fogarty Occlusion Catheter
N.A.
MHRA
GE Medical Systems Hong
2009/006/024/291/013
FSCA
2009/07/06
GE Signa Excite 1.5T MR systems
MHRA
Kong Ltd.
Solutions Health Care
2009/006/022/301/001
FSCA
2009/07/06
Likoscale Adaptor
MHRA
Products
2009/001/028/301/003
FSCA
2009/07/06
Karomed COMM-METAL Supreme Profiling Bed
N.A.
MHRA
2009/006/016/261/001
FSCA
2009/07/06
Sidhil Bradshaw Bariatric Bed
N.A.
MHRA
2009/004/014/401/004
FSCA
2009/07/06
Wescott Medical Sae-Flo
N.A.
MHRA
Philips Dental Application v4.0.0 to v4.0.1.9999 on the Extended
Philips Health Care (Great
2009/006/010/291/008
FSCA
2009/07/06
MHRA
Brilliance Workspace
China)
Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump
Medtronic
N.A.
Firm Initiated Field Action 2009/07/06
Medtronic International Ltd.
Battery Performance
International Ltd.
Philips Health Care (Great
48839
2009/07/07
Philips Intellivue MP70 Patient Monitor System (Model # M8007A)
Type II
Health Canada
China)
Philips Mulitdiagnost Eleva-Flat Detector and Allura XPER FD10/10Philips Health Care (Great
48595
2009/07/07
Type II
Health Canada
Main Unit
China)
Philips Achieve 3.0T MRI System-Main Unit and Achieva 1.5T MRI
Philips Health Care (Great
49149
2009/07/07
Type II
Health Canada
System-Main Unit
China)
Philips Health Care (Great
49151
2009/07/07
Philips Brilliance 6/10/16 Slice CT-SERTWR Dent
Type II
Health Canada
China)
Zimmer PTE Ltd. (Hong
48913
2009/07/07
Zimmer ZMR Hip System-Stems
Type II
Health Canada
Kong branch)
Zimmer PTE Ltd. (Hong
48988
2009/07/07
Zimmer Alumina Ceramic Femoral Head
Type II
Health Canada
Kong branch)
Zimmer PTE Ltd. (Hong
48914
2009/07/07
Zimmer 2.7mm Cortical Screw Self-Tapping
Type II
Health Canada
Kong branch)
48408
2009/07/07
Smith & Nephew Disposable Endoscopic Surgery Blades
Type II
Smith & Nephew LTD
Health Canada
GE Medical Systems Hong
46833
2009/07/07
GE Muse Cardiology Information System
Type II
Health Canada
Kong Ltd.
GE Medical Systems Hong
46236
2009/07/07
GE Carescape V100
Type II
Health Canada
Kong Ltd.
Varian Medical Systems
49074
2009/07/07
Varian Aria Radiation Oncology
Type II
Health Canada
Pacific Inc.
48035
2009/07/07
Getinge Washer Disinfectors with transformer
Type II
N.A.
Health Canada
48997
2009/07/07
Data Innovations Instrument Manager
Type II
N.A.
Health Canada
Picis OR Manager, Preop Manager, Anesthesia Manager, PACU
48937
2009/07/07
Type II
N.A.
Health Canada
Manager, Critical Care Manager
Medical Device Control Office
184
Agent Contact
Telephone No
2810 7533
2412 2310
N.A.
N.A.
2783 1838
N.A.
2213 3371
2555 9421
N.A.
2783 1838
2688 2933
N.A.
N.A.
N.A.
2821 5480
2919 1362
2821 5480
2821 5480
2821 5480
2821 5480
2992 0968
2992 0968
2992 0968
2992 0968
2783 1838
2783 1838
2724 2836
N.A.
N.A.
N.A.
Department of Health
The Government of HKSAR
Boston Scientific
Hong Kong Ltd
FDA
Z-1606-2009
Firm Initiated Field
Action
Class I
FDA
Z-1482-2009 to Z-1485-2009
Class II
2009/07/09
Zimmer Steinmann Pins (Model no. 00-0187-03-69)
FDA
Z-1481-2009
Class II
2009/07/09
Zimmer Gender Solutions Natural Knee Flex System (Product No. 005410-017-01)
FDA
Z-1477-2009
Class II
2009/07/09
Philips Brilliance iCT software v2.5.0 (Model 728306)
FDA
Z-1582-2009
Class II
2009/07/09
GE Centricity PACS Software
FDA
Z-1549-2009
Class II
2009/07/09
FDA
Z-1474-2009 to Z-1476-2009
Class II
2009/07/09
GE Medical Systems Hong
Kong Ltd.
2783 1838
FDA
Z-1525-2009
Class II
2009/07/09
Stryker China Ltd
2518 6915
FDA
Z-1526-2009 to Z-1531-2009
Class II
2009/07/09
N.A.
N.A.
FDA
Z-1539-2009
Class II
2009/07/09
N.A.
N.A.
FDA
FDA
Z-1489-2009 to Z-1503-2009
Z-1524-2009
Class II
Class II
2009/07/09
2009/07/09
N.A.
N.A.
N.A.
N.A.
FDA
Z-1247-2009
Class II
2009/07/09
N.A.
N.A.
BD
N.A.
Firm Initiated Field
Action
2009/07/09
BD
2575 8668
MHRA
MDA/2009/043
MDA
2009/07/10
Boston Scientific Hong
Kong Ltd
2960 7136
2009/07/10
Medtronic International Ltd.
2919 1362
2009/07/10
Medtronic International Ltd.
2919 1362
Boston Scientific Flexima Biliary Catheter System
Respironics BiPAP Focus Noninvasive Ventilator System
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate
(Model no. 6420-00-002, 6420-01-002, 6420-00-200, 6420-01-200)
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System;
Innova 3100/3100IQ Cardiovascular Imaging System and Innova
4100/4100IQ Cardiovascular Imaging System
Stryker Xia Dual Anterior Staple (Catalog no. 03820115)
Biomet OSS FINN Proximal Femoral Trial, OSS Letson Proximal
Femoral Trial, OSS Elliptical Proximal Femoral Tral
Bard StartLock Intravenous (IV) Catheter Stabilization Kit (Catalog no
IVK0124)
Arrow various devices
Ascension Normed TX8 Driver (Catalog no 503004268)
Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling Tube
Mount (DCTM)
BD 60ml Lurt-Lok Syringes (Recorder Number 309653; Lot No.:
819101A)
Boston Scientific Flexima and Percuflex drainage catheter family (pigtail
style, peripheral interventions), Percuflex and percutaneous model
drainage catheter family (urology)
Medtronic Model 8551 Synchromed Refill Kits w/ reversed UBD and Mfg
Dates
Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT-397,
MMT-398 and MMT-399
Boston Scientific LeVeen Needle Electrodes - 5.0cm
Zimmer Intertrochanteric / Subtrochanteric Fixation Tapered Reamer 002258-050-00
Smith & Nephew Disposable Impactor Cap 74120152 for use with BHR
Acetabular Cups
Aidapt VB539 Solo Deluxe Shower Seat and VB535 Solo Deluxe
Shower Seat with Pads
Unipath Clearview hCG Pregnancy Test 506788
Medtronic
International Ltd.
Medtronic
International Ltd.
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
N.A.
N.A.
N.A.
2009/07/08
2009/07/09
2009/07/10
Boston Scientific Hong
Kong Ltd
Celki Medical Company
Zimmer PTE Ltd. (Hong
Kong branch)
Zimmer PTE Ltd. (Hong
Kong branch)
Zimmer PTE Ltd. (Hong
Kong branch)
Philips Health Care (Great
China)
GE Medical Systems Hong
Kong Ltd.
Boston Scientific Hong
Kong Ltd
Zimmer PTE Ltd. (Hong
Kong branch)
2960 7136
2268 9258
2992 0968
2992 0968
2992 0968
2821 5480
2783 1838
2960 7136
MHRA
2009/006/008/291/011
FSCA
2009/07/13
MHRA
2009/006/019/601/002
FSCA
2009/07/13
Smith & Nephew LTD
2648 7700
MHRA
2009/006/029/261/001
FSCA
2009/07/13
N.A.
N.A.
MHRA
2009/005/011/291/018
FSCA
2009/07/13
Zimmer Dynesys Top Loading Spacer Cutter
MHRA
2009/006/018/291/006
FSCA
2009/07/13
Microm (a part of ThermoFisher Scientific) STP 420D Tissue Processor
Biodiagnostics MPO QuickCard
Nopac Healthcare Chelmer 200
MHRA
MHRA
MHRA
2009/006/023/291/002
2009/006/023/601/001
2009/006/002/301/001
FSCA
FSCA
FSCA
2009/07/13
2009/07/13
2009/07/14
Siemens Stratus CS Acute Care Troponin I CalPak.
FDA
Z-1246-2009
Class II
2009/07/20
Genicon Suction irrigation device (Cat no. 700-005-010, 700-010-005)
Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling Tube
Mount (DTCM)
RSW International First Steps medicine feeder
FDA
Z-1406-2009 to Z-1407-2009
Class II
2009/07/20
N.A.
Zimmer PTE Ltd. (Hong
Kong branch)
N.A.
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
FDA
Z-1247-2009
Class II
2009/07/20
N.A.
N.A.
MHRA
MDA/2009/045
MDA
2009/07/21
N.A.
N.A.
MHRA
2009/007/006/081/012
FSCA
2009/07/21
N.A.
N.A.
Vital Signs Broselow / Hinkle Pediatric Emergency System Intraosseus
Modules
Medical Device Control Office
185
2992 0968
N.A.
2992 0968
N.A.
N.A.
N.A.
2810 7533
N.A.
Department of Health
The Government of HKSAR
Aqua Joy Premier Plus and Junior Plus bathlifts
Zimmer Nexgen Rotating Hinge Knee-Femoral Component and Nexgen
Rotating Hinge Knee-Tibial Component
Baxter Isolex 300 and 300I Magnetic Cell Separator
Abbott Stat G3+ Cartridges (Model no.: 06F03-01 and 06F03-02; Lot:
P08321C)
Brainlab M3 Micro-MLC for Varian with MLC (Model: 41600-3, 41600-5,
41600-6)
Litecure LCT-1000 Therapy Laser
Nobel Biocare Impression Coping Closed Tray Regular Platform
05x9mm (Lot 687218)
Hill-Rom Flexicair (Model I3000, M4000)
Wallac Delfia Xpress PAPP-A Kit (Model no. 6003-0020)
Gyrus Acmi (Olympus) Sur-Catch No Tip Nitinol Stone Basket (Model
no. 5711222)
Vygon Neonatal / Paediatric 96 hour I.V. Filter 0807.204
Penumbra Neuron Delivery Catheter 053
Elekta Desktop Pro
Bemis Quick Fit 3000cc Suction Liner
Medos Medizintechnik Hilite Oxygenators (models 7000, 7000LT, 2800,
2400LT, 1000 & 800LT)
Siemens Stratus CS Acute Care Troponin I CalPak
Medtronic One Source Pack, One Source Pack Magellan and Ideal
MAXPAC Total System
GE Centricity PACS RA 1000 Workstation software (for diagnostic
image analysis)
Philips TumorLoc Software for the Brilliance Big Bore (BB) and the CT
Extended Brilliance Workstation (EBW) (Model # 4550 116 02431)
Johnson & Johnson Sterrad 50 Sterilizer (Product Code 10050)
Sybaritic Hydration Station with Pedestal (Part # E30003-01 and E3000301D)
Gendex VixWin Platinum Imaging Software, versions 1.0, 1.1 and 1.2
Radiometer Waste bottles Part No/Article no. a) 905-590/D512 and b)
905-802/D513
Biomet 3i ACT3020 Twist Drills
One Lambda Flow Class I and Flow Class II Positive Control Serum
Oxoid Oxidase Identification Sticks BR0064A
Intuitive Surgical Da Vinci S Surgical System
Boston Scientific Prolieve Thermodilatation System Kit
Stryker E-Cylinder Canister Holder (Model# 0682-000-449, 0682-001111)
Stryker Dall Miles Trochanter Cable Grip System (Model # 6704-0-210;
Serial # 29233201)
Stryker S3 Med/Surg Bed Fowler (Model# 302S3-000-000) and Secure
II Med/Surg Bed Fowler (Model# 3002-000-000)
Stryker Trident Acetabular Surgical Protocol
Smith & Nephew Genesis II Femorals (Model # 71420026, Lot #
08HM17084)
Smith & Nephew Exogen Bone Healing System (Model # 71034101)
Smith & Nephew BHR Acetabular Cups (Model#74120152)
Toshiba Digical Radiography Imaging System (Model# TFD-3000A1/WV)
Medical Device Control Office
MHRA
2008/005/007/401/005
FSCA
2009/07/21
Health Canada
49105
Type II
2009/07/22
Health Canada
48344
Type II
Health Canada
48497
Type II
Health Canada
47235
Health Canada
49192
Health Canada
Health Canada
Health Canada
2992 0968
2009/07/22
N.A.
Zimmer PTE Ltd. (Hong
Kong branch)
Baxter Healthcare Ltd
2009/07/22
Abbott Laboratories LTD.
2593 2211
Type II
2009/07/22
BrainLAB Ltd
2417 1881
Type II
2009/07/22
N.A.
N.A.
48621
Type II
2009/07/22
Nobel Biocare Asia Ltd
2845 1266
49146
48607
Type II
Type II
2009/07/22
2009/07/22
N.A.
N.A.
Health Canada
49030
Type II
2009/07/22
MHRA
MHRA
MHRA
MHRA
2009/007/010/601/002
2009/007/010/081/010
2009/003/010/291/010
2009/006/019/601/003
FSCA
FSCA
FSCA
FSCA
2009/07/22
2009/07/22
2009/07/22
2009/07/22
N.A.
N.A.
Olympus Hong Kong and
China Ltd
N.A.
N.A.
N.A.
N.A.
MHRA
2009/006/025/081/008
FSCA
2009/07/22
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
2810 7533
Medtronic Internation Ltd
2919 1362
FDA
Z-1555-2009
Class II
2009/07/23
FDA
Z-1550-2009 to Z-1552-2009
Class II
2009/07/23
GE Medical Systems Hong
Kong Ltd.
Philips Health Care (Great
China)
Johnson & Johnson Hong
Kong Ltd
N.A.
2807 8516
2170 5678
N.A.
N.A.
N.A.
N.A.
FDA
Z-1543-2009
Class II
2009/07/23
FDA
Z-1542-2009
Class II
2009/07/23
FDA
Z-1570-2009
Class II
2009/07/23
FDA
Z-1245-2009
Class II
2009/07/23
N.A.
N.A.
FDA
Z-1548-2009
Class II
2009/07/23
N.A.
N.A.
FDA
Z-1554-2009
Class II
2009/07/23
N.A.
N.A.
MHRA
MHRA
MHRA
MHRA
Boston Scientific
Hong Kong Ltd
Health Canada
2009/007/017/081/002
2009/007/003/081/001
2009/007/006/601/008
2009/007/006/081/011
FSCA
FSCA
FSCA
FSCA
2009/07/23
2009/07/24
2009/07/24
2009/07/24
N.A.
N.A.
N.A.
N.A.
N.A.
Firm Initiated Field Action
2009/07/24
49172
Type II
2009/07/27
Ositek (Hong Kong) Inc. Ltd
N.A.
N.A.
N.A.
Boston Scientific Hong
Kong Ltd
Stryker China Ltd
Health Canada
49278
Type II
2009/07/27
Stryker China Ltd
2518 6915
Health Canada
49199
Type II
2009/07/27
Stryker China Ltd
2518 6915
Health Canada
49269
Type II
2009/07/27
Stryker China Ltd
2518 6915
Health Canada
49201
Type II
2009/07/27
Smith & Nephew LTD
2648 7700
Health Canada
Health Canada
49177
49557
Type II
Type II
2009/07/27
2009/07/27
2648 7700
2648 7700
Health Canada
49202
Type II
2009/07/27
Smith & Nephew LTD
Smith & Nephew LTD
Sanko Medical Systems
(HK) LTD
186
2783 1838
2821 5480
2738 6027
2960 7136
2518 6915
238400688
Department of Health
The Government of HKSAR
Zimmer Coonrad/Morrey Total Elbow System (Model # 32-8105-038-00;
Lot# 61249897, 61249899)
Health Canada
49362
Type II
2009/07/27
Roche Amplilink Software v 3.1.1, v 3.1.2, v3.2, v3.2.1, v3.2.2
Health Canada
48878
Type II
2009/07/27
Health Canada
49032
Type II
2009/07/27
N.A.
N.A.
Health Canada
49409
Type II
2009/07/27
N.A.
N.A.
2009/07/27
Vastec Medical Limited
2897 1912
2009/07/27
Medtronic International Ltd.
2919 1362
2009/07/27
2009/07/27
N.A.
N.A.
Philips Health Care (Great
China)
N.A.
N.A.
Cardiac Science Quinton QStress TM55 Stress Treadmill (Serial #
11040079567, 11040079568)
Advanced Bionics Removable Magnet Hires 90K (Model# CI 1400-01,
CI-1400-01, CI-1400-02H)
Zimmer PTE Ltd. (Hong
Kong branch)
Roche Diagnostics (Hong
Kong) Ltd
2992 0968
2485 7510
Vastec Medical
Limited
Medtronic
International Ltd.
MHRA
MHRA
2009/007/017/081/005
2009/007/017/081/001
Firm Initiated Field
Action
Firm Initiated Field
Action
FSCA
FSCA
MHRA
2009/007/020/291/020
FSCA
2009/07/27
MHRA
2009/007/021/081/008
FSCA
2009/07/27
N.A.
N.A.
MHRA
MHRA
MHRA
MHRA
2009/007/021/301/001
2009/006/025/081/007
2009/007/008/081/004
MDA/2009/048
FSCA
FSCA
FSCA
MDA
2009/07/27
2009/07/27
2009/07/27
2009/07/29
N.A.
N.A.
Stryker China Ltd
AGFA Hong Kong Limited
N.A.
N.A.
2518 6915
2555 9421
MHRA
2009/006/015/291/028
FSCA
2009/07/29
N.A.
N.A.
MHRA
Boston Scientific
Hong Kong Ltd
MHRA
2009/004/029/401/010
2009/07/29
2009/007/010/601/001
FSCA
Firm Initiated Field
Action
FSCA
MHRA
2009/007/016/081/002
FSCA
2009/07/31
DePuy LCS Duofix Femoral Component
Trulife RM512700 extra long double adjustable soft handle elbow
crutches
Roche Diagnostics Factor V Leiden Kit
MHRA
2009/007/024/081/003
FSCA
2009/07/31
MHRA
2009/007/007/401/005
FSCA
2009/07/31
MHRA
2009/007/015/081/009
FSCA
2009/07/31
Maxter Cathéters Oral / enteral feeding syringe
MHRA
2009/001/016/401/004
FSCA
2009/07/31
N.A.
Boston Scientific Hong
Kong Ltd
Abbott Laboratories LTD.
Roche Diagnostics (Hong
Kong) Ltd
Johnson & Johnson
Medical (HK)
N.A.
Roche Diagnostics (Hong
Kong) Ltd
N.A.
Trinity Biotech Mumps IgM 1 Plate (Trinity Elisa Kit Model# 2325960)
Medtronic Integrated Power Console System (Ref# 1898001 & EC300)
Innogenetics INNO-LIA HCV Score (product code: 80538)
Innogenetics Innotest hPLAP (product code: 80326)
Philips BrightView Gamma Camera
Cyberonics VNS Therapy Programming Software, used with VNS
Therapy Pulse and Pulse Duo Generators
Mountway CU-3000 Smart Charger (for use with Neptune and Aquila)
Ö ssur Icelock Expulsion Valve 551
Stryker Various titanium bone screws and modular join prostheses
Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D 5.1.
Applied Medical Resources 15x100mm Kii Optical Access System, nonthreaded
Remploy Access heavy duty manual wheelchair
Boston Scientific RF Ablation System Foot Switch used with EPT-1000
Cardiac Ablation Systems (Cat#840)
Abbott Clinical Chemistry Total Bilirubin (List number: 6L45-20 & 6L4540)
Roche Diagnostics CoaguChek XS, CoaguChek XS Plus
Medical Device Control Office
N.A.
N.A.
N.A.
187
2009/07/29
2009/07/30
2821 5480
N.A.
2960 7136
2593 2211
2485 7510
2738 6027
N.A.
2485 7510
N.A.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - June 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Reference No. by
Alert Type by
Date of Issue
Agent Contact
Description of Product
Local Agent
Information*
Source
Source
(YYYY/MM/DD)
Telephone No
2009/06/01
Hologic Discovery and Explorer X-ray Bone Densitometer Systems
2009/004/029/061/013
FSCA
N.A.
N.A.
MHRA
2009/06/01
CME McKinley T34 Syringe Driver
2009/004/028/291/009
FSCA
N.A.
N.A.
MHRA
GE Medical
GE Signa Ovation systems with CTL Array, XL Body Flex and Open Body
FSCA
2009/06/01
2783 1838
Systems Hong
MHRA
Coils
2009/003/012/061/013
Kong Ltd.
2009/06/01
ThermoFisher Scientific Salmonella Chromogenic medium PO0958A
2009/005/008/601/004
FSCA
N.A.
N.A.
MHRA
DePuy PFC Sigma Cruciate Retaining Non-Porous Size 5 Left Femoral
2009/005/014/081/001
FSCA
2009/06/01
N.A.
N.A.
MHRA
Component
2009/06/01
KeyMed, Olympus, Aloka WM-NP1 (Workstation)
2009/005/007/061/003
FSCA
N.A.
N.A.
MHRA
2009/06/01
Stryker Triathlon TS Knee System Offset Adapter Trial
2009/005/013/081/011
FSCA
Stryker China Ltd
2518 6915
MHRA
Teleflex Medical (Athlone) Arrow 12 French Triple-Lumen 20cm & 16cm
2009/06/01
2009/005/014/081/003
FSCA
N.A.
N.A.
MHRA
Large-Bore Central Venous Catheters
2009/06/01
Moria Evolution 3E
2009/003/023/401/006
FSCA
N.A.
N.A.
MHRA
2009/06/01
Welch Allyn Vital Signs Monitor VSM 300
2008/012/005/601/002
FSCA
N.A.
N.A.
MHRA
2009/06/01
Aerocrine NIOX and NIOX Flex, 03-1000 resp 03-1000-F
2009/005/014/051/012
FSCA
N.A.
N.A.
MHRA
Siemens
Siemens Medical Acuson X300 System with Swiftlink Connector DL260
2009/005/014/081/012
FSCA
2009/06/01
2810 7533
Healthcare
MHRA
Diagnostic Limited
2009/06/01
Medical Devices Group Computer treatment planning
2009/005/017/601/002
FSCA
N.A.
N.A.
MHRA
2009/06/01
Smith & Nephew Legion Pressfit Stems 71424053 & 71424043
2009/004/016/051/009
FSCA
N.A.
N.A.
MHRA
2009/06/01
Stryker Mantis Rod Inserter Shaft
2009/005/006/061/001
FSCA
N.A.
N.A.
MHRA
2009/06/01
ThermoFisher PB0378A
2009/005/006/601/001
FSCA
N.A.
N.A.
MHRA
2009/06/01
ThermoFisher PO1110A
FSCA
N.A.
N.A.
MHRA
2009/005/006/601/002
2009/06/01
Roche Diagnostics (Hong Kong) Ltd2485 7510
Roche Diagnostics Elecsys Folate III
2009/004/029/061/008
FSCA
MHRA
King Health
2009/06/01
Merit Medical Systems Prelude Short Sheath Introducer
2009/004/024/051/002
FSCA
2481 3787
MHRA
Limited
2009/06/01
CalMed Op-Flex Poole (Handle Set) contained within Procedure Packs
2009/005/014/291/013
FSCA
N.A.
N.A.
MHRA
Siemens
Siemens Medical ACUSON Sequoia, auxiliary CW transducer
2009/005/014/081/013
FSCA
2009/06/01
2810 7533
Healthcare
MHRA
Diagnostic Limited
Medmont E300 Corneal Topographer, DV2000 Digital Imaging Software and
Park World
2009/06/02
45746
Type II
2880 9689
Health Canada
M700 Automated Perimeter
Development Ltd
Ethicon (JNJ) Endopath Endoscopic Linear Cutters (Model # LONG45A;
2009/06/02
47966
Type II
N.A.
N.A.
Health Canada
ATB45, ATW45; NAW45)
2009/06/02
CMS Focal Software CD
48015
Type II
N.A.
N.A.
Health Canada
Uninet
2009/06/02
Immucor Gallileo Echo Blood Analyzer (Model 87000)
47888
Type II
2838 8423
Health Canada
Technology LTD
2009/06/02
FisherDiagnostics Infinity Glucose Hexokinase Reagent (Catalog # TR15498)
47989
Type II
N.A.
N.A.
Health Canada
2009/06/02
Premier Dental Integra CEM (Model# 3001410)
48059
Type II
N.A.
N.A.
Health Canada
Otto Bock Asia
2009/06/02
Leckey Four-point Pelvic Harness (Model no 122-719)
47922
Type II
2598 9772
Health Canada
Pacific Limited
Sunrise Mobility Quickie LXI Manual Wheelchair (Model# LXI-034741, LXI2009/06/02
47380
Type II
N.A.
N.A.
Health Canada
034609, LXI-034740, LXI-034500)
Beckman Coulter Synchron Systems Ammonia (AMM) Reagent
2009/06/02
Beckman Coulter Hong Kong Ltd 2240 6150
47835
Type II
Health Canada
(Model#439770)
2009/06/02
Sonomed Vumax Ophthalmic Ultrasound Scanner (Model#SHFS35-S)
47987
Type II
N.A.
N.A.
Health Canada
Boston Scientific
2009/06/02
Boston Scientific Contak Renewal 4 CRT-D and Vitality 2 Acid
47031
Type II
2960 7136
Health Canada
Hong Kong Ltd
2009/06/03
MEDEX SBI Injector
2009/003/010/601/001
FSCA
N.A.
N.A.
MHRA
Promotal SAS Quest and Duolys exam couches and Ambéo, 3181 and 3185
2009/06/03
2009/005/011/291/012
FSCA
N.A.
N.A.
MHRA
chairs
2009/06/03
GE Healthcare Definium 5000 digital X-ray systems
2009/005/007/051/002
FSCA
N.A.
N.A.
MHRA
Medical Device Control Office
188
Department of Health
The Government of HKSAR
Siemens
Healthcare
Diagnostic Limited
2009/06/03
N.A.
2009/06/03
N.A.
Varian Medical
2009/06/03
Systems Pacific
Johnson &
2009/06/04
Johnson Medical
ArjoHuntleigh
2009/06/05
(Hong Kong) Ltd
2009/06/05
Beckman Coulter Hong Kong Ltd
MHRA
2009/003/016/291/004
FSCA
MHRA
MHRA
Varian Medical
Systems Pacific Inc.
2009/002/027/401/005
2009/004/023/061/002
FSCA
FSCA
Firm Initiated Field
Action
Depuy (JNJ) Knee Replacement Implant
MHRA
MDA/2009/037
MDA
Arjo Maxilift
MHRA
2009/004/016/261/001
FSCA
Beckman Coulter AutoMate Sample Processing Systems
MHRA
2009/005/014/601/001
BD Syringe 10ml Luer-Lok
BD
N.A.
FSCA
Firm Initiated Field
Action
GE Healthcare ApexPro Telemetry System
FDA
Z-1227-2009
Class II
2009/06/08
Alcon 25 GA Total Plus Pak and Vitrectomy 25 GA Custom Pak
FDA
Z-1412-2009 to Z1413-2009
Class II
2009/06/08
Kimberly-Clark Synthetic Powder Free Vinyl Exam Gloves (Size: S, M and L)
(Cat. No. 55031, 55032, 55033)
FDA
Z-1414-2009
Class II
2009/06/08
Abbott ARCHITECT Reaction Vessel (List no 7C15-01)
FDA
Z-1398-2009
Class II
2009/06/08
Abbott Cell-Dyn Ruby Hematology Analyzer with System Softare Version
2.0ML (List no. 08H67-01)
FDA
Z-1398-2009
Class II
2009/06/08
Siemens Medical Immulite 2000 and Immulite 2500 digital Fluidics PC Board
(Part no. 450116-0002)
FDA
Z-1399-2009
Class II
2009/06/08
MEDRAD Sterile Disposable Syringe Kit (Catalog. no DSK 130-Q)
FDA
Z-1228-2009
Class II
2009/06/08
Synthes Spine Square Nut MR Safe (Catalog no. 03.311.060)
FDA
Z-1324-2009
Class II
2009/06/08
Class II
2009/06/08
Class II
2009/06/08
FSCA
FSCA
FSCA
2009/06/08
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
2009/06/08
N.A.
N.A.
2009/06/08
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Ortho Clinical
2009/06/08
2737 5504
Diagnostics
Siemens Medical Symbia S and Symbia T
Marflow AG - Medical Equipment Grabit 3 prong grasping forcep
Corin Uniglide Unicondylar Knee - femoral component
Varian Clinacs with C Series version 7.x and the SRS Motion Disable Option
Synthes Spine InSitu Bender Cutter Kit Wide Sterile (Cat. No. 530.521S) and
InSitu Bender Cutter Kit Narrow Sterile (Cat. No. 530.522S)
N.A.
Zimmer TM-400 Broach Handle
AGA Medical Amplatzer Cardiac Plug
Zimmer TransFx External Fixation System drill bit, quick connect
MHRA
MHRA
MHRA
Z-1248-2009 to Z1249-2009
Z-1267-2009 to Z1307-2009
2009/005/011/291/010
2009/002/018/291/006
2009/005/007/061/017
Ortho-Clinical Diagnostics Veridex LLC CellTracks AutoPrep System
MHRA
2009/005/012/081/014
FSCA
Biomet Microfixation Arthrosimplicity and OnPoint Scope kits, Becton
Dickinson syringe component
MHRA
2009/004/002/601/001
FSCA
Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire
FDA
FDA
2009/06/03
2009/06/05
BD
GE Medical
Systems Hong
Kong Ltd.
Alcon Hong Kong
Ltd
Kimberly-Clark
(Hong Kong)
Limited
Abbott
Laboratories LTD.
Abbott
Laboratories LTD.
Siemens
Healthcare
Diagnostic Limited
Medrad Asia
Pte.Ltd
Synthes (Hong
Kong) Ltd
Synthes (Hong
Kong) Ltd
N.A.
2810 7533
N.A.
N.A.
2724 2836
2738 6027
2508 9553
2240 6150
2575 8668
2783 1838
2568 0636
2334 3361
2593 2211
2593 2211
2810 7533
65-6752 5318
2724 2032
2724 2032
N.A.
2009/06/08
N.A.
N.A.
2810 7533
N.A.
MHRA
2009/005/027/081/003
FSCA
2009/06/08
Siemens
Healthcare
Diagnostic Limited
MHRA
2009/005/027/291/008
FSCA
2009/06/08
N.A.
MHRA
2009/005/021/601/001
FSCA
2009/06/09
Beckman Coulter Hong Kong Ltd 2240 6150
MHRA
2007/005/024/061/002
FSCA
2009/06/09
Philips Synergy Flex-M / Shoulder Coil
MHRA
2009/005/028/051/005
FSCA
2009/06/09
Mölnlycke Phaco Pack Shepton Mallet JAV 17177
MHRA
2009/005/029/081/003
FSCA
2009/06/09
Siemens Medical Immulite 2000 / Immulite 2500 Chemiluminescent Substrate
Module
Trinity Biotech TriniCAL Reference Plasma and TriniCHECK Control Levels 1,
2&3
Beckman Coulter UniCel DxC 880i, 860i, 680i & 660i Synchron Access
Clinical Systems
Invacare Harrier Plus, HD & XHD
Medical Device Control Office
189
N.A.
Philips Health
Care (Great China)
N.A.
N.A.
2821 5480
N.A.
Department of Health
The Government of HKSAR
Gambro AK200 S equipped with UFD and AK 200 ULTRA S in combination
with BiCart Select
Allergan Medical FloWatch-PAB
Gambro Hong Kong
Ltd
MHRA
Firm Initiated Field
Action
2009/005/028/051/010
FSCA
N.A.
2009/06/10
2009/06/11
Gambro Hong
Kong Ltd
N.A.
GE Medical
Systems Hong
Kong Ltd.
N.A.
N.A.
N.A.
Philips Health
Care (Great China)
Varian Medical
Systems Pacific
2839 9710
N.A.
GE Healthcare Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ &
3131IQ
MHRA
2009/006/002/081/006
FSCA
2009/06/11
Tosoh Bioscience Hemoglobin F&A2 control set
Trinity Biotech TriniCLOT aPPT HS
EBI Titanium Cannulated Screws and Bone Screws
MHRA
MHRA
MHRA
2009/005/014/051/010
2009/005/022/081/001
2009/004/024/601/004
FSCA
FSCA
FSCA
2009/06/11
2009/06/11
2009/06/11
MHRA
2009/006/003/291/017
FSCA
2009/06/12
Varian Medical
Systems Pacific Inc.
N.A.
Firm Initiated Field
Action
2009/06/12
Class II
2009/06/15
Stryker China Ltd
2518 6915
Class II
2009/06/15
2518 6915
Class II
2009/06/15
Stryker China Ltd
TERUMO CHINA
(H.K.) LTD.
Class II
2009/06/15
N.A.
N.A.
2009/06/15
48206
Class II
Firm Initiated Field
Action
Type II
Philips MD Allura FD
Varian Eclipse Treatment planning System, version 8.6 and earlier (Product
Code: H48)
Stryker Gamma3 Plus Obese Targeting System, Gamma3S Trochanteric Nail
170 and Gamma 3
Stryker Surgical Table Headrest (Catalog/Part # 0788-300-012)
Terumo Advanced Perfusion System 1 Central Control Monitor (Catalog no
802100)
Biomet Dual Offset Broach Handle, Clamping Style, Left (REF 31-555403)
and Right (REF 31-555404)
Spectranetics SLS II Lasr Sheath Kit, 14F (REF 500-012)
Varian CLINAC Software Versions 6.X and 7.X (Remote Auto Motions)
Zimmer Nexgan LPS and Nexgen LPS-Flex Femoral Components
FDA
Z-1349-2009 to Z1351-2009
Z-1418-2009
FDA
Z-1224-2009
FDA
FDA
FDA
Varian Medical
Systems Pacific Inc.
Health Canada
Z-1352-2009 to Z1353-2009
Z-1264-2009
N.A.
2783 1838
N.A.
N.A.
N.A.
2821 5480
2722 8122
2866 0811
N.A.
N.A.
Varian Medical
2009/06/15
2722 8122
Systems Pacific
2009/06/15
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Roche
2009/06/15
2485 7510
Diagnostics (Hong
Abbott
2009/06/15
2593 2211
Laboratories LTD.
2009/06/15
Stryker China Ltd
2518 6915
Siemens
2009/06/15
2810 7533
Healthcare
Diagnostic Limited
Roche PSM with Validation Module (Model# 03009696001, 03265439001)
Health Canada
47890
Type II
Abbott i-STAT 1 Analyzer System-Instrument (Model/Catalog # 06F16-10)
Health Canada
48245
Type II
Stryker Austin Moore Stems - Curved 43mm (Model/Catalog# 6939-0-430)
Health Canada
48207
Type II
Siemens Acuson S2000 VA10 (Model / Catalog# 10041461)
Health Canada
48077
Type II
Health Canada
47349
Type II
2009/06/15
N.A.
N.A.
Health Canada
48072
Type II
2009/06/15
N.A.
N.A.
Health Canada
48229
Type II
2009/06/15
N.A.
N.A.
Health Canada
46283
Type II
2009/06/15
N.A.
N.A.
Health Canada
47701
Type II
2009/06/15
Health Canada
48079
Type II
2009/06/15
N.A.
ViewSonic Hong
Kong
Roche
Diagnostics (Hong
Abbott
Laboratories LTD.
N.A.
N.A.
GE Medical
Systems Hong
Kong Ltd.
N.A.
Ortho Clinical
Diagnostics
Philips Health
Care (Great China)
Cook Zenith Renu AAA Converter, Zenith Renu AAA Main Body and Zenith
AAA Main Body Bifurcated Stent
Medline Penrose Drain
Ansell Healthcare Derma Prene Ultra Surgical Glove (Model/Catalog #
851365 / 851470)
Motion Concepts Tilt/Elevating Seating System and Tilt/Elevate/Recline
Seating System
Walter Lorenz Surgical (Biomet Microfixation) Dean Scissors (Model: 09-0142)
Viewsonic VGM 19" Monitor
Roche Accu-chek Performa
Abbott POWERSAIL Coronary Dilatation Catheter
ThermoFisher PO0171A brilliant green agar
Heliosphere Bag Intragastric Balloon
GE Healthcare Ge Signa Hdx 3T MR Systems, Ge Signa Hdxt 3T MR
Systems
Edwards Lifesciences Introflex Tuohy-Borst Valve Introducer
Ortho-Clinical Diagnostics VITROS 3600 immunodiagnostic system, VITROS
5600 integradeted system
Philips CareVue Chart Release C.O. (Part Number 862246)
Medical Device Control Office
Roche Diagnostics
(Hong Kong) Ltd
Abbott Laboratories
LTD.
MHRA
MHRA
Firm Initiated Field
Action
Firm Initiated Field
N.A.
Action
2009/006/004/601/002
FSCA
MDA/2009/040
MDA
N.A.
2009/06/16
2009/06/16
2009/06/17
2009/06/19
MHRA
2009/006/008/291/012
FSCA
2009/06/19
MHRA
2009/005/028/051/012
FSCA
2009/06/19
MHRA
2009/006/002/051/003
FSCA
2009/06/22
FDA
Z-1436-2009
Class II
2009/06/22
190
N.A.
3690 1398
2481 3387
2593 2211
N.A.
N.A.
2783 1838
N.A.
N.A.
2821 5480
Department of Health
The Government of HKSAR
Synthes Zero-P StarDrive Screwdriver Shaft, T8 (Catalog# 03.617.902)
Innovative Neurotronics WalkAide Stimulator System Control Module (Part
No. 20-0100)
TEVA Medical Device TEVADAPTOR Closed Drug Reconstitution and
Transfer System (Model no. MG412110)
BD Beaver Arthro-Lok Pointed Tip 4mm Blade (Cat no. 376780)
Arrow International Pediatric Two-Limen Central Venous Catheterization Set
with Blue FlexTip Catheter (Cat no. CS-14502)
Select Healthcare Locomotor lifting slings for adults and children
Philips Avalon Fetal Monitor
Boston Scientific Resolution Clip
Philips Respironics MicroElite Nebulizer Compressors (Medel Product No.
91709 to 91716, Respironics Product No. 1053626, 1053677 to 1053683)
FDA
Z-1348-2009
Class II
2009/06/22
Synthes (Hong
Kong) Ltd
2724 2032
FDA
Z-1435-2009
Class II
2009/06/22
N.A.
N.A.
FDA
Z-1244-2009
Class II
2009/06/22
N.A.
N.A.
BD
2575 8668
BD
Cemma Enterprise
Co., Ltd
MHRA
MHRA
Boston Scientific
Hong Kong Ltd
Firm Initiated Field
N.A.
Action
Firm Initiated Field
N.A.
Action
MDA/2009/041
MDA
2009/006/010/291/016
FSCA
Firm Initiated Field
N.A.
Action
2009/06/22
2009/06/22
2009/06/23
2009/06/23
2009/06/22
MHRA
2009/005/013/081/008
FSCA
2009/06/24
Terumo Advanced Perfusion System 1 (Catalog no 802100)
Health Canada
46444
Type II
2009/06/25
Bard Vacora Vacuum Biopsy System (Model# VC10118P) and Vacora
Vacuum Biopsy System-Cannula (Model# VC10118MR)
Health Canada
47925
Type II
2009/06/25
GE Healthcare AW Volumeshare2 - Software Options (Model# B79011MA)
Health Canada
45984
Type II
2009/06/25
Stryker Vertier Table Headrest Attachment (Model # 0788-300-012)
ACIST Angiographic System - Manifold Kit (Model # BT2000)
CMS XIO Radiation Treatment Planning System
R&D Systems Quantikine IVD Human B2-Microglobulin (Lot # 260980)
MedovationsInsufflation Tubing With Filter (Model no SU1101)
Medical Devices Group Computer treatment planning release 4.34.00 through
4.40.00
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
48498
48480
48447
48674
48488
Type II
Type II
Type II
Type II
Type II
2009/06/25
2009/06/25
2009/06/25
2009/06/25
2009/06/25
MHRA
2009/006/011/601/001
FSCA
2009/06/25
Siemens Artiste digital linear accelerators with syngo RT Therapist version 4.1
connected to LANTIS
MHRA
2009/006/008/291/014
FSCA
2009/06/25
Siemens Artiste digital linear accelerator with syngo RT Therapist Version 4.1
build 67 and build 122
MHRA
2009/006/008/291/013
FSCA
2009/06/25
PENTAX Suction Valve (Types, Of-B136, Of-B140, Of-B163, Of-B179 in
endoscopy)
MHRA
2009/005/020/291/005
FSCA
2009/06/25
Siemens Mavig Portegra 2
Advanced Sterilization Products (JNJ) STERRAD 50 Sterilization System
(Product Code 10050) and STERRAD NX Sterilization System (Prodoct Code
Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler
(REF J-ES-090500-BL)
FDA
Z-1437-2009 to Z1443-2009
Class II
2009/06/26
FDA
Z-1419-2009 to Z1420-2009
Class II
2009/06/26
Z-1416-2009
Class II
2009/06/26
Class II
2009/06/26
FDA
GE Signa Ovation 0.35T, GE Signa Openspeed 0.7T
Terumo pre-connected haemoconcentrator with drainage bag (adult or
paediatric)
MHRA
Z-1453-2009 to Z1469-2009
2009/006/002/081/003
MHRA
2009/006/009/081/006
FSCA
Siemens Advia Centaur Hepatitis B Core Total (HBcT) Assay
MHRA
2009/006/011/291/002
FSCA
Bard E LUMINEXX Biliary Stent
FDA
Ormesa New Bug
MHRA
Ethicon (JNJ) Endoloop Ligature Pds II Suture
MHRA
Medical Device Control Office
2008-011-013-301001
2009/006/012/291/005
191
FSCA
FSCA
FSCA
Cemma
Enterprise Co., Ltd
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great China)
TERUMO CHINA
(H.K.) LTD.
N.A.
2412 2310
N.A.
N.A.
2960 7136
2821 5480
2866 0811
N.A.
GE Medical
Systems Hong
Kong Ltd.
Stryker China Ltd
N.A.
N.A.
N.A.
N.A.
2518 6915
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Siemens
Healthcare
Diagnostic Limited
Siemens
Healthcare
Diagnostic Limited
N.A.
Siemens
Healthcare
Diagnostic Limited
Johnson &
Johnson Hong
AR Burkill & Sons
(HK) Ltd
N.A.
2783 1838
2810 7533
2810 7533
N.A.
2810 7533
2738 6027
2541 1041
N.A.
2009/06/26
GE Medical Systems Hong Kong Ltd.
2783 1838
TERUMO CHINA
2009/06/26
2866 0811
(H.K.) LTD.
Siemens
2009/06/26
2810 7533
Healthcare
Diagnostic Limited
2009/06/26
N.A.
N.A.
Johnson &
2009/06/29
2738 6027
Johnson Medical
Department of Health
The Government of HKSAR
DxS Therascreen: EGFR29 Mutation Kit
MHRA
ThermoFisher Scientific PO0287A Yersinia Agar (CIN Med)
MHRA
Possum HC603C IR Mains Switch
Maquet Servo 300 ventilator (SV300)
MHRA
MHRA
Medical Device Control Office
2009/005/028/051/014
2009/006/017/601/003
,
2009/004/023/301/001
MDA/2009/042
192
FSCA
2009/06/29
N.A.
N.A.
FSCA
2009/06/29
N.A.
N.A.
FSCA
MDA
2009/06/29
2009/06/30
N.A.
N.A.
N.A.
N.A.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - May 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Reference No. by
Date of Issue
Agent Contact
Description of Product
Source of Information*
Alert Type by Source
Local Agent
Source
(YYYY/MM/DD)
Telephone No
N.A.
04-五月-09
Roche Diagnostics (Hong Kong) Ltd
2485 7510
Roche ACCU-CHEK Spirit Insulin Pump
Press Release
FDA
2009/004/017/061/012
04-五月-09
Accuray Asia Ltd
2247 8628
Accuray Synchrony Respiratory Tracking System
FSCA
MHRA
2008/006/025/261/001
04-五月-09
Sunrise Medical Breezy 100 and Breezy 300
FSCA
N.A.
N.A.
MHRA
2009/003/011/061/002
04-五月-09
Elekta XVI (Synergy® kV Detector)
FSCA
N.A.
N.A.
MHRA
2009/003/025/061/007
04-五月-09
Great Bear cubCATH Intermittent Catheter AVP10
FSCA
N.A.
N.A.
MHRA
2009/003/025/061/017
04-五月-09 Maquet Hong Kong Ltd
2393 9511
Maquet MEDAP BORA UP 2080 Universal suction pump
FSCA
MHRA
2009/004/022/291/006
04-五月-09
Nucletron Oncentra Prostate CT/MR option
FSCA
N.A.
N.A.
MHRA
Medtronic
Firm Initiated Field
Medtronic Sprinter OTW Product (TPL 970)
Medtronic International Ltd
N.A.
05-五月-09
2919 1362
International
Action
Ltd.
Stryker
Z-1182-2009 to Z-1194-2009
07-五月-09
Stryker PainPump2
Class II
2518 6915
FDA
China Ltd
Cardinal
Z-1237-2009
07-五月-09
Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module (Model 8120)
Class II
N.A.
FDA
Health
Siemens
Healthcare
Z-1235-2009
07-五月-09
Siemens Syngo Imaging (Model# 10 014 063)
Class II
2810 7533
FDA
Diagnostic
Limited
Z-1319-2009 to Z-1322-2009
07-五月-09
Tri-State Centurion Products
Class II
N.A.
N.A.
FDA
Starry
Wright Medical Screwdriver for 3.5mm Screws (DARCO System, REF: DC4261)
Z-1208-2009
Class II
07-五月-09
2961 4503
Medical
FDA
Technology,
Z-1317-2009
07-五月-09
Hill-Rom TotalCare Bed (Model P1900)
Class II
N.A.
N.A.
FDA
Medtronic
Firm Initiated Field
Medtronic Model 37085 Restore 1x4 DBS Extension Kit
Medtronic International Ltd
N.A.
07-五月-09
2919 1362
International
Action
Ltd.
Firm Initiated Field
Smith &
N.A.
07-五月-09
Smith & Nephew Blades
Smiths & Nephew Ltd
9651 5523
Action
Nephew LTD
2008/011/010/061/017
08-五月-09
Invacare XLT Self Propelling Wheelchair with rear wheels set back - anti tipper
FSCA
N.A.
N.A.
MHRA
Biosite
Z-1391-2009
11-五月-09
Biosite Triage Cardiac Panel
Class I
2855 6883
FDA
Incorporated
Boston
Boston Scientific Hong
Firm Initiated Field
Boston Scientific Safety and Standard Push PEG Kits
N.A.
11-五月-09
2960 7136
Scientific
Kong Ltd
Action
Hong Kong
Boston
Boston Scientific Hong
Firm Initiated Field
Boston Scientific Neuroform3 Microdelivery Stent System
N.A.
11-五月-09
2960 7136
Scientific
Kong Ltd
Action
Hong Kong
Firm Initiated Field
Smith &
Z-1004-2009
11-五月-09
Smith & Nephew Reflection Microstable Acetabular Liner (REF 71740250)
Smiths & Nephew Ltd
2648 7700
Action
Nephew Ltd
N.A.
13-五月-09
BD Insuline Syringe (Cat no. 328420)
BD
Firm Initiated Field
BD
2575 8668
2009/001/020/301/001
13-五月-09
Molift Smart
FSCA
N.A.
N.A.
MHRA
2009/004/028/061/014
13-五月-09
ThermoFisher TPHA Test Kit.
FSCA
N.A.
N.A.
MHRA
Johnson &
Johnson & Johnson
Firm Initiated Field
Cordis Cypher Select Sirolimus Eluting Coronary Stents (Hub Crack)
N.A.
13-五月-09
2738 6027
Johnson
Medical (HK)
Action
Medical (HK)
Siemens
Healthcare
Z-1233-2009
14-五月-09
Siemens Mammomat Novation DR (Model No. 06646900)
Class II
2810 7533
FDA
Diagnostic
Limited
Medical Device Control Office
193
Department of Health
The Government of HKSAR
GE Medical
Systems
Hong Kong
Ltd.
2783 1838
14-五月-09
N.A.
N.A.
Varian
Medical
Systems
Pacific Inc.
2724 2836
N.A.
N.A.
GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6, 5.0.7, 5.0.8 and 4.1
FDA
Z-1232-2009
Class II
14-五月-09
Nova Biomedical Stat Profile Critical Care Xpress (CCX and CXX+), CCX Creatinine Membrane
Kit for CCX analyzer (Catalog # 35238)
FDA
Z-1328-2009
Class II
Varian 4DITC Version 8.1x or Varian Treatment (VT) for Elekta, Siemens and GE Saturne
Linacs Versions 6.6.5046 and 6.6.5048 with ARIA Server versions 8.1.15, 8.5.11 and 8.6.07
Bard Truguide Coazial Biopsy Needle (Model: C4140A, C1810B, C1813B, C1816B, C1820B,
C2013B, C2016B, C2020B)
Stryker Restoration Modular Cone Bodies (Model: 6276-1-121, 6276-1-125, 6276-1-219, 62761-325)
Varian Medical Systems
Pacific Inc.
N.A.
Firm Initiated Field
Action
15-五月-09
Health Canada
47695
Type II
14-五月-09
Stryker
China Ltd
Boston
Scientific
Hong Kong
N.A.
N.A.
N.A.
Beckman
Coulter Hong
Kong Ltd
N.A.
N.A.
N.A.
Beckman
Coulter Hong
Kong Ltd
Health Canada
47576
Type II
14-五月-09
Health Canada
47581
Type II
14-五月-09
Health Canada
Health Canada
Health Canada
47734
47238
47582
Type II
Type II
Type II
15-五月-09
15-五月-09
15-五月-09
Beckman Coulter Flow-set Fluorospheres (Model: 6607007)
Health Canada
47347
Type II
15-五月-09
Biomet Orthopedics C2A Ringloc Acetabular System - 28 mm (Model: 12-115112)
Biomet Microfixation Byrd Screw 2.0x6mm Self Drilling (Model: 01-0267)
Bard Max-Core Disposable Bipsy Instr. (Model: MC1810, MC1816, MC1820)
Health Canada
Health Canada
Health Canada
47389
46721
47251
Type II
Type II
Type II
15-五月-09
15-五月-09
15-五月-09
Beckman Coulter Access Systems Total BHCG Reagent Kit (Model: 33500)
Health Canada
47348
Type II
15-五月-09
Health Canada
46908
Type II
15-五月-09
N.A.
N.A.
Health Canada
47632
Type II
15-五月-09
N.A.
N.A.
Health Canada
Health Canada
47393
47714
Type II
Type II
15-五月-09
15-五月-09
N.A.
N.A.
Philips Holter
Health Canada
47704
Type II
15-五月-09
B. Braun IV set with Universal Spike, 2 Ultrasite (Model: 352079/CSP152VSL), Primary IV Set
with 3 Ultrasite (Model: 352049, 375100)
Health Canada
47750
Type II
15-五月-09
BMH Medical Combi Sling (626002), Sling Deluxe Child (626002C), Sling Mesh Deluxe Child
(626002C-M), Sling Deluxe Oversize (626003), Sling
Health Canada
47789
Type II
15-五月-09
Cardiac Pacemakers Cognis CRT-D HE (N106), Cognis CRT-D (N107), Teligen ICD (VR-HE
DF1)(E110), Teligen ICD (DR-HE IS-1)(E110)
Health Canada
47936
Type II
15-五月-09
MHRA
MDA/2009/032
MDA
18-五月-09
N.A.
Firm Initiated Field
Action
19-五月-09
N.A.
N.A.
Philips
Health Care
(Great China)
B. Braun
Medical
Hong Kong
Arjo
Huntleigh
(Hong Kong)
Boston
Scientific
Hong Kong
N.A.
Medtronic
International
Ltd.
Boston Scientific Percutaneous combination stent (Model: 410-111, 112, 126, 202-207, 304305)
UNOMEDICAL Paradigm Silhouette Infusion Set (Model: MMT-377600, 378600, 381600,
382600)
Norwex Silvercare Toothbrush (Model: 22963)
Spacelabs Medical Medical Flat Panel Power Supply (Model: 010-1619-00, 010-1655-00)
Arrow International A) Percutaneous Sheet, B) Central Venous Catheterization Set/Kit, C)
Temporary Pacing Catheter, D) Two-lumen Central Catheterization Kit, E) Percutaneous
Sheath Introducers Sets, F) Stopcocks, G) Arterial Access Products, H) Thrombolic Device
Rotator Drive Unit, I) Tretorola Percutaneous Thombolic Device, J) Percutaneous Sheath
Introducer, K) Super Arrow-Flex Percut Sheath Intro, L) Stopcock with Luer Lock, M) Stopcock
Manifold, N) Multi-Lumen Percut Sheath Introducer, O) Stopcock with Luer Lock, P) Stopcock
with Luer Lock, Q) Blood Administration Sets, R) Extension Sets, S) Trerotola Percut.
Medxi Heparin pre-filled syringes (Model: 3706, 3780, 3781, 3786, 3787), Saline pre-filled
syringes )3704, 37043, 37043B, 37043B, 37043BNC, 3705C, 3705NC, 3706)
Ace Surgical Supply 5/0 Polyglycolic Acid Absorbable Suture (Model: 34630)
Wallac OYT Neogram Amino Acids Mass Spec Kit
ALL Models Bioprosthetic Heart valves
Medtronic Kappa 600/700/900 Series and Sigma 100/200/300 Series Pacemakers
Medical Device Control Office
Medtronic International Ltd.
194
2518 6915
2960 7136
N.A.
N.A.
N.A.
2240 6150
N.A.
N.A.
N.A.
2240 6150
2821 5480
2277 6125
2508 1416
2960 7136
N.A.
2919 1362
Department of Health
The Government of HKSAR
Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)
FDA
Z-1411-2009
Class I
BD 20ml Luer-Lok Syringe (Recorder Number 309661)
Roche MagNA Pure LC Workstation
BD
FDA
N.A.
Z-1255-2009
Firm Initiated Field
Class II
GE Centricity TriWin Laboratory Information System
FDA
Z-1397-2009
Class II
Varian Acuity (Auto-fit MLC feature)
Varian Medical Systems
Pacific Inc.
N.A.
Firm Initiated Field
Action
Varian Acuity (Changes to Asymmetric and Symmetric Field Axis Properties During Verification
Simulation
Varian Medical Systems
Pacific Inc.
N.A.
Firm Initiated Field
Action
Boston Scientific Hong
Kong Ltd
N.A.
Firm Initiated Field
Action
Radiometer Medical ABL800 Flex analyser
ThermoFisher Scientific Columbia Blood Agar PB0122A
Trinity Biotech TriniCLOT aPTT S
Biomet Orthopedics Offset tibial tray adaptor 5.0mm
Unisurge OP-Flex Poole (handle set) contained within Procedure Packs
Integra LifeScience Licox Oxygen Catheter Micro-Probes (models CC1 and CC1.2)
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
2009/004/021/061/004
2009/004/023/601/001
2009/004/028/061/018
2009/003/005/601/002
2009/003/020/061/016
2009/004/024/051/001
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
Oxoid (Ely) ProSpecT Adenovirus R240096
MHRA
2009/004/023/601/003
FSCA
Siemens Dimension Enzymatic Creatinine Flex Reagent Cartridge
MHRA
2009/004/027/291/022
FSCA
Biomet Microfixation Lactosorb Pectus Stabiliser
Trinity Biotech Captia Measles IgM ELISA test kit
Stanmore Implants METS Modular Tumour System
KeyMed, Olympus, Aloka Endoscope - MU-1
Edwards Lifesciences Aquarius systems GEF08200, GEF09500, GEF09600, GEF09700
Roche cobas 6000 analyzer series (including cobas c 501 and cobas e601 modules)
Middleware Solutions instrument Manager Standard and Middleware Solutions instrument
MHRA
MHRA
MHRA
MHRA
MHRA
2009/004/015/601/003
2009/004/017/061/009
2009/004/009/061/008
2008/012/023/601/003
2009/004/006/291/009
FSCA
FSCA
FSCA
FSCA
FSCA
Celki Medical
2268 9258
Company
19-五月-09
BD
2575 8668
21-五月-09
Roche Diagnostics (Hong Kong) Ltd
2485 7510
GE Medical
Systems
21-五月-09
2783 1838
Hong Kong
Ltd.
Varian
Medical
21-五月-09
2724 2836
Systems
Pacific Inc.
Varian
Medical
22-五月-09
2724 2836
Systems
Pacific Inc.
Boston
22-五月-09
2960 7136
Scientific
Hong Kong
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
Hong Kong
South East
25-五月-09
2802 6333
Chemicals &
Instruments
Siemens
Healthcare
25-五月-09
2810 7533
Diagnostic
Limited
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
25-五月-09
N.A.
N.A.
FDA
Z-1393-2009 to Z-1394-2009
Class II
29-五月-09
Roche Diagnostics (Hong Kong) Ltd
2485 7510
GE Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System
FDA
Z-1195-2009
Class II
29-五月-09
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0 (model no 270-2000)
FDA
Z-1395-2009
Class II
29-五月-09
Remel Staphaurex Plus Kit (Catalog. no. R30950102 and R30950201)
FDA
Z-1400-2009
Class II
29-五月-09
Firm Initiated Field
Firm Initiated Field
Action
FSCA
29-五月-09
Boston Scientifc FORTE GUIDE WIRE
BD Insyte Autoguard IV Catheter (Cat. No. 381812; Lot no. 8171780)
Smith & Nephew DYONICS 25 tubeset kits (Cat no. 7211005; 7211006)
Cardinal Health Esteem Blue with Neu-Thera Polyisoprene Surgeon Gloves
Medical Device Control Office
BD
N.A.
Smiths & Nephew Ltd
N.A.
MHRA
2009/005/007/051/005
195
19-五月-09
29-五月-09
29-五月-09
GE Medical
Systems
Hong Kong
Ltd.
Bio-Rad
Pacific Ltd.
Hong Kong
South East
Chemicals &
Instruments
BD
Smith &
Nephew LTD
N.A.
2783 1838
N.A.
2802 6333
2575 8668
2648 7700
N.A.
Department of Health
The Government of HKSAR
Wright Medical Darco Cannulated Hex Driver
MHRA
2009/003/003/291/016
FSCA
29-五月-09
Rocialle InHealth Procedure Packs containing Suction Catheter
MHRA
2009/005/013/291/002
FSCA
29-五月-09
Medical Device Control Office
196
Starry
Medical
Technology,
N.A.
2961 4503
N.A.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - April 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Alert Type by
Date of Issue
Description of Product
Reference No. by Source
Information*
Source
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
N.A.
N.A.
Tri-State Centurion Products
FDA
N.A.
Class I
2009/04/02
Roche COBAS c 11 Analyzer with ISE Module option, GMMI No. 04777433001
FDA
Z-1009-2009
Class II
2009/04/02
Roche Diagnostics (Hong Kong) Ltd 2485 7510
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM V 4.0, MODEL NO 270-2600
FDA
Z-1041-2009
Class II
2009/04/02
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300 and 5400-300
FDA
Z-1052-2009
Class II
Lecia QCA and iQCA software
DiaSorin LIASON ® Chemiluminescence Analyzer Model #15970 Colorimeter, Photometer,
Spectrophotometer for clinical use
Medtronic Physio-Control Bisphasic LIFEPAK® 12 Defibrillator/monitor
3M No Sting Barrier Film (Model 3346E)
FDA
Z-1040-2009
FDA
Z-1042-2009
Medtronic
International Ltd
N.A.
3M
N.A.
Bio-Rad Pacific Ltd.
N.A.
2009/04/02
Stryker China Ltd
2518 6915
Class II
2009/04/02
Leica Microsystems
Ltd
2564 6699
Class II
2009/04/02
N.A.
N.A.
2009/04/02
Medtronic
International Ltd.
2919 1362
3M
2806 6349
Firm Initiated Field
Action
Firm Initiated Field
Action
2009/04/03
GE Healthcare ViewPoint Image Archiving and Reporting System
MHRA
2009/001/007/401/004
FSCA
2009/04/06
Gas Control Equipment Sabre Therapy Probe Regulator
MHRA
2009/003/024/291/011
FSCA
2009/04/06
GE Medical
Systems Hong
Kong Ltd.
N.A.
CODAN Burette Sets
MHRA
2009/003/023/291/013
FSCA
2009/04/06
N.A.
Roche Ambulatory insulin infusion pump. Accu-Chek Spirit
MHRA
MDA/2009/024
MDA
2009/04/07
Roche Diagnostics (Hong Kong) Ltd 2485 7510
Biomet Biolox Delta Ceramic Heads 28mm, +5mm (T1 taper)
MHRA
2009/003/017/061/004
FSCA
2009/04/07
N.A.
N.A.
ThermoFisher Columbia blood agar - PB0122A
MHRA
2009/003/024/601/003
FSCA
2009/04/07
N.A.
GE Healthcare S/5 iCentral and iCentral Client (L-NET05 and L-NETC05)
FDA
Z-1039-2009
Class II
2009/04/14
N.A.
GE Medical
Systems Hong
Kong Ltd.
Stryker Electric Stretcher with the Quick Drop CPR option (Model 1050 and Model 1550)
FDA
Z-1230-2009 to Z-1231-2009
Class II
2009/04/14
Stryker China Ltd
2518 6915
Stelkast Dual Taper Wedge Pressed Fit Femoral Component
FDA
Z-1073-2009
Class II
2009/04/14
N.A.
N.A.
Zues Scientific Sm ELISA Test System (Product no.: 2Z2831G and 43270CE)
FDA
Z-1089-2009
Class II
2009/04/14
N.A.
N.A.
Trumpf Medical ILED Surgical Light (Model no ILED3, ILED5 and ILED5K)
FDA
Z-1122-2009
Class II
2009/04/14TRUMPF China (Hong Kong) Ltd.
Theragenics Spacers of varying lengths
FDA
Z-1020-2009
Class II
2009/04/14
N.A.
N.A.
Johnson & Johnson
Medical (HK)
N.A.
Firm Initiated Field
Action
2009/04/14
Johnson & Johnson
Medical (HK)
2738 6027
MHRA
2009/003/026/601/014
FSCA
2009/04/15
N.A.
N.A.
FDA
Z-1210-2009 to Z-1222-2009
Class I
2009/04/16
N.A.
N.A.
Johnson and Johnson Ethicon Endo-Surgery Device - Ets-FLEX45
Tepnel Quick-Type for LIFEMATCH Update CD
Teleflex Medical (Arrow) 30, 40 and 50 cc Intra-Aortic Ballloon
Medical Device Control Office
197
2783 1838
N.A.
N.A.
2783 1838
2880 9808
Department of Health
The Government of HKSAR
Cardinal Health (Viasys Healthcare) Sonora Transcranial Doppler (TCD) System (Model
Sonara, Part no 982A0469 and 982A0470)
FDA
Z-0998-2009 to Z-0999-2009
Class II
2009/04/16
Biomet Offset Tibial Tray Adaptor, 5.0 MM, Sterile, REF 141491
FDA
Z-1061-2009
Class II
Cardinal Health
N.A.
2009/04/16
N.A.
N.A.
Abbott Laboratories
LTD.
2593 2211
Abbott CELL-Dyn Ruby Hematology Analyzer (List no 08H67-01)
FDA
Z-1064-2009
Class II
2009/04/16
Roche/Hitachi Modular Analytics System (Modular D2400 Module; P800 Module; D Module; D
Module)
FDA
Z-1065-2009 to Z-1068-2009
Class II
2009/04/16
Roche Diagnostics (Hong Kong) Ltd 2485 7510
Boston Scientific Convoy Advanced Delivery Sheath Kit and Soft Tip Sheath Multipurpose
Introducing Sheath Kit
FDA
Z-1071-2009 to Z-1072-2009
Class II
2009/04/16
GE Healthcare Infinia Hawkeye and Hawkeye 4
FDA
Z-1094-2009 to Z-1095-2009
Class II
2009/04/16
GE Healthcare Infinia, Hawkeye for Infinia and Infinia Hawkeye 4
FDA
Z-1119-2009 to Z-1121-2009
Class II
2009/04/16
Cardinal Health ReadyMed Elastomeric Ambulatory Pump
FDA
Z-1170-2009
Class II
2009/04/16
Cardinal Health
N.A.
Medtronic Physio Control Internal Sterilizable Paddles and Handles without discharge control for
use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors
FDA
Z-1171-2009
Class II
2009/04/16
Medtronic
International Ltd.
2919 1362
Bard Dual Port Wizard Low Profile Replacement Gastrostomy Device
FDA
Z-1096-2009 to Z-1117-2009
Class II
2009/04/16
N.A.
N.A.
Integra Bilayer Matrix Wound Dressing, 8" x 10" (20cm x 25cm); Non-pyrogenic
FDA
Z-1174-2009
Class II
2009/04/16
N.A.
N.A.
diaDexus PLAC Test Reagent Kit (Catalog no 90110)
FDA
Z-1204-2009
Class II
2009/04/16
N.A.
N.A.
Teleflex Medical Pilling Coronary Scissors (Cataolg no 352164-352169 & 352178)
FDA
Z-1175-2009 to Z-1181-2009
Class II
2009/04/16
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
GE Medical
Systems Hong
GE Medical
Systems Hong
2960 7136
2783 1838
2783 1838
Siemens HM Reaction Vessels (RXV1A)
MHRA
2008/012/002/061/010
FSCA
2009/04/16
i-sens Caresens II BGM
Others
N.A.
N.A.
2009/04/17
Siemens
Healthcare
BioScan Ltd
Sybron Pitt Easy Implant
MHRA
2008/012/002/061/010
FSCA
2009/04/20
N.A.
N.A.
James Leckey EAS Floor Mat
MHRA
2009/003/016/301/002
FSCA
2009/04/22
N.A.
N.A.
Homecraft Rolyan Frimley folding stool model AA1550
2810 7533
3589 6670
MHRA
2009/001/030/401/010
FSCA
2009/04/22
N.A.
N.A.
Stryker Modular Replacement System (MRS) Cemented Stems
FDA
Z-1251-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
Stryker AxSOS T8 Screwdriver and AxSOS Torque Limiting Screwdriver
FDA
Z-1062-2009 to Z-1063-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
Stryker Trio Small Offset Connector Non Sterile (Catalog no 48902015)
FDA
Z-0986-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
2783 1838
GE Healthcare Infinia, Infinia Hawkeye and Infinia Hawkeye 4
FDA
Z-1001-2009 to Z-1003-2009
Class II
2009/04/23
GE Medical
Systems Hong
Abbott AxSYM HBsAg Reagent Pack, AxSYM CMV IgG Regent Pack, AxSYM CORE 2.0
Reagent Pack, AxSYM Folate Reagent Pack, AxSYM Myoglobin Reagent Pack and AxSYM
Troponin-I ADV Reagent Pack
FDA
Z-1046-2009 to Z-1051-2009
Class II
2009/04/23
Abbott Laboratories
LTD.
2593 2211
Maquet ALM Prismatic Surgical Light 9551 DF and ALM Prismatic Surgical Light 54004 SF
FDA
Z-1153-2009 to Z-1154-2009
Class II
2009/04/23
Maquet Hong Kong
LTD.
2393 9511
Cardiovascular System DiamondBack 360, CSI ViperWire Orbital Atherectomy Guide Wire
(REF: GW14335FRM)
FDA
Z-1250-2009
Class II
2009/04/23
N.A.
N.A.
MHRA
2009/003/030/061/008
FSCA
2009/04/23
N.A.
N.A.
St.Jude Medical EP-4 Stimulator 2 and 4 channels and EP WorkMate containing the EP4
stimulator
Medical Device Control Office
198
Department of Health
The Government of HKSAR
Philips HeartStart XL M4735A Defibrillator/Monitor
Philips Health Care
(Great China)
N.A.
Firm Initiated Field
Action
2009/04/23
Philips Health Care
(Great China)
Philips Health Care
(Great China)
2821 5226
N.A.
Firm Initiated Field
Action
2009/04/23
Philips Health Care
(Great China)
Philips HeartStart MRx/MRxE M3535A/M3536A/M3536J Defibrillator/Monitor
2821 5226
ThermoFisher BO0332D Ringers Solution 1/4 Strength lot 1067747
Stryker Restoration Modular Cone Bodies
MHRA
2009/001/029/601/001
FSCA
2009/04/29
N.A.
N.A.
MHRA
2009/003/025/291/008
FSCA
2009/04/29
Stryker China Ltd
2518 6915
Abbott Hematology Reagent Syringe (List no 08H49-02)
FDA
Z-1069-2009
Class II
2009/04/30
Abbott Laboratories
LTD.
2593 2211
Berchtold Operon Electrical Operating Room Table
FDA
Z-1123-2009
Class II
2009/04/30
N.A.
N.A.
Pointe Scientific Liquid Auto HDL CHolesterol Reagent Set
FDA
Z-1200-2009 to Z-1201-2009
Class II
2009/04/30
N.A.
N.A.
DiaDexus PLAC Test Calibrator Kit (Catalog No. 90108 and 10-0108)
FDA
Z-1205-2009
Class II
2009/04/30
N.A.
N.A.
Medical Device Control Office
199
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - March 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of
Source of
Reference No. by
Alert Type by
Agent Contact
Issue
Description of Product
Local Agent
Information*
Source
Source
Telephone No
(YYYY/MM/D
D)
Draeger Medical Oxylog 3000 Ventilator (2M86955)
Health Canada
44596
Type II
2009/03/03
Oxoid Limited Oxoid Fraser Broth Base (CM0895B)
Health Canada
45182
Type II
2009/03/03
Biomet Modular Microplasty Cup Inserter
Health Canada
43310
Type II
Miltex Stainless Steel Surgical Blades
Health Canada
46242
Ohio Willow Wood Duralite Pyramid Receiver Proximal Adapter (FND-136102)
Health Canada
44165
N.A.
2009/03/03
N.A.
South East Chemicals &
Instruments Ltd.
N.A.
Type II
2009/03/03
N.A.
N.A.
Type II
2009/03/03
N.A.
N.A.
GE Medical Systems Hong
Kong Ltd.
GE Medical Systems Hong
Kong Ltd.
N.A.
N.A.
GE Diamond Mammography X-Ray Equipment (81000)
Health Canada
44731
Type II
2009/03/03
GE Datrex-Ohmeda Network and Icentral (M1113714, M1113715)
Health Canada
44822
Type II
2009/03/03
Health Canada
44184
Type II
2009/03/03
Stryker China Ltd
2518 6915
Health Canada
45981
Type II
2009/03/03
Stryker China Ltd
2518 6915
Stryker (Howmedica Osteonics) Securefit Hip Stem - 132 degree, Securefit
Hip Stem - 127 degree, Solar Shoulder - Humeral Component, Ostenoics
Omnifit Hip Stem
Stryker (Howmedica Osteonics) Osteonics Omnifit M-HA Hip Stem, Accolade
TMZF Press Fit Stem 132 Degree, Accolade TMZF Press Fit Stem 127
Degree
GE OEC Mobile Elite C-Arms Gen. Platform, OEC Mobile Elite - Arms Cooling
Siemens Immulite 2000 system-analyzer class III & II, Immulite 2000 Instrument Class IV
Health Canada
44335
Type II
Health Canada
46193
Type II
Philips Gemini GXL 6/10/16 Slice PET/CT, Gemini TF 16 PET?CT system,
Gemini TF 64 PET/CT System
Health Canada
Draeger Evita 4, Evita 2 Dura, Evita XL
DORC international MembraneBlue© 0.5ml syringe
GE Medical Systems Hong
2009/03/03
Kong Ltd.
Siemens Healthcare Diagnostic
2009/03/03
Limited
2783 1838
2783 1838
2783 1838
2810 7533
46137
Type II
2009/03/03
Philips Health Care (Great
China)
Health Canada
42978
Type II
2009/03/03
N.A.
N.A.
MHRA
MDA/2009/017
MDA
2009/03/04
N.A.
N.A.
2821 5480
Philips Diagnostic Ultrasound System (Model HD3 and HDI4000)
FDA
Z-0522-2009 to Z-0523-2009
Class II
2009/03/05
Medtronic Surgical Membrane Oxygenator
FDA
Z-0975-2009
Class II
2009/03/05
Philips Health Care (Great
China)
Medtronic International Ltd.
Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Enegry Suction Probe
(Model no 279-351-200)
FDA
Z-0972-2009
Class II
2009/03/05
Stryker China Ltd
2518 6915
Abbott ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge)
(List no: 07L02-01)
FDA
Z-0951-2009
Class II
2009/03/05
Abbott Laboratories LTD.
2593 2211
Abbott Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator (List
No. 1E69-03)
FDA
Z-0950-2009
Class II
2009/03/05
Abbott Laboratories LTD.
2593 2211
Terumo Advanced Perfusion System 1
FDA
Z-0909-2009 to Z-0910-2009
Class II
2009/03/05
TERUMO CHINA (H.K.) LTD.
2866 0811
Excelsior Medical Sterile Field Saline Flush (Product codes: E0100 20, 100
92-240 and 100 92-30)
FDA
Z-0973-2009
Class II
2009/03/05
N.A.
N.A.
Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophillic
Coating (REF USH-526-R, GPN REF G49966)
FDA
Z-0980-2009
Class II
2009/03/05
N.A.
N.A.
2009/03/05
N.A.
N.A.
2009/03/10
Medtronic International Ltd.
2919 1362
Welch Allyn AED 10 and former MRL Jumpstart Automated External
Defibrillators
Medtronic Physio-Control Lifepak 20 defibrillator/monitor - Keypad
Medical Device Control Office
Welch Allyn
N.A.
Medtronic
International Ltd
N.A.
Firm Initiated Field
Action
Firm Initiated Field
Action
200
2821 5480
2919 1362
Department of Health
The Government of HKSAR
Sunrise Medical Quickie Groove battery powered wheelchairs
MHRA
CMS Software 4.3.1 through 4.40.00
MDA/2009/018
MDA
2009/03/10
N.A.
N.A.
MHRA
2009/002/015/601/001
FSCA
2009/03/10
N.A.
N.A.
Cardiac Science Powerheart and First Save AED
FDA
Z-0916-2009 to Z-0922-2009
Class II
2009/03/12
N.A.
N.A.
InteliFUSE Drill Bit (REF: DB.150.JL and DB.200.JL)
FDA
Z-1032-2009 to Z-1033-2009
Class II
2009/03/12
N.A.
N.A.
Johnson & Johnson Medical
(HK)
2738 6027
Johnson and Johnson (Animas) Meter Remote for OneTouch Ping Glucose
Management System
FDA
Z-0955-2009
Class II
2009/03/12
Zimmer Orthosoft Navitrack, OS Unicodylar Knee 1.0- Universal
FDA
Z-0985-2009
Class II
2009/03/12Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Stryker Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS
Femoral Components (Catalog no 5532-G-713 & 5532-G-813)
FDA
Z-1013-2009
Class II
2009/03/12
Stryker China Ltd
2518 6915
Medtronic VARI-STIM III Nerve Locator/Stimulator
FDA
Z-0947-2009
Class II
2009/03/12
Medtronic International Ltd.
2919 1362
Hospira Symbiq One-Channel (List no 16026-04) and Two-Channel (list no
16027-04) Infusion System
FDA
Z-0944-2009
Class II
2009/03/12
Hospira Limited
2898 2886
GE Healthcare Innova Biplane 3131
MHRA
2008/006/013/601/413
FSCA
Zimmer NCB cancellous screw 4.5mmx 48mm Self tapping
MHRA
2009/002/020/291/022
FSCA
GE Medical Systems Hong
2009/03/13
Kong Ltd.
2009/03/13Zimmer PTE Ltd. (Hong Kong branch)
VYGON PROTECT-A-SPIRAL – 300CM
MHRA
2009/002/026/601/003
FSCA
2009/03/13
N.A.
IPSOGEN JAK2 MutaScreen Kit
MHRA
2009/002/010/291/016
FSCA
2009/03/16
Philips Multi Diagnost Eleva FD - Leaking X-Ray Tube Grid
MHRA
2008/011/020/061/028
FSCA
2009/03/16
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
2009/03/16
N.A.
Philips Health Care (Great
China)
Boston Scientific Hong Kong
Ltd
BD
N.A.
Firm Initiated Field
Action
2009/03/17
Boston Scientific Wiseguide Guide Catheter
BD Falcon 100 x 20 mm Tissue Culture - Treated Dish (BD Cat no 353003)
BD
2783 1838
2992 0968
N.A.
N.A.
2821 5226
2960 7136
2575 8668
MHRA
2008/011/006/301/002
FSCA
2009/03/18
N.A.
N.A.
Stryker Triathlon Primary
Health Canada
46302
Type II
2009/03/18
Stryker China Ltd
2518 6915
Stryker Triathlon Primary Cemented Baseplate (5520-B-400)
Health Canada
46208
Type II
2009/03/18
Stryker China Ltd
2518 6915
Smith & Nephew Tandem Unipolar 46 mm Femoral Heads (126646)
Health Canada
46556
Type II
2009/03/18
Smith & Nephew LTD
N.A.
2992 0968
Unihoist University Bath Hoist and University Bath Hoist Transporter
Zimmer Minimally Invasive Solutions Technology Offset RASP Handles
Health Canada
46270
Type II
2009/03/18
Zimmer PTE Ltd. (Hong Kong
branch)
Technidata Logiciel TDHIsto/CytoSoftware
Health Canada
44729
Type II
2009/03/18
N.A.
N.A.
Computerized Medical Systems Focal Software CD
Health Canada
46521
Type II
2009/03/18
N.A.
N.A.
Bard Fantrac "Paul" Gastric Access Port Kit (Model 5729)
Health Canada
45860
Type II
2009/03/18
N.A.
N.A.
Genzyme Diagnostics Enzymatic Creatinine Assay
Health Canada
46641
Type II
2009/03/18
N.A.
N.A.
Nipro Blood Tubing Set for Hemodialysis (A230TR/V810TR)
Health Canada
45627
Type II
2009/03/18
N.A.
N.A.
Armstrong Medical Amsorb Plus Prefilled Bubble-Can Universal WTOV
Health Canada
46652
Type II
2009/03/18
N.A.
N.A.
Cardinal Health Sterile Pacemaker and Defibrillator Pack (SAN30PAXXX),
Sterile Shoulder Pack (SOP30ASXXX)
Health Canada
46636
Type II
2009/03/18
Cardinal Health
N.A.
PDSII Monofilament suture, Coated Vicryl Absorable Suture, PDS II Suture,
Monocryl Plus Antibacterial Suture, Coated Vicryl Plus Antibacterial Ethicon
Suture
Health Canada
46404
Type II
2009/03/18
Johnson & Johnson Medical
(HK)
2738 6027
Medical Device Control Office
201
Department of Health
The Government of HKSAR
Baxter Healthcare Colleague Volumetric Infusion Pump, Colleague 3
Volumetric Infusion Pump, Colleague Guardian Enhanced CXE Pump,
Colleague Guardian Enhanced 3CXE Pump, French Colleague CXE
Volumetric Pump, French Colleague 3 CXE Volumetric Pump
Health Canada
Biomet Sports Medicine 9-10mm Ezloc Femoral Fixation Device (904781)
45280
Type II
2009/03/18
Health Canada
44280
Type II
2009/03/18
GE Innova 3100/3100IQ and Innova 4100 /4100IQ
FDA
Z-1092-2009 to Z-1093-2009
Class II
2009/03/19
Medtronic PROSTIVA RE Model 8929 Hand Piece
FDA
Z-1060-2009
Class II
Medtronic TSRH 3DX Implant Set and TSRH Spinal System
FDA
Z-1014-2009 to Z-1017-2009
Class II
Stryker Cordless Driver 3 Handpiece, Rotary Handpiece, Reciprocating Saw,
Sternum Saw, Sagittal Saw and Precision Oscillating Tip Saw
FDA
Z-1021-2009 to Z-1030-2009
Zimmer Most Hinged Tibia Baseplate Spacer (REF 5020-06-001)
FDA
Integra Mosail Putty and Dermal Regeneration Template-TS
Pointe Scientific Glucose Oxidase Reagent
Remel Wellcolex colour salmonella Kits, R30858301 (50 tests)/R30858302
ConMed Fortis II
Philips GXR RF Systems with DI (EasyDiagnost Eleva)
CORONA MEDICAL Patient Beds (Side Rails)
GE AS/3 Anaesthesia Delivery Unit, S/5 Anaesthesia Delivery Unit, and ADU
Carestation
Baxter Healthcare Ltd
N.A.
2807 8516
N.A.
2009/03/19
GE Medical Systems Hong
Kong Ltd.
Medtronic International Ltd.
2919 1362
2009/03/19
Medtronic International Ltd.
2919 1362
Class II
2009/03/19
Stryker China Ltd
2518 6915
Z-0996-2009
Class II
2009/03/19Zimmer PTE Ltd. (Hong Kong branch)
FDA
Z-1034-2009 to Z-1035-2009
Class II
2009/03/19
N.A.
N.A.
FDA
Z-1091-2009
Class II
2009/03/19
N.A.
N.A.
MHRA
2009/003/006/051/003
FSCA
2009/03/19
Hong Kong South East
Chemicals & Instruments Ltd
2802 6333
2009/03/19
ConMed Limited
N.A.
2009/03/19
Philips Health Care (Great
China)
2821 5226
2009/03/20
N.A.
N.A.
FSCA
2009/03/23
GE Medical Systems Hong
Kong Ltd.
2783 1838
ConMed Limited
Philips Health
Care (Great China)
CORONA
MEDICAL
N.A.
N.A.
N.A.
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
2783 1838
2992 0968
MHRA
2009/002/013/601/003
Medtronic
International Ltd
N.A.
Firm Initiated Field
Action
2009/03/23
Medtronic International Ltd.
2919 1362
Maquet Servo ventilators 300 and 300A
MHRA
MDA/2009/020
MDA
2009/03/25
Maquet Hong Kong Ltd
2393 9511
Smiths Medical Near empty flag kits product code 0131-0122 and halfnut,
leadscrew and flag kits product code 0131-0236 for 3000 series graseby
syringe pumps
MHRA
2009/002/020/291/012
FSCA
2009/03/25
GOODMAN MEDICAL SUPPLIES LTD
GE Datex-Ohmeda Aisys and GE Datex-Ohmeda Avance Anesthesia
Machines
MHRA
2009/002/017/601/001
FSCA
2009/03/25
Draeger Medical Patient monitor bracket
MHRA
2009/003/010/051/014
FSCA
2009/03/25 Draeger Medical Hong Kong Ltd.
Aidapt VR231 Lenham adjustable height commode
MHRA
2009/001/007/401/004
FSCA
2009/03/25
N.A.
N.A.
2009/03/25
Abbott Laboratories LTD.
2593 2211
2009/03/26
BD
2575 8668
2738 6027
Medtronic Sprint Fidelis Lead
Abbott Xience V Everilimus Eluting Coronary Stent System, 2.5 x 28mm
BD PrepStain System (Model no.: 799-14000-00)
Abbott
Laboratories LTD.
N.A.
Firm Initiated Field
Action
FDA
Z-1090-2009
Class II
GE Medical Systems Hong
Kong Ltd.
2332 4455
2783 1838
2877-3077
LifeScan (Johnson and Johnson) OneTouch SureStep Test Strips (Part no.:
020-052-01 and 010-359-04)
FDA
Z-1070-2009
Class II
2009/03/26
Johnson & Johnson Medical
(HK)
Rochester Medical Magic3 (Intermittent Catheter) and HydroSil (Intermittent
Catheter)
FDA
Z-1074-2009 to Z-1087-2009
Class II
2009/03/26
N.A.
N.A.
Biosite Triage Drugs of Abuse Panel (Model No 95000)
FDA
Z-1088-2009
Class II
2009/03/26
Biosite Incorporated
2855 6883
N.A.
Firm Initiated Field
Action
2009/03/26
BD
2575 8668
BD Insyte Autoguard Shielded IV Catheter
Medical Device Control Office
BD
202
Department of Health
The Government of HKSAR
Boston Scientific Flexima and Percuflex Drainage Catheter Family (Pigtail
Style)
GE Mobile Care Server L-WEB05 and iCentral L-NET05
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap
Shunt Ventricular Catheter, BioGlide
Novo Nordisk NovofineR Needles 31G, 0.25 mm x 6 mm lot number 08J02S
Boston Scientific
Hong Kong Ltd
N.A.
MHRA
2008/009/018/601/004
FSCA
2009/03/27
FDA
N.A.
Class I
2009/03/30
Medtronic International Ltd.
2919 1362
MHRA
MDA/2009/021
MDA
2009/03/30
N.A.
N.A.
2009/03/30
Astrazeneca Hong Kong Ltd
2491 5206
2009/03/31
Suburfarm Investment &
Trading Co.
2780 9421
AstraZeneca Nebuchamber
Astrazeneca Hong
Kong Ltd
N.A.
ZOLL AED Plus Defibrillator
Health Canada
N.A.
Medical Device Control Office
Firm Initiated Field
Action
Firm Initiated Field
Action
Urgent Safety
Information
203
2009/03/27
Boston Scientific Hong Kong
Ltd
GE Medical Systems Hong
Kong Ltd.
2960 7136
2783 1838
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - February 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Reference No. by
Alert Type by
Date of Issue
Agent Contact
Description of Product
Local Agent
Information*
Source
Source
(YYYY/MM/DD)
Telephone No
Medtronic
Firm Initiated
Medtronic
N.A.
2009/02/02
Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor
2919 1350
International Ltd
Field Action
International Ltd.
Beckman Coulter UniCel DxC 880i Synchron Access Clinical Systems
MHRA
2009/001/023/601/001
FSCA
2009/02/02
Beckman Coulter Hong Kong Ltd
2240 6150
Xcelens IDEA 613XC
MHRA
2009/001/026/291/003
FSCA
2009/02/02
Stryker GAMMA3 Trochanteric Nail 180 Operative Technique
MHRA
2009/001/008/291/002
FSCA
2009/02/02
Activate Patron Bohemia TOM Cross Country Chassis
MHRA
2008/009/016/401/009
FSCA
James Leckey Advanced, Contoured Advanced, Squiggles Saddle and
Squiggles Early Sitting Seating Sytems
MHRA
2008/011/027/061/008
ThermoFisher BO0471D, 0.1% Peptone Water + 0.85% Salt
MHRA
ThermoFisher EB0348D, Maximum Recovery Diluent
MHRA
2518 6915
2009/02/02
N.A.
Stryker China
Ltd
N.A.
FSCA
2009/02/02
N.A.
N.A.
2009/001/026/601/005
FSCA
2009/02/02
N.A.
N.A.
2009/001/026/601/006
FSCA
2009/02/02
N.A.
N.A.
MHRA
Johnson &
Johnson Medical
(HK)
BD
2009/001/028/601/002
FSCA
2009/02/02
GE Centricity PACS RA1000 Workstation
FDA
Z-0836-2009
Firm Initiated
Field Action
Firm Initiated
Field Action
Class II
iCAD 3TP TheraMap Software and 3TP PrecisionPoint Software
FDA
Z-0653-2009 to Z-0654-2009
Class II
2009/02/05
Smith &
Nephew LTD
Johnson &
Johnson
Medical (HK)
BD
GE Medical
Systems Hong
N.A.
Virtus Expressaire, Disposable Tourniquet Cuff (Cuff type A70107010,
A70107011)
FDA
Z-0907-2009 to Z-0908-2009
Class II
2009/02/05
N.A.
Fresenius Medical CombiSet True Flow Series, Hemodialysis Blood Tubing
FDA
Z-0859-2009 to Z-0860-2009
Class II
2009/02/05
Fresenius Medical Care Asia Pacific
2802
Ltd.2900
Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only
(Catalog no.: R6357A, R6397A)
FDA
Z-0854-2009
Class II
2009/02/05
N.A.
N.A.
Coloplast EasiCath intermittent urinary catheters
MHRA
MDA/2009/007
MDA
2009/02/05
N.A.
N.A.
Teleflex Medical Ligating clips
MHRA
MDA/2009/008
MDA
2009/02/09
N.A.
N.A.
FSCA
Firm Initiated
Field Action
FSCA
2009/02/09
N.A.
9651 5523
2009/02/10
N.A.
Smiths &
Nephew Ltd
N.A.
BD
886-2722-5660
Smith & Nephew BHR BRIDGING CUP, 66MM PRODUCT CODE 74120366
Johnson and Johnson DePuy Vac-Mix plus pre-packed with Endurance Bone
Cement
BD FACS Sample Prep Assistant (SPA or SPA II)
Johnson and Johnson (DePuy) DNP Anatomic Fracture Repair System
Smith & Nephew Compass PIP Hinge
Doddmed Metrax Primedic HeartSave AED, HeartSave AED-M
N.A.
N.A.
2009/001/026/291/007
MHRA
Smiths & Nephew
N.A.
Ltd
2008/011/010/061/024
MHRA
2009/02/03
2009/02/03
2009/02/05
2009/02/09
N.A.
N.A.
N.A.
2738 6027
886-2722-5660
2783 1838
N.A.
N.A.
N.A.
BD Vacutainer Plastic Sodium Heparin Blood Collection Tube with Green BD
Hemogard Closure, 13 x 75 mm, 4 ml.
MHRA
2009/001/030/291/008
FSCA
2009/02/10
Zimmer Coonrad/Morrey Total Elbow System Surgical Technique
MHRA
2009/002/005/291/017
FSCA
Johnson and Johnson STERRAD 50 Sterilization System
MHRA
2009/001/030/291/010
FSCA
ThermoFisher BO0348N Maximum Recovery Diluent
MHRA
2009/001/029/601/002
FSCA
2009/02/10
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Johnson &
2009/02/10
2738 6027
Johnson
2009/02/10
N.A.
N.A.
Medtronic
International Ltd
N.A.
Firm Initiated
Field Action
2009/02/11
Medtronic O-Arm Intraoperative Imaging System (Catalog no.: BI-700-0027)
FDA
Z-0624-2009
Class II
2009/02/12
Terumo Advanced Perfusion System 1
FDA
Z-0670-2009 to Z-0674-2009
Class II
2009/02/12
Stryker Restoration Modular Conical Distal Stem, Titanium Alloy (Catalog no 62767-017 (17mm); 6276-7-014 (14mm))
FDA
Z-0884-2009
Class II
2009/02/12
Medtronic LIFEPAK 20 Defibrillator / Monitor
Medical Device Control Office
204
Medtronic
International Ltd.
Medtronic
International Ltd.
TERUMO
CHINA (H.K.)
Stryker China
Ltd
2919 1362
2919 1362
2866 0811
2518 6915
Department of Health
The Government of HKSAR
Stryker various modular components
FDA
Z-0888-2009 to Z-0902-2009
Class II
2009/02/12
Stryker China
Ltd
2518 6915
Biomet MicrofixationLactosorb System (REF: 915-1006); Lactosorb, Office
Fixation Kit (REF: 915-1000); MF Set (REF: 01-6871); Office System (REF: 016851)
FDA
Z-0864-2009 to Z-0867-2009
Class II
2009/02/12
N.A.
N.A.
Activate Hi-Lo Powered Wheelchair
MHRA
2008/010/001/061/003
FSCA
2009/02/12
N.A.
N.A.
Invacare Flamingo Hoist
MHRA
2009/001/022/301/001
FSCA
2009/02/12
N.A.
N.A.
MHRA
MHRA
BrainLAB Ltd
2008/012/030/401/007
2008/007/023/401/007
FSCA
FSCA
Firm Initiated
Field Action
2009/02/12
2009/02/12
N.A.
N.A.
N.A.
N.A.
2009/02/12
BrainLAB Ltd
2417 1881
Millipore Corporation Bioscience Simulfluor Flu A/B Immunofluor Assay
(Model:3121, 5250)
Health Canada
45681
Type II
2009/02/13
Millipore Hong
Kong
2803 9249
Baxter Healthcare Rear Case Assembly For Auto Syringe (Model: 1M8560R)
Health Canada
43803
Type II
2009/02/13
Baxter
Healthcare Ltd
2807 8516
Problem Solving Concepts Prosolv Cardiovascular Image and Information
Management
Health Canada
46106
Type II
2009/02/13
N.A.
N.A.
Encore Medical Modular Femoral Neck
Health Canada
44847
Type II
2009/02/13
N.A.
N.A.
Tremblay Harrison Minute Lab PSA Semi-Quantitative Test (Model: PSD-A1,
PSS-A1)
Health Canada
46147
Type II
2009/02/13
N.A.
N.A.
Imaging Sciences International Gendex GXCB-500 Cone Beam 3-D Imaging
(Model: 45997)
Health Canada
45997
Type II
2009/02/13
N.A.
N.A.
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
45821
Type II
2009/02/13
2838 8423
Medtronic Durepair Dura Regeneration Matrix
Health Canada
45672
Type II
2009/02/13
Uninet
Technology
MedtronicLTD
Bio-Rad Laboratories Bioplex 2200 Detector Calibration Packs
Health Canada
45218
Type II
2009/02/13
Bio-Rad Laboratories Liquicheck Cardiac Markers Control LT - Trilevel (145),
Level 1(146), Level 2 (147), Level 3 (148), Trilevel Minipak (145x)
Health Canada
45219
Type II
2009/02/13
ThermoFisher BO0351G, Tryptone soya broth, lot number 1066679
MHRA
2009/001/026/601/003
FSCA
2009/02/13
N.A.
TRB Chemedica Visiol Syringe 20mg/ml
MHRA
2008/012/023/291/008
FSCA
2009/02/13
N.A.
N.A.
BD Insyte Autogard I.V Catheter
MHRA
2009/001/030/291/009
FSCA
2009/02/16
BD
886-2722-5660
Elekta Precise Treatment Table
MHRA
2009/002/011/291/007
FSCA
2009/02/16
N.A.
BioMerieux Bacteriology culture medium. Chocolate agar + PolyViteX VCAT3 agar
MHRA
MDA/2009/011
MDA
2009/02/17
2356 7033
Mast Laboratories V Factor Catridges
MHRA
2009/002/009/601/001
FSCA
2009/02/18
N.A.
Biomerieux
China Ltd. (HK
office)
N.A.
STAAR Surgical Aquaflow collagen glaucoma drainage device
MHRA
2008/011/024/291/008
FSCA
2009/02/18
N.A.
N.A.
Spacelabs Healthcare Blease 700/900 Ventilator
MHRA
2009/002/005/291/006
FSCA
2009/02/18
N.A.
N.A.
FDA
Z-0863-2009
Class II
2009/02/19
N.A.
N.A.
Mecall UNISTAT L floor stand
Vitech Scientific Starrsed Compact Interrliner
BrainLAB Radiolucent Spine Reference Clamp
Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit
N.A.
Stryker PainPump (Prodcut no.: 0500-166-025, 0500-166-050, 0500-200-000;
REF: 500-166-25; 500-166-50, 500-200
FDA
Z-0923-2009 to Z-0925-2009
Class II
2009/02/19
Stryker PainPump 2 Blockaid (REF 575-100)
FDA
Z-0926-2009
Class II
2009/02/19
Stryker AVS AL Spacer Trial Inserter; Non Sterile (Catalog no 48329800)
FDA
Z-0936-2009
Class II
2009/02/19
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis)
FDA
Z-0928-2009
Class II
2009/02/19
Medical Device Control Office
205
International Ltd.
Bio-Rad Pacific
Ltd.
Bio-Rad Pacific
Ltd.
Stryker China
Ltd
Stryker China
Ltd
Stryker China
Ltd
GE Medical
Systems Hong
2919 1362
N.A.
N.A.
N.A.
N.A.
2518 6915
2518 6915
2518 6915
2783 1838
Department of Health
The Government of HKSAR
Siemens Artiste MV Digital Linear Accelerator System equipped with 160 MCL
Accessory Holder
FDA
Z-0949-2009
Class II
AGFA IMPAX Cardiovascular Polling Procedure version 1.00.09
FDA
Z-0945-2009
Class II
Siemens
Healthcare
2810 7533
Diagnostic
2009/02/19 AGFA Hong Kong Limited 2555 9421
Posey Connecting Straps and Belts/Locking Cuffs
FDA
Z-0934-2009
Class II
2009/02/19
N.A.
N.A.
Advanced Bionics HR90K Platinum Series Headpiece; Platinum Series
Headpiece ; S-Series Long Range Headpiece, S- Series Short Range Headpiece
FDA
Z-0956-2009 to Z-0959-2009
Class II
2009/02/19
N.A.
N.A.
Synthes Nfix II System, N-Hance System, TI N-Hance Rod, Nflex Stabilization
System
FDA
Z-0963-2009 to Z-0968-2009
Class II
2009/02/19
Synthes (Hong
Kong) Ltd
2724 2032
Teleflex Medical CC IAB Catheters/Volume Connectors
MHRA
2009/002/010/291/018
FSCA
2009/02/20
Maquet Heartstring II Proximal Seal System
MHRA
2009/002/013/051/002
FSCA
2009/02/23
Blatchford Endolite 30mm Pyramid Adapt
MHRA
2008/009/008/401/012
FSCA
2009/02/23
Siemens Sireskop SX and AXIOM Sireskop SD
MHRA
2009/002/013/051/003
FSCA
2009/02/23
Tyco Shiley 3.0 Cuffless Paediatric Tracheostomy
MHRA
2009/001/023/291/001
FSCA
Johnson and Johnson (DePuy) Total knee replacement implant femoral
components – PFC SIGMA
MHRA
MDA/2009/016
MDA
Edwards Lifesciences Swan-Ganz Thermodilution Catheters
MHRA
2009/002/018/291/008
FSCA
Abbott RealTime HIV-1 Assay
MHRA
2009/002/019/291/015
FSCA
ConMed Endoscopic Disposable Polypectomy Snares and Gastrostomy Feeding
Systems - EnTake PEG
MHRA
2009/002/018/291/007
FSCA
Varian Medical Systems Eclipse treatment planning system (Model no. H48,
versions 6.5/7.x and Inspiration 8.0)
FDA
Z-0861-2009
Class II
2009/02/26
Varian Medical Systems Pacific Inc.
2724 2836
Boston Scientific Atlantis PV Peripheral Imaging Catheter (Model no H749364560)
FDA
Z-0837-2009
Class II
2009/02/26
Philips M8000-64100 Table Mount
FDA
Z-0817-2009
Class II
2009/02/26
Siemens Drive Belt for Radiation Therapy Simulation Systems SIMVIEW 3000
and SIMVIEW NT with CT option or IDI
FDA
Z-0646-2009
Class II
2009/02/26
Siemens MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo
Panels and MicroScan Synergies Plus Negative Panels
FDA
Z-0540-2009 to Z-0541-2009
Class II
2009/02/26
Zoll Monitor portion of the LifeVest device (Model no. WCD3000 and WCD3100)
FDA
Z-0883-2009
Class II
2009/02/26
N.A.
N.A.
Ossur 3" Titanium Skull Pin, 3" Ceramic Tip Pin,2 1/4" Ceramic Tip Pin
FDA
Z-0594-2009 to Z-0596-2009
Class II
2009/02/26
N.A.
N.A.
Mako Surgical Femoral Array (Model no 0150ARR00001) and Tibial Array (Model
no 0150ARR00002)
FDA
Z-0915-2009
Class II
2009/02/26
N.A.
N.A.
Baxter System 1000 and Arena Haemodialysis instruments
MHRA
2009/002/010/291/017
FSCA
2009/02/27
Baxter Healthcare Ltd
2807 8516
Edwards Lifesciences Fem-FlexII Paediatric Catheter
MHRA
2009/002/018/291/010
FSCA
2009/02/27
N.A.
GE Giraffe Warmer & Panda iRes
MHRA
2009/001/021/601/001
FSCA
2009/02/27
Bio-Rad Laboratories Variant II Sytem with CDM 3.5 software, 3.6T System
Health Canada
46347
Type I
2009/02/27
Boston Scientific Precision Spinal Cord stimulation system
Health Canada
44523
Type II
2009/02/27
Bard Access Ponsky Non-Ballon Gastrostomy tube
Health Canada
42263
Type II
2009/02/27
N.A.
GE Medical
Systems Hong
Bio-Rad Pacific
Ltd.
Boston Scientific
Hong Kong Ltd
N.A.
Medical Device Control Office
206
2009/02/19
N.A.
Maquet Hong
Kong LTD.
N.A.
2393 9511
Siemens
2810 7533
Healthcare
2009/02/24
Tyco Healthcare (HKSAR) LTD3157 7220
Johnson &
2009/02/25
2738 6027
Johnson
Medical (HK)
2009/02/25
N.A.
N.A.
Abbott
2009/02/25
2593 2211
Laboratories
2009/02/25
N.A.
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great
Siemens
Healthcare
Diagnostic
Siemens
Healthcare
Diagnostic
N.A.
2960 7136
2821 5480
2810 7533
2810 7533
2783 1838
N.A.
2960 7136
N.A.
Department of Health
The Government of HKSAR
Fresenius Medical Patient On Line
Medical Device Control Office
Health Canada
41821
Type II
207
2009/02/27
Fresenius
Medical Care
2802 2900
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - January 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Source of
Alert Type by Date of Issue
Agent Contact
Description of Product
Reference No. by Source
Local Agent
Information*
Source
(YYYY/MM/DD
Telephone No
TERUMO CHINA
Z-0445-2009 to Z-0446-2009
2009/01/02
Terumo Advanced Perfusion System 1 (Model 801763 and 801764)
Class II
2866 0811
FDA
(H.K.) LTD.
CTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel
Boston Scientific
Z-0476-2009
2009/01/02
Class II
2960 7136
FDA
Harvesting System with VASOVIEW Flexible Endoscopic Tools
Hong Kong Ltd
Z-0486-2009
2009/01/02
FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66-FA-SF)
Class II
N.A.
N.A.
FDA
Smiths Medical Wallace Oocyte Recovery Needles, Oocyte Recovery sets
Gold Pacific
Z-0593-2009
2009/01/02
Class II
2544 2602
FDA
(Product no. ONS1633LL-750 and ONS1733LL-750)
Enterprises
Siemens
SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)
Z-0524-2009
Class
II
2009/01/02
2810 7533
Healthcare
FDA
Diagnostic Limited
Z-0480-2009
2009/01/02
Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025)
Class II
N.A.
N.A.
FDA
Z-0500-2009
2009/01/02
Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001)
Class II
N.A.
N.A.
FDA
Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation Chair
2008/011/028/061/020
2009/01/07
FSCA
Stryker China Ltd
2518 6915
MHRA
Model 6253
Johnson &
Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II
2008/012/009/061/007
FSCA
2009/01/07
2738 6027
Johnson Medical
MHRA
(HK)
2008/012/009/061/003
2009/01/08
ArthroCare Saber 30 with Integrated Cable Wand
FSCA
N.A.
N.A.
MHRA
2008/012/009/061/015
2009/01/08
EV3 Marathon Flow Directed Micro Catheter Catalog Number 105-5055
FSCA
N.A.
N.A.
MHRA
GE Medical
GE Centricity Ultra Laboratory System Software
Z-0472-2009
Class II
2009/01/08
2783 1838
Systems Hong
FDA
Kong Ltd.
Siemens
Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace
Z-0543-2009 to Z-0545-2009
Class II
2009/01/08
2810 7533
Healthcare
FDA
Diagnostic Limited
Z-0507-2009 to Z-0508-2009
2009/01/08
Alphatec Spine Novel PEEK VBR XS
Class II
N.A.
N.A.
FDA
Z-0604-2009
2009/01/08
Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K
Class II
N.A.
N.A.
FDA
Z-0610-2009
2009/01/08
Stryker Leibinger New Generation/Universal Mandibular System
Class II
Stryker China Ltd
2518 6915
FDA
Z-0617-2009
2009/01/08
Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator
Class II
N.A.
N.A.
FDA
CovaTec Flexi-Seal Fecal Management System Advanced Odor Control Kit.
Z-0618-2008
2009/01/08
Class II
N.A.
N.A.
FDA
Rx only
Z-0644-2009 to Z-0645-2009
2009/01/08
Edwards Lifesciences EndoClamp aortic catheter
Class II
N.A.
N.A.
FDA
2008/012/003/061/001
2009/01/09
Hyphen BioMed Biophen Heparin 6 (various lots)
FSCA
N.A.
N.A.
MHRA
Siemens
Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay
2008/012/023/051/001
FSCA
2009/01/09
2810 7533
Healthcare
MHRA
Diagnostic Limited
2008/011/005/601/004
2009/01/09
Arcomedical Infusion Syramed SP6000 Syringe Pumps
FSCA
N.A.
N.A.
MHRA
Boston
Scientific
Firm Initiated
Boston Scientific
N.A.
2009/01/13
Boston Scientific Safety and Standard Push PEG Kits
2960 7136
Hong Kong
Field Action
Hong Kong Ltd
Ltd
2008/012/016/061/007
2009/01/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Zimmer NexGen® Complete Knee Solution Provisional Articular Surface
FSCA
MHRA
2008/012/015/601/005
2009/01/14
ThermoFisher BO0366G Brain heart infusion, lot number 1070312
FSCA
N.A.
N.A.
MHRA
GE Medical
GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP Fluoroscopic
Z-0341-2009 to Z-0342-2009
Class II
2009/01/14
2783 1838
Systems Hong
FDA
x-Ray System
Kong Ltd.
Z-0439-2009 to Z-0440-2009
2009/01/14
Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and RL-01
Class II
N.A.
N.A.
FDA
Z-0505-2009
2009/01/14
Innovative Implant Sinu-Lift System (Model SLS-1)
Class II
N.A.
N.A.
FDA
Z-0517-2009 to Z-0521-2009
2009/01/14
Biomet Compress Instrument Anchor Plug Holders
Class II
N.A.
N.A.
FDA
Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared and Pro
Z-0600-2009 to Z-0603-2009
2009/01/14
Class II
N.A.
N.A.
FDA
2000
Medical Device Control Office
208
Department of Health
The Government of HKSAR
Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no 04522320190)
FDA
Z-0542-2009
Class II
GE Solar 8000M System
FDA
Z-0285-2009
Class II
Siemens CT syngo Dual Energy Viewer (Model 10094833)
FDA
Z-0647-2009
Class II
Hitachi CXR4 Computed Tomography Scanner
ACIST CVi Angiographic Injection System (Model: CVi Toshiba interface
Cable)
Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX)
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate (Ref
6420-01-230)
Frontier Medical Repose Mattress and Cushion
FDA
FDA
FDA
Z-0608-2009
Z-0643-2009
Z-0607-2009
Class II
Class II
Class II
2009/01/14
Roche Diagnostics (Hong Kong) Ltd2485 7510
GE Medical
2009/01/14
2783 1838
Systems Hong
Kong Ltd.
Siemens
2009/01/14
2810 7533
Healthcare
Diagnostic Limited
2009/01/14
N.A.
N.A.
2009/01/14
N.A.
N.A.
2009/01/14
N.A.
N.A.
FDA
Z-0871-2009
Class II
2009/01/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
MHRA
Boston
Scientific
Hong Kong
Ltd
2008/009/015/301/001
FSCA
2009/01/15
N.A.
N.A.
N.A.
Firm Initiated
Field Action
2009/01/15
Boston Scientific
Hong Kong Ltd
2960 7136
45354
Type II
2009/01/15
Stryker China Ltd
2518 6915
43740
Type II
2009/01/15
N.A.
N.A.
Boston Scientific Stonetome Single-Use Stone Removal Device
Stryker Intouch Bed Model 2130 with positionpro (model: 2130-000-000),
Health Canada
Intouch Bed Model 2140 with Positionpro (model: 2140-000-000)
Biomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office Fixation
Health Canada
Kit, C) 1.5/IMF Small Office Set
Toshiba Aquilion One (TSX-310A/2)
Health Canada
44879
Type II
2009/01/15
Invacare Careguard Mattress
Health Canada
45093
Type II
2009/01/15
Medtronic DLP Pericardial / Intracardiac Sump
Health Canada
45468
Type II
2009/01/15
Philips Easydiagnost Eleva
Health Canada
45433
Type II
2009/01/15
Convatec Flexi-Seal FMS Advanced Odor Control
Health Canada
45051
Type II
2009/01/15
KCI Kinair IV
Health Canada
45500
Type II
2009/01/15
Maquet Maquet Foot Paddle
Health Canada
44983
Type II
2009/01/15
Philips Multi Diagnostic Eleva-Flat Detector-IM
Health Canada
44908
Type II
2009/01/15
Stryker Patient Registration Mask (Box of 5)
Coloplast Philips Bougle
Health Canada
Health Canada
45115
45314
Type II
Type II
2009/01/15
2009/01/15
Roche Diagnostics Process System Manager
Health Canada
44820
Type II
2009/01/15
Smith & Nephew Reflection Hip PE Inlay (7174-0250)
Health Canada
45263
Type II
2009/01/15
Synthes (Canada) Synfix LR, Low Profile U-Joint Driver
Health Canada
45120
Type II
2009/01/15
KCI Therapulse ATP
Health Canada
44999
Type II
2009/01/15
Biomerieux Vitek 2 GN Card
Health Canada
44650
Type II
2009/01/15
Abbott Voyager RX Coronary Dilation Catheter (1011759-08, 1011759-12)
Health Canada
44757
Type II
2009/01/15
Health Canada
44817
Type II
2009/01/15
Health Canada
45310
Type II
2009/01/15
Health Canada
45351
Type II
2009/01/15
Philips A) Allura XER FD10/10, B) Allura XPER FD20/10 System, C) Integris
H5000C Cardiology Imaging System (722016), D) Integris Allura (722043*),
E) Allura XPER FD10, F) Allura XPER FD20 System
Philips A) Allura XPER FD20/10 System, B) Integris H5000C Cardiology
Imaging System (722016), C) Integris Allura (722043*), D) Allura XPER
FD10, E) Allura XPER FD20 System
Stryker A)Intouch Critical Care Bed Model 2130 (2130-000-000), B) Intouch
critical Care Bed Model 2140 (2140-000-000)
Medical Device Control Office
209
Sanko Medical
Systems (HK)
Direct Health LTD
Medtronic
International, Ltd.
Philips Health
Care (Great
Bristol-Myers
Squibb (HK) LTD.
N.A.
Maquet Hong
Kong LTD.
Philips Health
Care (Great
Stryker China Ltd
Coloplast (HK)
LTD
Roche
Diagnostics
Smith & Nephew
LTD
Synthes
International Ltd.
N.A.
Biomerieux China
Ltd. (HK office)
Abbott
Laboratories LTD.
Philips Health
Care (Great
China)
Philips Health
Care (Great
China)
Stryker China Ltd
238400688
N.A.
2919 1300
2821 5480
2510 6146
N.A.
2393 9511
2821 5480
2518 6915
3628 7427
2485 7510
2648 7700
N.A.
N.A.
2356 7033
2593 2211
2821 5480
2821 5480
2518 6915
Department of Health
The Government of HKSAR
St Jude Medical Epicor LP Connecting Cable
MHRA
2008/012/010/061/001
FSCA
2009/01/20
BioMerieux Vironostika HIV Uni-Form II Ag/Ab
MHRA
2008/011/019/061/001
FSCA
2009/01/20
Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units)
MHRA
2008/010/002/401/007
FSCA
Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay
MHRA
2008/012/001/061/004
FSCA
Biomet Sterile 1/3 Tubular Plates (85 mm x 7 Holes)
ThermoFisher BO0351E, Tryptone soya broth, lot number 1045903
Ortho Solutions FPS Locking Screws (14mm/18ms)
ThermoFisher TPHA Test Kit
MHRA
MHRA
MHRA
MHRA
2008/012/002/291/002
2008/012/015/601/004
2008/010/017/401/001
2008/012/022/051/001
FSCA
FSCA
FSCA
FSCA
BioMerieux Chocolate PolyViteX VCAT3 agar
MHRA
2008/012/001/601/001
FSCA
Diagnostica Stago STA - Cuvettes
MHRA
2008/012/030/291/017
FSCA
Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H49-02
MHRA
2008/012/022/601/003
FSCA
Smiths Medical BCI 9200 Advisor Vital Signs Monitor
CMS Software 4.3.1 through 4.40.00
Sorin Mini Bypass Bag
Days Healthcare Walking frame
Olympus PK7300 blood grouping system
MHRA
MHRA
MHRA
MHRA
MHRA
2008/012/030/061/006
2008/012/012/601/004
2008/012/031/061/002
2008/010/007/401/016
2008/012/023/051/002
FSCA
FSCA
FSCA
FSCA
FSCA
Siemens Sentinel Apolipoprotein B
MHRA
2009/001/005/061/005
FSCA
Otto Bock Blizzard Active Wheelchair
Bausch & Lomb Akreos Advanced Optics Aspheric Lens
MHRA
MHRA
2008/012/029/301/002
2008/012/019/291/002
FSCA
FSCA
Maquet SERVO 300A Automode
MHRA
2008/012/016/061/001
FSCA
Philips Pulmonary Toolkit
MHRA
2008/012/029/291/001
FSCA
Medtronic MicroTargetingTM Drive System and Accessories
Baxter System 1000 Series of Hemodialysis Instruments with 4.D.0.3 or
4.D.0.4 Software
Kivi Uniloc wheelchair docking system AKE 04
Varian Medical Systems Eclipse 8.5 (build 8.2.2X) systems with distributed
Calculation Framework (DCF) 8.2.22 (Model no H48)
MHRA
2008/012/030/291/011
FSCA
N.A.
N.A.
Biomerieux China
2356 7033
Ltd. (HK office)
2009/01/20
N.A.
N.A.
Siemens
2009/01/20
2810 7533
Healthcare
Diagnostic Limited
2009/01/20
Goodman Medical Supplies Ltd 2332 4455
2009/01/20
N.A.
N.A.
2009/01/20
N.A.
N.A.
2009/01/20
N.A.
N.A.
Biomerieux China
2009/01/21
2356 7033
Ltd. (HK office)
2009/01/21
Healthpro Technology Co. Ltd
N.A.
Abbott
2009/01/21
2593 2211
Laboratories LTD.
2009/01/21
Goodman Medical Supplies Ltd 2332 4455
2009/01/21
N.A.
N.A.
2009/01/21
N.A.
N.A.
2009/01/21
N.A.
N.A.
2009/01/21
Olympus Hong Kong and China Limited
2170 5603
Siemens
2009/01/21
2810 7533
Healthcare
Diagnostic Limited
2009/01/21
N.A.
N.A.
2009/01/21
Bausch & Lomb (Hong Kong ) Ltd 2213 3371
Maquet Hong
2009/01/21
2393 9511
Kong LTD.
Philips Health
2009/01/22
2821 5480
Care (Great
2009/01/22
Medtronic International, Ltd.
2919 1300
MHRA
2009/001/013/291/003
FSCA
2009/01/22 Baxter Healthcare Ltd
MHRA
2009/001/012/301/001
FSCA
2009/01/22
FDA
N.A.
Class II
2009/01/22
Varian Medical Systems Pacific Inc.2724 2836
GE Centricity Enterprise Web 3.0 software
FDA
Z-0870-2009
Class II
2009/01/22
GE Medical
Systems Hong
Kong Ltd.
2783 1838
Stryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630-G-108)
and Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no: 5630-G-122)
FDA
Z-0869-2009
Class II
2009/01/22
Stryker China Ltd
2518 6915
N.A.
Siemens
Healthcare
Diagnostic Limited
Siemens
Healthcare
Diagnostic Limited
Abbott
Laboratories LTD.
Johnson &
Johnson Medical
(HK)
2807 8516
N.A.
Siemens Ariste MV Digital Linear Accelerator
FDA
Z-0857-2009
Class II
2009/01/22
Dade Behring (a Siemens Company) Dimension EXL Clinical Chemistry
System
FDA
Z-0581-2009
Class II
2009/01/22
Abbott Clinical Chemistry Bilirubin Calibrator
FDA
Z-0580-2009
Class II
2009/01/22
Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE Cup
FDA
Z-0532-2009 to Z-0539-2009
Class II
2009/01/22
FDA
Z-0129-2009
Class II
2009/01/22
Beckman Coulter Hong Kong Ltd 2240 6150
FDA
Z-0873-2009 to Z-0882-2009
Class II
2009/01/22
Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP
Software Version 2.2 (Part no 626553)
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block
Medical Device Control Office
210
N.A.
2810 7533
2810 7533
2593 2211
2738 6027
N.A.
Department of Health
The Government of HKSAR
Accuray RoboCouch Patient Support System (Model No 025007)
VIBE Quantum Pulse machine
Sterilmed various products
Nutricia Enteral feeding pump
Schulke & Mayr Mikrozid sensitive wipes
Cardinal Health Alaris GP LVP (Model 80063UN01), Alaris GP Guardrails
Volumetric Pump (Model 80263UN01-G)
Proact Medical Green System Duo Laryngoscope Handle
FDA
FDA
FDA
MHRA
MHRA
Z-0856-2009
Z-0582-2009
Z-0546-2009 to Z-0577-2009
MDA/2009/004
2008/011/019/061/022
Class II
Class II
Class II
MDA
FSCA
2009/01/22
2009/01/22
2009/01/22
2009/01/23
2009/01/23
Accuray Asia Ltd
N.A.
N.A.
N.A.
N.A.
2247 8628
N.A.
N.A.
N.A.
N.A.
MHRA
2009/001/005/061/007
FSCA
2009/01/23
N.A.
N.A.
MHRA
2008/010/024/401/007
FSCA
2009/01/23
N.A.
GE OEC 7600 and OEC 7700
MHRA
2009/001/009/061/002
FSCA
2009/01/29
Elekta Leksell GainmaPlan / Leksell SurgiPlan
Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade
MHRA
MHRA
2008/012/017/061/006
2009/001/007/061/008
FSCA
FSCA
2009/01/29
2009/01/29
Roche Hitachi 917 Modular Analytics
MHRA
2008/011/026/291/009
FSCA
2009/01/29
ThermoFisher Lactose peptone water with Durham's tube - BO0435B
Joint Replacement Instrumentation BiPolar Head
A2U Nano supportive seating system
Advanced Healthcare Technology Babypod II, Evo2 and Evo3
MHRA
MHRA
MHRA
MHRA
2009/001/012/601/001
2009/001/008/061/005
2008/012/023/401/006
2008/012/012/401/010
FSCA
FSCA
FSCA
FSCA
2009/01/29
2009/01/29
2009/01/29
2009/01/29
Siemens Somatom Definition AS
MHRA
2008/012/012/291/003
FSCA
2009/01/29
Siemens syngo Workflow MLR
MHRA
2008/012/022/051/003
FSCA
2009/01/29
Stryker Pneumo Sure XL High Flow Insufflator
Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M.
tuberculosis Complex, ACCUPROBE M. avium Complex
Croma-Pharma Quatrix Acrylic Intraocular lenses with a preloaded injector
ThermoFisher Oxoid Staphytect Plus Dry Spot Kit
Invacare Action® 2000 Manual Wheelchair
MHRA
2009/001/016/291/004
FSCA
2009/01/29
N.A.
GE Medical
Systems Hong
Kong Ltd.
N.A.
Stryker China Ltd
Roche
Diagnostics
N.A.
N.A.
N.A.
N.A.
Siemens
Healthcare
Diagnostic Limited
Siemens
Healthcare
Diagnostic Limited
Stryker China Ltd
MHRA
2009/001/014/601/004
FSCA
2009/01/29
N.A.
N.A.
MHRA
MHRA
MHRA
2009/001/012/291/017
2008/010/017/061/003
2008/010/020/401/012
FSCA
FSCA
FSCA
2009/01/29
2009/01/29
2009/01/29
N.A.
N.A.
N.A.
MHRA
2009/001/021/291/004
FSCA
2009/01/29
N.A.
N.A.
N.A.
Philips Health
Care (Great
Coloplast (HK)
LTD
Bausch & Lomb
(Hong Kong ) Ltd
2821 5480
Philips PCR Eleva
Coloplast Philips Catheter, 1Eye, Female Metric Thread (Catalogue no.
AG55)
Bausch & Lomb High Speed Vitrectomy cutter product (CX4804)
Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing (Model
no 0350600006)
Stryker Vision 3 Flat Panel Shroud (Part#0682-000-414, 0682-000-415 and
0682-000-416)
Stryker Dri-Lok Disposable Cannula
Coloplast
(HK) Ltd
Bausch &
Lomb
N.A.
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
2009/01/30
2009/01/30
2783 1838
N.A.
2518 6915
2485 7510
N.A.
N.A.
N.A.
N.A.
2810 7533
2810 7533
2518 6915
3628 7428
2213 3371
FDA
Z-0652-2009
Class II
2009/01/30
Stryker China Ltd
2518 6915
FDA
Z-0625-2009
Class II
2009/01/30
Stryker China Ltd
2518 6915
FDA
Z-0868-2009
Class II
2009/01/30
2518 6915
FDA
Z-0597-2009
Class II
2009/01/30
FDA
Z-0001-2009
Class II
2009/01/30
FDA
Z-0629-2009
Class II
2009/01/30
GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ
FDA
Z-0473-2009 to Z-0475-2009
Class II
2009/01/30
Cardinal Health Esmark Elastic Bandage
INGfertility Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant
Alimed Gait Belt (Transfer Aid) (Model 72108, 72109)
Quantimetrix QuanTscopics Urine Microscopics Contro
Hill- Rom 70 Semi-Electric Bed (Model HS-968)
FDA
FDA
FDA
FDA
FDA
Z-0615-2009 to Z-0616-2009
Z-0626-2009
Z-0598-2009
Z-0513-2009 to Z-0516-2009
Z-0506-2009
Class II
Class II
Class II
Class II
Class II
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
Stryker China Ltd
Philips Health
Care (Great
Philips Health
Care (Great
Accuray Asia Ltd
GE Medical
Systems Hong
Kong Ltd.
N.A.
N.A.
N.A.
N.A.
N.A.
Philips Vertical drive brake on patient supports
Philips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner
System (software)
Accuray CyberKnife Robotic Radiosurgery System
Medical Device Control Office
211
2821 5480
2821 5480
2247 8628
2783 1838
N.A.
N.A.
N.A.
N.A.
N.A.
Department of Health
The Government of HKSAR
Ansell Healthcare Products Conform XT - Gloves (Model: 69318)
Ossur HF ReSolve Open Back Halo Ring
Health Canada
Health Canada
45563
45100
Type II
Type II
2009/01/30
2009/01/30
Maquet Reservoirs (BEQ-VHK 2001)
Health Canada
45565
Type II
2009/01/30
Styker Dri-Lok Disposable Cannulas
Health Canada
45616
Type II
2009/01/30
BHM Medical Ergolift, Ergolift-2
Health Canada
45626
Type I
2009/01/30
Roche Diagnostics Process System Manager (Model: 3009696001)
Health Canada
45358
Type I
2009/01/30
Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K)
Harvest Technologies Autologous Platelet Concentrate System (Model: APC201)
Philips A) Multidiagnost Eleva - Image Intensifier (70832), B) Multidiagnost
Eleva - Flat Detector (70834), C) Omnidiagnost Eleva (Model: 708027)
White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ Zirconia
Disc
MC Healthcare Products QP2508 Hand Pendant (Model: HB43-U010-00/01
Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500-415)
Health Canada
41402
Type II
2009/01/30
Health Canada
45706
Type II
2009/01/30
Health Canada
45311
Type II
2009/01/30
Health Canada
Health Canada
Health Canada
44705
45786
45802
Type II
Type II
Type II
2009/01/30
2009/01/30
2009/01/30
Medical Device Control Office
212
N.A.
N.A.
Maquet Hong
Kong LTD.
Stryker China Ltd
Arjo Huntleigh
(Hong Kong) Ltd.
Roche
Diagnostics
Baxter Healthcare
Ltd
N.A.
Philips Health
Care (Great
N.A.
N.A.
N.A.
N.A.
N.A.
2393 9511
2518 6915
2508 1416
2485 7510
2807 8516
N.A.
2821 5480
N.A.
N.A.
N.A.
Department of Health
The Government of HKSAR
of Medical Device Safety Alerts - December 2008
MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN081201
Autoadapt DriveLOC and Carosafe II
MHRA
2008/003/006/301/002
FSCA
01-十二月-08
N/A
N/A
SN081202
Liko LikoScale 200
MHRA
2008/005/029/401/009
FSCA
01-十二月-08
N/A
N/A
SN081203
Diamed ID DiaScreen Prophylax
MHRA
2008/011/021/061/012
FSCA
01-十二月-08
DIAMED-CHINA LTD.
251 262 38
SN081204
ThermoFisher Staphaurex Plus
MHRA
2008/011/024/601/002
FSCA
01-十二月-08
N/A
N/A
SN081205
Philips Omni, Multi and Easy Diagnost Systems using GCF Velara
Generator with Tube Grid switch
MHRA
2008/011/021/291/003
FSCA
01-十二月-08
Philips Healthcare - Great China
2821 5480
SN081206
Zimmer Silhouette Axial Torque Wrench
MHRA
2008/011/021/061/010
FSCA
01-十二月-08
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN081207
Edwards Lifesciences Aquarius software operating manuals
MHRA
2008/011/024/291/007
FSCA
01-十二月-08
N/A
N/A
SN081208
Siemens Syngo Dynamics version 4.2, 5.x, 6.0
MHRA
2008/009/008/061/001
FSCA
02-十二月-08 Siemens Healthcare Diagnostic Limited
SN081209
Integra LifeSciences Uni-CP Compression Forceps (Spreader)
(Catalog no 339001ND)
FDA
Z-0307-2009
Class II
04-十二月-08
N/A
N/A
SN081210
Boston Scientific RF Ablation System Foot Switch
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field Action
05-十二月-08
Boston Scientific Hong Kong Ltd
2960 7136
SN081211
Boston Scientific Flextome Cutting Balloon w/Over-the-Wire
Delivery System
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field Action
05-十二月-08
Boston Scientific Hong Kong Ltd
2960 7136
SN081212
Johnson and Johnson ENDOPATH Electrosurgery Probe Plus II
Johnson & Johnson
Medical (HK)
N/A
Firm Initiated Field Action
05-十二月-08
Johnson & Johnson Medical (HK)
2738 6027
SN081213
Medtronic EnTrust® Implantable Cardioverter Defibrillators
MHRA
2008/011/021/061/005
FSCA
08-十二月-08
Medtronic International, Ltd.
2907 5911
SN081214
Otto Bock Healthcare 3R66 – Modular Polycentric Knee Joint
SN081215
Varian Linear accelerators other than Clinac
SN081216
GE Healthcare CT/e and HiSpeed X/I families of Computed
Tomography systems
SN081217
SN081218
Baxter COLLEAGUE Triple Channel Mono, and CXE Volumetric
Infusion Pumps 2M8153K and 2M9163
AMO Healon D Ophthalmic Viscosurgical Device (Lot No.
UD30654)
2810 7533
MHRA
2008/011/006/301/001
FSCA
08-十二月-08
N/A
N/A
Varian Medical
Systems Pacific Inc.
N/A
Firm Initiated Field Action
10-十二月-08
Varian Medical Systems Pacific Inc.
2722 8123
GE Medical Systems
Hong Kong Ltd.
N/A
Firm Initiated Field Action
10-十二月-08
GE Medical Systems Hong Kong Ltd.
2783 1888
MHRA
2008/011/028/061/015
FSCA
15-十二月-08
Baxter Healthcare Ltd
2807 8555
FDA
Z-0343-2009
Class I
15-十二月-08
AMO Asia Limited
2480 3330
SN081219
Integra NeuroSciences Gravity Compensating Accessory
FDA
Z-0458-2009
Class I
15-十二月-08
N/A
N/A
SN081220
Posey Synthetic Leather and Biothane Waist and Wrist Restraints
(Catalog No 2217SL and 2217B)
FDA
Z-0286-2009
Class II
15-十二月-08
N/A
N/A
SN081221
Siemens AXIOM Artis System
FDA
Z-0312-2009 to Z-0317-2009
Class II
15-十二月-08 Siemens Healthcare Diagnostic Limited
2810 7533
SN081222
Siemens syngo MultiModality WorkPlace (MM WP), software
product (Model No 10140720)
FDA
Z-0324-2009
Class II
15-十二月-08 Siemens Healthcare Diagnostic Limited
2810 7533
SN081223
Terumo Sarns Sternal Saw II System Power Unit
FDA
Z-0358-2009 to Z-0359-2009
Class II
15-十二月-08
2529 0451
Medical Device Control Office
213
TERUMO CHINA (H.K.) LTD.
Department of Health
The Government of HKSAR
SN081224
SN081225
Medtronic 5F, 6F, 7F BardSelect 1cm Percutaneous Catheter
Introducer Set
Johnson and Johnson STERRAD NX Sterilizer (Product Code
10033)
FDA
Z-0441-2009 to Z-0444-2009
Class II
15-十二月-08
Medtronic International, Ltd.
2907 5911
FDA
Z-0484-2009
Class II
15-十二月-08
Johnson & Johnson Medical (HK)
2738 6027
SN081226
Radiometer Calibrator 1 Solution for the ABL700 Series
FDA
Z-0457-2009
Class II
15-十二月-08
N/A
N/A
SN081227
Cardinal Health GSI Audera (version 2.6 Software) System
FDA
Z-0195-2009
Class II
15-十二月-08
N/A
N/A
SN081228
Stryker Pain Pump 2 Blockaid (0575-100-000)
Health Canada
44921
Type II
17-十二月-08
Stryker China Ltd
2518 6988
SN081229
Smiths Medical Disposable Norothermic IV Admin. Sets (DI-100, DI50)
Health Canada
44870
Type II
17-十二月-08
Smiths Medical (S.E. Asia) Ltd.
2317 0988
SN081230
Oxoid Filteredhorse Serum (SR0035C)
Health Canada
44449
Type II
17-十二月-08
South East Chemical & Instrument Ltd
28026333
SN081231
BHM Battery Model NDA 0200-20
Health Canada
45060
Type II
17-十二月-08
BHM Medical Inc.
N/A
SN081232
Technidata TD-Synergy Software (TD-SYS-01)
Health Canada
44744
Type II
17-十二月-08
N/A
N/A
SN081233
Orasure Intercept Mirco-Plate EIA Kit (Model: 61452, 61454, 61456)
Health Canada
44505
Type II
17-十二月-08
N/A
N/A
SN081234
Hill-Rom Liko Uno 100, 101, 102 Patient Lift
Health Canada
44701
Type II
17-十二月-08
N/A
N/A
Health Canada
44646
Type II
17-十二月-08
N/A
N/A
Health Canada
44525
Type II
17-十二月-08
Philips Healthcare - Great China
2821 5480
SN081235
SN081236
InteleViewer module of the Intel PACS and Intele Viewer
Workstation (V3-X-X)
Philips EGM Essential Gas Module (GI M1013A, G5 M1019A),
Intellivue Patient Monitoring Sys. (M8002A, M8004A, M8007A),
Intellivue Patient Monitor (M8105A, M8105AT)
Clinical Instruments Carotid Shunt Outlying / Inlying with T-Port
Health Canada
44867
Type II
17-十二月-08
N/A
N/A
SN081238
Beckman Coulter UniCel Dxl Access Immunoassay Systems Wash
Buffer II Lots 70662 and 70637
MHRA
2008/011/027/601/001
FSCA
17-十二月-08
Beckman Coulter Hong Kong Ltd
2240 6150
SN081239
Siemens CT Syngo Dual Energy Viewer
MHRA
2008/010/031/061/006
FSCA
17-十二月-08 Siemens Healthcare Diagnostic Limited
SN081240
Fresenius Medical Care 5008 dialysis machine
MHRA
2008/012/001/061/001
FSCA
17-十二月-08
N/A
N/A
SN081241
Smiths Medical Deltec Cozmo Insulin Pump Model number 1800
MHRA
2008/011/027/061/013
FSCA
17-十二月-08
Smiths Medical (S.E. Asia) Ltd.
2317 0988
SN081242
Terumo Sarns Level Sensor II Pads (Ref 195240)
FDA
Z-0311-2009
Class II
18-十二月-08
TERUMO CHINA (H.K.) LTD.
2866 0811
SN081243
Terumo Advanced Perfusion System 1 (Model no.: 801040,
801041, 816570, 816571)
FDA
Z-0354-2009 to Z-0357-2009
Class II
18-十二月-08
TERUMO CHINA (H.K.) LTD.
2866 0811
SN081244
GE Centricity PACS RA1000 Workstation
FDA
Z-0460-2009
Class II
18-十二月-08
GE Medical Systems Hong Kong Ltd.
2783 1888
SN081245
Siemens Dade Behring Dimension Enzymatic Creatinine Flex
reagent cartridge, DF270
FDA
Z-0485-2009
Class II
18-十二月-08 Siemens Healthcare Diagnostic Limited
SN081246
Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit
FDA
Z-0414-2009
Class II
18-十二月-08
N/A
N/A
SN081247
Acumed Modular Shoulder Body Assembly
FDA
Z-0477-2009
Class II
18-十二月-08
N/A
N/A
SN081248
Promega RNAgents Total RNA Isolation System (Cat. #Z5110)
FDA
Z-0483-2009
Class II
18-十二月-08
Bio-Gene Technology Ltd
2646 6101
SN081249
Medtronic LIFEPAK® 9, LIFEPAK 9P, LIFEPAK 12, LIFEPAK
20/20e External Sterilizable Paddles and Pediatric Paddles
MHRA
2008/011/024/291/001
FSCA
19-十二月-08
Medtronic International, Ltd.
2907 5911
SN081250
Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades
FDA
N/A
Class I
22-十二月-08
N/A
N/A
SN081237
Medical Device Control Office
214
2810 7533
2810 7533
Department of Health
The Government of HKSAR
SN081251
Bard feeding kits (containing ConMed grasping snares)
SN081252
Medtronic Reveal DX Insertable Cardiac Monitor (ICM)
SN081253
Joerns Healthcare Oxford disposable slings
SN081254
Stryker Custom Cranial Implant Kits
SN081255
SN081256
Boston Scientific iLab Ultrasound Imaging System, models 120INS
and 240INS
Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale,
Manual 4-Point DPS and scale
Bard Pacific Health
Care Co Ltd
Medtronic
International Ltd
N/A
Firm Initiated Field Action
22-十二月-08
Bard Pacific Health Care Co Ltd
886-2-2503-1900
N/A
Firm Initiated Field Action
23-十二月-08
Medtronic International, Ltd.
2907 5911
MHRA
MDA/2008/088
MDA
23-十二月-08
N/A
N/A
FDA
N/A
Class I
29-十二月-08
Stryker China Ltd
2518 6988
FDA
Z-0338-2009
Class II
30-十二月-08
Boston Scientific Hong Kong Ltd
2960 7136
FDA
Z-0412-2009 to Z-0413-2009
Class II
30-十二月-08
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
SN081257
Beckman Coulter Vidiera NsP Nucleic Sample Preparation
FDA
Z-0454-2009
Class II
30-十二月-08
Beckman Coulter Hong Kong Ltd
2240 6150
SN081258
Alfa Wassermann ACE and ACE Alera Hemoglobin A1C
FDA
Z-0482-2009
Class II
30-十二月-08
N/A
N/A
SN081259
FHC MicroTargeting Electrode
FDA
Z-0497-2009 to Z-0498-2009
Class II
30-十二月-08
N/A
N/A
SN081260
Arjo Maxi Move, Model NDA0200-20 Batteries Pack
FDA
Z-0503-2009
Class II
30-十二月-08
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
SN081261
Bk Medical Single-use sterile puncture attachment UA1256-U
FDA
Z-0504-2009
Class II
30-十二月-08
N/A
N/A
SN081262
Boston Scientific Convoy Advanced Delivery Sheath Kits
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field Action
30-十二月-08
Boston Scientific Hong Kong Ltd
2960 7136
SN081263
Boston Scientific Gold Probe Single-Use Bi-Polar
Electrohemostasis Catheters
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field Action
30-十二月-08
Boston Scientific Hong Kong Ltd
2960 7136
SN081264
Wescott Medical Sae-Flo MD Extension Set with Y-Connector
MHRA
2008/010/022/601/001
FSCA
31-十二月-08
N/A
N/A
SN081265
Siemens Leonardo Workstation
MHRA
2008/004/010/061/006
FSCA
31-十二月-08 Siemens Healthcare Diagnostic Limited
SN081266
Biotronik EDP 30/A
MHRA
2007/002/007/401/009
FSCA
31-十二月-08
Medical Device Control Office
215
N/A
2810 7533
N/A
Department of Health
The Government of HKSAR
of Medical Device Safety Alerts - November 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
FDA
N/A
Class I
2009/11/03
N/A
N/A
SN081101
vibe Technologies, Vibrational Integrated Biophotonic Energizer
(VIBE) Machine Multi-Frequency Field Generator
SN081102
Beckman Coulter UniCel® DxI® 800 and UniCel DxI 600 Access®
Immunoassay Systems and UniCel DxC 880i SYNCHRON®
Access Clinical System
MHRA
2008/010/027/601/002
FSCA
2008/11/03
Beckman Coulter Hong Kong Ltd
N/A
SN081103
Smiths Medical Wallace Oocyte Recovery Needle
MHRA
2008/010/022/061/011
FSCA
2008/11/03
N/A
N/A
SN081104
Pride Jazzy 1121 power chairs
MHRA
2008/004/024/401/003
FSCA
2008/11/03
N/A
N/A
SN081105
TomoTherapy Hi-Art System
MHRA
2008/010/014/061/018
FSCA
2008/11/03
N/A
N/A
SN081106
Teleflex Medical Great Ormond Street Tracheostomy Cannula Set
MHRA
2008/006/018/061/013
FSCA
2008/11/03
N/A
N/A
SN081107
Cardiac Science Powerheart AEDs
MHRA
2008/002/011/061/010
FSCA
2008/11/03
N/A
N/A
SN081108
TerumoTenderflow Pediatric Arterial Cannula
MHRA
2008/010/028/061/006
FSCA
2008/11/03
N/A
N/A
SN081109
Biomet Various AGC /5+ Reamer /Hiploc Instrument cases
MHRA
2008/010/027/601/003
FSCA
2008/11/03
N/A
N/A
SN081110
Biomet EZloc Femoral Fixation 9-10mm Standard Length -- 904781
MHRA
2008/010/014/601/004
FSCA
2008/11/03
N/A
N/A
SN081111
Abbott Voyager NC Coronary Dilatation Catheter (4.5mm diameter)
Abbott Laboratories
Ltd
N/A
Firm Initiated Field Action
2008/11/05
Abbott Laboratories Ltd.
2593 2211
SN081112
Tyco Healthcare (Covidien) ReliOn Insulin Syringes
FDA
N/A
Press Release
2008/11/06
Tyco Healthcare (HKSAR) LTD
3157 7220
SN081113
Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation
FDA
Z-0184-2009 to Z-0187-2009
Class II
2008/11/07
Medtronic International, Ltd.
2907 5911
SN081114
B Braun Smallbore T-Port Extension Set (Item no 474515) (
FDA
Z-0199-2009
Class II
2008/11/07
B Braun Medical Hong Kong
2277 6125
SN081115
SN081116
Siemens Axiom Aristos FX Multipurpose Radiography System
(Model no 7414803)
Siemens Acuson/Sonovista X300 Ultrasound systems (Software
version 2.0.1 - 2.0.05, 3.0.01 and 3.0.02
FDA
Z-0163-2009
Class II
2008/11/07
FDA
Z-0086-2009
Class II
2008/11/07
Siemens Healthcare Diagnostic
Limited
Siemens Healthcare Diagnostic
Limited
Siemens Healthcare Diagnostic
Limited
2810 7533
2810 7533
SN081117
Siemens Coherence Therapist Systems
FDA
Z-0089-2009 to Z-0099-2009
Class II
2008/11/07
SN081118
Siemens Syngo Imaging with versions VB20B, VB20D, VB20G,
VB25B,VB30A, VB30A-SP1 and VB30A-SP2 (Model no 10014063)
FDA
Z-0102-2009
Class II
2008/11/07
SN081119
Siemens Acuson X300 Ultrasound Systems (Model no. 10037409,
10038837, 10348531, 10132987, 10133170, 10348532, 10348533)
FDA
Z-0111-2009
Class II
2008/11/07
SN081120
Siemens Artiste MV System (Part no 8139789)
FDA
Z-0116-2009
Class II
2008/11/07
SN081121
Stryker Osteosynthesis Reduction Spoon (Product Code 18060125)
FDA
Z-0191-2009
Class II
2008/11/07
Stryker China Ltd
2518 6988
SN081122
Stryker Ray TFC Device with End Caps
FDA
Z-0151-2009
Class II
2008/11/07
Stryker China Ltd
2518 6988
Medical Device Control Office
216
Siemens Healthcare Diagnostic
Limited
Siemens Healthcare Diagnostic
Limited
Siemens Healthcare Diagnostic
Limited
2810 7533
2810 7533
2810 7533
2810 7533
Department of Health
The Government of HKSAR
SN081123
GE Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision Software
FDA
Z-0112-2009
Class II
2008/11/10
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081124
Baxter Auto Syringe AS50 Infusion Pump (Product Code 1M8550)
FDA
Z-0152-2009
Class II
2008/11/10
Baxter Healthcare Ltd
2807 8500
FDA
Z-0006-2009 to Z-0012-2009
Class II
2008/11/10
Roche Diagnostics (Hong Kong) Ltd
2485 7510
FDA
Z-0165-2009
Class II
2008/11/10
Roche Diagnostics (Hong Kong) Ltd
2485 7510
SN081125
SN081126
Roche Diagnostic LDL_C, IRON2, CREP2, STFR, HDLC3, ALBT2,
NAPA2
Roche/Hitachi Modular E Module immunoassay analyzer (GMMI
Nos. 04998642001 and 03617505001)
SN081127
Philips Respiratory Gating System (Model # 455011203131 and
455011203191)
FDA
Z-0132-2009
Class II
2008/11/10
Philips Healthcare - Great China
2821 5480
SN081128
Philips M3811B Telemonitoring Clinical Review Software (version
Build 1.1.2.11d, B.02.07)
FDA
Z-0100-2009
Class II
2008/11/10
Philips Healthcare - Great China
2821 5480
SN081129
Smith & Nephew GlobTek, Inc. Power Supply for Medical Use (Par
no: TR9CE4000LCP-Y-MED Model GTM21097-5012)
FDA
Z-0162-2009
Class II
2008/11/10
Smith & Nephew Limited
2648 7700
SN081130
Facet Technologies Premier Value Lancing Device (UPC Code:
840986016707)
FDA
Z-0174-2009
Class II
2008/11/10
N/A
N/A
SN081131
Biomet brand Modular Microplasty Cup Inserter (Model 31-400600)
FDA
Z-0181-2009
Class II
2008/11/10
N/A
N/A
SN081132
Pointe Scientific Liquid AST (SGOT) Reagent Set, AST R1 Reagent
FDA
Z-0171-2009
Class II
2008/11/10
N/A
N/A
SN081133
Maquet Accessory Head Rest for Alphastar Operating Tables (USA
Part no 1130 67FO)
FDA
Z-0161-2009
Class II
2008/11/10
Maquet Hong Kong Ltd
2393 9511
SN081134
Allez Spine Laguna Pedicle Screw System, Del Mar Pedicle Screw
System, Cross Connectors
FDA
Z-0153-2009 to Z-0155-2009
Class II
2008/11/10
N/A
N/A
SN081135
Intraop Medical Mobetron Model 1000, mobile electron linear
accelerator
FDA
Z-0014-2009
Class II
2008/11/10
N/A
N/A
SN081136
Medline Latex Free C- Section CDS-LF, Vaginal Delivery CDS-LF,
Labor Kit & Postpartum CDS-LF, Mom/Baby Admit Kit-LF
FDA
Z-0015-2009 to Z-0019-2009
Class II
2008/11/10
N/A
N/A
SN081137
Hill-Rom Envision E700 Low Airloss Therapy Surface
FDA
Z-0088-2009
Class II
2008/11/10
N/A
N/A
SN081138
Applied Medical Separator Abdominal Access System, Lap
Banding Kit, Lap Roux-EN-Y Kit
FDA
Z-0023-2009 to Z-0029-2009
Class II
2008/11/10
N/A
N/A
SN081139
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary
Stent System
FDA
Z-0035-2009 to Z-0085-2009
Class II
2008/11/10
N/A
N/A
SN081140
Cook Endoscopy Zilver Expandable Metal Biliary Stent System,
ZILBS-10-6
FDA
Z-0113-2009
Class II
2008/11/10
Cook Asia (Hong Kong) Ltd.
2781 0232
SN081141
Joerns Healthcare Mermaid, Dipper and Ranger bath hoists
MHRA
MDA/2008/079
MDA
2008/11/10
N/A
N/A
SN081142
MHRA
2008/011/003/061/010
FSCA
2008/11/10
N/A
N/A
MHRA
2008/010/030/061/016
FSCA
2008/11/10
MHRA
2008/010/031/061/003
FSCA
2008/11/10
Roche Diagnostics (Hong Kong) Ltd
Siemens Healthcare Diagnostic
Limited
2485 7510
SN081144
Tosoh Bioscience TSKgel G8 Variant HSi
Roche Diagnostics MODULAR ANALYTICS Software version
08.03
Siemens Syngo Imaging
SN081145
CODAN Pressure Monitoring Kit STP-90R
MHRA
2008/002/028/401/002
FSCA
2008/11/10
N/A
N/A
SN081146
Stryker Humerus Head Fixed and HMRS - Distal Humerus Cone
MHRA
2008/010/015/061/005
FSCA
2008/11/11
Stryker China Ltd
2518 6988
SN081143
Medical Device Control Office
217
2810 7533
Department of Health
The Government of HKSAR
SN081147
Biomet AGC V2 Total Knee Moulded ArComTibial Components
MHRA
2008/009/025/401/008
FSCA
2008/11/11
N/A
N/A
SN081148
ThermoFisher BO0077M, Tryptone soya broth
MHRA
2008/011/005/601/005
FSCA
2008/11/11
N/A
N/A
SN081149
GE Healthcare Signa MR 2239500, 5116064 and 5118162
MHRA
2008/011/004/051/004
FSCA
2008/11/11
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081150
Bio-Rad Variant II Turbo Hemoglobin Testing System with CDM 4.0
MHRA
2008/011/005/061/009
FSCA
2008/11/11
N/A
N/A
SN081151
Bio-Rad Variant II Turbo HCook Zenith Flex AAA Endovascular
Graft emoglobin Testing System with CDM 4.0
MHRA
2008/008/007/061/009
FSCA
2008/11/12
Cook Asia (Hong Kong) Ltd.
2781 0232
SN081152
Maquet Pedal 1009.81 for operating tables
MHRA
2008/011/003/061/013
FSCA
2008/11/12
Maquet Hong Kong Ltd
N/A
SN081153
KYMCO Healthcare Midi XL
MHRA
2008/010/027/261/001
FSCA
2008/11/12
N/A
N/A
SN081154
Days healthcare Strider Maxi and Strider Midi 4+
MHRA
2008/010/023/301/002
FSCA
2008/11/12
N/A
N/A
SN081155
Sunrise Medical OXFORD Midi 150A lifts
MHRA
2008/004/014/401/003
FSCA
2008/11/13
N/A
N/A
SN081156
Marshall Products adult and paediatric manual resuscitators
MHRA
2008/010/029/401/001
FSCA
2008/11/13
N/A
N/A
SN081157
TSCI Fluido SA 200
MHRA
2008/011/006/051/008
FSCA
2008/11/13
N/A
N/A
SN081158
Biomet Vanguard Width Checker 67.5 / 70 / 75
Health Canada
40888
Type II
2008/11/14
Goodman Medical Supplies Ltd
2332 4455
2810 7533
SN081159
Siemens AG Syngo Imaging (Model 10014063)
Health Canada
44245
Type II
2008/11/14
Siemens Healthcare Diagnostic
Limited
SN081160
B-K Medical Single Use Sterile Puncture UA 1256-U
Health Canada
44063
Type II
2008/11/14
S & V Sanford Instrument
N/A
SN081161
Roche Hitachi D-Dimer
Health Canada
43711
Type II
2008/11/14
Roche Diagnostics (Hong Kong) Ltd
2485 7510
SN081162
Kerr Premise Unidose
Health Canada
44081
Type II
2008/11/14
N/A
N/A
SN081163
Ondal Stryker Vision 3 Elect Mon Shroud
Health Canada
44076
Type II
2008/11/14
Stryker China Ltd
2518 6988
SN081164
Ondal Flat Panel/Navigation Arm
Health Canada
44179
Type II
2008/11/14
Stryker China Ltd
2518 6988
SN081165
Biomet Microfixation Lactosorb 1.5MM 8Hole STR EXT Plate
Health Canada
43369
Type II
2008/11/14
Goodman Medical Supplies Ltd
2332 4455
SN081166
GE Centricity PACS Software
Health Canada
42408
Type II
2008/11/14
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081167
Medtronic Synchromed EL, Synchromed II infusion pumps
Health Canada
44005
Type II
2008/11/14
Medtronic International, Ltd.
2907 5911
SN081168
Terumo Advanced Perfusion System 1
Health Canada
42752
Type II
2008/11/14
TERUMO CHINA (H.K.) LTD.
2866 0811
SN081169
Synthes sternal Fixation System - Cable Ferrule
Health Canada
44393
Type II
2008/11/14
SN081170
Siemens Somatom Sensation / Cardiac 64
Health Canada
44298
Type II
2008/11/14
N/A
Siemens Healthcare Diagnostic
Limited
SN081171
Tripath Prepstain System
Health Canada
44291
Type II
2008/11/14
BD Asia Ltd (Hong Kong)
2575 8668
SN081172
Medrad 3.0 T Prostat eCoil
Health Canada
44234
Type II
2008/11/14
Ultronics Enterprises Ltd
2764 5208
SN081173
Terumo Level Sensor Transducer
Health Canada
43401
Type II
2008/11/14
TERUMO CHINA (H.K.) LTD.
2866 0811
SN081174
TomoTherapy Hi-Art System
Health Canada
44265
Type II
2008/11/14
N/A
N/A
Medical Device Control Office
218
N/A
2810 7533
Department of Health
The Government of HKSAR
SN081175
Gambro Prismaflex system
Health Canada
44403
Type II
2008/11/14
Gambro China Ltd
N/A
SN081176
Gerno Model 35X Proflexx Stretcher
Health Canada
44082
Type II
2008/11/14
Goodman Medical Supplies Ltd
2332 4455
SN081177
BC Unicel DXC 6001 Assay Protocol File, Access Immunoassay
system Protocol file, Access System 2 Protocol File, Sysnchron LXI
725 Assay Protocol file
Health Canada
44259
Type II
2008/11/14
Beckman Coulter Hong Kong Ltd
2240 6150
SN081178
Pascal Siltrax Plus 8 Gingival Retraction Cord
Health Canada
43384
Type II
2008/11/17
N/A
N/A
SN081179
ACS Holter Reporter Master VII Analyzer
Health Canada
43854
Type II
2008/11/17
N/A
N/A
SN081180
Angio 3-0 Nylon Suture Product
Health Canada
44163
Type I
2008/11/17
N/A
N/A
SN081181
Thomas Medical Products 18 gage XTW needles
FDA
Z-0131-2009
Class II
2008/11/17
N/A
N/A
SN081182
7F Bard SSV 13 cm Split Sheath with Valve and sideport (Catalog
No: 808700)
FDA
Z-0280-2009
Class II
2008/11/17
N/A
N/A
SN081183
Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3
FDA
Z-0207-2009
Class II
2008/11/17
N/A
N/A
SN081184
Drummond Scientific Iris Sample Processing SafeCrit 75mm and
40mm Tubes, Separation Technology ClearCRIT Capillary Tubes
FDA
Z-0208-2009 to Z-0211-2009
Class II
2008/11/17
N/A
N/A
SN081185
Iverness Medical BioStar OIA FLU AB (Catalog 90007)
FDA
Z-0212-2009
Class II
2008/11/17
N/A
N/A
SN081186
Pointe Scientific Liquid Glucose HEX (R1); HEX (R2); HEX; HEXO
Reagent Sets
FDA
Z-0219-2009 to Z-0224-2009
Class II
2008/11/17
N/A
N/A
SN081187
Porter Instrument Bag Tee Assembly Model (P1407A)
FDA
Z-0228-2009
Class II
2008/11/17
N/A
N/A
SN081188
Biomet Microfixation HT X-Drive Screw
FDA
Z-0282-2009
Class II
2008/11/17
N/A
N/A
SN081189
Advanced Bionics Preision Charger 1.0 (Model # SC-5300)
FDA
Z-0271-2009
Class II
2008/11/17
N/A
N/A
SN081190
Alcon PurePoint System Operator's Manual (Catalog no
8065751131 Rev. B)
FDA
Z-0274-2009
Class II
2008/11/17
Alcon Hong Kong Ltd
2568 0636
SN081191
Terumo Sarns Level Sensor II (Yellow and Red) (Part # 195215
and # 195274)
FDA
Z-0295-2009 to Z-0296-2009
Class II
2008/11/17
TERUMO CHINA (H.K.) LTD.
2866 0811
SN081192
TERUMO Advanced Perfusion System 1 Base (Model 801763 and
801764)
FDA
Z-0203-2009 to Z-0204-2009
Class II
2008/11/17
TERUMO CHINA (H.K.) LTD.
2866 0811
2810 7533
SN081193
Siemens AXIOM Artis and Artis zee
FDA
Z-0193-2009 to Z-0194-2009
Class II
2008/11/17
Siemens Healthcare Diagnostic
Limited
SN081194
Animas (Johnson & Johnson ) One Touch Ping Glucose Monitoring
System
FDA
Z-0283-2009
Class II
2008/11/17
Johnson & Johnson Medical (HK)
2738 6027
SN081195
Stryker Hipstar V40 Femoral Stem Howemedica
FDA
Z-0227-2009
Class II
2008/11/17
Stryker China Ltd
2518 6988
SN081196
Gyrus ACMI (Olympus) dissector PlasmaKnife (DPK) (Catalog no
7035-3005)
FDA
Z-0273-2009
Class II
2008/11/17
Olympus Hong Kong and China
Limited
2170 5678
SN081197
Philips Intera, Achieva and Panorama HFO (Philips MR), 3160
(Precess) MRI Patient Monitoring System (Invivo)
MHRA
2008/009/025/061/013
FSCA
2008/11/17
Philips Healthcare - Great China
2821 5480
SN081198
Unomedical Unilect 4831Q and 4841P Short Term Monitoring
Electrodes
MHRA
2008/010/023/061/011
FSCA
2008/11/18
N/A
N/A
SN081199
Siemens ADVIA Centaur® and ACS:180® Systems
MHRA
2008/011/004/061/009
FSCA
2008/11/18
N/A
N/A
Medical Device Control Office
219
Department of Health
The Government of HKSAR
B Braun Diacap Ultra Dialysis Fluid and Online Filter, 7107366 and
7107365
MHRA
2008/010/007/061/011
FSCA
2008/11/18
B Braun Medical Hong Kong
2277 6125
MHRA
2008/010/030/061/008
FSCA
2008/11/18
Stryker China Ltd
2518 6988
Johnson & Johnson
Medical (HK)
N/A
Firm Initiated Field Action
2008/11/19
Johnson & Johnson Medical (HK)
2738 6027
Baxter Healthcare
Ltd
N/A
Firm Initiated Field Action
2008/11/19
Baxter Healthcare Ltd
2807 8516
SN0811104 Beckman Coulter Power Processor with LX Connections, 6605741
MHRA
2008/011/005/601/001
FSCA
2008/11/20
Beckman Coulter Hong Kong Ltd
2240 6150
SN0811105 Clinical Innovations ClearView Uterine Manipulator
MHRA
2008/011/013/061/003
FSCA
2008/11/20
N/A
N/A
SN0811106 Coloplast EasiCath Catheter and EasiCath Luer Lock Catheter
MHRA
2008/011/011/291/008
FSCA
2008/11/20
N/A
N/A
SN0811107 Stanmore Implants METS Femoral Shaft
MHRA
2008/011/014/061/012
FSCA
2008/11/20
N/A
N/A
FDA
Z-0287-2009
Class II
2008/11/21
Boston Scientific Hong Kong Ltd
2960 7136
SN0811100
SN0811101 Stryker V40 ORTHINOX femoral head 28/-4 mm & 28/0 mm
SN0811102 Johnson & Johnson Sterrad 100S Sterilizers
SN0811103
Baxter COLLEAGUE Triple Channel Mono CX and CXE Volumetric
Infusion Pumps (Product Codes: 2M8153K)
Boston Scientific NAMIC Custom Angiographic Kit
SN0811108
(REF/Catalog#60190254)
SN0811109
Sunquest Laboratory System (Software version: Sunquest
Laboratory v5.4.2, v6.1, v6.2 and v6.3)
FDA
Z-0214-2009
Class II
2008/11/21
N/A
N/A
SN0811110
Gabauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin
Refrigerant (Aerosol Can) (P/N 0386-0020-20)
FDA
Z-0218-2009
Class II
2008/11/21
N/A
N/A
SN0811111 Smith & Nephew SOFTSILK 1.5 SCREW, 8mm x 20mm
MHRA
2008/011/014/061/008
FSCA
2008/11/21
N/A
N/A
SN0811112 Codman, A J&J Archimedes implantable infusion pump
MHRA
2008/004/021/061/008
FSCA
2008/11/21
Johnson & Johnson Medical (HK)
2738 6027
Comis Orthopaedics MIHR Modular Femoral Head Sleeve Size 0,
product code 028-10-2
MHRA
2008/009/002/061/011
FSCA
2008/11/21
N/A
N/A
Philips IntelliVue Patient Monitors (the table mount, part# M8000SN0811114
64100)
MHRA
2008/011/019/061/021
FSCA
2008/11/24
Philips Healthcare - Great China
2821 5480
SN0811115 GE Giraffe OmniBed (Cleaning & Care Guidelines)
MHRA
2008/011/018/601/002
FSCA
2008/11/24
GE Medical Systems Hong Kong Ltd.
2783 1838
SN0811116 Phadia Varelisa U1RNP Antibodies Kit (model 17096)
Health Canada
44383
Type II
2008/11/24
SN0811117 Siemens Axiom Luminos DRF (Model 10252047)
Health Canada
44442
Type II
2008/11/24
2810 7533
SN0811118 Fisher and Paykel RT240 & RT340 Adult Breathing Circuit
Health Canada
44527
Type II
2008/11/24
N/A
Siemens Healthcare Diagnostic
Limited
Foxwood Medical Supplies
Health Canada
44440
Type II
2008/11/24
Smiths Medical (S.E. Asia) Ltd.
2317 0988
Health Canada
44551
Type II
2008/11/24
Siemens Healthcare Diagnostic
Limited
2810 7533
Health Canada
44535
Type II
2008/11/24
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
MHRA
2008/011/003/061/012
FSCA
2008/11/26
N/A
N/A
FDA
Z-0004-2009
Class II
2008/11/28
Johnson & Johnson Medical (HK)
2738 6027
FDA
Z-2388-2008
Class II
2008/11/28
Medtronic International, Ltd.
2907 5911
SN0811125 Terumo Advanced Perfusion System 1 (Model 801040 and 801041)
FDA
Z-0309-2009 to Z-0310-2009
Class II
2008/11/28
TERUMO CHINA (H.K.) LTD.
2866 0811
Abbott CELL-DYN Sapphire Hematology Analyzer (List no 08H00SN0811126
01, 08H00-03)
FDA
Z-0306-2009
Class II
2008/11/28
Abbott Laboratories Ltd.
2593 2211
SN0811113
SN0811119
Smiths Potex Blue Line Ultra Tracheostomy Kit (Model
100/812/070)
SN0811120 Siemens Symbia T Series (Model 10275009)
SN0811121
SN0811122
SN0811123
SN0811124
BHM Arjo Maxi 500 (KM560101, KM560104, KM560108,
KM560181, KM560184, KM560188)
Bard WIZARD Dual Port Low Profile Replacement Gastrostomy
Device
Johnson and Johnson Lifescan One Touch Litra Test Strips (Part
no 020-994-02)
Medtronic Physio-Control Lifepak 20 Defibrillator/monitor
Medical Device Control Office
220
N/A
2770 6877
Department of Health
The Government of HKSAR
Biomet Vanguard DCM Plus 16mm x 63/67mm Tibial Bearing (REF
183726)
FDA
Z-0289-2009
Class II
2008/11/28
N/A
N/A
SN0811128 Zimmer Alumina Ceramic Femoral Head
FDA
Z-0299-2009 to Z-0304-2009
Class II
2008/11/28
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Stelkast Proven Cemented Semi-Constrained Total Knee (Part No.
SN0811129
SC1591-38)
FDA
Z-0308-2009
Class II
2008/11/28
N/A
N/A
SN0811130 Theken Spine Bone Marrow Aspiration Kit (Part no 50-20-001)
FDA
Z-0272-2009
Class II
2008/11/28
N/A
N/A
SN0811127
Medical Device Control Office
221
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - October 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN081001
Medtronic INDURA 1P Intrathecal Catheter (Model 8709SC),
Intrathecal Catheter (Model 8731SC), Sutureless Pump Connector
Revision Kit (Model 8678) and Intrathecal Catheter Pump Segment
Revision Kit (Model 8596SC)
FDA
Z-2380-2008 to Z-2383-2008
Class I
02-十月-08
Medtronic International, Ltd.
2907 5911
SN081002
Medtronic IsoMed Refill Kit (Model 8553)
FDA
Z-1903-2008
Class II
02-十月-08
Medtronic International, Ltd.
2907 5911
SN081003
Stryker Osteonics Scorpio Total Knee
FDA
Z-2079-2008
Class II
02-十月-08
Stryker China Ltd
2518 6988
SN081004
Stryker Hoffman II compact Sterile Wrist Kit
FDA
Z-2080-2008
Class II
02-十月-08
Stryker China Ltd
2518 6988
SN081005
Stryker Universal Notch Preparation Guide amd X-Celerate
Universal Block Pegless
FDA
Z-1690-2008 to Z-1691-2008
Class II
02-十月-08
Stryker China Ltd
2518 6988
SN081006
GE Healthcare Definium 8000 Digital Radiographic System
FDA
Z-1822-2008
Class II
02-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081007
GE Healthcare Definium 8000 Digital Radiographic System
FDA
Z-1882-2008
Class II
02-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081008
GE Definium 8000 (model 5135678) and GE Precision 500D
(model 2403790-3)
FDA
Z-1476-2008 to Z-1477-2008
Class II
02-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081009
GE OEC 9600 C-arm Fluoroscopy System
FDA
Z-1709-2008
Class II
02-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081010
GE 1.5T and 3.0 T Signa HDx MR System and GE Signa Excite
1.5T MR System, GE Signa Excite 3.0T MR System
FDA
Z-2210-2008 to Z-2211-2008
Class II
02-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081011
Siemens Radiation Therapy Systems
FDA
Z-2095-2008 to Z-2104-2008
Class II
02-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081012
Siemens Ultrasound Transducer 17L5HD
FDA
Z-2230-2008
Class II
02-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081013
Accuray CyberKnife Ronotic Radiosurgery System radiation
therapy device
FDA
Z-2056-2008
Class II
02-十月-08
Accuray Asia Ltd
2247 8628
SN081014
Varian VariSource CT/MR Ring & Tandem Applicator Set
FDA
Z-2081-2008
Class II
02-十月-08
Varian Medical Systems Pacific Inc.
2724 2836
SN081015
Smith & Nephew TRIGEN Hind Foot Fusion Nail
FDA
Z-2082-2008 to Z-2088-2008
Class II
02-十月-08
Smith & Nephew Limited
SN081016
Merit Medical Arnot-Ogden Med Ctr Hip Pack (REF: K12T-02160A
and K12T-02159A)
FDA
Z-1808-2008 to Z-1809-2008
Class II
02-十月-08
N/A
N/A
SN081017
Naviscan PEM Flex Solo II PET Scanner
FDA
Z-2229-2008
Class II
02-十月-08
N/A
N/A
SN081018
Biogenex Laboratories Xmatrx FISH Automated Staining System
FDA
Z-1471-2008
Class II
02-十月-08
N/A
N/A
SN081019
Abbott Total Bilirubin
MHRA
2008/009/018/601/005
FSCA
02-十月-08
Abbott Laboratories Ltd.
2806 4021
SN081020
Immucor Galileo Echo
MHRA
2008/009/022/061/013
FSCA
02-十月-08
N/A
N/A
SN081021
ConMed VCareR Uterine Manipulators
MHRA
2008/009/002/061/001
FSCA
02-十月-08
N/A
N/A
SN081022
Sendal 3101-TJ Transfusion Set
MHRA
2008/009/011/061/010
FSCA
02-十月-08
N/A
N/A
Medical Device Control Office
222
2645 8703
Department of Health
The Government of HKSAR
SN081023
Diagnostica Stago (STA) Neoplastine CI (Plus) 10
MHRA
2008/009/025/061/010
FSCA
02-十月-08
Healthpro Technology Co. Ltd
N/A
SN081024
Spacelabs Ultraview Digital Telemetry Reciever, model 90478
MHRA
2008/008/014/061/012
FSCA
02-十月-08
N/A
N/A
SN081025
ThermoFisher Tryptone soya broth BO0351G
MHRA
2008/009/023/601/003
FSCA
02-十月-08
N/A
N/A
SN081026
Nebion, LLC HLX-8 Magnetic Resonance Device
FDA
N/A
Class I
06-十月-08
N/A
N/A
SN081027
Kimal K-Flow access catheters
MHRA
2008/008/026/401/004
FSCA
06-十月-08
N/A
N/A
SN081028
Draeger Zeus Anaesthetic machines software version 4.01
MHRA
2008/009/015/051/009
FSCA
06-十月-08
Draeger Medical Hong Kong Ltd.
2877 3077
SN081029
GENICON 5 mm Pyramidal Trocars
MHRA
2008/009/026/061/009
FSCA
06-十月-08
N/A
N/A
SN081030
GE Healthcare Aisys Anaesthesia machine
MHRA
2008/009/025/061/011
FSCA
06-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081031
Remploy Access and Accent attendant propelled wheelchairs
MHRA
MDA/2008/070
MDA
08-十月-08
N/A
N/A
SN081032
Park House Alternating air mattress pumps models PHP198,396,
398 and 399
MHRA
MDA/2008/071
MDA
08-十月-08
N/A
N/A
SN081033
Hoggi BINGO Rehab Pushchair
MHRA
2008/005/030/061/019
FSCA
08-十月-08
N/A
N/A
SN081034
Sunrise Medical Breezy Moonlite Wheelchairs
MHRA
2008/005/028/401/006
FSCA
08-十月-08
N/A
N/A
SN081035
Hologic: ATEC 1212-20 Handpieces
MHRA
2008/009/026/061/014
FSCA
09-十月-08
N/A
N/A
SN081036
ThermoFisher Columbia Blood Agar, PB0122A
MHRA
2008/010/002/601/002
FSCA
09-十月-08
N/A
N/A
SN081037
Siemens Medical Solutions Diagnostics ADVIA Chemistry Controls
1 and 2
MHRA
2008/010/001/061/008
FSCA
09-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081038
Abbott ClearStar model number M771
MHRA
SN081039
Baxter FLOGARD 6201 Volumetric Infusion Pump (Product Code
2M8063)
SN081040
2008/010/001/061/012
FSCA
09-十月-08
Abbott Laboratories Ltd.
2806 4021
Baxter Healthcare
Ltd
N/A
Firm Initiated Field
Action
10-十月-08
Baxter Healthcare Ltd
2807 8500
NeoMedix Trabectome I/A Console, Model Number 550014,
surgical aspirator
FDA
Z-0071-2008
Class II
13-十月-08
N/A
N/A
SN081041
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
FDA
Z-0368-2008
Class II
13-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081042
GE Healthcare Innova 3100 and 4100 Digital Fluoroscopic Imaging
System with Bolus Chasing
FDA
Z-1516-2008 to Z-1517-2008
Class II
13-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
FDA
Z-1547-2008
Class II
13-十月-08
N/A
N/A
FDA
Z-1692-2008
Class II
13-十月-08
COVIDEN
3157 7220
SN081043
SN081044
ev3" 55442-2920, sterile EO, single Use, Visi-Pro BalloonExpandable Peripheral
Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS)
Model 802
SN081045
Toshiba America Medical Systems (TAMS) Aquilion 32 CT and 64
CT system, computed tomography x-ray system
FDA
Z-1707-2008 to Z-1708-2008
Class II
13-十月-08
Sanko Medical Systems (HK) Ltd.
2384 0688
SN081046
Siemens Medical Solutions, syngo Dynamics 6.0 Workplace;
Picture archiving and communication system
FDA
Z-1751-2008
Class II
13-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081047
Siemens Medical Solutions, Mevatron Digital Linear Accelerator
FDA
Z-1753-2008 to Z-1763-2008
Class II
13-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081048
X-STOP Interspinous Process Decompression (lPD) System
FDA
Z-1765-2008
Class II
13-十月-08
N/A
N/A
Medical Device Control Office
223
Department of Health
The Government of HKSAR
SN081049
GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ
Xpress Pro or Plus Module; for diagnostic image analysis
FDA
Z-2183-2008
Class II
13-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081050
Cook Vital Port Vascular Access System Polysulfone Petite
FDA
Z-2190-2008 to Z-2191-2008
Class II
13-十月-08
Cook Asia (Hong Kong) Ltd.
2781 0232
SN081051
Brainlab VectorVision (VV) Sky Navigation Platform
FDA
Z-2209-2008
Class II
13-十月-08
BrainLAB Ltd. (Hong Kong)
FDA
Z-2213-2008 to Z-2214-2008
Class II
13-十月-08
N/A
N/A
FDA
Z-2219-2008 to Z-2224-2008
Class II
13-十月-08
N/A
N/A
FDA
Z-2235-2008
Class II
13-十月-08
Philips Healthcare - Great China
2821 5480
SN081052
SN081053
SN081054
Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long
Tibial Base
Applied Medical Silhouette Xtraflo Device with SL-6 Hydrophilic
Coating
Philips and Neusoft NeuViz Dual series computed Tomography
Scanner System, X-Ray System
SN081055
Abaxis, Inc.Piccolo Chemistry Analyzer software version 6.121
FDA
Z-2286-2008 to Z-2287-2008
Class II
13-十月-08
N/A
N/A
SN081056
Philips and Neusoft NeuViz Dual series computed Tomography
Scanner System, X-Ray System
FDA
Z-2307-2008
Class II
13-十月-08
Philips Healthcare - Great China
2821 5480
SN081057
Varian Medical Systems Eclipse device, model H48, Version 6.5
FDA
Z-2308-2008
Class II
13-十月-08
Varian Medical Systems Pacific Inc.
2724 2836
FDA
Z-2329-2008
Class II
13-十月-08
N/A
N/A
FDA
Z-2347-2008
Class II
13-十月-08
N/A
N/A
SN081058
SN081059
SCC Soft Computer SoftPath GUI Release Software Versions 3.17
and 4.1
Kyphon KyphX Osteo Introducer System with blunt tip introducer
stylet
SN081060
Steris Small Renaissance Eagle 3000
FDA
Z-2350-2008
Class II
13-十月-08
N/A
N/A
SN081061
Boston Scientific Platinum Plus Guidewire
FDA
Z-2362-2008 to Z-2365-2008
Class II
13-十月-08
Boston Scientific Hong Kong Ltd
2960 7136
SN081062
BD Ace Heat Therapy
FDA
Z-2431-2008
Class II
13-十月-08
N/A
N/A
SN081063
Zimmer Universal Optical Tracker Fixation, not sterile, REF 111.031
FDA
Z-2445-2008
Class II
13-十月-08
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN081064
Smith & Nephew Caption Disposable Platelet Concentrator Kit Ref
71178200 and Ref 71178202
FDA
Z-2446-2008 to Z-2447-2008
Class II
13-十月-08
Smith & Nephew Limited
SN081065
Siemens SOMATOM Emotion 6 and Emotion 16 Computed
tomography X-ray system
FDA
Z-2452-2008 to Z-2453-2008
Class II
13-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081066
ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500
FDA
Z-2458-2008
Class II
13-十月-08
N/A
N/A
SN081067
American Medical 700 CX MS Pump IZ, Preconnect Penoscrotal,
18 cm, Sterile EO, REF 72404232
FDA
Z-2461-2008
Class II
13-十月-08
N/A
N/A
SN081068
SCC SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3
FDA
Z-2463-2008
Class II
13-十月-08
N/A
N/A
SN081069
BD Anaesthesia Kits and Epidural Filter
MHRA
2008/010/006/061/006
FSCA
14-十月-08
BD Asia Ltd (Hong Kong)
2575 8668
SN081070
GE Healthcare Advantage Workstation Suite-Card IQ
MHRA
2008/010/006/061/010
FSCA
14-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081071
GE Healthcare AMX Series Mobile RAD System(AMX 4 and AMX
4+
MHRA
2008/010/002/061/004
FSCA
14-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081072
Thomas Medical Products SafetSheath family
MHRA
2008/009/029/061/018
FSCA
14-十月-08
N/A
N/A
SN081073
ThermoFisher Xpect Giardia/ Cryptosporidium Kit
MHRA
2008/008/014/061/008
FSCA
14-十月-08
N/A
N/A
SN081074
CASMED 500cc Single Patient Use Infusion Cuffs
MHRA
2008/010/001/061/001
FSCA
14-十月-08
N/A
N/A
N/A
Firm Initiated Field
Action
15-十月-08
Boston Scientific Hong Kong Ltd
2960 7136
SN081075
Boston Scientific Atlantis PV 15 MHz Imaging Catheter
Medical Device Control Office
2645 8703
Boston Scientific
Hong Kong Ltd
224
Department of Health
The Government of HKSAR
Boston Scientific
Hong Kong Ltd
Medtronic
International Ltd
SN081076
Boston Scientific Excelsior SL-10 Microcatheter
SN081077
Medtronic (Physio-Control) LIFEPAK CR Plus defibrillator/
LIFEPAK EXPRESS defibrillator
SN081078
Acumed Locking Tarsometatarsal Plate, Locking Proximal
Metatarsal Wedge Plate, Locking Clavicle Plate
FDA
Z-2108-2008 to Z-2132-2008
SN081079
Portland Orthopaedics Margron DTC Hip Replacement System
FDA
SN081080
Curlin Medical Model 2000, 4000 and 600 CMS/ Plus Ambulatory
Infusion Pump, PainSmart, PainSmart IOD Ambulatory Infusion
System
SN081081
Firm Initiated Field
Action
Firm Initiated Field
Action
15-十月-08
Boston Scientific Hong Kong Ltd
2960 7136
15-十月-08
Medtronic International, Ltd.
2907 5911
Class II
16-十月-08
N/A
N/A
Z-1931-2008 to Z-2001-2008
Class II
16-十月-08
N/A
N/A
FDA
Z-1896-2008 to Z-1900-2008
Class II
16-十月-08
N/A
N/A
ArthroCare ArthroWand Covator with Integrated Cable Wand
(Catalog no AC4340-01)
FDA
Z-2309-2008
Class II
16-十月-08
ArthoCare Asia Pacific
2159 7436
SN081082
Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00
FDA
Z-2314-2008
Class II
16-十月-08
N/A
N/A
SN081083
Propper short gas-chex EO sterilization indicators (Recorder no
269001)
FDA
Z-2330-2008
Class II
16-十月-08
N/A
N/A
SN081084
Oscor Permanent Pacing Lead
FDA
Z-2333-2008
Class II
16-十月-08
N/A
N/A
SN081085
Smiths Medical Deltec 3000 Large Volume Infusion Pump and
Deltec Micro 3100 Large Volume Infusion Pump
FDA
Z-1604-2008 to Z-1605-2008
Class II
16-十月-08
N/A
N/A
SN081086
Nova Biomedical Varta Easypack XL Lithium Polymer Batteries
(P/N 41772 and 42215)
FDA
Z-1472-2008
Class II
16-十月-08
N/A
N/A
SN081087
Stryker Rejuvenate Broach
FDA
Z-2349-2008
Class II
16-十月-08
Stryker China Ltd
2518 6988
FDA
Z-2007-2008
Class II
16-十月-08
Stryker China Ltd
2518 6988
FDA
Z-2310-2008
Class II
16-十月-08
AMO Asia Limited
2480 3330
Abbott Laboratories Ltd.
2806 4021
SN081088
SN081089
Stryker 6.5 Cancellous Bone Screw 25mm (Catalog No 2030-65251)
AMO WaveScan WaveFront System Version 3.90/3.901 (Part No.
0070-1478)
N/A
N/A
SN081090
Abbott Flexiflo Quantum Pump Set (List # 50604)
FDA
Z-2305-2008
Class II
16-十月-08
SN081091
FDA
Z-2212-2008
Class II
16-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
FDA
Z-2241-2008
Class II
16-十月-08
Medtronic International, Ltd.
2907 5911
FDA
Z-2356-2008 to Z-2361-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
FDA
Z-2145-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081095
Siemens Acuson CV70 Ultrasound Systems
Medtronic SPECIFY 3998 Lead Kit for Spinal Cord Stimulation
(SCS)
GE Innova 3100/3100IQ, 2100IQ, 4100/4100IQ, Advantx-E, Innova
2121-1Q/2121-1Q and Innova 2000
GE Precision RXi Digital remote X-Ray Imaging R&F System
(model 5117828)
GE Definium 800 Digital Radiographic System (Model 5135678)
FDA
Z-1883-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081096
GE Datex-Ohmeda Engstrom Carestation
FDA
Z-1829-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081097
GE Proteus XR/a Eclipse Collimator (Model # 2379827)
FDA
Z-1713-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081098
GE Precision 500D and Advantx Legacy Radiographic and
Fluoroscopic systems
FDA
Z-1610-2008 to Z-1611-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081099
GE Innova 3100 Digital Fluoroscopic Imaging and Innova 4100
Digital Fluoroscopic Imaging
FDA
Z-1521-2008 to Z-1522-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN0810100
GE OEC 9800 Fluoroscopic X-Ray System and OEC 9900 Elite
Fluoroscopic X-Ray System
FDA
Z-1885-2008
Class II
16-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN0810101
Siemens Dimension Clinical Chemistry System - Enzymatic
Creatinine Flex Reagent Cartridge DF270
MHRA
2008/010/007/061/010
FSCA
17-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN081092
SN081093
SN081094
Medical Device Control Office
225
Department of Health
The Government of HKSAR
SN0810102
Spacelabs Healthcare 90496 and 91496 Command Module NIBP
Option
MHRA
2008/010/003/061/005
FSCA
17-十月-08
N/A
N/A
SN0810103
Johnson & Johnson Biosense Webster NAVISTAR RMT 4mm,
8nn DS and THERMOCOOL Catheters
MHRA
2008/010/009/061/005
FSCA
17-十月-08
Johnson & Johnson Medical (HK)
2738 6027
SN0810104
Varian C-Series Clinac Linear Accelerator
Health Canada
44028
Type I
17-十月-08
Varian Medical Systems Pacific Inc.
27242836
SN0810105
Varian Acuity, Ximatron
Health Canada
43747
Type I
17-十月-08
Varian Medical Systems Pacific Inc.
27242836
SN0810106
Immucor Galileo / Capture-R Ready test wells
Health Canada
43677
Type I
17-十月-08
N/A
N/A
SN0810107
Immucor Galileo Echo / CaptureR Ready Scrn strip
Health Canada
43678
Type I
17-十月-08
N/A
N/A
SN0810108
Ferno 35-A Mobile Transporter
Health Canada
43920
Type II
17-十月-08
Goodman Medical Supplies Ltd
2332 4455
SN0810109
Anspach effort A) 12.6mm Boring Tool, B) 9.5mm Boring Tool
Health Canada
43458
Type II
17-十月-08
N/A
N/A
SN0810110
Cardinal Health Custom Sterile Procedure Pack
Health Canada
43591
Type II
17-十月-08
N/A
N/A
SN0810111
Sirona Dental System GMBH Galileos 3D X-Ray with Galaxis 1.5
Health Canada
43380
Type II
17-十月-08
N/A
N/A
SN0810112
Siemen Axiom Artis, Axiom Artis DMP
Health Canada
43745
Type II
17-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN0810113
Roche Cobas Integra System-Smphetamines, Roche HitachiOnline Amphetamines
Health Canada
43716
Type II
17-十月-08
Roche Diagnostics (Hong Kong) Ltd
2485 7510
SN0810114
Welch Allyn Fiber Optic Sigmoidoscope, Insufflation Bulbs
Health Canada
43629
Type II
17-十月-08
Ultronics Enterprises Ltd
2764 5208
SN0810115
Cybernius Medical Nepfrocare Software
Health Canada
43736
Type II
17-十月-08
N/A
N/A
SN0810116
Biomerieux Oberva Data Management System
Health Canada
42986
Type II
17-十月-08
Biomerieux China Ltd (HK)
2356 7033
SN0810117
Stryker Communication Ophit DVI Extender
Health Canada
43879
Type II
17-十月-08
Stryker China Ltd
2518 6988
SN0810118
Immco Diagnostic West Nile Virus IGG Indirect Elisa
Health Canada
43722
Type II
17-十月-08
N/A
N/A
SN0810119
Griener Bio One Vacuette Lithium Heparin Blood Collection Tube
Health Canada
43583
Type II
17-十月-08
Mekim Ltd
2774 8300
Bausch & Lomb
(Hong Kong) Limited
N/A
Firm Initiated Field
Action
21-十月-08
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
MHRA
2008/010/007/601/002
FSCA
23-十月-08
N/A
N/A
MHRA
2008/010/010/061/004
FSCA
23-十月-08
N/A
N/A
SN0810123
Orasure Oral Fluid Positive Control, Oral Fluid Negative Control,
Oral Fluid Cutoff Calibrator
MHRA
2008/010/010/061/006
FSCA
23-十月-08
N/A
N/A
SN0810124
Radiometer ABL700 Series Calibration 1 Solution
MHRA
2008/009/008/061/002
FSCA
23-十月-08
N/A
N/A
SN0810125
Nucletron Oncentra Prostate System (with option CT/MRI imaging)
MHRA
2008/006/027/401/003
FSCA
23-十月-08
N/A
N/A
SN0810126
BD Vacutainer Blood Collection Tubes
MHRA
2008/009/006/601/001
FSCA
23-十月-08
BD Asia Ltd (Hong Kong)
SN0810127
Homecraft Rolyan 2” and 4” Savanah raised toilet seats
MHRA
MDA/2008/075
MDA
24-十月-08
N/A
N/A
MHRA
MDA/2008/076
MDA
24-十月-08
N/A
N/A
24-十月-08
Boston Scientific Hong Kong Ltd
2960 7136
24-十月-08
Boston Scientific Hong Kong Ltd
2960 7136
27-十月-08
Swedish Trading Co., Ltd
SN0810120
SN0810121
SN0810122
SN0810128
SN0810129
Bausch & Lomb Medalist Toric (SofLens 66 Toric) Contact Lenses
(Lot no. W64067390, W64067389, W64067246) and Medalist One
Day Plus, SofLens daily disposable (hilaflcon B) Visibility Tinted
Contact Lenses (Lot no X10050809A and R10050805A)
ThermoFisher EB0212E, Cooked meat medium, lot number
1048169
Qualigen Fast Pack Total PSA Lot 0807002
Lomax Mobility Kid Active folding manual wheelchair with swing
away footrests
Boston Scientific TruPath Biopsy Device and easy Core Biopsy
Device
SN0810130
Boston Scientfic easyCore Biopsy System (Endoscopy)
SN0810131
Steris Quick Connect component (p/n 201048)
Medical Device Control Office
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
FDA
N/A
N/A
Z-2462-2008
226
Firm Initiated Field
Action
Firm Initiated Field
Action
Class II
Department of Health
The Government of HKSAR
SN0810132
Philips Ultraview Digital Telemetry Transmitter (Model 91341-09)
FDA
Z-2336-2008
Class II
27-十月-08
Philips Healthcare - Great China
2821 5480
SN0810133
Zimmer Quicklock Tracker (Size 2, Ref 111.100)
Sunrise Medical Quickie Groove Power Wheelchair with Transit
option
Biomet Exact Calcar Planer Rasp Style Blade (REF 31-473795 to
31-473798)
FDA
Z-2444-2008
Class II
27-十月-08
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
FDA
Z-2339-2008
Class II
27-十月-08
N/A
N/A
FDA
Z-2370-2008 to Z-2373-2008
Class II
27-十月-08
N/A
N/A
SN0810136
Cardinal Health NicoletOne photic adapter cable 085-463700
FDA
Z-2389-2008
Class II
27-十月-08
Cardinal Health
SN0810137
Angiodynamics Centros Chronic Hemodialysi Curved Catheter Set
(Catalog no./REF 10303101 to 10303103)
FDA
Z-2396-2008 to Z-2398-2008
Class II
27-十月-08
N/A
N/A
SN0810138
Arjo Kwiktrak Gate System
FDA
Z-2434-2008
Class II
27-十月-08
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
SN0810139
B. Braun Horizon Pump Set, Adult Metriset, Safeline Metriset,
Metriset Burette Set, Burette Set, Add-On Burette Set
FDA
Z-2407-2008 to Z-2414-2008
Class II
27-十月-08
B Braun Medical Hong Kong
2277 6125
SN0810140
ACIST BRACCO AT P54 AngioTouch Kit
FDA
Z-2406-2008
Class II
27-十月-08
Pacific Medical (Hong Kong) Ltd.
2343 8009
FDA
Z-2405-2008
Class II
27-十月-08
Beckman Coulter Hong Kong Ltd
2240 6150
SN0810134
SN0810135
SN0810141
SN0810142
SN0810143
Beckman Coulter Synchron Acetaminophen (ACTM) Reagent (Part
No. 472169)
Cardinal Health NicoletOne 5.30.2 Software
Boston Scientific easy Core Biopsy Device (Peripheral
Interventions)
Baylis Medical BMC RF Cannula - Part # PMF20-100-10CS; Lot
PFFA211107
FDA
Z-2459-2008
Class II
27-十月-08
Cardinal Health
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
27-十月-08
Boston Scientific Hong Kong Ltd
2960 7136
MHRA
2008/010/002/061/003
FSCA
27-十月-08
N/A
N/A
SN0810145
GE Healthcare Giraffe and Panda Warmers
MHRA
2008/010/014/601/001
FSCA
27-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN0810146
Medtronic OptiVol CareAlert and CareLink Transmissions Issue
MHRA
2008/010/016/061/016
FSCA
27-十月-08
Medtronic International, Ltd.
2919 1300
SN0810147
Invacare Typhoon 1 & 2 Power Wheelchairs
MHRA
2008/008/018/301/001
FSCA
27-十月-08
N/A
N/A
SN0810148
Thoratec HeartMate II LVAS
FDA
N/A
Press Release
27-十月-08
N/A
N/A
SN0810149
Helena Laboratories Manual D-dimer 5250
MHRA
2008/010/010/061/012
FSCA
28-十月-08
N/A
N/A
SN0810150
Metrax Primedic DefiMonitor XD Series
MHRA
2008/010/006/061/011
FSCA
29-十月-08
N/A
N/A
SN0810151
Tryton Side Branch Stent
MHRA
2008/010/014/061/023
FSCA
29-十月-08
N/A
N/A
SN0810152
Inverness Panbio West Nile Virus IgM Capture ELISA
MHRA
2008/010/022/061/008
FSCA
29-十月-08
N/A
N/A
SN0810153
Biomet 2.00mm Crimp Sleeve, item: 350805, lot 568400
MHRA
2008/010/013/601/004
FSCA
29-十月-08
N/A
N/A
SN0810154
Edwards Lifesciences Vigilance II Monitor VIG2/VIG2E
MHRA
2008/010/010/061/011
FSCA
29-十月-08
N/A
N/A
SN0810155
Stryker Circlip retaining system
MHRA
2008/010/009/061/007
FSCA
29-十月-08
Stryker China Ltd
2518 6988
SN0810156
Stryker System 6 and Cordless Driver 3 Handpiece
MHRA
2008/010/015/061/013
FSCA
29-十月-08
Stryker China Ltd
2518 6988
SN0810157
Respironics BIPAP Focus Ventilator System
MHRA
2008/010/009/061/028
FSCA
29-十月-08
CELKI Medical Company
SN0810158
Siemens IMMULITE® 2000/2500 Substrate Module L2SUBM 252
MHRA
2008/010/023/061/015
FSCA
29-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN0810159
DLS Medical Wound dressing pack avm3550, Woundcare pack
avm3633, Basic care pack avm3757
MHRA
2008/009/026/601/002
FSCA
30-十月-08
N/A
N/A
SN0810160
BRAHMS PAPP-A Kryptor Lots 566034 and 566036
MHRA
2008/010/010/061/007
FSCA
30-十月-08
N/A
N/A
SN0810161
Ergolet Luna Track Hoist Handset
MHRA
2008/004/004/401/002
FSCA
30-十月-08
N/A
N/A
SN0810162
Sidhil Universal Standard and High Siderails
MHRA
2008/008/018/401/004
FSCA
30-十月-08
N/A
N/A
SN0810163
R82 X-Panda size 2 High-Low Frame
MHRA
2008/004/025/401/012
FSCA
30-十月-08
N/A
N/A
SN0810164
Spacelabs Healthcare Ultraview SL Command Module (Model
90496 and 91496)
FDA
Z-2342-2008 to Z-2343-2008
Class II
30-十月-08
N/A
N/A
SN0810144
Medical Device Control Office
227
Department of Health
The Government of HKSAR
SN0810165
Zimmer Durom cup, Metasul Durom acetabular compenent
FDA
Z-2415-2008 to Z-2426-2008
Class II
30-十月-08
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN0810166
Medtronic BI-700-00027 0-arm 1000 Imaging System mobile X-ray
System
FDA
Z-2034-2008
Class II
30-十月-08
Medtronic International, Ltd.
2907 5911
SN0810167
Siemens Sonoline G50/G60 Ultrasound System (Software versions
1.0.0 to 1.5.0b)
FDA
Z-2468-2008
Class II
30-十月-08
Siemens Healthcare Diagnostic Limited
2810 7533
SN0810168
GE Precision MPi (Model 5126893 -, 2385125, 2398238)
FDA
Z-2142-2008 to Z-2144-2008
Class II
30-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
SN0810169
GE Healthcare Innova 2100IQ, 3100 IQ, 4100 IQ Digital
Fluoroscopic Imaging System (Versatile cardiac and Vascular
FDA
Z-1518-2008 to Z-1520-2008
Class II
30-十月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
Medical Device Control Office
228
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - September 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN080901
Invacare Reliant 100 / 150 / 200 / 250
MHRA
2008/001/008/401/008
FSCA
2008/09/02
N/A
N/A
SN080902
Sybron Pitt Easy implants
MHRA
2008/008/019/061/013
FSCA
2008/09/02
N/A
N/A
SN080903
Liftech Gemini Ceiling Track Hoist
MHRA
2008/006/011/291/006
FSCA
2008/09/02
N/A
N/A
SN080904
Boston Scientific Platinum PlusT Guidewire (Peripheral)
2008/09/03
Boston Scientific HK Limited
2960 7136
SN080905
Medtronic Adjustable Valve Model 6248VAL and Attain 6216A and
6218A System Kits
2008/09/03
Medtronic International, Ltd.
2907 5911
SN080906
Physio Control LIFEPAK CR Plus
SN080907
Boston Scientific
Hong Kong Ltd
Medtronic
International Ltd
N/A
N/A
Firm Initiated Field
Action
Firm Initiated Field
Action
Medtronic
International Ltd
N/A
Firm Initiated Field
Action
2008/09/03
Medtronic International, Ltd.
2907 5911
Ev3 Primus GPS Biliary Stent Systems (Ref: BXB35-08-37-75)
FDA
Z-2170-2008
Class II
2008/09/04
N/A
N/A
SN080908
Ev3 Protege GPS Biliary Stent Systems (Ref: SERB65-06-60-120)
FDA
Z-2169-2008
Class II
2008/09/04
N/A
N/A
SN080909
Arjo Nautica (GK) Mattress Stretcher
FDA
Z-1234-2008
Class II
2008/09/04
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
SN080910
Smiths Medical CADD-MS"3 Ambulatory Infusion Pumps (Model
7400, Rx only)
FDA
Z-1641-2008
Class II
2008/09/04
Goodman Medical Supplies Ltd
2332 4455
SN080911
Philips Medical General X-Ray System types with Digital Spot
Imaging (DSI) software (Software version: rel 6)
FDA
Z-2160-2008
Class II
2008/09/04
Philips Healthcare - Great China
2821 5480
SN080912
Stryker Stem Trial, Triathlon Revision Instruments
FDA
Z-2157-2008 to Z-2158-2008
Class II
2008/09/04
Stryker China Ltd
2518 6988
SN080913
Stryker Xcelerate Patella System Reamer Shaft Assembly (Product
no.: 8001-1702)
FDA
Z-1778-2008
Class II
2008/09/04
Stryker China Ltd
2518 6988
SN080914
Medtronic Midas Rex Legend tapered dissecting tool (Model
F2/8TA23)
FDA
Z-2156-2008
Class II
2008/09/04
Medtronic International, Ltd.
2907 5911
SN080915
Medtronic Physio Control, FASTPAK batteries
FDA
Z-1567-2008
Class II
2008/09/04
Medtronic International, Ltd.
2907 5911
SN080916
GE Healthcare Corometrics Model 250 series Maternal/ Fetal
Monitor (Models 256 and 259, part no 2024489-002)
FDA
Z-2154-2008
Class II
2008/09/04
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080917
GE Healthcare Precision RXi 23A/32A Remote X-Ray Imaging R&F
System
FDA
Z-1563-2008 to Z-1565-2008
Class II
2008/09/04
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080918
Siemens Medical Syn go Imaging XS (Model no 7502029)
FDA
Z-1643-2008
Class II
2008/09/04
Siemens Ltd.
2810 7533
SN080919
Hill-Rom Century+ Bed (Model P1400 HBSM siderail upgrade kits)
FDA
Z-1777-2008
Class II
2008/09/04
N/A
N/A
SN080920
Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement
FDA
Z-1696-2008 to Z-1697-2008
Class II
2008/09/04
N/A
N/A
SN080921
Acumed 3.5mm x 32.5mm Cortical Screw used with the Polarus
Humeral Fixation System
FDA
Z-2155-2008
Class II
2008/09/04
N/A
N/A
SN080922
Pacific Consolidated Industries Mobile Oxygen Storage Tank,
MOST 20-2B (Part no 793080-002)
FDA
Z-2201-2008
Class II
2008/09/04
N/A
N/A
SN080923
Pride Mobility Q-Logic Controller Software
FDA
Z-1776-2008
Class II
2008/09/04
N/A
N/A
Medical Device Control Office
229
Department of Health
The Government of HKSAR
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/09/05
Boston Scientific HK Limited
2960 7136
Genzyme Seprafilm Adhesion Barrier (Product Number: 4301-02
and 4301-05)
FDA
Z-1647-2008 to Z-1648-2008
Class II
2008/09/08
Genzyme Asia Limited
2810 1613
SN080926
Sunrise Medical Quickie Rhythm Power Wheelchair with QC (nonexpandable) electronics (Model no. EIPW10 and EIPW13)
FDA
Z-1531-2008 to Z-1532-2008
Class II
2008/09/08
N/A
N/A
SN080927
Caire Generation 4 electronic liquid gauges
FDA
Z-1716-2008
Class II
2008/09/08
N/A
N/A
SN080928
Huntleigh Healthcare Maxisky 600
MHRA
2007/010/018/401/014
FSCA
2008/09/08
N/A
N/A
SN080929
Peacocks Medical Fitzyou Moulded Wheelchair seat Systems
MHRA
2007/010/016/261/001
FSCA
2008/09/08
N/A
N/A
SN080930
Invacare Scanbed SB750
MHRA
2007/011/015/061/004
FSCA
2008/09/08
N/A
N/A
SN080931
Abbott Universal Clamp Reduction Tool
MHRA
2008/008/014/061/004
FSCA
2008/09/09
Abbott Laboratories Ltd.
2806 4021
SN080932
GE Healthcare Signa HDx Scanner
MHRA
2008/008/027/061/019
FSCA
2008/09/09
GE Medical Systems HK Ltd
2783 1838
SN080933
Intersurgical Solus Laryngeal Mask Airway
MHRA
2008/008/027/061/028
FSCA
2008/09/09
N/A
N/A
SN080934
Johnson and Johnson Cordis LuMend Outback Re-entry catheter
MHRA
2008/008/021/061/008
FSCA
2008/09/09
Johnson & Johnson Medical (HK)
2738 6027
SN080935
Bausch & Lomb AMVISC and AMVISC PLUS - Viscoelastic (Ref:
DV-2007-8041)
Bausch & Lomb
(Hong Kong) Limited
N/A
Firm Initiated Field
Action
2008/09/10
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
SN080936
Innovacon Prostate Specific Antigen
MHRA
2008/008/029/061/022
FSCA
2008/09/10
N/A
N/A
SN080937
Drager Primus, Apollo, Pallas Devices
MHRA
2008/008/029/061/020
FSCA
2008/09/10
Draeger Medical Hong Kong Ltd.
2877 3077
SN080938
STERIS 20 Sterilant Concentrate
MHRA
2008/007/015/401/008
FSCA
2008/09/10
Swedish Trading Co. Ltd.
N/A
SN080939
Gambro SteriChek Sensitive Total Chlorine Reagent Strips
MHRA
2008/008/012/061/011
FSCA
2008/09/11
Gambro Hong Kong Limited
N/A
SN080940
Medtronic Neurostimulator programmers
MHRA
MDA/2008/065
MDA
2008/09/12
Medtronic International, Ltd.
2907 5911
SN080941
Edwards Lifesciences Ascendra Balloon Catheter
MHRA
2008/008/027/061/007
FSCA
2008/09/12
N/A
N/A
SN080942
Sirona type B, VS and S Siroclaves and Siromini
MHRA
2008/009/002/061/004
FSCA
2008/09/12
N/A
N/A
SN080943
Boston Scientific ALTRUA® Implantable Pacemaker
MHRA
2008/009/003/061/007
FSCA
2008/09/12
Boston Scientific HK Limited
2960 7136
SN080944
GE Precision 500D Classical Radiographic-Fluoroscopic X-Ray
System (Model# 2289299-2)
FDA
Z-0369-2008
Class II
2008/09/12
GE Healthcare
2609 9233
SN080945
Abbott InCompass Spinal Fixation System T-Handle Driver and
PathFinder Spinal Fixation System T-Handle Driver
FDA
Z-1592-2008 to Z-1593-2008
Class II
2008/09/12
Abbott Laboratories Ltd.
2806 4021
SN080946
Otsuka UBiT® -IR300 Infrared Spectrophotometer, software
versions 7.0, 7.01 and 7.11
FDA
Z-1749-2008
Class II
2008/09/12
Otsuka Pharmaceutical (HK) Ltd
2881 6299
2008/09/12
Goodwin Health Care Ltd
N/A
SN080924
Bostson Scientific Smash Balloon Dilatation Catheter
SN080925
Goodwin Health
Care Ltd
Firm Initiated Field
Action
Firm Initiated Field
Action
SN080947
Invivo Lithium Polymer Wireless Module Batteries
SN080948
Teleflex Weck Clips products : Hemolok clips, Horizon Clips and
Hemoclip
Solar-med Limited
N/A
2008/09/12
Solar-med Limited
2425 0926
SN080949
Vital Signs Light Wand Orotracheal Lighted Stylet
MHRA
2008/008/028/061/002
FSCA
2008/09/16
N/A
N/A
SN080950
Cook Zenith AAA Stent-Graft
MHRA
2006/005/017/401/009
FSCA
2008/09/16
Cook Asia Ltd
N/A
SN080951
Philips Healthcare iSite PACS
MHRA
2008/008/026/061/019
FSCA
2008/09/16
Philips Healthcare - Great China
2821 5480
Medical Device Control Office
N/A
230
Department of Health
The Government of HKSAR
SN080952
ThermoFisher BO0366D Brain Heart Infusion
MHRA
2008/009/002/601/004
FSCA
2008/09/16
N/A
N/A
SN080953
R82 A/S Hip Belt
MHRA
2008/009/005/061/006
FSCA
2008/09/16
N/A
N/A
SN080954
Philips Healthcare HDI4000 Diagnostic Ultrasound System
MHRA
2008/009/010/061/004
FSCA
2008/09/16
Philips Healthcare - Great China
2821 5480
SN080955
Philips Healthcare HD3 Diagnostic Ultrasound System
MHRA
2008/009/010/061/010
FSCA
2008/09/16
Philips Healthcare - Great China
2821 5480
2008/09/16
BD Asia Ltd (Hong Kong)
2575 8668
2008/09/16
Johnson & Johnson Medical (HK)
2738 6027
2008/09/17
Boston Scientific HK Limited
2960 7136
SN080956
SN080957
BD FACSAria Sorters running BD FACSDiva Software, version 3.0
or later
Johnson and Johnson ASP Automatic Endoscope Reprocessor
(AER)
BD Asia Ltd (Hong
Kong)
Johnson & Johnson
Medical Hong Kong
Boston Scientific
Hong Kong Ltd
N/A
N/A
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
SN080958
Boston Scientific iLabR Ultrasound Imaging Systems
SN080959
GE Healthcare Responder 2000 Defibrillator
MHRA
2008/008/013/061/012
FSCA
2008/09/18
GE Medical Systems HK Ltd
2783 1838
SN080960
Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts
MHRA
MDA/2008/066
MDA
2008/09/19
Stryker China Limited
2518 6988
SN080961
Philips Healthcare BV Pulsera and Endura
Abbott AGA Medical Corporation AMPLATZER Delivery System
(REF 9-DEL-10F-45/80) and AMPLATZER Sizing Balloon II (REF 9SB-24)
Abbott Free Style Blood Glucose Monitoring System Test Strips
MHRA
2008/009/010/061/008
FSCA
2008/09/19
Philips Healthcare - Great China
2821 5480
FDA
Z-2192-2008 to Z-2193-2008
Class II
2008/09/19
Abbott Laboratories Ltd.
2806 4021
FDA
Z-1813-2008
Class II
2008/09/19
Abbott Laboratories Ltd.
2806 4021
FDA
Z-1784-2008
Class II
2008/09/19
Abbott Laboratories Ltd.
2806 4021
FDA
Z-1526-2008
Class II
2008/09/19
GE Medical Systems Hong Kong Ltd.
2783 1838
FDA
Z-1825-2008
Class II
2008/09/19
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080962
SN080963
SN080964
SN080965
SN080966
Abbott PathFinder Cannulated T-Handle Bone Awl (Part No. 11552)
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom
Carestation (Model# 1505-3272-00)
GE Centricity AW Suite 2.0 Software running on the Centricity RA
1000 or RA600/CA1000 Workstation
N/A
SN080967
Medtronic CD Horizon Agile Dynamic Stabilization Device
FDA
Z-1408-2008 to Z-1441-2008
Class II
2008/09/19
Medtronic International, Ltd.
2907 5911
SN080968
Medtronic Physio-Control LIFEPAK 20 and LIFEPAK 20e
Difibrillator/monitor
FDA
Z-2009-2008 to Z-2011-2008
Class II
2008/09/19
Medtronic International, Ltd.
2907 5911
SN080969
Medtronic Suction Jar Lid for Medela Vario 18 Vacuum Pump
FDA
Z-2168-2008
Class II
2008/09/19
Medtronic International, Ltd.
2907 5911
SN080970
GE 1.5 T and 3.0 T Signa HDX MR System Model No. 2226300,
2377062-61, 2395001, 2395001-2, 5107849 and 5127452
FDA
Z-2225-2008
Class II
2008/09/19
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080971
Siemens Linear Medical Accelerators equipped with COHERENCE
Therapist R2.1 and Primeview 3 i R 2.1
FDA
Z-1768-2008
Class II
2008/09/19
Siemens Ltd.
2810 7533
SN080972
Siemens SIMIVIEW 3000, SIMVIEW NT and MEV ASIM S systems
(Instructions" TH003/08/S" update)
FDA
Z-2196-2008
Class II
2008/09/19
Siemens Ltd.
2810 7533
SN080973
Stryker Scorpio Total Knee Posteriorly Stabilized Femoral
Component #7R and #7l (Catalog # 71-4107R and 71-4506L)
FDA
Z-1814-2008
Class II
2008/09/19
Stryker China Ltd
2518 6988
SN080974
Stryker Gamma3 System Set Screwdriver, Flexible Shaft and
Gammas Set Screwdriver Instrument Set, Orthopedic Device
FDA
Z-1626-2008 to Z-1627-2008
Class II
2008/09/19
Stryker China Ltd
2518 6988
SN080975
Stryker Digital System Ultra (SDC Ultra) (Model no.: 240-050-988)
FDA
Z-1316-2008
Class II
2008/09/19
Stryker China Ltd
2518 6988
SN080976
Covidien/Mallinckrodt CT9000/ CT9000ADV (Model no.: 241300)
FDA
Z-1828-2008
Class II
2008/09/19
COVIDIEN
3157 7220
SN080977
Biomet EZLoc 7-8mm TM Femoral Fixation (Catalog No 904780)
FDA
Z-1782-2008
Class II
2008/09/19
N/A
N/A
SN080978
Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem
Inserter (Part number 31-555610)
FDA
Z-1318-2008
Class II
2008/09/19
N/A
N/A
Medical Device Control Office
231
Department of Health
The Government of HKSAR
SN080979
Varian Medical Varis Aria Radiation Oncology Version 8.1
FDA
Z-2194-2008
Class II
2008/09/19
Varian Medical Systems Pacific Inc.
2724 2836
SN080980
Telefex Weck - DuraHook (Catalog #382800, 382805)
FDA
Z-1856-2008 to Z-1857-2008
Class II
2008/09/19
Solar-med Limited
2425 0926
SN080981
AGFA IMPAX 6.2.1 System (PAC)
FDA
Z-1245-2008
Class II
2008/09/19
AGFA Hong Kong Limited
2555 9421
SN080982
AGFA IMPAX 4.1 and WEB1000 Versions 3.1
FDA
Z-1243-2008 to Z-1244-2008
Class II
2008/09/19
AGFA Hong Kong Limited
2555 9421
FDA
Z-1893-2008 to Z-1894-2008
Class II
2008/09/19
Baxter Healthcare Ltd
2807 8500
FDA
Z-1588-2008 to Z-1589-2008
Class II
2008/09/19
Bio-Rad Pacific Ltd.
2789 3300
FDA
Z-1819-2008 to Z-1820-2008
Class II
2008/09/19
N/A
N/A
FDA
Z-1698-2008
Class II
2008/09/19
N/A
N/A
FDA
Z-1823-2008 to Z-1824-2008
Class II
2008/09/19
N/A
N/A
BD Asia Ltd (Hong
Kong)
N/A
Firm Initiated Field
Action
2008/09/22
BD Asia Ltd (Hong Kong)
2575 8668
SN080983
SN080984
SN080985
SN080986
SN080987
SN080988
Baxter Healthcare (Edwards Lifesciences LLC) Fem-Flex II
Femoral Venous Cannula and Fem-Flex II Duraflo Treated Femoral
Venous Catheter
Bio-Rad VARIANT β-thalassemia Short Program Hemoglobin
Testing System(Model 270-0019 and 270-0002)
Allez Spine Laguna Pedicle Screw System (IT-FN1001 and ITFN1007)
Galil Medical Warming Catheter
Resonance Technology Headset Model no RTC-2K and RTC-551070
BD Vacutainer 16 x 100 MM Serum Blood Collection tubes, BD
Vacutainer 16 x 100 mm SSTII Advance Blood Collection tubes,
BD Vacutainer 16 x 100 Glass Calcium Chloride Blood Collection
tubes (FA 08002)
SN080989
MIM 4.0 and MIM 4.1
FDA
Z-1827-2008
Class II
2008/09/22
N/A
N/A
SN080990
FDA
Z-1800-2008 to Z-1807-2008
Class II
2008/09/22
N/A
N/A
FDA
Z-1790-2008 to Z-1799-2008
Class II
2008/09/22
N/A
N/A
SN080992
Merit Medical Systems Fluid Administration Set, Custom Kit
Mentor Psi-Tec Tubing, Autofuse Tubing, i-Vac Tubing, Lamis
Tubing Set, Y Tubing Set, Irrigation Tubing, Psi-Tec SYRINGE
Pump Infiltration Tubing, Contour Genesis Infiltration Tubing,
Contour Geneses Inf/IR Tubing AND Contour Genesis Aspiration
Tubing
Encore Medical Keramos Replacement Polyethlene Liner
FDA
Z-1785-2008
Class II
2008/09/22
N/A
N/A
SN080993
Orthodocs Cocoon
MHRA
2008/006/006/401/006
FSCA
2008/09/24
N/A
N/A
SN080994
Pride Mobility Quantum Vibe Power Chair
MHRA
2008/005/014/301/003
FSCA
2008/09/24
N/A
N/A
SN080995
MHRA
2008/009/011/061/008
FSCA
2008/09/24
Philips Healthcare - Great China
2821 5480
MHRA
2008/009/011/601/601/002
FSCA
2008/09/24
Beckman Coulter Hong Kong Ltd
2240 6150
SN080997
Philips BV Pulsera and Endura, C-arm
Beckman Coulter Access Immunoassay Systems HAV Ab Reagent
Kit
Tyco Healthcare Hot/Cold Pack
TGA
N/A
N/A
2008/09/24
COVIDIEN
3157 7220
SN080998
Various Hot/Cold Gel Pack
TGA
N/A
N/A
2008/09/25
N/A
N/A
SN080999
GE 1.5T and 3.0T Sigma HDx System and GE Signa Excite 1.5T
MR and 3.0T MR System
FDA
Z-1890-2008 to Z-1891-2008
Class II
2008/09/26
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081000
Philips Gallileo Automatic Collimator (Part Number 9896 010
00612, 9896 010 00614, 9896 010 00615)
FDA
Z-1886-2008
Class II
2008/09/26
Philips Healthcare - Great China
2821 5480
FDA
Z-1374-2008
Class II
2008/09/26
Philips Healthcare - Great China
2821 5480
FDA
Z-1542-2008
Class II
2008/09/26
N/A
N/A
SN081003
Philips OmniDiagnost Eleva X-Ray System
Hitachi Altaire MRI System Emergency Rundown Switch Unit
(ERDU)
Stryker OmniFit X-Ray Templates and OmniFit HFx Sell Sheets
FDA
Z-2054-2008 to Z-2055-2008
Class II
2008/09/26
Stryker China Ltd
2518 6988
SN081004
Stryker Triathlon Femoral Sizer
FDA
Z-1864-2008
Class II
2008/09/26
Stryker China Ltd
2518 6988
SN081005
Stryker Short Barrel Sideplate (Catalog no. 3362-0-404)
FDA
Z-2865-2008
Class II
2008/09/26
Stryker China Ltd
2518 6988
SN081006
Stryker Ureteral Kit (Model no.: 220-180-516) and Stryker Ureteral
Universal Kit (Model no.: 220-180-517)
FDA
Z-1866-2008 to Z-1867-2008
Class II
2008/09/26
Stryker China Ltd
2518 6988
SN080991
SN080996
SN081001
SN081002
Medical Device Control Office
232
Department of Health
The Government of HKSAR
SN081007
Zimmer 4.5 Compression plate-broad (REF 4945-10-01)
FDA
Z-2179-2008
Class II
2008/09/26
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN081008
Medtronic Physio-Control Internal Defibrillator Handles and Internal
Defibrillation Electrodes
FDA
Z-2035-2008 to Z-2036-2008
Class II
2008/09/26
Medtronic International, Ltd.
2907 5911
SN081009
Medtronic VNUS Medical U-CLIP Remocal Tool (UREM 1860)
FDA
Z-1609-2008
Class II
2008/09/26
Medtronic International, Ltd.
2907 5911
SN081010
Johnson and Johnson Depuy LCS Knee
FDA
Z-1812-2008
Class II
2008/09/26
Johnson & Johnson Medical (HK)
2738 6027
SN081011
Merit Fountain Indusion System, 4F (REF IS4-90-50)
FDA
Z-2107-2008
Class II
2008/09/26
N/A
N/A
SN081012
I-Flow On-Q C-bloc 400ml (REF CB005)
FDA
Z-2133-2008
Class II
2008/09/26
N/A
N/A
SN081013
I-Flow ON-Q PainBuster Infusion Pump (REF PS6504, Part No.
5001260)
FDA
Z-1869-2008
Class II
2008/09/26
N/A
N/A
SN081014
Intuitive Surgical da Vinvi S Surgical System (Model no IS2000)
FDA
Z-2204-2008
Class II
2008/09/26
N/A
N/A
SN081015
Intuitive Surgical DA Vinci Surgical System Model S Cardiac Probe
Gasper Instrument (Model IS2000)
FDA
Z-1811-2008
Class II
2008/09/26
N/A
N/A
SN081016
Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery
System, M-Style Cup with UVR and Mystic II M-Style Mushroom
Cup Vacuum Assisted Delivery System
FDA
Z-1887-2008 to Z-1889-2008
Class II
2008/09/26
N/A
N/A
SN081017
Integra LifeSciences PANTA Nails
FDA
Z-1877-2008
Class II
2008/09/26
N/A
N/A
SN081018
Accuracy Cyberknife Robotic Radiosurgery System
FDA
Z-1862-2008
Class II
2008/09/26
Accuray Asia Ltd
2247 8628
FDA
Z-1659-2008 to Z-1660-2008
Class II
2008/09/26
N/A
N/A
SN081019
GMP LS-232 Large 12 LeadWear Single Pack and LS-202 Large
LeadWear Combo Pack
Diamedix Is-anti-Gliadin IgG Enzyme Immunoassay Test kit
(Catalog no 720-800)
FDA
Z-1684-2008
Class II
2008/09/26
N/A
N/A
SN081021
Cardiac Science Electrode Adaptor Cable Quick-Combo System
(Model 9055)
FDA
Z-1714-2008
Class II
2008/09/26
N/A
N/A
SN081022
Sun Biomedical VisuaLine Single Dip Oxycodone, VisuaLine
Propoxyphene test system, VisuaLine Tricyclic Antidepressants
FDA
Z-1873-2008 to Z-1875-2008
Class II
2008/09/26
N/A
N/A
SN081023
Greiner Bio-One Vacuette, Plastic Cannula HOLDEX (Ref 450216)
FDA
Z-2134-2008
Class II
2008/09/26
Mekim Ltd
2774 8300
FDA
Z-2205-2008 to Z-2208-2008
Class II
2008/09/26
N/A
N/A
Health Canada
43308
Type II
2008/09/29
Philips Healthcare - Great China
2821 5480
SN081020
SN081024
SN081025
ICU Medical Hospira Intralock Lipid Compatible 3-Way Stopcock,
Hospira Monitoring Kit (PA Line) and Left Heart Kit
Philips Brilliance CT Big Bore System-Main Unit and Brilliance CT
System (16P)
SN081026
Philips Diagnost 94, Diagnost 96 and Diagnost 97
Health Canada
43340
Type II
2008/09/29
Philips Healthcare - Great China
2821 5480
SN081027
Philips Brilliance 64 Slice CT System-Main Unit
Health Canada
43322
Type II
2008/09/29
Philips Healthcare - Great China
2821 5480
SN081028
Philips Essenta DR
Health Canada
43360
Type II
2008/09/29
Philips Healthcare - Great China
2821 5480
SN081029
Philips Isite Pacs
Health Canada
43324
Type II
2008/09/29
Philips Healthcare - Great China
2821 5480
SN081030
Philips HDI 4000 System
Health Canada
43395
Type II
2008/09/29
Philips Healthcare - Great China
2821 5480
SN081031
Siemens Angiostar; Multistar D, P; Bicor HS, HS-ACS; Coroskop
HS, HS-ACS, HI-P, C and Neurostar Top
Health Canada
43314
Type II
2008/09/29
Siemens Ltd.
2810 7533
SN081032
Siemens Axiom Luminos TF
Health Canada
43288
Type II
2008/09/29
Siemens Ltd.
2810 7533
SN081033
GE Instatrak 3500 System
Health Canada
42398
Type II
2008/09/29
GE Medical Systems Hong Kong Ltd.
2783 1838
SN081034
Impac Medical Systems Sequencer (Model 40000-000000-RO)
Health Canada
43446
Type II
2008/09/29
N/A
N/A
SN081035
Zimmer Patient Helper Reinforced Overhead Bar
Health Canada
43273
Type II
2008/09/29
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN081036
Porex Surgical Ocular Conformers (Non-Vented and Vented)
Health Canada
43459
Type II
2008/09/29
N/A
N/A
Medical Device Control Office
233
Department of Health
The Government of HKSAR
SN081037
Medilab Beautytek Premium Edition
Health Canada
41783
Type II
2008/09/29
N/A
SN081038
Home Telehealth WebVMC Remote Nurse
MHRA
2008/008/018/061/010
FSCA
2008/09/29
N/A
N/A
SN081039
Covidien Argyle Suction Catheter
MHRA
2008/007/029/061/011
FSCA
2008/09/29
Covidien
2574 3251
SN081040
Bauerfeind AG Shin Tubes Mod. A3-Ti200/400 and A3-St200
MHRA
2007/009/018/401/005
FSCA
2008/09/29
N/A
N/A
SN081041
B Braun Microspeed Uni Mobile stand GA411
MHRA
2008/009/022/061/003
FSCA
2008/09/29
B Braun Medical Hong Kong
N/A
SN081042
Coloplast Folysil Xtra Silicone Indwelling Catheters
MHRA
2008/008/028/401/010
FSCA
2008/09/29
Coloplast (Hong Kong) Ltd
N/A
SN081043
Utah Intran Plus IUPC trays
MHRA
2008/009/016/051/001
FSCA
2008/09/30
N/A
N/A
SN081044
Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120
MHRA
2008/006/005/291/004
FSCA
2008/09/30
Siemens Ltd
2810 7533
SN081045
Draeger Sub-Acute Care Ventilator Carina
MHRA
2008/007/003/401/011
FSCA
2008/09/30
N/A
N/A
SN081046
BD Visitec High Viscosity Injector
MHRA
2008/009/022/061/010
FSCA
2008/09/30
BD Asia Ltd (Hong Kong)
2722 5660
SN081047
Johnson and Johnson Animas™ 2020 and IR 1200 Insulin Pump
MHRA
2008/009/022/061/015
FSCA
2008/09/30
Johnson & Johnson Medical (HK)
2738 6027
SN081048
Sybron Endo K3 Engine File G-Pack
Health Canada
43337
Type II
2008/09/30
N/A
N/A
SN081049
Adac Laboratories Precedence System (6 and 16 Slice)
Health Canada
43306
Type II
2008/09/30
N/A
N/A
SN081050
Apogee Intermittent Catheter
Health Canada
43335
Type II
2008/09/30
N/A
N/A
SN081051
Medacta AMIS Universal Table for Leg Positioner (Model no.
01.15.10.0172)
FDA
Z-1870-2008
Class II
2008/09/30
N/A
N/A
SN081052
EBI Trauma Fixation Systems
FDA
Z-2012-2008
Class II
2008/09/30
N/A
N/A
SN081053
Biomet Hybrid Glenoid Boss Cutter; item 406150
FDA
Z-1658-2008
Class II
2008/09/30
N/A
N/A
SN081054
Biomet OSS Interlok IM Stem
Z-1879-2008 to Z-1881-2008
N/A
N/A
Boston Scientific Precision Charger 1.0 (UPN M365SC53000)
Class II
Firm Initiated Field
Action
2008/09/30
SN081055
FDA
Boston Scientific
Hong Kong Ltd
2008/09/30
Boston Scientific HK Limited
2960 7136
Medical Device Control Office
N/A
234
N/A
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - August 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
SN080801
MDA/2008/059
MDA
Date of Issue
(YYYY/MM/DD)
2008/08/01
Bayer Healthcare
Agent Contact
Telephone No
2814 4836
SN080802
Levitronix CentriMag Systems
MHRA
2008/002/026/401/001
FSCA
2008/08/01
N/A
N/A
SN080803
Stryker Scorpio Series 7000 Tibial Impactor/Extractor
MHRA
2008/007/007/061/017
FSCA
2008/08/01
Stryker China Ltd
2518 6915
SN080804
ThermoFisher Scientific BO0348V Maximum recovery diluent
MHRA
2008/007/018/601/501
FSCA
2008/08/01
N/A
N/A
Baxter Healthcare
Ltd
N/A
Firm Initiated Field
Action
2008/08/04
Baxter Healthcare Ltd
2807 8500
Description of Product
Bayer Ascensia Contour blood glucose meters
Source of
Information*
MHRA
Reference No. by Source
Alert Type by Source
Local Agent
SN080805
Baxter FLOSEAL Endoscopic Applicator (#1500181)
SN080806
Arjo Carendo multi-purpose hygiene chair
MHRA
MDA/2008/060
MDA
2008/08/05
N/A
N/A
SN080807
CASMED 740 Series Multiparameter Monitor
MHRA
2008/007/022/061/001
FSCA
2008/08/05
N/A
N/A
SN080808
Siemens ADVIA Centaur CP immunoassay system
MHRA
MDA/2008/061
MDA
2008/08/05
N/A
N/A
SN080809
TomoTherapyR Hi-Art Treatment System
MHRA
2008/004/024/061/020
FSCA
2008/08/05
N/A
N/A
SN080810
TomoTherapyR Hi-Art Treatment System
MHRA
2008/004/024/061/021
FSCA
2008/08/05
N/A
N/A
SN080811
GE Healthcare Centricity Perinatal (formerly QS) System - PFILS
software
FDA
Z-2037-2008
Class II
2008/08/07
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080812
GE Healthcare Precision 500D Classical R&F System with control
room PC (Model no. 5117866-27)
FDA
Z-0274-2008
Class II
2008/08/07
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080813
Intuitive Surgical Da Vinci S 8mm Instrument Cannula (Model
IS2000, Part No. 400254-01, 400255-01)
FDA
Z-1348-2008
Class II
2008/08/07
N/A
N/A
SN080814
Synovis GEM 2753 Microvascular Anastomotic Coupler, 2.5mm
(REF GEM2753/1, P/N 5111-00250-010)
FDA
Z-2138-2008
Class II
2008/08/07
N/A
N/A
SN080815
Varian Acuity with Conebeam COMPUTED Tomography (Model
No. H77)
FDA
Z-1460-2008
Class II
2008/08/07
Varian Medical Systems Pacific Inc.
2724 2836
SN080816
Varian High-Definition 120 MultiLeaf Collimator (Product code: H56)
FDA
Z-1459-2008
Class II
2008/08/07
Varian Medical Systems Pacific Inc.
2724 2836
SN080817
Philips 1.5T Intera and 1.5T Achieva systems
MHRA
2008/007/022/051/005
FSCA
2008/08/08
Philips Medical System
2876 7525
SN080818
Biomet Pectus Table Top Bender (part # 01-3906)
MHRA
2008/001/018/291/026
FSCA
2008/08/11
N/A
N/A
2738 2818
SN080819
Johnson and Johnson Depu Delta XTEND
MHRA
2008/007/023/061/004
FSCA
2008/08/11
Johnson & Johnson Medical Hong
Kong
SN080820
Baxter COLLEAGUE Triple Channel Mono and CXE Volumetric
Infusion Pumps
MHRA
2008/007/022/051/006
FSCA
2008/08/13
N/A
N/A
SN080821
Stille Sonesta 6210 fluoroscopy procedure table
MHRA
MDA/2008/063
MDA
2008/08/13
N/A
N/A
SN080822
ThermoFisher EB0212E Cooked meat medium
MHRA
2008/007/021/601/503
FSCA
2008/08/13
N/A
N/A
SN080823
Regulatory Insight Rolling Walkers (Rollators)
Health Canada
42905
Type II
2008/08/13
N/A
N/A
SN080824
Maquet Servo-I (Model 640870800 E407E)
Health Canada
43009
Type II
2008/08/13
Maquet Hong Kong Ltd
2393 9511
Medical Device Control Office
235
Department of Health
The Government of HKSAR
SN080825
Teleflex Medical A) Dermahook Neuro Elastic Retractors 1/2", B)
Dermahook Neuro Elastic Retractors 1/4"
Health Canada
42249
Type II
2008/08/13
N/A
N/A
SN080826
Hologic A) Delphi Bone Densitometer, B) Discovery QDR Bone
Denositometer, C) Explorer QDR Bone Densitometer, D) QDR
4500 Bone Densitometer
Health Canada
43205
Type II
2008/08/13
N/A
N/A
SN080827
Acist Angiographic System - Table Kit
Health Canada
43028
Type II
2008/08/13
Pacific Medical (Hong Kong) Ltd.
2343 8009
SN080828
Brainlab AG Brainscan Treatment Planning Software
Health Canada
42381
Type II
2008/08/13
N/A
N/A
SN080829
Philips A) PCR AC-500/PCR-5000, B) PCR Corado Eleva, C)PCR
Compano System / PCR Eleva S Plus
Health Canada
43176
Type II
2008/08/13
Philips Medical System
2876 7525
SN080830
Philips Digital Diagnost
Health Canada
43190
Type II
2008/08/13
Philips Medical System
2876 7525
SN080831
Draeger Fabius Titro Anesthesia System
Health Canada
43160
Type II
2008/08/13
Draeger Medical Hong Kong Ltd.
2877 3077
SN080832
Hospira LifeCare PCA Label Utilility, Version 1.0 CD
FDA
Z-1181-2008
Class II
2008/08/14
Hospira Ltd
2285 8382
SN080833
Beckman Coulter Cytomics FC 500 Flow Cytometry System with
Data Innovations Instrument Manager (Part no 626553 and
6605628)
FDA
Z-1529-2008
Class II
2008/08/14
Beckman Coulter Hong Kong Ltd
2240 6150
SN080834
3M Comply EO Chemical indicators Strips (Catalog # 1251)
FDA
Z-1568-2008
Class II
2008/08/14
3M Hong Kong Ltd
2806 6314
SN080835
Johnson and Johnson Medical Advanced Sterilization Products
EvoTech Endoscope Cleaner & Reprocessor (Product Code 50004
AND 50004-002)
FDA
Z-1368-2008 to Z-1369-2008
Class II
2008/08/14
Johnson & Johnson Medical Hong
Kong
2738 2818
SN080836
Siemens IMMULITE / IMMULITE 1000 Progesterone
MHRA
2008/007/025/061/020
FSCA
2008/08/14
Siemens Ltd.
2810 7533
SN080837
Homecraft Rolyan Savanah Raised Toilet Seat Brackets
MHRA
2008/003/006/401/011
FSCA
2008/08/14
N/A
N/A
SN080838
Stryker REDUCTION SPOON 09MM
MHRA
2008/007/023/061/010
FSCA
2008/08/14
Stryker China Ltd
2518 6915
SN080839
Activate Patron Bohemia Strollers
MHRA
2006/010/011/081/003
FSCA
2008/08/14
N/A
N/A
SN080840
Sunrise Medical Lomax Kid Active Recliner Attendant Push
Wheelchairs
MHRA
2008/001/003/061/022
FSCA
2008/08/15
N/A
N/A
2008/08/15
N/A
N/A
2008/08/15
Varian Medical Systems Pacific Inc.
2722 8123
SN080841
Apline Microtargeting Electrode Cable
Apline BioMed
N/A
Varian Medical
Systems Pacific Inc.
N/A
Firm Initiated Field
Action
Firm Initiated Field
Action
SN080842
Varian Exact Couch Pinch Point
SN080843
GE Healthcare Solar 8000/i/M
MHRA
2008/007/024/601/510
FSCA
2008/08/18
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080844
Ortho Europe Uniaxial Foot
MHRA
2008/002/026/061/008
FSCA
2008/08/18
N/A
N/A
SN080845
Philips MRI Magnet Venting System Inspection
MHRA
2008/007/023/061/006
FSCA
2008/08/18
Philips Medical System
2876 7525
SN080846
ConMed Frazier and Poole Suction Instruments
MHRA
2008/007/015/061/018
FSCA
2008/08/18
N/A
N/A
SN080847
Medi-Plinth Three function electric foot switches
MHRA
2008/005/008/401/005
FSCA
2008/08/18
N/A
N/A
SN080848
Siemens Magnetom Mobile Systems
MHRA
2008/007/031/061/014
FSCA
2008/08/19
Siemens Ltd.
2810 7533
SN080849
KCI 500 ml Canister for Infovac
MHRA
2008/007/031/061/003
FSCA
2008/08/19
N/A
N/A
SN080850
Lomax Mobility Wheelchairs
MHRA
2006/007/019/081/009
FSCA
2008/08/19
N/A
N/A
SN080851
Medtronic MaximoR II Device
MHRA
2008/007/021/401/014
FSCA
2008/08/19
Medtronic International Limited
2919 1300
Medical Device Control Office
236
Department of Health
The Government of HKSAR
MHRA
2008/007/011/061/012
FSCA
2008/08/20
Roche Diagnotics (Hong Kong) Ltd.
2485 7510
Health Canada
N/A
N/A
2008/08/20
Baxter Healthcare Ltd
2807 8500
N/A
N/A
2008/08/21
Chiron Limited
2161 3104
2008/008/001/061/001
FSCA
2008/08/21
N/A
N/A
2008/008/004/051/010
FSCA
2008/08/21
Medtronic International Limited
2919 1300
FDA
Z-1621-2008
Class II
2008/08/21
Goodman Medical Supplies Ltd
2332 4455
FDA
Z-1443-2008 to Z-1444-2008
Class II
2008/08/21
Philips Medical Systems
2821 5480
FDA
Z-1442-2008
Class II
2008/08/21
Varian Medical Systems Pacific Inc.
2722 8123
FDA
Z-1525-2008
Class II
2008/08/21
BD Asia Ltd (Hong Kong)
2722 5660
FDA
Z-1527-2008 to Z-1528-2008
Class II
2008/08/21
BD Asia Ltd (Hong Kong)
2722 5660
FDA
Z-1830-2008 to Z-1853-2008
Class II
2008/08/21
N/A
N/A
SN080852
Roche Diagnostics modular analytics
SN080853
Edwards Lifescience Accusol 35 Harmofialysis solutions for Acute
Renal Therapy
SN080854
Chiron PROCLEIX (Assay Reagent)
Press
SN080855
ArthroCare Topaz XL ArthroWand
MHRA
SN080856
MedtronicLIFEPAK CR Plus and LIFEPAK Express Defibrillator
MHRA
SN080857
Smiths Medical CADD-MS 3 Ambulatory Infusion Pimp (Model
7400)
SN080858
Philips Medical Systems iSite PACS version 3.6.28.0 and version
4.1.17.0
SN080859
Varian Medical Systems On-Board Imager, versions 1.0.15 and
1.2.05 Imaging Accessory to Medical Linear Accelerator
SN080860
SN080861
SN080862
BD FACSDiva Software Versions 4.0.1 to 5.0.2 Flow Cytometry
Acquistion & Analysis software (Catalog no 641609)
BD Difco(tm) Shigella Antiserum Poly Group B (Catalog no. 228351
and 210722)
Atrium Medical HydraGlide Heparin coated PVC Straight Thoracic
Catheters with Tapered Connector Tip
SN080863
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom
Carestation (Model# 1505-3272-00)
FDA
Z-1526-2008
Class II
2008/08/21
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080864
Impac Medical Systems SEQUENCER, MOSAIQ versions 1.3 and
1.4 (Model # 40003-001000-RO)
FDA
Z-1515-2008
Class II
2008/08/21
N/A
N/A
SN080865
Medtronic PROSTIVAR RF Model 8929 Hand Piece
MHRA
2008/008/006/061/010
FSCA
2008/08/25
Medtronic International Limited
2919 1300
SN080866
BrainlabVectorVision Sky and/or BrainSUITE NET system
MHRA
2008/008/004/051/009
FSCA
2008/08/25
BrainLAB Ltd. (Hong Kong)
SN080867
Varian Exact Couch with Exact Couch Top
MHRA
2008/008/007/061/015
FSCA
2008/08/25
Varian Medical Systems Pacific Inc.
2722 8123
SN080868
Maquet Expiratory Valve Coils
MHRA
2008/007/016/061/004
FSCA
2008/08/25
Maquet Hong Kong Ltd
2393 9511
SN080869
GE Healthcare CT/SPECT Studies of Brain Scans
MHRA
2008/008/011/051/011
FSCA
2008/08/25
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080870
Altomed Irrigating handpiece A3404
MHRA
2008/008/005/051/002
FSCA
2008/08/25
N/A
N/A
SN080871
B Braun Prevision Implant System
MHRA
2008/008/004/061/010
FSCA
2008/08/25
B Braun Medical Hong Kong
N/A
SN080872
SN080873
GE Healthcare CT/SPECT Studies of Brain Scans
Cook Endoureterotomy Stent Set
MHRA
MHRA
2008/008/011/051/011
2008/007/021/061/001
FSCA
FSCA
2008/08/25
2008/08/25
GE Medical Systems HK Ltd
Cook Asia Ltd.
2783 1838
N/A
SN080874
Apex TS 1211/1311 Combo Unit
Health Canada
41710
Type II
2008/08/27
N/A
N/A
SN080875
Impac Medical Systems SEQUENCER (Model: 50200-000000-RO)
Health Canada
33877
Type I
2008/08/27
N/A
N/A
SN080876
Dentsply Osteograf N-300 (Model: 930000-304)
Health Canada
41213
Type II
2008/08/27
N/A
N/A
SN080877
Dentsply Lexicon size 15 dental hand files
Health Canada
40992
Type II
2008/08/27
N/A
N/A
SN080878
Synthes Labelling for Synthes Power Drive (Model: 530.1)
Health Canada
43294
Type II
2008/08/27
N/A
N/A
SN080879
BD BBL Staphyoside Test (Model: 240952, 240953)
Health Canada
41510
Type II
2008/08/27
BD Asia Ltd (Hong Kong)
2575 8668
SN080880
Tyco Argyle Suction Catheter (Model: 1180-851121, 1180-851147)
Health Canada
43260
Type II
2008/08/27
Tyco Healthcare (HKSAR) LTD
2574 3251
SN080881
Philips Allura XPER FD10, Allura XPER FD 20 system, Allura
XPER FD 20/10 System, Integris Allura, Integris H5000F
Cardiology Imaging System
Health Canada
43276
Type II
2008/08/27
Philips Medical System
2876 7525
Medical Device Control Office
237
Department of Health
The Government of HKSAR
SN080882
Philips Achieva 1.5T MRI System - Sense Torso Coil, Intera 1.5T
MRI System - Sense XL Torso Coil
SN080883
Health Canada
43296
Type II
2008/08/27
Philips Medical System
2876 7525
Siemens MicroScanR Dried Overnight Gram Negative and
Synergies plusR Negative Panels
MHRA
2008/008/013/061/009
FSCA
2008/08/27
Siemens Ltd.
2810 7533
SN080884
Johnson and Johnson Vicryl Rapide
MHRA
2008/008/011/061/007
FSCA
2008/08/27
Johnson & Johnson Medical (HK)
2738 2818
SN080885
Medtronic Deep Brain Stimulator lead kit with cap
MHRA
2008/008/015/061/004
FSCA
2008/08/27
Medtronic International Limited
2919 1300
SN080886
Molnlycke ProcedurePak
MHRA
2008/007/023/061/008
FSCA
2008/08/27
N/A
N/A
SN080887
Beckman Coulter Access Power Supply Assembly Seld (Part No.:
A48196/6845C)
FDA
Z-1183-2008
Class II
2008/08/28
Beckman Coulter Hong Kong Ltd
2240 6150
FDA
Z-1513-2008 to Z-1514-2008
Class II
2008/08/28
Boston Scientific HK Limited
2960 7136
FDA
Z-2139-2008
Class II
2008/08/28
Abbott Laboratories Ltd.
2806 4021
FDA
Z-1694-2008
Class II
2008/08/28
Covidien
2574 3251
SN080888
SN080889
SN080890
Boston Scientific VITALITY DR+ ICD (model 1872) and VITALITY
EL (models T127, T167, T177) ICD
Abbott CELL-DYN Sapphire Hematology Analyzer (List No. 08H0001)
Mallinckrodt OptiVantage DH Injection System (Catalog# V8400,
Part no. 241078 & Catalog# V8402, Part # 241079)
SN080891
Stryker Omnifit EON Surgical Protocol
FDA
Z-1750-2008
Class II
2008/08/28
Stryker China Ltd
2518 6988
SN080892
Stryker Radius Rod Persuader and Radius Capsin (Catalog #
486619190, 486619210)
FDA
Z-1377-2008 to Z-1378-2008
Class II
2008/08/28
Stryker China Ltd
2518 6988
SN080893
Siemens Medical charged-particle radiation therapy system
FDA
Z-1769-2008
Class II
2008/08/28
Siemens Ltd.
2810 7533
SN080894
Biomet Modular Microplasty Cup Inserter and Impactor
FDA
Z-1185-2008 to Z-1187-2008
Class II
2008/08/28
N/A
N/A
SN080895
Bio-Rad MONOLISA Anti-HBc EIA (Catalog no 26186)
FDA
Z-1189-2008
Class II
2008/08/28
Bio-Rad Pacific Ltd.
2789 3300
SN080896
GIVEN Diagnostic System with PillCam SB Capsule
FDA
Z-1447-2008
Class II
2008/08/28
N/A
N/A
SN080897
AMO Excimer Laser System
FDA
Z-1695-2008
Class II
2008/08/28
AMO Asia Limited
2480 3330
SN080898
Medline Bariatric Wheelchair
FDA
Z-1770-2008 to Z-1772-2008
Class II
2008/08/28
N/A
N/A
SN080899
FDA
Z-1773-2008
Class II
2008/08/28
N/A
N/A
FDA
Z-2140-2008
Class II
2008/08/28
N/A
N/A
SN080901
EKOS EndoWave Infusion System
Acumed Osteo-Clage Cable System Package Assembly (01-0001S)
StatSampler 200 uL, Li Heparin (Ref: SS2H)
FDA
Z-2234-2008
Class II
2008/08/28
N/A
N/A
SN080902
Philips HeartStart MRx Monitor/Defibrillator
MHRA
2008/008/018/061/026
FSCA
2008/08/28
Philips Medical System
2876 7525
SN080903
Smith & Nephew Dyonics 25 Tubeset kits
MHRA
2008/008/015/061/007
FSCA
2008/08/28
N/A
N/A
SN080904
Siemens Trugene HIV-1 Module for GuideLines Rules 11.0, 12.0 &
13.0
MHRA
2008/008/018/061/021
FSCA
2008/08/28
Siemens Limited
2810 7533
SN080905
Sorin D901 Lilliput 1/ D100 Dideco Kids
MHRA
2008/008/020/061/006
FSCA
2008/08/28
N/A
N/A
SN080906
Medtronic Disposable Magellan Kits and One Source Kits
MHRA
2008/008/021/061/010
FSCA
2008/08/28
Medtronic International Limited
2919 1300
SN080907
Baxter HOMECHOICE/HOMECHOICE PRO Automated Peritoneal
Dialysis System
MHRA
2008/005/028/061/023
FSCA
2008/08/29
Baxter Healthcare Ltd
2807 8500
SN080908
Leckey Squiggles Stander on Pivot Chassis
MHRA
2008/005/008/401/003
FSCA
2008/08/29
N/A
N/A
SN080909
Philips Allura Xper FD10 and FD10/10
MHRA
2008/007/002/061/011
FSCA
2008/08/29
Philips Medical System
2876 7525
SN080910
GE Voluson E8 Ultrasound Systems
MHRA
2008/005/019/601/350
FSCA
2008/08/29
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080911
BrainlabExac TRac Infrared Tracking Platform 5.0, 5.5
MHRA
2008/008/011/061/001
FSCA
2008/08/29
BrainLAB Ltd. (Hong Kong)
N/A
SN080912
Baylis Medical Toronto Transseptal Catheter Model TSC-50-75
MHRA
2008/008/021/061/001
FSCA
2008/08/29
N/A
N/A
SN080900
Medical Device Control Office
238
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - July 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
SN080701
MDA/2008/044
MDA
Date of Issue
(YYYY/MM/DD)
2008/07/02
N/A
Agent Contact
Telephone No
N/A
SN080702
Abbott Diagnostics ARCHITECT c8000 System
MHRA
2008/006/002/601/380
FSCA
2008/07/02
Abbott Laboratories Ltd.
2806 4021
SN080703
Anspach Sterile Single-use Cuting Burrs
MHRA
2008/006/011/291/004
FSCA
2008/07/02
N/A
N/A
SN080704
Arrow International Cannon catheter , Cannon catheter II and Edge
catheter
MHRA
2008/006/018/061/010
FSCA
2008/07/02
N/A
N/A
SN080705
TerumoTubing packs for extracorporeal circulation of blood
MHRA
2008/005/021/401/005
FSCA
2008/07/02
TERUMO CHINA (H.K.) LTD.
2866 0811
SN080706
BioMerieux Agars 43001, 43041, and 43401
MHRA
2008/006/018/601/425
FSCA
2008/07/02
Biomerieux China Ltd (HK)
N/A
SN080707
Handicare B.V. Beatle / Puma power wheelchairs
MHRA
2008/001/007/301/001
FSCA
2008/07/02
N/A
N/A
SN080708
Biomet UK Lactosorb L Template
MHRA
2008/005/021/061/017
FSCA
2008/07/02
N/A
N/A
SN080709
Stryker Reflex Revision Screwdriver
MHRA
2008/006/012/291/005
FSCA
2008/07/02
Stryker China Ltd
2518 6915
SN080710
BioLytical Laboratories INSTI HIV-1 /HIV-2 antibody test
MHRA
2008/006/011/401/013
FSCA
2008/07/02
N/A
N/A
SN080711
Sunrise Medical Groove Power Wheelchairs
MHRA
2008/003/003/261/001
FSCA
2008/07/03
N/A
N/A
SN080712
Medtronic Sutureless Connector Intrathecal Catheters
MHRA
2008/006/025/061/013
FSCA
2008/07/03
Medtronic International, Ltd.
2919 1300
SN080713
Remploy Access & Accent wheelchair
MHRA
2007/010/023/261/001
FSCA
2008/07/03
N/A
N/A
FDA
Z-1160-2008
Class II
2008/07/03
Beckman Coulter Hong Kong Ltd
2240 6150
FDA
Z-1236-2008
Class II
2008/07/03
Stryker China Ltd
2518 6915
SN080714
SN080715
Description of Product
Invacare Action³ manual wheelchair
Beckman Coulter Access Ultra sensitive Insulin Assay Kit (Part
Number 33410)
Stryker Solar HA Humeral Stem with Plasma Coating 7mm to
17mm
Source of
Information*
MHRA
Reference No. by Source
Alert Type by Source
Local Agent
SN080716
AGFA HeartLabCardiovascular DICOMstore (Model # L9M8E)
FDA
Z-1241-2008
Class II
2008/07/03
AGFA Hong Kong Limited
2555 9421
SN080717
AGFA HeartLab Cardiovascular Results Management Product
(Model No.: L58RZ and L9MWQ)
FDA
Z-1242-2008
Class II
2008/07/03
AGFA Hong Kong Limited
2555 9421
SN080718
AGFA IMPAX 6.2.1 Network Gateway Server, License Key
(Catalog # ABC)
FDA
Z-1306-2008
Class II
2008/07/03
AGFA Hong Kong Limited
2555 9421
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/07/03
Boston Scientific Hong Kong Ltd
2960 7136
SN080719
Boston Scientific Lumenis/Slimline Fiber Strippers
SN080720
Kentec Medical Reusable Ohmeda Compatible Finger Clip Sensor
(Model Number: E403-02, Product code: PS2225)
FDA
Z-1188-2008
Class II
2008/07/03
N/A
N/A
SN080721
Medline IL Latex-Free Breathing Bags,; Reservoir Bags
FDA
Z-1162-2008 to Z-1164-2008
Class II
2008/07/03
N/A
N/A
SN080722
Huntleigh Healthcare BabyCare crib trolleys
MHRA
MDA/2008/048
MDA
2008/07/03
N/A
N/A
SN080723
Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe
MHRA
MDA/2008/049
MDA
2008/07/03
Goodman Medical Supplies Ltd
2332 4455
Alcon Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/07/07
Alcon Hong Kong Ltd
2161 0844
MHRA
2008/001/010/401/007
FSCA
2008/07/07
N/A
N/A
MHRA
2008/006/025/181/011
FSCA
2008/07/07
Draeger Medical Hong Kong Ltd.
2877 3077
SN080724
SN080725
SN080726
Alcon MONARCH II IOL Delivery System - Cartridge Model B ( Pat
# 8065977758; Lot#: 174244, 174250)
Park House Healthcare PHP 198, PHP396, PHP398 & PHP399
Pumps
Draeger Medical Intensive Care ventilators
Medical Device Control Office
239
Department of Health
The Government of HKSAR
SN080728
TherapostureTheracare Beds supplied with Mesh Linked Padded
Rails
Medtronic SynchroMed® II Implantable Infusion Pump
MHRA
2008/005/029/291/001
FSCA
2008/07/07
Medtronic International, Ltd.
2919 1300
SN080729
Liko AB Universal SlingBar
MHRA
2008/006/024/071/002
FSCA
2008/07/07
N/A
N/A
SN080730
Invacare Harrier Heavy Duty (HD) battery powered wheelchair
MHRA
MDA/2008/050
MDA
2008/07/08
N/A
N/A
SN080731
Quest 88 Kaye Posture Control Walkers
MHRA
2007/011/015/401/003
FSCA
2008/07/08
N/A
N/A
SN080732
Steris Quick Connect (Model QXCXXXX)
Health Canada
38366
Type II
2008/07/10
Swedish Trading Co., Ltd
N/A
Health Canada
39224
Type II
2008/07/10
Cardinal Health
N/A
Health Canada
39313
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080727
MHRA
2007/009/027/401/001
FSCA
2008/07/07
N/A
N/A
SN080734
Cardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal
Pack, C) Sterile Cardiovascular Universal
Siemens Oncor Expression (Model 7360717, 8139839)
SN080735
Siemens AG Somatom Definition (Model 7741445)
Health Canada
39782
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080736
GE Healthcare Precision RX/I Remote Imaging System (Model
5117828)
Health Canada
40889
Type II
2008/07/10
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080737
Trinity Biotech D-Dimer High Control
Health Canada
41341
Type II
2008/07/10
N/A
N/A
2738 2818
SN080733
SN080738
Cordis Smart Control Nitinol Stent System (Model C10040SL)
Health Canada
41441
Type II
2008/07/10
Johnson & Johnson Medical Hong
Kong
SN080739
Siemens AG Magicview 300 (Model VA60A)
Health Canada
41521
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080740
Siemens Mevasim-S, Simview 3000, Simview NT
Health Canada
41532
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080741
Siemens Dimension Automated LDL Calibrator (Model DC131)
Health Canada
41796
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080742
Walter Lorenz Surgical 4MM Stella Osteotomes (Model 01-0575),
6MM Stella Osteotomes (Model 01-0576)
Health Canada
42037
Type II
2008/07/10
Swedish Trading Co., Ltd
N/A
SN080743
Nonin Model PalmSAT handheld pluse Oximeter
Health Canada
42163
Type II
2008/07/10
At-Home Healthcare Company Ltd
N/A
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
SN080744
Philips Collimators 989601000612, 989601000614, 989601000615
Health Canada
42275
Type II
2008/07/10
SN080745
Siemens Advia 120, 2120,
Health Canada
42277
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080746
Roche Myoglobin Control Set
Health Canada
42325
Type II
2008/07/10
Roche Diagnotics (Hong Kong) Ltd.
2485 7510
SN080747
AGFA Drystar AXYS
Health Canada
42393
Type II
2008/07/10
AGFA Hong Kong Limited
2555 9421
SN080748
Elekta Precise Treatment Table
Health Canada
42401
Type II
2008/07/10
Elekta Ltd
N/A
SN080749
Computerized Medical Systems Monaco
Health Canada
42691
Type II
2008/07/10
N/A
N/A
SN080750
FDA
Z-1246-2008 to Z-1296-2008
Class II
2008/07/10
N/A
N/A
FDA
Z-1307-2008
Class II
2008/07/10
AGFA Hong Kong Limited
2555 9421
SN080752
Edwards LifeStent FlexStar Biliary Stent System
AGFA Impax 4.5, 5.1, 5.2 ans 5.2x Picture Archiving System
(PACs)
Stryker Peek Electrosurgical Handle
Health Canada
34279
Type II
2008/07/11
Stryker China Ltd
2518 6915
SN080753
GE OEC Medical Systems Aspirators (Model 1006236-001)
Health Canada
36242
Type II
2008/07/11
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080754
Siemens Coherence Oncologist (Model 7351898)
Health Canada
42716
Type II
2008/07/11
Siemens Ltd.
2810 7533
SN080755
Balder Battery powered wheelchairs
MHRA
2008/004/003/301/001
FSCA
2008/07/11
N/A
N/A
Health Canada
42781
Type II
2008/07/11
Siemens Ltd.
2810 7533
MHRA
2007/012/006/061/004
FSCA
2008/07/14
N/A
N/A
SN080751
SN080756
SN080757
Siemens Mevatron Primus, Mevatron MX-2, Oncor Expression,
Oncor Impression IMRT Plus
Lomax Mobility Kid Active Folding Frame with Swing Away
Footrests
Medical Device Control Office
240
Department of Health
The Government of HKSAR
SN080758
Electric Mobility Scooters
MHRA
2007/008/002/301/003
FSCA
2008/07/14
N/A
N/A
SN080759
Q'Straint Wheelchair tie-downs
MHRA
2008/004/003/301/003
FSCA
2008/07/14
N/A
N/A
SN080760
Edwards Lifesciences Fogarty Fortis™ Catheter
MHRA
2008/006/030/061/018
FSCA
2008/07/14
N/A
N/A
SN080761
Philips Medical Systems Allura Xper and Integris Systems
MHRA
2008/007/001/061/020
FSCA
2008/07/14
PHAROS INTERNATIONAL LTD.
N/A
SN080762
Becton Dickinson BD™ Saline Syringers
MHRA
2008/006/030/061/002
FSCA
2008/07/14
BD Asia Ltd (Hong Kong)
2722 5660
SN080763
Gyrus ACMI Dual Lumen Catheter
MHRA
2008/006/027/601/455
FSCA
2008/07/14
N/A
N/A
SN080764
GE Healthcare vascular systems
MHRA
2008/007/001/061/014
FSCA
2008/07/14
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080765
Sorin Biomedica Cardio Freedom Solo Biological Heart Valve
MHRA
2008/007/009/061/010
FSCA
2008/07/14
N/A
N/A
SN080766
Zimmer NexGen® Complete Knee Solution
MHRA
2008/007/002/061/012
FSCA
2008/07/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN080767
Boston Scientific Platinum PlusT Cononary Guidwire
MHRA
2008/007/001/061/022
FSCA
2008/07/14
Boston Scientific HK Ltd
SN080768
Dade Behring StratusR CS Acute Care? Troponin I TestPaks
MHRA
2008/007/002/061/014
FSCA
2008/07/16
Siemens Ltd.
2810 7533
SN080769
Abbott ARCHITECT Total β-HCG calibrator
MHRA
2008/006/015/601/416
FSCA
2008/07/16
Abbott Laboratories Ltd.
2806 4021
SN080770
ArthroCare Covator Arthro Wand
MHRA
2008/004/016/401/009
FSCA
2008/07/16
N/A
N/A
2821 5480
MHRA
2008/007/003/061/008
FSCA
2008/07/17
Philips Medical Systems Regional
Office (Asia Pacific)
BD
N/A
Firm Initiated Field
Action
2008/07/21
BD Asia Ltd (Hong Kong)
2722 5660
CELKI Medical
Company
N/A
Firm Initiated Field
Action
2008/07/21
CELKI Medical Company
2268 9258
Kimal safety fistula needle
MHRA
MDA/2008/051
MDA
2008/07/22
N/A
N/A
Handicare Puma and Beatle battery powered wheelchairs
Nucletron SPOT Pro v3.0
MHRA
MHRA
MDA/2008/052
2008/007/003/061/009
MDA
FSCA
2008/07/22
2008/07/22
N/A
N/A
N/A
N/A
SN080777
Unomedical OP suction tubing
MHRA
MDA/2008/053
MDA
2008/07/24
N/A
N/A
SN080778
Smiths Medical Portex™ Blue Line Ultra tracheostomy kits
MHRA
MDA/2008/054
MDA
2008/07/24
N/A
N/A
SN080779
Philips Healthcare HeartStart OnSite automated external
defibrillators (AEDs)
MHRA
2008/007/003/061/012
FSCA
2008/07/24
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
SN080780
Dade Behring ADVIA Chemistry Systems
MHRA
2008/007/002/061/013
FSCA
2008/07/24
Siemens Ltd.
2810 7533
SN080781
Abbott Molecular m2000sp Instrument
MHRA
2008/007/003/601/464
FSCA
2008/07/24
Abbott Laboratories Ltd.
2806 4021
SN080782
Beckman Coulter GEN.S and LH SlideMakers
MHRA
2008/007/002/601/459
FSCA
2008/07/24
Beckman Coulter Hong Kong Ltd
2240 6150
SN080783
Roche cobas b 221 Software version 7.0
MHRA
2008/007/007/061/008
FSCA
2008/07/24
Roche Diagnotics (Hong Kong) Ltd.
2485 7510
SN080784
Applied Medical 15mm SeparatorR access systems
MHRA
2008/007/008/061/006
FSCA
2008/07/24
N/A
N/A
MHRA
2008/006/018/601/424
FSCA
2008/07/24
GE Medical Systems Hong Kong Ltd.
2783 1838
MHRA
2008/004/009/401/001
FSCA
2008/07/24
N/A
N/A
SN080787
Stryker Navigation Pin, Ortholock EX Pin, and Ortholock QLK-100
Docking System
MHRA
2008/006/024/051/008
FSCA
2008/07/24
Stryker China Ltd
2518 6915
SN080788
Bayer 5 second Contour blood glucose monitoring system
MHRA
2008/007/003/601/463
FSCA
2008/07/24
Bayer Healthcare
2814 4836
SN080789
DEAS Heated Wire Circuits
MHRA
2008/005/014/401/002
FSCA
2008/07/24
N/A
N/A
SN080790
Ventana Benchmark and Discovery Series Instruments
MHRA
2008/007/011/061/017
FSCA
2008/07/24
N/A
N/A
SN080771
Philips Medical Systems Biopsy Guide Starter Kits
SN080772
BD Vacutainer Blood Collection Tubes Containing Heparin
SN080773
Respironics PLV100 Ventilator (#RCA200802)
SN080774
SN080775
SN080776
SN080785
SN080786
GE Healthcare Innova ® single plane cardiovascular X‐ray imaging
systems
Q‟Straint Wheelchair QLK-100 Docking System
Medical Device Control Office
241
Department of Health
The Government of HKSAR
SN080791
Otto Bock HealthcareKimba Inline Twin Mobility Base Units
MHRA
2006/003/014/401/005
FSCA
2008/07/24
N/A
N/A
SN080792
Sunrise Medical Rumba Power Wheelchairs
MHRA
2007/009/020/291/012
FSCA
2008/07/24
N/A
N/A
SN080793
Orthodocs Cocoon
MHRA
2008/006/006/401/006
FSCA
2008/07/24
N/A
N/A
SN080794
Carina VT Homecare, intensive care and transport ventilators
MHRA
MDA/2008/055
MDA
2008/07/25
N/A
N/A
SN080795
Siemens Healthcare Laboratory analysers
MHRA
MDA/2008/056
MDA
2008/07/25
Siemens Ltd.
2810 7533
SN080796
Sunrise Medical Mermaid, Ranger & Dipper Bathing Products
MHRA
2007/012/004/061/013
FSCA
2008/07/25
N/A
N/A
SN080797
Agfa IMPAX Clients 6.x
MHRA
2008/006/013/061/001
FSCA
2008/07/25
AGFA Hong Kong Limited
2555 9421
SN080798
BD 60ml Luer-Lok Syringe (Recorder no. 309653)
BD
N/A
Firm Initiated Field
Action
2008/07/28
BD Asia Ltd (Hong Kong)
2722 5660
SN080799
Abbott Sequoia Spinal System Surgical Kits
FDA
Z-1479-2008
Class II
2008/07/28
Abbott Laboratories Ltd.
2806 4021
SN080800
Medtronic Intrathecal Catheter Pump Segment Revision Kit (Model
no 8596SC)
FDA
Z-1308-2008
Class II
2008/07/28
SN080801
BHM Medical Infrared (IR) Hand Control System
FDA
Z-1233-2008
Class II
2008/07/28
Arjo Far East Ltd
2508 9553
SN080802
AMS In-Fast Ultra Kit with Polypropylene Suture (Ref 72403885)
FDA
Z-1235-2008
Class II
2008/07/28
N/A
N/A
SN080803
Smiths Medical FLO2 Emergency Non-rebreather High Flow O2
System and Oxy-PEEP High Flow O2 with PEEP
FDA
Z-1379-2008 to Z-1380-2008
Class II
2008/07/28
N/A
N/A
SN080804
Celsus Laboratories Heparin Lithium Lithium Lyophilized
FDA
Z-1917-2008
Class II
2008/07/28
N/A
N/A
SN080805
Sunrise Medical Manual and Powered Wheelchairs
MHRA
2007/003/006/401/005
FSCA
2008/07/28
N/A
N/A
SN080806
Abbott ARCHITECT AFP assay
MHRA
2008/007/011/601/482
FSCA
2008/07/28
Abbott Laboratories Ltd.
2806 4021
SN080807
Hill-Rom Affinity® Four Birthing Bed
MHRA
2008/007/011/061/018
FSCA
2008/07/28
N/A
N/A
SN080808
Karomed COMM-METAL Supreme Profiling Bed
MHRA
2008/003/031/401/003
FSCA
2008/07/28
N/A
N/A
SN080809
Technical Service Consultants Urine collection bottle
MHRA
MDA/2008/057
MDA
2008/07/29
N/A
N/A
SN080810
Aidservice Medi-Tec Classic hoist
Troponin I Rapid Test and Myoglobin/CK-MB/Troponin I Combo
Test
Fresenius Injectomat 50ml syringe
MHRA
MDA/2008/058
MDA
2008/07/31
N/A
N/A
MHRA
2008/007/021/061/008
FSCA
2008/07/31
N/A
N/A
MHRA
2008/007/015/061/014
FSCA
2008/07/31
N/A
N/A
FSCA
2008/07/31
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
SN080811
SN080812
Medtronic International Ltd
2919 1300
SN080813
Philips Axis and Irix Gamma Cameras
MHRA
SN080814
Beckman Coulter Acetaminophen Reagent
MHRA
2008/007/024/601/509
FSCA
2008/07/31
Beckman Coulter Hong Kong Ltd
2240 6150
SN080815
Stryker Triathlon TS Fermoral Trial
FDA
Z-1572-2008 to Z-1587-2008
Class II
2008/07/31
Stryker China Ltd
2518 6915
SN080816
Beckman Coulter Cytomics FC 500 Flow Cytometry System with
CXP Software version 2.1 and 2.2
FDA
Z-2016-2008 to Z-2033-2008
Class II
2008/07/31
Beckman Coulter Hong Kong Ltd
2240 6150
SN080817
Biomet Vanguard DCM CR Tibial Bearing
FDA
Z-1375-2008 to Z-1376-2008
Class II
2008/07/31
N/A
N/A
SN080818
Medline Eudur02 Oxygen Concentrator with Oxygen Monitor
FDA
Z-1473-2008 to Z-1474-2008
Class II
2008/07/31
N/A
N/A
SN080819
Philips A)Brilliance 64 Slice CT System-Main Unit, B) Brilliance CT
Computed Tomography System,
Health Canada
42936
Type II
2008/07/31
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
Medical Device Control Office
2008/007/014/061/004
242
Department of Health
The Government of HKSAR
SN080820
Philips A) Brilliance 40/64 Slice CT System, B) Brilliance CT Big
Bore System-Main Unit, C) Brilliance CT System (16P), D)
Brilliance 6/10/16 Slice CT System
Health Canada
42569
Type II
2008/07/31
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
SN080821
Biomet Microfixation 1.5X5MM HT X-DR SCREW (Model 91-1505,
95-1505)
Health Canada
42390
Type II
2008/07/31
Biomet Microfixation
N/A
SN080822
GE Datex Ohmeda A) Giraffe Warmer M1118179, B) Panda
Warmer M1110875
Health Canada
42766
Type II
2008/07/31
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080823
Stryker Vertier Surgical Tables
Health Canada
43004
Type II
2008/07/31
Stryker China Ltd
2518 6915
SN080824
Gambro Bioline, Hermoline
Stryker 3.5MM Super 90-S Serfas Suction Probe (Model 0279-351300)
GE OEC Secondary Collimator Filter On OEC 9600 (Model
2274014)
Gambro Dasco SPA Phoenix Hemodialisis Delivery System (Model
6022933700)
Health Canada
42406
Type II
2008/07/31
Gambro Hong Kong Ltd
2839 7010
Health Canada
42939
Type II
2008/07/31
Stryker China Ltd
2518 6915
Health Canada
42974
Type II
2008/07/31
GE Medical Systems Hong Kong Ltd.
2783 1838
Health Canada
42906
Type II
2008/07/31
Gambro Hong Kong Ltd
2839 7010
SN080825
SN080826
SN080827
SN080828
Philips A) Prism 1000S, B) Prism 1000XP, C) Prism 2000S, D)
Prism 2000XP
Health Canada
32350
Type II
2008/07/31
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
SN080829
Maquet Cardipulmonary AG Remote Control Unit (Model 939401)
Health Canada
41063
Type II
2008/07/31
Maquet Hong Kong Ltd
2393 9511
SN080830
Zimmer Miller Bone Cement Injector Front Cartridge Kit (Model 005069-052-00)
Health Canada
43002
Type II
2008/07/31
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN080831
Stryker Howmedica Ostenoics Corporation Scorpio 7000 Tibial
Impactor Extractor (Model 3770-000)
Health Canada
42982
Type II
2008/07/31
Stryker China Ltd
2518 6915
SN080832
Biomet 3I Navigator Surgical Guide Kit (SGKIT)
Health Canada
42387
Type II
2008/07/31
Ositek Inc Ltd
8121 6601
SN080833
Fisher Scientific Formalin Neutral Buffered 10% (Model SF-100-20,
SF100-4)
Health Canada
42764
Type II
2008/07/31
N/A
N/A
SN080834
Wright Medical Technology Dynasty Trial Shell (Model 3300GG62,
3300GH64, 3300GH66, 3300GH68)
Health Canada
42696
Type II
2008/07/31
N/A
N/A
SN080835
Becton Dickson BBL MGIT Mycrobacteria Growth Tubes, Bactec
MGIT 960 PZA Kit
Health Canada
41508
Type II
2008/07/31
BD Asia Ltd (Hong Kong)
2722 5660
Medical Device Control Office
243
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -June 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
SN080601
Source of
Information*
Bausch and Lomb
Boston Scientific
Hong Kong Ltd
MHRA
MHRA
MHRA
Affaps
N/A
Date of Issue
(YYYY/MM/DD)
Firm Initiated Field Action 2008/06/02
Baush and Lomb
Agent Contact
Telephone No
2213 3371
N/A
Firm Initiated Field Action
2008/06/02
Boston Scientific Hong Kong Ltd
2960 7136
2008/005/006/291/003
2008/005/013/041/007
2008/005/014/061/004
N/A
FSCA
FSCA
FSCA
N/A
2008/06/02
2008/06/02
2008/06/02
2008/06/03
N/A
Siemens Ltd.
N/A
N/A
N/A
2810 7533
N/A
N/A
2008/005/009/121/006
FSCA
2008/06/04
Stryker China Ltd
2518 6988
42116
Type II
2008/06/05
Abbott Laboratories Ltd.
2806 4021
Health Canada
41996
Type II
2008/06/05
AGA Medical Corporation (Asia Pacific)
N/A
Arrow Balloon Temporary Pacing Catheter Kit
Health Canada
41991
Type II
2008/06/05
N/A
N/A
BHM Ergiscake Scake abd Swivel Bar
Health Canada
41995
Type II
2008/06/05
Arjo Far East Ltd
2508 9553
Health Canada
41858
Type II
2008/06/05
Bio-Rad Pacific Ltd.
2789 3300
SN080602
Description of Product
Baush and Lomb Zyoptix Treatment Calculator (Versions 1.1 and
1.2)
Boston Scientific FilterWire EZT Embolic Protection Systems
SN080603
SN080604
SN080605
SN080606
Hitachi Hi-Vision Ultrasound System
Siemens ADVIA Centaur CP
Thermogenesis Vapor Bypass Assembly (110v/220v)
Varian TPS Eclipse
SN080607
MHRA
Health Canada
SN080609
Stryker Kinemax Plus Revision TS Tibial Insert
Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E6903)
AGA Medical Amplatzer PFO Occluder
SN080610
SN080611
SN080608
SN080612
Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and
minipak
Bio-Rad Varient B-Thalassemia Short Program
Reference No. by Source
Alert Type by Source
Local Agent
Health Canada
42066
Type II
2008/06/05
Bio-Rad Pacific Ltd.
2789 3300
SN080614
Cardinal Health Sterile Mammoplasty Pack, Sterile Total Knee
Pack and Othopedie-Fusion Posterieure
Health Canada
42115
Type II
2008/06/05
Cardinal Health
N/A
SN080615
Cook Hilal Embolization Coils
Health Canada
42174
Type II
2008/06/05
Cook Asia (Hong Kong) Ltd.
2781 0232
SN080616
Hill-Rom 100 Low Beds
Health Canada
41708
Type II
2008/06/05
N/A
N/A
SN080617
Imaging Sciences I-CAT 17-19, 3D Dental Imaging System (Model
1-10-1-0) and I-Cat 3D Imaging System- Main Unit (Model 91400000-0000)
Health Canada
42021
Type I
2008/06/05
N/A
N/A
SN080618
Johnson and Johnson Depuy Lupine BR Anchor With Orthocord
Health Canada
42075
Type II
2008/06/05
Health Canada
42071
Type II
2008/06/05
Health Canada
40792
Type II
2008/06/05
Medtronic International, Ltd.
2919 1300
N/A
SN080613
SN080619
SN080620
Johnson and Johnson Ortho-Clinical Diagnostics Blood Gruping
Reagent Anti-S
Medtronic Lifepak Internal Defibillator Electrodes, Lifepak 9, 9p, 12
& 20 Int. Defibillator Handles
Johnson & Johnson Medical Hong
Kong
Johnson & Johnson Medical Hong
Kong
2738 2818
2738 2818
SN080621
Nova Biomedical Statstrip Glucose Hospital Meter
Health Canada
42078
Type II
2008/06/05
N/A
SN080622
Oxoid Haemophilus Selective Agar
Health Canada
42190
Type II
2008/06/05
N/A
N/A
SN080623
Philips Brilliance CT 16 Power Slice
Health Canada
40156
Type II
2008/06/05
Philips Electronics Hong Kong Ltd.
2876 7525
SN080624
Health Canada
42049
Type II
2008/06/05
Philips Electronics Hong Kong Ltd.
2876 7525
Health Canada
41278
Type II
2008/06/05
N/A
N/A
SN080626
Philips Suresigns VS3 Vital Signs Monitor
Pulmonetic Systems LTV 800, 950, 900 and 1000 Series
Ventilators
Randox Triglycerides
Health Canada
41875
Type II
2008/06/05
N/A
SN080627
Roche Elecsys Progesterone II
Health Canada
41845
Type II
2008/06/05
SN080628
SN080629
Stryker SDC Ultra
Tyco CT 9000 ADV Injector with Console
Health Canada
Health Canada
40955
42024
Type II
Type II
2008/06/05
2008/06/05
N/A
Roche Diagnostics (Hong Kong)
Limited
Stryker China Ltd
COVIDIEN
SN080630
Tyco Optivantage DH Power Injection System
Health Canada
42026
Type II
2008/06/05
COVIDEN
3157 7220
SN080631
Walter Lorenz Surgical Epker Osteotome (BOTH Slightly Curved
and Straight)
Health Canada
41577
Type II
2008/06/05
N/A
N/A
SN080625
Medical Device Control Office
244
2485 7510
2518 6988
3157 7220
Department of Health
The Government of HKSAR
SN080632
Zimmer Dermacarriers Skin Graft Carriers and Dermacarriers II
Skin Graft Carriers
SN080633
SN080634
Health Canada
42114
Type II
2008/06/05
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
AquaJoy battery chargers (Serial no. 0638)
MHRA
2007/011/026/401/005
FSCA
2008/06/06
N/A
N/A
IBG Immucor Galileo Echo
MHRA
2008/005/015/061/008
FSCA
2008/06/06
N/A
N/A
SN080635
Innogenetics INNO-LIA Syphilis Score (Product code 80542)
MHRA
2008/005/020/061/019
FSCA
2008/06/06
N/A
N/A
SN080636
Bausch & Lomb Zyoptix XP Microkeratome Motors (ZXP09183)
MHRA
2008/005/008/181/011
FSCA
2008/06/10
Baush and Lomb
2213 3371
SN080637
Gambro Ultra filter U 8000 S (batch no. 8-3011-H-01)
MHRA
2008/005/022/061/017
FSCA
2008/06/10
Gambro China Ltd
2839 7010
SN080638
Philips Motiva Remote Patient Management System
MHRA
2008/005/013/061/017
FSCA
2008/06/10
Philips Electronics Hong Kong Ltd.
2876 7525
MHRA
2008/005/021/061/004
FSCA
2008/06/10
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
MHRA
2008/003/022/601/200
FSCA
2008/06/11
N/A
N/A
MHRA
2008/003/031/061/005
FSCA
2008/06/11
GE Healthcare
2609 9233
SN080639
SN080640
Zimmer NexGen Complete Knee Solution Articular Surface
Insertion Instrument
CMS XiO/Focal
SN080641
GE Healthcare OEC Uroview 2800, 9800 Plus, MiniView 6800,
Flexiview 8800 Mobile C-Arm
SN080642
Siemens Mevatron and Oncor Control Console Versions V6.5.079,
V7.2.079 and V9.1.50
SN080643
Boston Scientific NAMIC MorseR Angiographic Manifold
SN080644
CalMed Pericardial Sump
SN080647
Cardinal Health U19 Socketed Integrated Circuit ("U19 IC"), Grey
Inter-Unit Interface Connectors ("IUI") and U9 Socket Integrated
Circuit ("U9 IC")
GE Healthcare Proteus XR/a Radiographic System (Model Number
2259976)
Siemens ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay
SN080648
Accuray CyberKnife - Axum/Standard Treatment Couch
SN080649
BD Obturators for Venflon, Insyte and Adsyte Pro
Galemed EMS Ventilator Single use non rebreathing patient circuit
(Product code: W196-002; Lot 20070709)
SN080645
SN080646
SN080650
MHRA
2008/005/001/291/016
FSCA
2008/06/11
Siemens Ltd.
2810 7533
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field Action
2008/06/12
Boston Scientific Hong Kong Ltd
2960 7136
FDA
Z-1175-2008 to Z-1177-2008
Class II
2008/06/12
N/A
N/A
FDA
Z-1710-2008 to Z-1712-2008
Class II
2008/06/12
Cardinal Health
N/A
FDA
Z-0842-2008
Class II
2008/06/12
GE Healthcare
2609 9233
FDA
Z-0580-2008
Class II
2008/06/12
Siemens Ltd.
2810 7533
Accuray Asia Ltd
N/A
Firm Initiated Field Action
2008/06/16
Accuray Asia Ltd
2247 8628
MHRA
2008/005/022/061/020
FSCA
2008/06/17
BD Asia Ltd (Hong Kong)
2575 8668
MHRA
2008/005/021/601/353
FSCA
2008/06/17
N/A
N/A
SN080651
GE Healthcare 3.0T Signa HD Scanner (3.0T Propeller T2 Flair
application)
MHRA
2008/005/030/061/027
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080652
GE Healthcare Advantage Workstation
MHRA
2008/005/030/061/023
FSCA
2008/06/17
GE Healthcare
2609 9233
MHRA
2008/006/003/291/010
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080653
GE Healthcare Centricity PASCS Software versions: 3.0.0X,
3.0.1X, 3.0.2.X AND 3.0.3X
GE Healthcare DST-XL Carmera
MHRA
2008/005/030/061/024
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080655
GE Healthcare Innova 2100IO, 3100/3100IQ and 4100/4100IQ
Cardiovascular X-ray System
MHRA
2008/005/030/061/034
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080656
GE Healthcare OEC 9900, 9800 and 8800 series
MHRA
2008/005/030/061/025
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080657
GE Healthcare Pressure Sensitive Device (PSD)
MHRA
2008/003/025/061/015
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080658
GE Healthcare S/5 iCentral versions L-NET03, L-NETC03, LNET05, L-NETC05
MHRA
2008/005/002/601/317
FSCA
2008/06/17
GE Healthcare
2609 9233
MHRA
2008/005/028/061/019
FSCA
2008/06/17
MHRA
2008/005/009/121/011
FSCA
2008/06/17
MHRA
2008/006/003/291/004
FSCA
2008/06/17
N/A
Johnson & Johnson Medical Hong
Kong
Philips Electronics Hong Kong Ltd.
2738 2818
SN080661
Hansen Medical Artisan Control Catheter
Johnson and Johnson Ethicon Endo-Surgery ENDOPATH ETS
35mm
Philips X-Ray Systems with Monitor Ceiling Suspension
SN080662
Siemens ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems
MHRA
2008/005/029/061/019
FSCA
2008/06/17
Siemens Ltd.
2810 7533
SN080654
SN080659
SN080660
Medical Device Control Office
245
N/A
2876 7525
Department of Health
The Government of HKSAR
SN080663
Specialised Orthotic Services Mojo, Maxi, Midi and Mini
MHRA
2008/003/007/261/001
FSCA
2008/06/17
N/A
N/A
SN080664
Stryker Secure II, Epic and Zoom Beds
MHRA
2008/003/006/061/012
FSCA
2008/06/17
Stryker China Ltd
2518 6988
SN080665
MHRA
Boston Scientific
Hong Kong Ltd
MHRA
2008/005/015/401/001
FSCA
2008/06/19
B Braun Medical Hong Kong
2277 6125
N/A
Firm Initiated Field Action
2008/06/19
Boston Scientific Hong Kong Ltd
2960 7136
SN080667
B Braun A/V Sets (Product Code 7210697)
Boston Scientific NexStent Carotid Stent & MonorailR Delivery
System
Cardinal Health LTV ventilators
2008/006/009/291/011
FSCA
2008/06/19
Cardinal Health
N/A
SN080668
Covidien Thoraseal II chest drainage unit
MHRA
MDA/2008/040
MDA
2008/06/19
COVIDIEN
3157 7220
SN080669
GE Healthcare Precision 500D and Advantx Legacy R&F X-ray
Systems
MHRA
2008/005/030/061/029
FSCA
2008/06/19
GE Healthcare
2609 9233
SN080670
GE Healthcare Engstrom Carestation
MHRA
2007/008/029/401/001
FSCA
2008/06/19
GE Healthcare
2609 9233
SN080671
Handicare Ibis XP power wheelchair
MNRA
2007/010/009/401/003
FSCA
2008/06/19
N/A
N/A
SN080672
Nottingham Rehab Supplies Columbia Toilet Support
MHRA
2007/012/018/401/006
FSCA
2008/06/19
N/A
N/A
SN080673
Baxa Exacta-Mix? 2400 Compounder
MHRA
2008/006/012/601/405
FSCA
2008/06/23
N/A
N/A
SN080674
BioMerieux VIDAS HBs AG Ultra
MHRA
2008/005/027/601/367
FSCA
2008/06/23
Biomerieux China Ltd (HK)
2356 7033
SN080675
Bio-Rad BIOPLEX 2200 SYPHILIS IgG Kit, EBV IgG KIT,
CALIBRATORS, AND CONTROLS and MULTI-ANALYTE
DETECTION SYSTEM
FDA
Z-1156-2008 to Z-1159-2008
Class II
2008/06/23
Bio-Rad Pacific Ltd.
2789 3300
SN080676
Boston Scientific Platinum PlusT Coronary Guidewire
N/A
Firm Initiated Field Action
2008/06/23
Boston Scientific Hong Kong Ltd
2960 7136
SN080677
Boston Scientific Safety PEG Kits
SN080678
SN080680
Conmed DetachaTip Surgical Instruments
GE LOGIQ3 Expert ultrasound scanner with software versions
4.0.5, 4.1.1 and 4.1.2
Huntleigh Healthcare Arjo Malibu
SN080681
SN080666
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
MHRA
N/A
Firm Initiated Field Action
2008/06/23
Boston Scientific Hong Kong Ltd
2960 7136
2008/006/009/291/009
FSCA
2008/06/23
N/A
N/A
FDA
Z-1155-2008
Class II
2008/06/23
GE Healthcare
2609 9233
MHRA
2007/009/007/301/001
FSCA
2008/06/23
Arjo Far East Ltd
2508 9553
Kimal Safety Fistula Needle
MHRA
2008/006/011/601/402
FSCA
2008/06/23
N/A
N/A
SN080682
Metrax Primedic Charger Basis
MHRA
2008/006/011/291/005
FSCA
2008/06/23
N/A
N/A
SN080683
PDG Bentley Manual Tilt Wheelchair
MHRA
2008/002/005/301/001
FSCA
2008/06/23
N/A
N/A
SN080684
Roche Diagnostics COBAS Integra 400 systems
MHRA
2008/006/005/291/003
FSCA
2008/06/23
Roche Diagnostics (Hong Kong) Ltd
2485 7510
SN080685
Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120
MHRA
2008/006/009/061/007
FSCA
2008/06/23
Siemens Ltd
2810 7533
SN080686
MHRA
2008/006/013/291/011
FSCA
2008/06/23
St Jude Medical
2996 7601
MHRA
2008/006/013/601/408
FSCA
2008/06/23
N/A
N/A
SN080688
St Jude Medical Livewire TC Ablation Catheter
ThermoFisher Scientific PB0124A Columbia agar with chocolated
horse blood
Unomedical OP tubing (Lot No 182281)
MHRA
2008/001/022/401/007
FSCA
2008/06/23
N/A
N/A
SN080689
Varian Medical Systems VARIS Vision/System 6.5
MHRA
2008/006/002/291/007
FSCA
2008/06/23
N/A
N/A
SN080690
Waldemar Link Megasystem-C Modular Components
MHRA
2008/004/010/061/011
FSCA
2008/06/23
N/A
N/A
SN080691
Coloplast Balloon Nephrostomy catheter with introducer (Ref. no.
AJ6812 - AJ6822)
N/A
Firm Initiated Field Action
2008/06/25
Coloplast (Hong Kong) Ltd
3628 7428
SN080692
Boston Scientific implantables devices, ICD and CRT-D
N/A
Firm Initiated Field Action
2008/06/26
Boston Scientific Hong Kong Ltd
2960 7136
SN080693
Computerized Medical Systems XIO Radiation Treatment Planning
System
Health Canada
42336
Type II
2008/06/27
N/A
N/A
SN080694
Philips Isite Ipacs (Model ISITE ENTERPRISE V.3.5, ISITE
RADIOLOGY V.3.5, IVAULT V.3.5)
Health Canada
42273
Type II
2008/06/27
Philips Medical Systems Regional
Office (Asia Pacific)
2821 5480
SN080679
SN080687
Medical Device Control Office
Coloplast (Hong
Kong) Ltd
Boston Scientific
Hong Kong Ltd
246
Department of Health
The Government of HKSAR
SN080695
Gambro cartridge blood set (Model 003410-510, 003410-710,
0141080XXXC)
Health Canada
42069
Type II
2008/06/27
Gambro Hong Kong Ltd
2839 7010
SN080696
Maquet HL 30 Perfusion System
Health Canada
41066
Type II
2008/06/27
Maquet Hong Kong Ltd
2393 9511
SN080697
Stryker Infravision Urethral Kit (Model 0220-180-516)
Health Canada
42415
Type II
2008/06/27
Stryker China Ltd
2518 6915
SN080698
Terumo Level Sensor II Pads, Gel included
Health Canada
41365
Type II
2008/06/27
TERUMO CHINA (H.K.) LTD.
2866 0811
SN080699
Medtronic Affinity NT Hollow Fiber Oxygenator Model CB511)
Health Canada
42402
Type II
2008/06/27
Medtronic-Mediland (Taiwan) Ltd
2919 1300
SN080700
GE Advantx LCLP+ Bi Plane Cardiac System, Advantx
LCN+Angiographic System, Innova 2000 Cardiovascular System,
Innova 2100 IQ Digital Imaging System, Innova 4100IQ Tables
Health Canada
40766
Type II
2008/06/27
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080701
ITC Protime Microagulation System (Model PROTIMEPST)
Health Canada
39337
Type II
2008/06/27
N/A
N/A
SN080702
Thermogenesis Autoxpress Platform System (Model 8-5101-0)
Health Canada
41781
Type II
2008/06/27
N/A
N/A
SN080703
Immucor Corqc Test System, Panoscreen I/II/III (Model)
Health Canada
42166
Type II
2008/06/27
N/A
N/A
Medical Device Control Office
247
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -May 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO
Ref. No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN080501
Abbott CELL-DYN Hemoglobin Reagent Syringe (Product
Descriptiion: CDS HGB SRNGW/BU)
FDA
Z-1165-2008
Class II
2008/05/02
Abbott Laboratories Ltd.
2806 4021
SN080502
Siemens ACUSON Sequoia Diagnostic Utrasound System
(Material Number 8245875, 8246951,8267697)
FDA
Z-0661-2008
Class II
2008/05/02
Siemens Ltd.
2810 7533
SN080503 Respironics Various Devices and Accessories
FDA
Z-1055-2008 to Z-1093-2008
Class II
2008/05/02
CELKI Medical Company
2268 9258
SN080504 Truelife walking frames for adults and children
MHRA
MDA/2008/031
MDA
2008/05/02
N/A
N/A
Baush and Lomb
N/A
Firm Initiated Field
Action
2008/05/05
Baush and Lomb
2213 3371
Accuray Asia Ltd
N/A
Firm Initiated Field
Action
2008/05/05
Accuray Asia Ltd
2247 8628
MHRA
2007/011/020/061/002
FSCA
2008/05/07
N/A
N/A
MHRA
2008/004/011/061/016
FSCA
2008/05/07
N/A
N/A
FDA
Z-1106-2008
Class II
2008/05/08
Stryker China Ltd
2518 6988
SN080510 GE Healthcare Centricity PACS RA1000 Workstation
FDA
Z-1104-2008
Class II
2008/05/08
GE Healthcare
2609 9233
SN080511 Siemens Coherence AG Therapist
FDA
Z-0971-2008 to Z-0981-2008
Class II
2008/05/08
Siemens Ltd.
2810 7533
SN080512 Seradyn QMS Vancomycin Reagents (Part Nimber 0373589)
FDA
Z-1102-2008
Class II
2008/05/08
N/A
N/A
SN080513 Siemens Advia Centaur System and Advia Centaur XP System
Health Canada
41756
Type II
2008/05/08
Siemens Ltd.
2810 7533
SN080514 Siemens Dimension TPSA Flex Reagent Cartridge
Health Canada
41721
Type II
2008/05/08
Siemens Ltd.
2810 7533
SN080515 Siemens Mevatron and Oncor Linear Accelerators
Health Canada
34725
Type II
2008/05/08
Siemens Ltd.
2810 7533
SN080516 Medtronic Hall Easy-Fit Prosthetic Heart VALVE (Aortic and Mitral)
Health Canada
41777
Type II
2008/05/08
Medtronic International, Ltd.
2919 1300
SN080517 Medtronic Bravo PH Capsule With Delivery System
Health Canada
39316
Type II
2008/05/08
Medtronic International, Ltd.
2919 1300
SN080518 Varian Medical Clinac High and Low Engery
Health Canada
41305
Type II
2008/05/08
Varian Medical Systems Pacific Inc.
N/A
SN080519 Cardinal Health Custom Sterile Total Joint Pack
Health Canada
41543
Type II
2008/05/08
N/A
N/A
2519 9182
N/A
SN080505 Bausch & Lomb XP MicroKeratome motors
SN080506
Accuray CyberKnife Robotic Radiosurgery System MultiPlan
Treatment Planning Sofetware (Catalog No 022986)
SN080507 Phonak Rubber Dome BTE hearing instruments
SN080508
Edwards Lifesciences Aquarius Regular Haemofiltration Machine
with software version 4.01.11
SN080509
Stryker Advanced Cement Mixer (ACM) Bowl and Base (REF 306554)
SN080520 Convatec Gentle Touch 70mm Colo/Ileo PostOp Kit
Health Canada
41524
Type II
2008/05/08
Convatec, A Division of E.R. Squibb &
Sons, L.L.C. (Hong Kong)
SN080521 National Biological Houva III
Health Canada
41407
Type II
2008/05/08
N/A
Medical Device Control Office
248
Department of Health
The Government of HKSAR
SN080522 Biosense Webster Lasso Variable Deflectable CIR Map Catheter
SN080523 Levitronix CentriMag Systems
Health Canada
41774
Health Canada
Type II
2008/05/08
N/A
N/A
41786
Type II
2008/05/08
N/A
N/A
Medtronic International
Ltd
N/A
Firm Initiated Field
Action
2008/05/08
Medtronic International, Ltd.
2919 1300
Health Canada
41574
Type II
2008/05/08
Biomerieux (Hong Kong)
2356 7033
Health Canada
41659
Type II
2008/05/08
Johnson & Johnson Medical Hong
Kong
2738 6000
SN080527 BHM Medical Medi-Lifter II Plus Patient Lift and Summit
Health Canada
41705
Type I
2008/05/08
N/A
N/A
SN080528 A.L.N. Vena Cave Filter / Introduction Kit
Health Canada
41639
Type I
2008/05/08
N/A
N/A
SN080529 Biomet 3i Certain Microminiplant Healing abutment
Health Canada
41552
Type II
2008/05/08
Ositek Inc Ltd
8121 6601
SN080530 Bio-Rad Liquicheck Sedimentation Rate Control
Health Canada
41293
Type II
2008/05/08
Bio-Rad Pacific Ltd.
2789 3300
MHRA
2008/004/009/301/001
FSCA
2008/05/08
N/A
N/A
Convatec
N/A
Firm Initiated Field
Action
2008/05/09
Convatec, A Division of E.R. Squibb &
Sons, L.L.C. (Hong Kong)
2519 9182
MHRA
2008/004/008/291/002
FSCA
2008/05/09
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
2008/05/14
Boston Scientific Hong Kong Ltd
2960 7128
2008/05/14
Boston Scientific Hong Kong Ltd
2960 7128
SN080524 Medtronic Heparin-Coated products
SN080525 Biomerieux Vitek GPS Quinupristin/Dalfoprist Cards
SN080526
Johnson and Johnson Ortho-Clinical Diagnostics Vitros 5,1 FS
Chemistry System
SN080531 Aidapt Isis shower board (Code No. R232)
SN080532 Covatec Active Life Little One (20917)
Zimmer Hemovac, HAS, Sergivac, Infection Control and MiniSN080533
Hemovac Systems
SN080534 Boston Scientific iReview SoftwareVer1.0
SN080535 Boston Scientific OMG Connector-A
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Firm Initiated Field
Action
Firm Initiated Field
Action
N/A
N/A
SN080536
Smiths Medical BCI Mini-Torr Plus NIBP Monitor with SpO2 & Builtin Printer, 6004
MHRA
2008/004/015/061/013
FSCA
2008/05/14
Goodwin Health Care Holdings Ltd
2408 8838
SN080537
P3 Medical Robertshaw Endobronchial tubes (PVC, Disposable)
MHRA
2007/012/022/601/001
FSCA
2008/05/14
Ultra Care Company Ltd
N/A
SN080538 Fisher & Paykel Healthcare Patient Warmers
MHRA
2008/004/022/061/020
FSCA
2008/05/14
N/A
N/A
SN080539 Gambro Spectra Optia Apheresis System
MHRA
2008/004/023/061/013
FSCA
2008/05/14
Gambro China Ltd
2839 9710
SN080540 Thoratec HeartMate II LVAS
Fisher Healthcare Sure-Vue Serum/Urine hCD-STAT (Catalog no.
SN080541 FHC-A202, Product Codes: FHC-A202-KFI3O and FHC-A202KFI5O)
SN080542 Medefil Heparin I.V. Flush Syringe
MHRA
2008/004/023/291/003
FSCA
2008/05/14
N/A
N/A
FDA
Z-1118-2008
Class II
2008/05/15
N/A
N/A
FDA
Z-1543-2008 to Z-1545-2008
Class II
2008/05/15
N/A
N/A
SN080543 Siemens ADVIA Centaur HAV IgM
FDA
Z-1119-2008
Class II
2008/05/15
Siemens Ltd.
2810 7533
SN080544 Philips Healthcare iSite PACS image management system
FDA
Z-1141-2008
Class II
2008/05/15
Philips Electronics Hong Kong Ltd.
2332 4455
FDA
Z-1594-2008 to Z-1602-2008
Class II
2008/05/15
COVIDIEN
3157 7244
2008/05/16
Boston Scientific Hong Kong Ltd
2960 7128
2008/05/16
Boston Scientific Hong Kong Ltd
2960 7128
SN080545 Tyco Healthcare Monoject Prefill
Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation
SN080546
Device
SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes
Medical Device Control Office
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Firm Initiated Field
Action
Firm Initiated Field
Action
N/A
N/A
249
Department of Health
The Government of HKSAR
SN080548
Baxter HomeChoice Automated Peritoneal Dialysis System
(Software v.10.210)
SN080549 Boston Scientific iLab UltraSound Imaging System
Baxter Healthcare
Ltd
N/A
Firm Initiated Field
Action
2008/05/16
MHRA
2008/004/024/061/011
FSCA
Baxter Healthcare Ltd
2807 8500
2008/05/19
Boston Scientific Hong Kong Ltd
2960 7128
2738 6000
SN080550 Johnson and Johnson Codman ARCHIMEDES Drug Pumps
MHRA
2008/004/021/061/008
FSCA
2008/05/19
Johnson & Johnson Medical Hong
Kong
SN080551 Respironics Humidifier Chambers
MHRA
2008/003/028/401/001
FSCA
2008/05/19
CELKI Medical Company
2268 9258
SN080552 Firstar Plastic Vaginal Speculum
MHRA
2007/011/014/401/001
FSCA
2008/05/19
Firstar Healthcare Co., Ltd
N/A
SN080553 Dragonmobility Power-chairs
MHRA
2008/001/017/301/001
FSCA
2008/05/19
N/A
N/A
SN080554 Waldemar Link Megasystem-C Modular Components
MHRA
2008/004/010/060/011
FSCA
2008/05/21
N/A
N/A
Biotrin Nephkit Alpha GST EIA (Product Code: BIO66NEPHA, Lot
SN080555
no 58KT036)
MHRA
2008/004/030/061/013
FSCA
2008/05/21
N/A
N/A
SN080556 Chiltern Invadex Shower Trolleys and Shower/Changing Stretchers
MHRA
2007/012/033/401/004
FSCA
2008/05/21
N/A
N/A
Smiths Medical Graseby Omnifuse and Omnifuse PCA Syringe
SN080557
Pumps
MHRA
2008/003/006/061/008
FSCA
2008/05/21
Goodman Medical Supplies Ltd
2332 4455
SN080558 Welch Allyn AED 10
MHRA
2008/004/016/061/023
FSCA
2008/05/21
N/A
N/A
SN080559 VIASYS AVEA Ventilator
FDA
Z-0982-2008 to Z-0986-2008
Class II
2008/05/22
VIASYS Healthcare (Hong Kong) Ltd
6305 5575
SN080560 Cardinal Health AirLife Infant Ncpap System Driver
FDA
Z-0987-2008
Class II
2008/05/22
N/A
N/A
SN080561
Siemens Syngo US Workplace Picture Archiving and
Communication System, software version 2.0, 94043
FDA
Z-1138-2008
Class II
2008/05/22
Siemens Ltd.
2810 7533
SN080562
Stryker Triathlon Baseplate Impactor Extractor (Catalog no. 65414-805)
FDA
Z-1105-2008
Class II
2008/05/22
Stryker China Ltd
2518 6988
FDA
Z-1103-2008
Class II
2008/05/22
Abbott Laboratories Ltd.
2806 4021
SN080564 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitor
MHRA
2008/004/024/061/014
FSCA
2008/05/22
Medtronic International, Ltd.
2919 1300
Stryker Pegless Universal Scorpio Notch Guide (Catalog no 8000SN080565 3303) and Universal Scorpio Notch Preparation Guide (Catalog no
7650-3363)
MHRA
2008/004/003/061/010
FSCA
2008/05/22
Stryker China Ltd
2518 6988
MHRA
2008/004/029/061/002
FSCA
2008/05/22
Dade Behring HK Ltd., A Siemens
Company
2810 7533
SN080567 B Braun Dialog+ Machines with DF Option
MHRA
2008/004/023/061/009
FSCA
2008/05/22
B Braun Medical Hong Kong
2277 6611
SN080568 Sysmex CS-Series - Coagulation Analyser (all versions)
MHRA
2008/004/025/061/001
FSCA
2008/05/22
N/A
N/A
SN080569 Biotrin Urinary Collagen IV EIA (Catalog Code BIO83)
MHRA
2008/004/001/061/002
FSCA
2008/05/22
N/A
N/A
SN080570 Masimo Rainbow Rad-57 Pluse CO-Oximeter
MHRA
MDA/2008/033
MDA
2008/05/22
N/A
SN080571 Dade Behring Stratus CS Cardiac Troponin I Calpak (CCTNI-CR)
MHRA
2008/004/030/601/310
FSCA
2008/05/23
Dade Behring N Latex CDT Kit (OPCS03) and N Latex CDT (kit)
SN080572
(OPCS05)
MHRA
2008/004/029/061/003
FSCA
2008/05/23
SN080573 Dade Behring Dimension Clinical Chemistry System
MHRA
2008/004/017/601/273
FSCA
2008/05/23
N/A
Dade Behring HK Ltd., A Siemens
Company
Dade Behring HK Ltd., A Siemens
Company
Dade Behring HK Ltd., A Siemens
Company
Abbott White Blood Cell (WBC) Reagent-Part A used with the
SN080563 CELL-DYN 4000 and CELL-DYN Sapphire Systems , Red cell
lysing reagent (List No. 01H77-01)
SN080566
Dade Behring Enzygnost Toxoplasmosis/IgG (OUNA27) in
combination with Sample Buffer POD lot 426707
Medical Device Control Office
250
2810 7533
2810 7533
2810 7533
Department of Health
The Government of HKSAR
Beckman Coulter Access and Access 2 Immunoassay Systems,
SYNCHRON LXi 725 System and UniCel DxC 600i System
MHRA
2008/004/028/601/297
FSCA
2008/05/23
Beckman Coulter
2240 6260
SN080575 Siemens ACUSON Antares, Ultrasound System
Health Canada
41792
Type II
2008/05/23
Siemens Ltd.
2810 7533
SN080576 Biosite Triage MeterPro
Health Canada
41867
Type II
2008/05/23
N/A
N/A
SN080577 Cardinal Health Custom Sterile Hip Pack
Health Canada
41842
Type II
2008/05/23
Cardinal Health
N/A
SN080578 Draeger Medical Oxylog 3000
Health Canada
41844
Type II
2008/05/23
Draeger Medical Hong Kong Ltd.
2877 3077
Johnson & Johnson
Medical Hong Kong
N/A
Firm Initiated Field
Action
2008/05/23
Johnson & Johnson Medical Hong
Kong
2738 6000
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/05/26
Boston Scientific Hong Kong Ltd
2960 7136
SN080581 ThermoFisher Scientific LAB VISION Pretreatment Module
MHRA
2008/005/009/121/004
FSCA
2008/05/26
N/A
N/A
SN080582 Invacare Harrier Heavy Duty (HD) Powered Wheelchairs
MHRA
2007/010/018/061/002
FSCA
2008/05/26
N/A
N/A
FDA
Z-1110-2008 to Z-1117-2008
Class II
2008/05/29
N/A
N/A
SN080584 Park House Healthcare VERSAtec Back
MHRA
2007/009/012/301/002
FSCA
2008/05/29
N/A
N/A
SN080585 BPR Medical FireSafe Cannula Valves (Firebreak)
MHRA
2008/004/008/061/008
FSCA
2008/05/29
N/A
N/A
SN080586 Gambro Hospal Blood Set
MHRA
2008/005/013/061/013
FSCA
2008/05/29
Gambro China Ltd
2839 7010
SN080587 Invacare Storm and Storm True Track (TT) wheelchairs
MHRA
MDA/2008/035
MDA
2008/05/29
N/A
N/A
SN080574
SN080579 Johnson and Johnson STERRAD Sterilization Systems Oil Mist
SN080580 Boston Scientific RotaWire Guidewire
SN080583 Pointe Scientific Liquid ALT (SGPT) reagent set
Medical Device Control Office
251
Department of Health
The Government of HKSAR
ry of Medical Device Safety Alerts -April 2008
MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO
Ref. No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN080401
Smith & Nephew Medullary Exchange Tube (Product Code
415113, Lot 07AM1186)
MHRA
2007/004/019/601/816
FSCA
2008/04/03
Smith & Nephew Healthcare Ltd.
2648 7700
SN080402
Varian CT/MR Ring and Tandem Combination Applicator Set
(AL13017000)
MHRA
2008/003/017/061/004
FSCA
2008/04/03
Varian Medical Systems Pacific Inc.
2724 2836
SN080403 Edwards Lifesciences VAMP Jr
MHRA
2008/003/017/061/015
FSCA
2008/04/03
N/A
N/A
SN080404 BrainLAB BrainScan
MHRA
2008/003/013/061/024
FSCA
2008/04/03
N/A
N/A
FDA
Z-1050-2008
Class II
2008/04/03
Medtronic International, Ltd.
2919 1300
FDA
Z-1310-2008 to Z-1313-2008
Class II
2008/04/03
Terumo China (H.K.) Ltd.
2866 0811
FDA
Z-1353-2008 to Z-1360-2008
Class II
2008/04/03
N/A
N/A
AMO Asia Limited
N/A
Firm Initiated Field
Action
2008/04/07
AMO Asia Limited
2480 3330
SN080405 LIFEPAK 20 Defibrillator/monitor
SN080406
Terumo Cardiovascular Procedure Kit (P/N 70932-01, 64789-01,
70295-02, 70579-04)
SN080407 Pointe Scientific Liquid Alkaline Phosphatase Reagent Set
SN080408
AMO WHITESTAR SIGNATURE Phacoemulsification System
(NGP680300)
SN080409
ConMed Linvatec Hall Surgical Blades, Sterile, Single-use,
packaged in Bilsters
MHRA
2008/003/017/291/001
FSCA
2008/04/08
N/A
N/A
SN080410
RITA Starburst XLie Radiofrequency Ablation Probe and Talon
Radiofrequency Ablation Probe
MHRA
2008/003/019/061/007
FSCA
2008/04/08
N/A
N/A
MHRA
MDA/2008/023
MDA
2008/04/09
Hospira Ltd
2285 8382
SN080412 Skryker ACL Workstation slider (Model Number: 234-010-503)
FDA
Z-1107-2008
Class II
2008/04/10
Stryker China Ltd
2518 6988
SN080413 Hill-Rom Affinity 4 Birthing Bed (Model P3700B)
FDA
Z-0617-2008
Class II
2008/04/10
N/A
N/A
SN080414 Siemens Mevatron, Oncor, Primus Linear Accelerators
FDA
Z-1394-2008 to Z-1407-2008
Class II
2008/04/10
Siemens Ltd.
2810 7533
MHRA
2008/003/013/291/008
FSCA
2008/04/10
N/A
N/A
MHRA
2008/003/013/291/014
FSCA
2008/04/11
Stryker China Ltd
2518 6988
MHRA
2008/001/003/061/013
FSCA
2008/04/11
N/A
N/A
MHRA
2008/003/012/061/002
FSCA
2008/04/11
N/A
N/A
MHRA
2008/002/029/601/139
FSCA
2008/04/14
N/A
N/A
MHRA
2008/003/025/061/013
FSCA
2008/04/14
Abbott Laboratories Ltd.
2806 4021
SN080411 Hospira Butterfly winged needle infusion set
SN080415 Leica Bond maX systems with cversion 03.05.08 Software instaled
SN080416
Stryker Scorpio Knee Femoral Component (Catalog No. 705211R, 71-5211R, Lot Code: KNAMED, V8WMED)
SN080417 Medivance Instruments Velopex Extra X
SN080418
Thermogenesis Disposable Processing Set for the AXP System 85101
SN080419 Elekta Stereotactic Body Frame CT and MRI indicators
SN080420
Abbott OPTIUM-H Blood Glucose Test Strips (Lot no. 53929/ Part
No. 80111-01)
Medical Device Control Office
252
Department of Health
The Government of HKSAR
SN080421
Arcomedical 3101-TJ (FSB123) Blood Set with Lower Y site
(Batches C8446)
SN080422 Boston Scientific RX Plastic Biliary Stents
SN080423
Boston Scientific Precision Implantable Pluse Generator (UPN
M365SC11100)
SN080424 Boston Scientific Mach 1 Guide Catheter
SN080425 Boston Scientific Single-Use Rotatable Snares
SN080426 Boston Scientific SteeroCath-Dx and SteeroCath-T Catheters
SN080427
Boston Scientific Epic Over-The-Wire Self-Expanding Nitinol Stent
with Delivery System Stent System
SN080428 Boston Scientific Smash Balloon Dilation Catheter
SN080429 Boston Scientific Various Products
MHRA
2008/003/013/601/181
FSCA
2008/04/14
N/A
N/A
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/04/15
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/15
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/15
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/15
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/15
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/16
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/16
Boston Scientific Hong Kong Ltd
2960 7128
2008/04/16
Boston Scientific Hong Kong Ltd
2960 7128
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
Firm Initiated Field
Action
N/A
N/A
N/A
N/A
N/A
N/A
N/A
FDA
Z-1448-2008 to Z-1458-2008
Class II
2008/04/17
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
Medtronic AneuRx AAAdvantage Endovascular Stent Graft with
the Xcelerant Delivery System
FDA
Z-0689-2008
Class II
2008/04/17
Medtronic International, Ltd.
2919 1300
Myelotec Steerable Video Guided Catheter (Product Code 2000
SN080432
and 2010)
FDA
Z-0586-2008 to Z-0587-2008
Class II
2008/04/17
N/A
N/A
SN080433 CES Ultra, Cranial Electrotherapy Stimulator
FDA
Z-0712-2008
Class II
2008/04/17
N/A
N/A
Ormco Grengloo (Unidose Tips), Bracket adhesive and tooth
SN080434
conditioner (Part Number 740-0322)
FDA
Z-0916-2008
Class II
2008/04/17
L&S Dental Supplies Limited
2815 8115
SN080435 Nonin Model 2500 PalmSAT handheld pluse Oximeter
FDA
Z-0843-2008
Class II
2008/04/17
N/A
N/A
MHRA
2008/003/031/291/008
FSCA
2008/04/17
Abbott Laboratories Ltd.
2806 4021
SN080430 Zimmer Hemovac Wound Drainage Device Infection Control Kits
SN080431
SN080436 Abbott Vascular Xact Rapid Exchange Carotid Stent System
SN080437
PROACT Silicone Disposable Armoured LMA SAD-LA6320, SADLA6325, SAD-LA3300, SAD-LA6340, SAD-LA6350
MHRA
2007/012/021/401/014
FSCA
2008/04/18
N/A
N/A
SN080438
Siemens Medical IMMULITE 2000 CEA kit L2KCE2,6 lot 232 and
IMMULITE 2500 CEA kit L5KCE2,6 lot 111
MHRA
2008/002/028/601/134
FSCA
2008/04/18
Siemens Ltd.
2810 7533
SN080439 Huntleigh Healthcare Well-Shin WS-023 power lead adapters
MHRA
MDA/2008/027
MDA
2008/04/18
N/A
N/A
SN080440 Huntleigh Healthcare Birthright birthing bed mattresses
MHRA
MDA/2008/026
MDA
2008/04/18
N/A
N/A
SN080441 BHM Medical Maxi Sky 600, V4 and V4i Ceiling Lifts
Health Canada
41375
Type II
2008/04/21
N/A
N/A
SN080442 Smiths Medical BCI 3180 Pulse Oximeter (Model 3180)
Health Canada
41371
Type II
2008/04/22
Goodwin Health Care Holdings Ltd
2408 8838
SN080443 Biohorizons Implant System Ratchet Extender (Model # 300-205)
Health Canada
41433
Type II
2008/04/22
Specialists' Dental Supplies Limited
9656 7000
Health Canada
41374
Type II
2008/04/22
Specialists' Dental Supplies Limited
9656 7000
SN080444
Biohorizons Single-Stage Implant System 122-800 Kit (Model 122800)
Medical Device Control Office
253
Department of Health
The Government of HKSAR
SN080445 Elekta PrecisePlan (Model # MRT 7131, MRT 7161)
Health Canada
41295
Type II
2008/04/22
N/A
N/A
SN080446 Elekta iViewGT Electronical Portal Imaging (Model XRT 1261)
Health Canada
41295
Type II
2008/04/22
N/A
N/A
Health Canada
41158
Type II
2008/04/22
N/A
N/A
Health Canada
41183
Type II
2008/04/22
N/A
N/A
Somagen IgM HRP ELISA Kit (Model LAPL-K-HRP-001GM, LAPLK-HRP-001M)
Tornier Aequalis Shoulder (Kelled Glenoid and Cemented
SN080448 Glenoid) and Latitude Elbow Prosthesis Cap, Radial Head and
Ulnar Compon.
SN080449 Meridian Bioscience Immunocard Toxins A & B
SN080447
Health Canada
41330
Type II
2008/04/22
N/A
N/A
SN080450 Trinity Biotech MDA Auto Dimer (Product Code T3103)
MHRA
2008/004/003/061/016
FSCA
2008/04/23
N/A
N/A
SN080451 ITC AVOXimeter 1000 / AVOXimeter 1000E
MHRA
2008/002/021/061/018
FSCA
2008/04/23
N/A
N/A
SN080452 MEDNET TOPS OUS Fusion System
MHRA
2008/001/025/291/005
FSCA
2008/04/23
N/A
N/A
MHRA
2008/002/029/601/140
FSCA
2008/04/23
N/A
N/A
MHRA
MDA/2008/028
MDA
2008/04/23
N/A
N/A
GE Medical Systems
Hong Kong Ltd.
N/A
Firm Initiated Field
Action
2008/04/24
GE Medical Systems Hong Kong Ltd.
2783 1838
Cook Peel-Away Introducer set and Cook TPN Lumen Catheter
SN080456
set
FDA
Z-0892-2008 to Z-0904-2008
Class II
2008/04/24
Cook Asia (Hong Kong) Ltd.
2781 0232
SN080457 BioRad BioPlex 2200 Instrument
FDA
Z-0575-2008
Class II
2008/04/24
Bio-Rad Pacific Ltd.
2789 3300
SN080453
Medfor S400 and S227 Femoral Head Storage Pot, Labelled,
double wrapped
SN080454 Merlin Medical Disposable pen torch (Model no. W2137)
SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes)
Medical Device Control Office
254
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -March 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO
Ref. No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN080301
Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit
(CATALOG# IB0900G)
Health Canada
40290
Type II
2008/03/03
N/A
N/A
SN080302
Zoll Medical E Series Debribillator with 12 Lead ECG
Health Canada
40588
Type II
2008/03/03
N/A
N/A
SN080303
Stryker Howmedica Modular Replacement System, Distal Fem
Health Canada
39226
Type I
2008/03/03
Stryker China Ltd
2518 6988
SN080304
Walter Lorenz Surgical Pectus Table Top Bender (Trading as:
Biomet Microfixation)
Health Canada
39755
Type II
2008/03/03
N/A
N/A
SN080305
Balt Extrusion Goldbal Detachable Balloons
Health Canada
39555
Type II
2008/03/03
N/A
N/A
SN080306
Roche Accutrend GC
Health Canada
39757
Type II
2008/03/03
Roche Diagnostics (Hong Kong)
Limited
2485 7510
SN080307
Stryker Howmedica Trident acetabular shell and Trident
hemispherical shell
Health Canada
40619
Type II
2008/03/03
Stryker China Ltd
2518 6988
SN080308
Elekta Precise Plan
Health Canada
40747
Type II
2008/03/03
N/A
N/A
SN080309
Elekta Precise Treatment Table
Health Canada
40457
Type II
2008/03/03
N/A
N/A
SN080310
Elekta Leksell GammaPlan 8.0
Health Canada
40497
Type II
2008/03/03
N/A
N/A
SN080311
Abbott Cell Dyn Sapphire Analyzer (model # 08H00-01)
Health Canada
40557
Type II
2008/03/03
Abbott Laboratories Ltd.
2806 4021
SN080312
B Braun Aesculap FT420T-FT430T Caspar Aneurysm Clips APP
Health Canada
40744
Type I
2008/03/03
B. Braun Medical (HK) Ltd
2277 6611
SN080313
Conmed Endoscopic Ligating Clip Applier (ELC)
Health Canada
39961
Type II
2008/03/03
N/A
N/A
SN080314
Technidata TD-Synergy V03.11.A
Health Canada
40014
Type II
2008/03/03
N/A
N/A
SN080315
BD Luer Slip Syringe Products (REF 301294, 301295, 30020)
MHRA
2008/002/001/181/009
FSCA
2008/03/05
BD
2518 6988
SN080316
Terumo Weighed Flexible Sucker (Ref Code 804113)
MHRA
2008/002/020/061/003
FSCA
2008/03/05
Terumo China (H.K.) Ltd.
2866 0811
SN080317
Trinity Biotech Bartels Viral Respiratory Screening and
Identification Kit (Prodcut Code B1029-86)
MHRA
2008/002/021/291/008
FSCA
2008/03/05
N/A
N/A
SN080318
WMS Disposable Pen Torch W2137 (Batch Q01403, Q01408,
Q01371)
MHRA
2007/011/006/401/010
FSCA
2008/03/05
N/A
N/A
SN080319
Baush and Lomb ReNu Comfort Drops (Lot No 225747 and
225757)
MHRA
2008/002/011/061/014
FSCA
2008/03/05
Baush and Lomb
2213 3371
SN080320
Arjo Ambulift Hoist
MHRA
MDA/2008/010
MDA
2008/03/05
N/A
N/A
SN080321
Advanced Bionics Precision Implantable Pluse Generator Kit
(Model No. SC-1110)
FDA
Z-0960-2008 to Z-0961-2008
Class II
2008/03/06
N/A
N/A
Medical Device Control Office
255
Department of Health
The Government of HKSAR
SN080322
American Medical Systems, Inc., GreenLight HPS Fiber Optic
(ADDStat) (Part Number: 0010-2090B)
FDA
Z-0131-2008
Class II
2008/03/06
N/A
N/A
SN080323
TENET Medical Engineering Wrist Stabilization Kit
FDA
Z-0577-2008 to Z-0579-2008
Class II
2008/03/06
N/A
N/A
SN080324
Orthofix TrueLok External Ring Fixation System, Telescopic Linear
Distractor (Catalog No. 50-10185)
FDA
Z-0674-2008
Class II
2008/03/06
N/A
N/A
SN080325
Philips Medical Allura XPER FD10 and FD10/10 with AD7
MHRA
2008/002/021/291/001
FSCA
2008/03/12
Philips Electronics Hong Kong Ltd.
2876 7525
SN080326
VNS Therapy Demipulse Generator (103) and Demipulse Duo
Generator (104)
MHRA
2008/002/021/061/003
FSCA
2008/03/12
N/A
N/A
SN080327
Smiths Medical Logical, NovaTrans, and Transtar Invasive
Pressure Monitoring Kits with Trigger Flush Device
MHRA
2008/002/025/291/022
FSCA
2008/03/12
N/A
N/A
SN080328
Biomet Vanguard Width Checker (Item Number # 32-487062)
MHRA
2008/002/019/061/010
FSCA
2008/03/12
N/A
N/A
SN080329
Zimmer Pulsavac Plus Wound Debridement System, Pulsavac
Plus AC Component Kit, Pulsavac Fan Spray Kit and Hip Kit
FDA
Z-0856-2008 to Z-0865-2008
Class II
2008/03/19
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN080330
Stryker Disposable StrykeProbe 32 cm L-Tip and Spatula Tip
FDA
Z-0573-2008 to Z-0574-2008
Class II
2008/03/19
Stryker China Ltd
2518 6988
SN080331
Siemens ACUSON Aspen Diagnostic Ultrasound System (Model
Number 8247887)
FDA
Z-0719-2008
Class II
2008/03/19
Siemens Ltd.
2810 7533
SN080332
Zimmer Allofit Shell Size 50 (Model 4244, Lot 2406181)
Health Canada
39593
Type II
2008/03/19
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN080333
Zimmer Hemovac Infection Control Kits
Health Canada
40972
Type II
2008/03/19
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN080334
Siemens Syngo Dynamica (Model 100 90 679; Serial # 92241,
93477, 95243, 95248)
Health Canada
40885
Type II
2008/03/19
Siemens Ltd.
2810 7533
SN080335
Siemens Leonardo Workstation (Model 7129534, Serial # 10413,
10434, 10599)
Health Canada
40580
Type II
2008/03/19
Siemens Ltd.
2810 7533
SN080336
Abbott Clinical Chemistry Phenytoin (Model IE07-20)
Health Canada
41000
Type II
2008/03/19
Abbott Laboratories Ltd.
2806 4021
SN080337
Siemens Dade Behring Complement Reagents (Model OWZD11;
Lot# 542849)
Health Canada
39678
Type II
2008/03/19
Siemens Ltd.
2810 7533
SN080338
Boston Scientific Advanced Bionics Clinician's Programmer
Navigation V1.02 (Model P/N 9055528-001, SC-7150)
Health Canada
40881
Type II
2008/03/19
Boston Scientific Hong Kong Ltd
2960 7128
SN080339
Draeger Medical Fabius GS (Model# 8604700)
Health Canada
40720
Type II
2008/03/19
Draeger Medical Hong Kong Ltd.
2877 3077
SN080340
Beckman Coulter IMMAGE C-Reactive Protein CRP Reagent
(Model # 447280)
Health Canada
40898
Type II
2008/03/19
Beckman Coulter Hong Kong Ltd.
2240 6260
SN080341
VIASYS Microjack Patient Interface (Model # GP 320000-00)
Health Canada
40966
Type II
2008/03/19
VIASYS Healthcare (Hong Kong) Ltd
6305 5575
SN080342
Cardinal Health Sterile Bowel Resection-Lithotomy Pack and
Major Surgery Packs
Health Canada
40924
Type II
2008/03/19
N/A
N/A
SN080343
Johnson & Johnson, Ortho-Clinical Blood Grouping Reagent AntiLe Bioclone (Model# 715280)
Health Canada
38920
Type II
2008/03/19
Johnson & Johnson Medical Hong
Kong
2738 2818
SN080344
Coopersurgical Mystic II Pump with M-Style Mushrooncup (Model
no 10057)
Health Canada
40725
Type II
2008/03/19
N/A
N/A
SN080345
Computerized Medical Systems Focal Workstation
Health Canada
40151
Type II
2008/03/19
N/A
N/A
SN080346
Allez Spine Size 8 Pedicle Screws (Catalo # LG-PR0835, LGPR0840, LG-PR0845, LG-PR0850, LG-PR0855, LG-PR0880)
FDA
Z-0186-2008 to Z-0191-2008
Class II
2008/03/25
N/A
N/A
Medical Device Control Office
256
Department of Health
The Government of HKSAR
SN080347
GE Healthcare Mobile Fluoroscopy X-Ray System OEC Model
7600 AND 7700
FDA
Z-0716-2008 to Z-0717-2008
Class II
2008/03/25
GE Medical Systems Hong Kong Ltd.
2783 1838
SN080348
Linemaster Wireless Footswitch Accessory (Model SP-9970214005112010 and SP-9970214-005112232)
FDA
Z-0933-2008
Class II
2008/03/25
N/A
N/A
SN080349
Smith & Nephew Exu-Dry Wound Burn Dressing
FDA
Z-1199-2008 to Z-1217-2008
Class II
2008/03/25
Smith & Nephew Healthcare Ltd.
2648 7700
SN080350
Stryker VertePort 10G Access Cannula w/Long Stylet System,
10G Cement Cannula, 10G Access Canula (short) and 11 G
Cement Cannula
FDA
Z-1192-2008 to Z-1195-2008
Class II
2008/03/25
Stryker China Ltd
2518 6988
SN080351
Abbott CELL-DYN 1800 System with CELL-DYN 22 Calibrators
and the CELL-DYN Calibrators abd CELL-DYN 16 Controls (Part
# 07H77-01)
FDA
Z-0455-2008
Class II
2008/03/25
Abbott Laboratories Ltd.
2806 4021
SN080352
ALN IVC Filter (Lot: 0107A, 0207A, 0207B, 0307A & 0407A)
MHRA
2007/012/012/401/002
FSCA
2008/03/25
N/A
N/A
SN080353
GE Heatlhcare Advantx-E, Innova 2000, 2100IQ, 3100/3100IQ
AND 4100/4100IQ
MHRA
2008/002/026/061/016
FSCA
2008/03/26
Siemens Ltd.
2810 7533
SN080354
ASTRA PEP/RMT Products (Prodtuct Ref 71001, 71002, 71006,
71007, 71042 and 71052)
MHRA
2008/002/027/291/003
FSCA
2008/03/26
N/A
N/A
SN080355
Jenx Bee Chair
MHRA
2008/002/001/301/001
FSCA
2008/03/26
N/A
N/A
SN080356
AKW 2000 Series Seats
MHRA
2007/009/017/601/005
FSCA
2008/03/26
N/A
N/A
SN080357
Olympus AU2700 Clinical Chemistry Analyser (Models : ALL;
Serial: ALL)
MHRA
2008/003/003/291/003
FSCA
2008/03/26
Olympus Hong Kong Ltd
2376 1805
SN080358
BIO-RAD ScanGel
MHRA
2008/003/004/061/009
FSCA
2008/03/26
Bio-Rad Pacific Ltd.
2789 3300
SN080359
Sidhil Millennium Freedom Bed (Product Code(s) 1262, 1263,
1263/LOW)
MHRA
2007/010/031/061/007
FSCA
2008/03/26
N/A
N/A
SN080360
Arcomedical 3100-J (FSB499) Burette Set (Batch N1068)
MHRA
2008/003/012/291/012
FSCA
2008/03/26
N/A
N/A
SN080361
Trulife Heel & Elbow and the Heel & Ankle Gelbodies
MHRA
MDA/2008/013
MDA
2008/03/26
N/A
N/A
SN080362
Etac Patient Turner (Model 411973300)
MHRA
MDA/2008/018
MDA
2008/03/26
N/A
N/A
Medtronic
International Ltd
N/A
Firm Initiated Field
Action
2008/03/26
Medtronic International, Ltd.
2919 1300
Cryocath
Technologies Inc.
N/A
Firm Initiated Field
Action
2008/03/26
Cryocath Technologies Inc.
N/A
SN080363
Medtronic LIFEPAK 1000
SN080364
Cryocath FlexCath Steerable Sheath(Ref 3FC12)
SN080365
American Medical Systems GreenLight HPS System (Part No.
0010-0070 and 0010-0075)
FDA
Z-0130-2008
Class II
2008/03/27
N/A
N/A
SN080366
Gambro cartridge blood set with Phoenix Hemodialysis System
FDA
Z-1367-2008
Class II
2008/03/27
Gambro China Ltd
2576 2688
SN080367
Draeger TI500 Isolette Infant Incubator (Catalog no.: MU20505),
GT500 Globe Trotter Transport System (Catalog no.: MU20508)
and Globe Trotter IC (Catalog no.: MU20509)
FDA
Z-1051-2008 to Z-1053-2008
Class II
2008/03/27
Draeger Medical Hong Kong Ltd.
2877 3077
SN080368
Smith & Nephew CALAXO Bioabsorbable Interference Screw
FDA
Z-0593-2008 to Z-061612008
Class II
2008/03/27
Smith & Nephew Healthcare Ltd.
2648 7700
Medical Device Control Office
257
Department of Health
The Government of HKSAR
SN080369
Siemens Magnetom Harmony Mobile MRI System, Magnetom
Harmony syngo , Magenetom Symphony Magnetom Sonata
syngo and Magnetom Symphony syngo
FDA
Z-1042-2008 to Z-1049-2008
Class II
2008/03/27
Siemens Ltd.
2810 7533
SN080370
Abbott Clinical Chemistry Creatine Kinase (Model LN 7D63-30)
FDA
Z-1109-2008
Class II
2008/03/27
Abbott Laboratories Ltd.
2806 4021
SN080371
Stryker Orthopaedics, UHR Universal Bipolar Component, Hip
Prosthesis Component
FDA
Z-0621-208 to Z-0656-2008
Class II
2008/03/27
Stryker China Ltd
2518 6988
SN080372
Stryker Orthopaedics Locking Screw T7 (Catalog no 40-27622)
FDA
Z-1297-2008
Class II
2008/03/27
Stryker China Ltd
2518 6988
SN080373
Ventana Image Analysis Ssystem (VIAS) PATHWAY anti-HER2/neu (4B5) primary antibody with software version 2.3.0.2 (Model
no. VIAS-799-10000-00)
FDA
Z-0571-2008
Class II
2008/03/27
N/A
N/A
SN080374
Bausch and Lomb Non-Sterile Multiple-use Phaco needles
Bausch and Lomb
N/A
2008/03/27
Baush and Lomb
2213 3371
SN080375
Boston Scientific COGNIS CRT-D device
Boston Scientific
Hong Kong Ltd
N/A
2008/03/27
Boston Scientific Hong Kong Ltd
2960 7128
SN080376
Osypka Medical External Dual Chamber Pluse Generator PACE
203H
MHRA
2008/002/022/401/004
FSCA
2008/03/28
N/A
N/A
SN080377
Volker Nursing Beds (Models 3010 and 5020)
MHRA
MDA/2008/020
MDA
2008/03/28
N/A
N/A
SN080378
Linet Hospital beds Eleganza Standard, Smart and Deluxe models
MHRA
MDA/2008/021
MDA
2008/03/28
N/A
N/A
SN080379
Smiths Medical CADD-MS 3 Ambulatory Infusion Pump (Model
7400, Recorder No 21-7401-54 and 21-7411-51)
MHRA
2008/002/026/291/005
MDA
2008/03/28
Goodman Medical Supplies Ltd
2332 4455
SN080380
Philips Brilliance CT Systems
Health Canada
39694
Type II
2008/03/31
Philips Electronics Hong Kong Ltd.
2876 7525
SN080381
Philips Carevue Chart Release C v C.00.00-06 and Intellivue
Clinical Info Portfolio D
Health Canada
41242
Type II
2008/03/31
Philips Electronics Hong Kong Ltd.
2876 7525
SN080382
Steris Tenzor Carbon Fiber Orthopedic Traction
Health Canada
41089
Type II
2008/03/31
Swedish Trading Co., Ltd
N/A
SN080383
Steris C1160 Tray used with Steris System 1
Health Canada
41078
Type II
2008/03/31
Swedish Trading Co., Ltd
N/A
SN080384
Steris Amsco Remanufactured Prevacuum Sterilizers
Health Canada
41256
Type II
2008/03/31
Swedish Trading Co., Ltd
N/A
SN080385
Smiths Medical Flo-2 kit With Mask
Health Canada
41199
Type II
2008/03/31
N/A
N/A
SN080386
Radiometer Medical ABL80'S With Software Version 1.10
Health Canada
38880
Type II
2008/03/31
N/A
N/A
SN080387
International Technidyne Corp Avoximeter 1000E Oximeter
Health Canada
41136
Type II
2008/03/31
N/A
N/A
SN080388
Maquet Jostra Heater-Cooler Unit 30 System
Health Canada
41072
Type II
2008/03/31
Maquet Hong Kong Ltd
N/A
SN080389
Biosense Webster Navistar RMT Diagnostic/Ablation Catheter
Health Canada
41193
Type II
2008/03/31
N/A
N/A
SN080390
Popper And Sons Perfektum Toomey Evacuating Syringe
Health Canada
40097
Type II
2008/03/31
N/A
N/A
SN080391
Tomotherapy Hi-Art System
Health Canada
41091
Type II
2008/03/31
TomoKnife (Hong Kong) Ltd
2609 0974
Medical Device Control Office
Firm Initiated Field
Action
Firm Initiated Field
Action
258
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -February 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO
Ref. No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA080201
Organogenesis Apligraf, interactive wound and burn dressing (Lot
# GS0711.20.01.2A and GS0711.22.01.2A)
FDA
Z-0675-2008
Class II
01-二月-08
N/A
N/A
SA080202
Fertility Technology Resources Tucker Embryo Catheter and
Morton IUI Catheter
FDA
Z-0662-2008 to Z-0667-2008
Class II
01-二月-08
N/A
N/A
SA080203 Hoana LifeBed Patient Vigilance System (Model# 010135-01)
FDA
Z-0592-2008
Class II
01-二月-08
N/A
N/A
SA080204 AADCO Rayshield Frame Mounted Overhead X-Ray Barrier
FDA
Z-0552-2008
Class II
01-二月-08
N/A
N/A
VNUS 7F ClosureFAST Catheter (Order# CF7-7-60 and CIF7-7SA080205
100)
FDA
Z-0542-2008 to Z-0543-2008
Class II
01-二月-08
N/A
N/A
SA080206
Ventana Benchmark, Benchmark XT, Benchmark LT, Discovery
and Discovery XT Slide Staining System
FDA
Z-0537-2008 to Z-0541-2008
Class II
01-二月-08
N/A
N/A
SA080207
Intuitive Surgical EndoWrist (Part # 400214-02, 400214-03,
420214-02 and 420214-03)
FDA
Z-0258-2008
Class II
01-二月-08
N/A
N/A
FDA
Z-0120-2008
Class II
01-二月-08
N/A
N/A
SA080208 AmniSure ROM Test (Model # FMRT-1)
SA080209
Biomet Straight Magnum Inserter Handle (REF# or Catalo #
S313141)
FDA
Z-0115-2008
Class II
01-二月-08
Goodman Medical Supplies Ltd
2332 4455
SA080210
Johnson and Johnson Depuy TK2 Compression Hip Screw
Trauma Plate (REF 8315-35-004, 8315-35-104)
FDA
Z-0434-2008 to Z-0435-2008
Class II
01-二月-08
Johnson & Johnson Medical Hong
Kong
2738 2818
SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01)
FDA
Z-0551-2008
Class II
01-二月-08
Abbott Laboratories Ltd.
2806 4021
SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20)
FDA
Z-0127-2008
Class II
01-二月-08
Abbott Laboratories Ltd.
2806 4021
FDA
Z-0529-2008
Class II
01-二月-08
N/A
N/A
Health Canada
40047
Type II
04-二月-08
Sanko Medical System (HK) Ltd
2384 0688
MHRA
2008/001/024/291/004
FSCA
04-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
MHRA
2008/001/024/601/003
FSCA
04-二月-08
Abbott Laboratories Ltd.
2806 4021
MHRA
2008/001/014/291/020
FSCA
04-二月-08
Stryker China Ltd
2518 6988
SA080213
Superior Oxy Serve II Oxygen Conserving Regulator (Model #
MCRB-870-6)
SA080214 Toshiba Aquilion 32, 64, Super 4 and Toshiba 256-Slice Scanner
Philips Brilliance Big Bore CT Scanners using software v2.2.1
SA080215
through v2.2.5
SA080216
Abbott AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0
(List # 3D54-08)
SA080217 Stryker Burs
SA080218
Siemens Urea Nitrogen (BUN) Flex reagent cartridge (DF21) (Lot
no. FC8283 and FH8271)
MHRA
2008/001/021/601/002
FSCA
04-二月-08
Siemens Ltd.
2810 7533
SA080219
Roche COBAS AmpliPrep/ COBAS Taqman & High Pure
System/COBAS Taqman 48
MHRA
2007/011/019/291/011
FSCA
04-二月-08
Roche Diagnostics (Hong Kong)
Limited
2485 7510
Medical Device Control Office
259
Department of Health
The Government of HKSAR
SA080220 Corin Cormet Head Trial Size 4/44
SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups
MHRA
2008/001/023/291/002
FSCA
Firm Initiated Field
Action
Firm Initiated Field
Action
04-二月-08
N/A
N/A
04-二月-08
Stryker China Ltd
2518 6988
06-二月-08
CELKI Medical Company
2268 9258
Stryker China Ltd
N/A
CELKI Medical
Company
N/A
Intuitive Surgical da Vinci S Surgical System 8mm instrument
SA080223 cannula, 8mm Long instrument cannula and 5 mm instrument
cannula (Part#:420002-01. 420004-01 and 420011-01)
FDA
Z-0657-2008 to Z-0659-2008
Class II
11-二月-08
N/A
N/A
Intuitive Surgical da Vinci S Surgical System 5 mm instrument
cannula (Part#:420011-01)
FDA
Z-0669-2008
Class II
11-二月-08
N/A
N/A
Baxter RenalSoft v.2.0 Patient Management Software Suite - HD
SA080225 Module and Baxter Renal Software Suite v3.0 and v3.1 - Renal
Link HD Module
FDA
Z-0527-2008 to Z-0528-2008
Class II
11-二月-08
Baxter Healthcare Ltd
2807 8555
Philips Gemini 16 and 64-slice PET/CT Systems, Gemini GXL 6,
10 and 16 slice PET/CT Systems
FDA
Z-0461-2008 to Z-0462-2008
Class II
11-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
SA080227 Philips Page Writer Touch Cardiograph (Model # 860284)
FDA
Z-0124-2008
Class II
11-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ
FDA
Z-0690-2008 to Z-0692-2008
Class II
11-二月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
Blackstone Hallmark Anterior Cervical Plate System (REF#62SA080229
3140)
FDA
Z-0478-2008
Class II
11-二月-08
N/A
N/A
SA080230 Biomet CC Cruciate Tibial Tray (Product no 141232, 141234)
FDA
Z-0706-2008 to Z-070-2008
Class II
11-二月-08
N/A
N/A
SA080231 Spacelabs Medical, Ultraview Multigas Anaylzer (Model 91518)
FDA
Z-0660-2008
Class II
11-二月-08
N/A
N/A
SA080232 Molnycke Health Care Laparoscopic Cholecysectomy
MHRA
2008/001/031/291/002
FSCA
12-二月-08
N/A
N/A
SA080233 Schiller FRED Easy Defibrillator
MHRA
2008/001/024/291/003
FSCA
12-二月-08
Ultronics Enterprises Ltd
2764 5208
SA080234 Days Healthcare Viper & Viper Plus Powerchairs
MHRA
2008/001/022/301/002
FSCA
13-二月-08
N/A
N/A
SA080222 Respironics Esprit ventilators
SA080224
SA080226
SA080235
Arkray Assure 3 Blood Glucose Test Strips (PRODUCT NO
555050)
FDA
Z-0699-2008
Class II
18-二月-08
N/A
N/A
SA080236
Biomet Ringloc Instrumentation Impactor Plate (Ref/Part # 31400620 - 31-400623, 31-400626, 31-400628)
FDA
Z-0700-2008 to Z-0705-2008
Class II
18-二月-08
Goodman Medical Supplies Ltd
2332 4455
SA080237 Inotech Brand Heparin Adsobent (Catalog# HA-1)
FDA
Z-0934-2008
Class II
18-二月-08
N/A
N/A
SA080238 Horizon Cardiology Hemo Monitoring System
FDA
Z-0710-2008
Class II
18-二月-08
N/A
N/A
FDA
Z-0738-2008
Class II
18-二月-08
Fresenius Medical Care Asia-Pacific
Ltd.
2802 2900
(1) 2781 0232;
(2) 2541 1041
SA080239
Fresenius Medical Care Optiflux 180NR Advanced Fresenius
Polysulfone (Catalog no. 0500318E)
SA080240 Cook THSCF-35-260-3-AUS2
SA080241
Medtronic Kyphon Functional Anesthetic Discography (F.A.D.)
Catheter System (Catlog # D014, D01B)
SA080242 Medtronic Cardioblate Gemini-s model 49260
SA080243 Siemens Dade Behring BEP III System
Medical Device Control Office
FDA
Z-0135-2008
Class II
18-二月-08
(1) Cook Asia (Hong Kong) Ltd.; (2)
A.R. Burkhill & Sons (Hong Kong) Ltd.
FDA
Z-0948-2008 to Z-0949-2008
Class II
18-二月-08
Medtronic International, Ltd.
886-22183-6130
FDA
Z-0727-2008
Class II
18-二月-08
Medtronic International, Ltd.
886-22183-6130
MHRA
2008/002/005/061/014
FSCA
20-二月-08
Siemens Ltd.
2810 7533
260
Department of Health
The Government of HKSAR
SA080244 Care & Independence Systems InChair Sling
GE Healthcare InstaTrak 3500 Plus with the Cranial Application for
SA080245
Image Guide Surgery
GE Healthcare Clinical Information Centre (CIC) Pro v5.0.3 and
SA080246
5.0.6
Abbott Comfort T-handle Hudson Connector with Impactor Cap
SA080247
(Part # 1006-1)
MHRA
2007/004/030/261/002
FSCA
20-二月-08
N/A
N/A
MHRA
2008/002/011/061/008
FSCA
21-二月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
MHRA
2008/002/006/601/033
FSCA
21-二月-08
GE Medical Systems Hong Kong Ltd.
2783 1838
FDA
Z-0880-2008
Class II
22-二月-08
Abbott Laboratories Ltd.
2806 4021
SA080248
Siemens Mevatron KD2 Medical Charged-Particle Radiation
Therapy System
FDA
Z-0677-2008 to Z-0687-2008
Class II
22-二月-08
Siemens Ltd.
2810 7533
SA080249
Roche LIPC Lipase Colorimetric Reagent (Catalog No.:
03029590322)
FDA
Z-0688-2008
Class II
22-二月-08
Roche Diagnostics (Hong Kong)
Limited
2485 7510
FDA
Z-0718-2008
Class II
22-二月-08
Varian Medical Systems Pacific Inc.
2724 2836
FDA
Z-0718-2008
Class II
22-二月-08
N/A
N/A
Varian VARiS 1.4g; Linear Accelerator with RTP Exchange v6.2,
SA080250
v6.6 and v8.0 (Models : ALL)
Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24)
(Product Code: 866.2500; Part No. 173400)
Rockwell Medical RenalPure Liquid Acid Concentrate R-006, RSA080252 235 and R-259 ; Glacial Acidic Acid and Dri-Sate Glacial Acidic
Acid
SA080253 ConMed Electrosurgical blades and Needles
FDA
Z-0871-2008 to Z-0875-2008
Class II
22-二月-08
N/A
N/A
MHRA
2008/002/011/061/011
FSCA
22-二月-08
N/A
N/A
SA080254 Unipath SmartCheck INR POC Meter and Consumables
MHRA
2008/002/020/061/008
FSCA
22-二月-08
N/A
N/A
SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX
MHRA
2008/002/006/291/001
FSCA
22-二月-08
Roche Diagnostics (Hong Kong)
Limited
2485 7510
SA080256 Philips General X-Ray System
MHRA
2008/002/012/061/007
FSCA
22-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
SA080257 Philips X-Ray System Types Omni Diagnost Eleva
MHRA
2008/002/013/061/004
FSCA
22-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
FDA
N/A
Press Release
26-二月-08
N/A
N/A
MHRA
2008/002/012/061/008
FSCA
27-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
MHRA
2008/002/015/061/001
FSCA
27-二月-08
Medtronic International, Ltd.
886-22183-6130
MHRA
2008/002/014/601/063
FSCA
27-二月-08
N/A
N/A
Bausch and Lomb
N/A
Firm Initiated Field
Action
27-二月-08
Baush and Lomb
2213 3371
Baxter Heparin Sodium Injection multi-dose, single dose vials and
SA080263
HEP-LOCK heparine flush products (lots: ALL)
FDA
N/A
Press Release
29-二月-08
Baxter Healthcare Ltd
2807 8555
Siemens Primus Linear Accelerator System and Mevatron Linear
Accelerator Systems
FDA
Z-0850-2008 to Z-0852-2008
Class II
29-二月-08
Siemens Ltd.
2810 7533
FDA
Z-0732-2008
Class II
29-二月-08
Siemens Ltd.
2810 7533
FDA
Z-0731-2008
Class II
29-二月-08
Carestream Health Hong Kong Limited
2564 9759
MHRA
MDA/2008/008
MDA
29-二月-08
N/A
N/A
FDA
Z-0581-2008 to Z-0584-2008
Class II
29-二月-08
N/A
N/A
SA080251
Chattem Icy Hot Heat Therapy Air Activated Heat adhesive
SA080258
heating patch - (i) Back; (ii) Arm, Neck, and Leg
SA080259
Philips Easy Diagnost Eleva family, Easy Diagnost Classic family
and Diagnost 76 plus family
SA080260 Medtronic Internal Defrillation Handles and Electrodes
SA080261
Baxa Corporation EM4200 Exacta-Mix Compounder Operating
Software V1.05, 1.06 & 1.06.1
SA080262 Bausch and Lomb Stellaris Vision Enhancement System
SA080264
Siemens Syngo Imaging System with VB30A version of software
SA080265
(Model No. 10014063)
Kodak DirectView Model DR 3000 System, Stationary X-Ray
SA080266
System
Hill-Rom Avantguard 1200 and 1400 with manually operated lockSA080267
out function
SA080268 Hill-Rom Affinity Birthing Bed (Model P3600, P3700A, P3700B)
Medical Device Control Office
261
Department of Health
The Government of HKSAR
Intuitive Surgical daVinci S Surgical System (Model No. IS2000)
SA080269 and Surgical Endoscopic Instrument Control System (Model No
IS2000)
Intuitive Surgical daVinci S Surgical System, Endoscopic
SA080270 Instrument Control System (Model No IS2000) with Isolation
Transformer and Vision Cart (Model VS1000 and VS2000)
FDA
Z-0079-2008
Class II
29-二月-08
Chindex
2892 0301
FDA
Z-0151-2008 to Z-0152-2008
Class II
29-二月-08
N/A
N/A
FDA
Z-0724-2008 to Z-0726-2008
Class II
29-二月-08
N/A
N/A
SA080272 Philips Digital Diagnost Family
MHRA
2008/002/019/063/003
FSCA
29-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
SA080273 Philips EasyVision RAD
MHRA
2008/002/020/061/007
FSCA
29-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog
SA080274
No 1320-0231)
MHRA
2008/002/006/061/001
FSCA
29-二月-08
Stryker China Ltd
2518 6988
MHRA
2008/002/019/061/020
FSCA
29-二月-08
Philips Electronics Hong Kong Ltd.
2876 7525
29-二月-08
Johnson & Johnson Medical Hong
Kong
2738 2818
SA080271
SA080275
Nova EZ CHEM Creatinine Meter, Control Solution and Linearity
Solution
Philips Digital Diagnost family, Bucky Diagnost family, Easy
Diagnost family, Thoravision
SA080276 Depuy polyethylene knee bearings
Medical Device Control Office
MHRA
2007/010/031/061/010
262
FSCA
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -January 2008
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO
Ref. No.
Description of Product
Source of
Information*
Reference No. by Source
Alert Type by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA080101
Medtronic CD Horizon Agile Dynamic Stabilization Device
MHRA
2007/011/013/061/020
FSCA
2008/01/02
Medtronic International, Ltd.
2919 1362
SA080102
Smiths Medical Graseby 500 and 505 volumetric infusion pumps
(Models: ALL)
MHRA
MDA/2007/100
MDA
2008/01/02
Smiths Medical (S.E. Asia) Ltd.
N/A
SA080103
Medtronic Satellite Spinal System, Satellite Sphere CoCr, Satellite
System Sphere PEEK and Material Stainless Steel/Radel
FDA
Z-0192-2008 to Z-0210-2008
Class II
2008/01/03
Medtronic International, Ltd.
2919 1362
SA080104
Roche Ammonia/Ethanol/CO2 Calibrator, Control N (Normal) and
Control A (Abnormal) (Catalog no. 20751995190, 20752401190,
20753009190)
FDA
Z-0377-2008 to Z-0379-2008
Class II
2008/01/03
Roche Diagnostics (Hong Kong)
Limited
2485 7510
SA080105
Rita Medical Vortex VX Port System (REF/Part no.: P5455K;
Catalog No.: P5455, Latex Free, Sterile)
FDA
Z-0149-2008
Class II
2008/01/03
N/A
N/A
SA080106
Ellex Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with
Software Version 3.0 and Biometry A-Scan modality
FDA
Z-0148-2008
Class II
2008/01/03
N/A
N/A
FDA
Z-0153-2008 to Z-0154-2008
Class II
2008/01/03
N/A
N/A
FDA
Z-0456-2008
Class II
2008/01/03
N/A
N/A
FDA
Z-0523-2008 to Z-0524-2008
Class II
2008/01/03
N/A
N/A
MHRA
2007/012/006/061/016
FSCA
2008/01/07
N/A
N/A
SA080107
SA080108
SA080109
SA080110
Precept Medical Products Tape Fog Shield Surgical Mask Green
Fiberglass Free and Foam Fog Shield Surgical Mask Green
Fiberglass Free (Reorder#65-3322 and 65-3320)
Microbiologics P.vulgaris, DuoPacksI (Product Catalog # 0691P,
ARCC 0427; Exp 2008-9)
BatteryZone Life+cel (OEM P/N 9146-001 and 9141-001 ; Part #
7L877 and 2L561)
Hill-Rom SM647 Medical Charis and SM608 Relaxation Chairs
(Serial no HRP000698167 - HRP000733692)
SA080111
Philips Digital Diagnost Family
MHRA
2007/009/006/401/002
FSCA
2008/01/07
Philips Electronics Hong Kong Ltd.
2876 7525
SA080112
ThermoFisher Scientific DADE Cardiac TL Assayed Cardiac
Marker Control
MHRA
2007/012/018/051/002
FSCA
2008/01/07
N/A
N/A
SA080113
Horcher Lifting System Powered Patient Positioner
MHRA
2007/007/010/401/004
FSCA
2008/01/07
N/A
N/A
SA080114
Select Healthcare DUO Transfer Slide Deluxe and Duo Transfer
Slide (Model LOCO-400A and LOCO-410A)
MHRA
2007/008/006/401/005
FSCA
2008/01/07
N/A
N/A
SA080115
Smiths Medical CADD Medication Cassette Reservoirs (Recorder
No.: 21-7002-24, 21-7001-24, 21-7100-24)
MHRA
2007/012/018/051/001
FSCA
2008/01/09
Goodman Medical Supplies Ltd
2332 4455
SA080116
ProTime Microcoagulation System PROTIMEINT
MHRA
2007/011/028/291/005
FSCA
2008/01/09
N/A
N/A
SA080117
Stryker Distal Depth Screw Guage (Catalog. no. 12146000,
LOT/BATCH NO:K532495)
MHRA
2007/011/027/061/012
FSCA
2008/01/09
Stryker China Ltd
2518 6988
SA080118
Stryker Stretchers (Model No.: 660, 721, 735, 1001, 1002, 1005,
1015, 1020, 1069)
MHRA
2007/012/013/061/010
FSCA
2008/01/09
Stryker China Ltd
2518 6988
N/A
SA080119
SA080120
SA080121
SA080122
Fresenius Medical Care multiFiltrate acute dialysis system
BD 5ml and 10ml Syringe Luer Lok Tip, Bulk, Sterile Convenience
Paks
bioMerieux, BacT/ALERT FA Culture Bottles (Lot no 1017685,
101793 and 1017788)
Abbott CELL-DYN Sapphire Hemoglobin Reagent Analyzer
Syringes (List no 08H49-02)
Medical Device Control Office
2007/012/017/051/003
FSCA
2008/01/09
Fresenius Medical Care Asia Pacific
Ltd.
BD
N/A
Firm Initiated Field
Action
2008/01/09
BD
2575 8668
FDA
Z-0457-2008
Class II
2008/01/11
Biomerieux (Hong Kong)
2356 7033
FDA
Z-0301-2008
Class II
2008/01/11
Abbott Laboratories Ltd.
2806 4201
MHRA
263
Department of Health
The Government of HKSAR
SA080123
Siemens IMMULITE/IMMULITE 1000, IMMULITE 2000 and
IMMULITE 2500 Operators
MHRA
2008/001/004/601/001
FSCA
2008/01/14
Siemens Ltd.
2810 7533
SA080124
Siemens Syva Emit II Plus Amphetamines Assay (Catalog No
9C039ul, Lot Z10)
MHRA
2008/001/003/601/002
FSCA
2008/01/14
Siemens Ltd.
2810 7533
SA080125
Smith & Nephew Wrist Stabilization Kit (Part # 7691, 7692, 7693 ;
Lot # 20060605)
MHRA
2007/012/020/061/001
FSCA
2008/01/14
Smith & Nephew Healthcare Ltd.
SA080126
Fresenius Kabi Orchestra Base Primea
MHRA
2008/001/007/061/010
FSCA
2008/01/14
N/A
SA080127
AMO VISX STAR excimer laser chair
MHRA
2008/001/004/061/010
FSCA
2008/01/14
THI Holdings Inc.
SA080128
Stephan Neonatel Transport Ventilator
MHRA
2007/012/007/061/002
FSCA
2008/01/15
N/A
N/A
SA080129
BD FACSDiva software v6.0 and 6.1 with the HP XW4400
Computer System
MHRA
2008/001/008/061/012
FSCA
2008/01/15
BD
2575 8668
SA080130
Fannin GU Fibrillator Unit 3821
MHRA
2008/001/009/291/003
FSCA
2008/01/15
N/A
N/A
SA080131
Datascope CS 100 Intro-Aortic Balloon Pump and CS 300 IntraAortic Balloon Pump
MHRA
2008/001/009/291/002
FSCA
2008/01/15
Datascope Corp Asia-Pacific
2647 9713
SA080132
Boston Scientific Stainless Steel Greenfield Vena Cava Filter
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/01/16
Boston Scientific Hong Kong Ltd
2960 7128
SA080133
Boston Scientific Slimline 200 Micron Delivery System
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/01/16
Boston Scientific Hong Kong Ltd
2960 7128
SA080134
Boston Scientific Galaxy 2 and ClearView Systems
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/01/16
Boston Scientific Hong Kong Ltd
2960 7128
SA080135
Boston Scientific ICD and CRT-D devices implanted subpectorally
with the serial number facing the ribs
Boston Scientific
Hong Kong Ltd
N/A
Firm Initiated Field
Action
2008/01/16
Boston Scientific Hong Kong Ltd
2960 7128
SA080136
Siemens Biograph 6, 16, 40-3 Ring, 40 TruePoint, 64-3 Ring and
DUO LSO
FDA
Z-0247-2008 to Z-0252-2008
Class II
2008/01/16
Siemens Ltd.
2810 7533
SA080137
Johnson and Johnson CORDIS FireStar and Dura Star RX PTCA
Dilatation Catheters
Johnson & Johnson
Medical Hong Kong
N/A
Firm Initiated Field
Action
2008/01/16
Johnson & Johnson Medical Hong
Kong
2738 2818
SA080138
Abbott ARCHITECT i System Assay CD-ROM-WW (List No. (LN)
6E59)
FDA
Z-0299-2008
Class II
2008/01/17
Abbott Laboratories Ltd.
2806 4021
SA080139
Ventena Medical System's Symphony Staining System, KPA
(Model # : 2200000; catalog# 900-SYM1 and 900-SYM3)
FDA
Z-0300-2008
Class II
2008/01/17
N/A
N/A
SA080140
Toshiba Aplio XG Diagnostic Ultrasound System (Model: SSA790A with version 1.1 software)
FDA
Z-0305-2008
Class II
2008/01/17
N/A
N/A
SA080141
Encore Medical VariLift Bone Plug w/ End Cup
FDA
Z-0306-2008 to Z-0311-2008
Class II
2008/01/17
N/A
N/A
SA080142
Siemens ACUSON Antares, Ultrasound System
FDA
Z-0297-2008 to Z-0298-2008
Class II
2008/01/17
Siemens Ltd.
2810 7533
SA080143
Oasis Medical PremierEdge MICROSURGICAL KNIFE
FDA
Z-0485-2008 to Z-0516-2008
Class II
2008/01/17
N/A
N/A
SA080144
Fisher and Paykel Healthcare Cosycot UPS
MHRA
2007/005/010/401/004
FSCA
2008/01/17
Tokibo Co. (HK) Ltd.
2418 9698
SA080145
Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay
Systems
MHRA
2008/001/003/291/003
FSCA
2008/01/17
Siemens Ltd.
2810 7533
SA080146
VacSax and GelSax Disposable Suction Liners
MHRA
2007/011/023/401/002
FSCA
2008/01/17
Goodwin Health Care Ltd
2408 8838
SA080147
Baxter Healthcare Home Choice Automated PD System and
Home Choice Pro Automated PD System
Health Canada
39272
Type II
2008/01/18
Baxter Healthcare Ltd
2807 8555
SA080148
Baxter Healthcare Infusor 2mL/HR
Health Canada
39388
Type II
2008/01/18
Baxter Healthcare Ltd
2807 8555
Medical Device Control Office
264
2645 8703
N/A
Department of Health
The Government of HKSAR
SA080149
BD difco Shigella antiserum poly groupb
Health Canada
39695
Type II
2008/01/18
BD
2575 8668
SA080150
BD vacutainer push button blood collection sets with pre-attached
holder (Model# 367352, 368656)
Health Canada
39405
Type II
2008/01/18
BD
2575 8668
SA080151
BD Calibrite APC Beads (Model # 340487)
Health Canada
39352
Type II
2008/01/18
BD
2575 8668
SA080152
Philips Medical Allura XPER FD20 System (S/N 297)
Health Canada
39575
Type II
2008/01/18
Philips Electronics Hong Kong Ltd.
2876 7525
SA080153
Philips Medical BV Endura and BV Pulsera (Model# MMC 2011,
MMC 2011)
Health Canada
39582
Type II
2008/01/18
Philips Electronics Hong Kong Ltd.
2876 7525
SA080154
Varian RPM Respiratory Gating System
Health Canada
39358
Type II
2008/01/18
Varian Medical Systems Pacific Inc.
2724 2836
SA080155
Roche Diagnostics Coagucheck XS PT strips 2x24, 24,6 tests
(Model#4625315017, 4625358017, 4625374190)
Health Canada
39425
Type II
2008/01/18
Roche Diagnostics (Hong Kong)
Limited
2485 7510
SA080156
Bio-Rad Amplicheck Swab CT/GC Control A positif (Model # 133,
133X)
Health Canada
39423
Type II
2008/01/18
Bio-Rad Pacific Ltd.
2789 3300
SA080157
Cardinal Health Medley Pump Module (Model 8100LVP)
Health Canada
39408
Type II
2008/01/18
N/A
N/A
SA080158
Henry Schien Mirror Defogger (Model# 1000459, 17-20902)
Health Canada
39386
Type II
2008/01/18
N/A
N/A
SA080159
M.C. Healthcare Maxxum Hi/Lo Bed
Health Canada
39652
Type II
2008/01/18
N/A
N/A
SA080160
BHM Medical 1000LB Scale, 300KG,Class 3 Scales, 800 LB
Scale, Ergolift with Scale
Health Canada
39427
Type II
2008/01/18
N/A
N/A
St. Jude Medical
N/A
Firm Initiated Field
Action
2008/01/18
St. Jude Medical
N/A
SA080161
St. Jude Medical Epic, Atlas and Convert Family of ICDs
SA080162
Smith & Nephew Universal Hip Extractors (Part No. 72200626)
MHRA
2008/001/004/061/003
FSCA
2008/01/21
Smith & Nephew Ltd.
N/A
SA080163
Philips M3170 IntelliVue Patient Link running software versions
J.00.23, J.00.24, J.00.25 and J.00.26
MHRA
2008/001/011/061/026
FSCA
2008/01/21
Philips Electronics Hong Kong Ltd.
2876 7525
MHRA
2007/012/024/601/003
FSCA
2008/01/21
Abbott Laboratories Ltd.
2806 4021
FDA
Z-0150-2008
Class II
2008/01/24
Datascope Corp Asia-Pacific
2647 9713
SA080164
SA080165
Abbott CELL-DYN 4000 and CELL-DYN Sapphire WBC Reagent
(Part A, List # 01H77-01)
Datascope Panorama Patient Monitoring Network, Panorma
Telepack 608
SA080166
Sechrist Hyperbaric Chanmber Curney
FDA
Z-0733-2008 to Z-0737-2008
Class II
2008/01/24
N/A
N/A
SA080167
Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay
Systems
MHRA
2008/001/017/291/012
FSCA
2008/01/24
Siemens Ltd.
2810 7533
SA080168
Alcon Ophthalmic Procedure Pack
MHRA
2008/001/004/061/006
FSCA
2008/01/24
Alcon Hong Kong Ltd
2568 0636
SA080169
Wescor Osmocoll SS-025, SS-038 and SS-039
MHRA
2008/001/017/291/013
FSCA
2008/01/24
N/A
N/A
SA080170
Medtronic Synchromed EL, Synchromed II and IsoMed drug
infusion pumps
Medtronic
International Ltd
N/A
Firm Initiated Field
Action
2008/01/24
Medtronic International, Ltd.
2891 4456
SA080171
ev3 IntraStent Unmounted Balloon Expandable Stents
MHRA
2008/001/011/291/003
FSCA
2008/01/28
Conmed Limited
2854 4413
SA080172
Chattanooga Electrotherapy Devices (Intelect and Vectra Series)
MHRA
2007/012/020/061/019
FSCA
2008/01/28
N/A
N/A
SA080173
Lombard Medical Aorfix Stent Grafts
MHRA
2008/001/017/291/011
FSCA
2008/01/28
N/A
N/A
SA080174
Dixons Tudor Edwards Double Rib
MHRA
2008/001/017/601/001
FSCA
2008/01/28
N/A
N/A
SA080175
Cyberonics VNS Therapy Lead Model 302
MHRA
2008/001/002/061/002
FSCA
2008/01/28
GM Medical
N/A
SA080176
BD FACS Sample Prep Assistant II instruments
MHRA
2007/010/002/061/013
FSCA
2008/01/28
BD
2575 8668
Medical Device Control Office
265
Department of Health
The Government of HKSAR
SA080177
Stryker V40 Femoral Heads
SA080178
Johnson and Johnson STERRAD Sterilizer System (50, 100S,
200 and NX Sterilizers)
MHRA
2007/012/004/061/009
SA080179
Medtronic Model 8870 N'Vision Clinican Programmer Software
Application Card
MHRA
SA080180
Biosite Triage Micro C. Difficile Panel (Catalog no 96000)
SA080181
AM2 PAT Inc Pre-Filled Heparin Lock Flush Syringes and Normal
Saline IV Flush Syringes (All Lots and All Sizes)
Medical Device Control Office
MHRA
2008/001/016/121/001
2008/01/30
Stryker China Ltd
2518 6988
FSCA
2008/01/30
Johnson & Johnson Medical Hong
Kong
2738 2818
2008/001/003/291/014
FSCA
2008/01/30
Medtronic International, Ltd.
2891 4456
MHRA
2008/001/017/291/003
FSCA
2008/01/30
N/A
N/A
FDA
N/A
Class I/Press Release
2008/01/31
N/A
N/A
266
FSCA
Department of Health
The Government of HKSAR