Major Safety Alerts in November 2009 (This page is subject to

Transcription

Major Safety Alerts in November 2009 (This page is subject to further review)
The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the summary
of October 2009 and more details will be provided when available
*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
Agent Contact
MDCO Ref. No.
Description of Product
Reference No. by Source
Alert Type by Source
Local Agent
Information*
(YYYY/MM/DD)
Telephone No.
URIT Uritest 13G urine test strips
MHRA
N.A.
MDA
2009/11/04
N.A.
N.A.
Major Safety Alerts in October 2009 (This page is subject to further review)
The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the summary
of October 2009 and more details will be provided when available
Source of
Date of Issue
Agent Contact
MDCO Ref. No.
Local Agent
Information*
(YYYY/MM/DD)
Telephone No.
Unomedical Manual Pulmonary Resuscitators
FDA
N.A.
Press Release
2009/10/06
N.A.
N.A.
Qualitest Pharmaceuticals Accusure® Insulin
Syringes
FDA
N.A.
Press Release
2009/10/29
N.A.
N.A.
Monthly Summary of Medical Device Safety Alerts - September 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Agent Contact
Telephone No
SN090901
GE Healthcare Innova 2000, 3100 and 4100
MHRA
2009/008/026/291/006
FSCA
03-Sep-09
GE Medical Systems Hong Kong Ltd.
2783 1838
SN090902
Medi-Plinth Equipment GY02E GP Gynae Examination Couch
MHRA
2009/008/026/291/019
FSCA
03-Sep-09
N.A.
N.A.
SN090903
Smiths Medical Omnifuse GB/EN with Lockable Cover (product code: 0157-0001)
MHRA
2009/008/024/291/008
FSCA
03-Sep-09
N.A.
N.A.
SN090904
AMO (Abbott Medical Optics, Inc.) WaveScan Offline Programming Module (OPM)
Software, Version 3.67
AMO Asia Limited
N.A.
Firm Initiated Field Action
03-Sep-09
AMO Asia Limited
2401 5711
SN090905
Philips Healthcare HeartStart MRx M3536A
MHRA
2009/008/024/081/013
FCSA
04-Sep-09
Philips Health Care (Great China)
2821 5226
SN090906
Stryker Transport Stretcher 737, Stryker SM104 M-Series Stretcher 1007, Stryker
Trauma Stretcher 1027, Stryker Eye Surgery Stretcher 1079
MHRA
2009/008/026/291/007
FSCA
04-Sep-09
Stryker China Ltd
2518 6915
SN090907
GE Healthcare Innova 2100IQ, 2121IQ, 3100IQ, 3131IQ and 4100IQ with GE
Fluoro UPS 20KVA
MHRA
2009/008/026/291/012
FSCA
04-Sep-09
2783 1838
SN090908
Philips Respironics Esprit Ventilator System, Model no V1000 (Product no
1001456)
FDA
Z-1813-2009
Class II
04-Sep-09
Celki Medical Company
2268 9201
SN090909
Hospira Phoenix Infusion System with MedNet Software
FDA
Z-1815-2009
Class II
04-Sep-09
Hospira Limited
2898 2886
SN090910
Stryker Reflex Hybrid Level Anterior Cervical Plate, Reflex Hybrid variable selfdrilling screw and Reflex Hybrid Variable Self-Tapping Screw
FDA
Z-1958-2009 to Z-1960-2009
Class II
04-Sep-09
Stryker China Ltd
2518 6915
SN090911
Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection
system)
FDA
Z-1934-2009
Class II
04-Sep-09
N.A.
N.A.
SN090912
Teleflex Medical Sheri-I-Bronch Endobronchial Tube Kit and Sher-I-SWIV Double
Swivel Tracheal Tube
Health Canada
50274
Type I
07-Sep-09
N.A.
N.A.
SN090913
Teleflex Medical Surgical Scissors
Health Canada
49787
Type II
07-Sep-09
N.A.
N.A.
SN090914
Stryker Pain Pimp Catheters, Infusion Sets and Pain Pump2 Kits
Health Canada
49458
Type II
07-Sep-09
Stryker China Ltd
2518 6915
SN090915
Roche CoaguChek XS Instrument (Model# 3666794) and CoaguChek XS Plus
Monitor (Model # 04800842190)
Health Canada
50168
Type II
07-Sep-09
Roche Diagnostics (Hong Kong) Ltd
2485 7510
SN090916
Toshiba Aquillion One (Model # TSX-301A/2)
Health Canada
50342
Type II
07-Sep-09
Sanko Medical Systems (HK) LTD
238400688
SN090917
Zimmer Versys Hip System Femoral Head (Model # 801802802)
Health Canada
50277
Type II
07-Sep-09
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
SN090918
Bio-Rad Laboratories Anti-Cardiolipin IGM Test Kit (Model# 425-2020)
Health Canada
50175
Type II
07-Sep-09
Bio-Rad Pacific Ltd.
N.A.
SN090919
Diagnostic Systems Laboratories (DSL) Active Cortisol Enzyme Immunoassay Kit
(Model# DSL-10-2000)
Health Canada
50075
Type II
07-Sep-09
Beckman Coulter Hong Kong Ltd
2240 6150
SN090920
Technidata TDWorkstation Working With Sebia Hyris (Model# TD-WST-01)
Health Canada
50203
Type II
07-Sep-09
N.A.
N.A.
SN090921
Accuray CyberKnife Robotic Radiosurgery System (Model#28000)
Health Canada
50252
Type II
07-Sep-09
Accuray Asia Ltd
2247 8628
SN090922
Invacare Action 3 Comfort
MHRA
2009/001/020/301/002
FSCA
07-Sep-09
Direct Health LTD
N.A.
SN090923
Invacare Birdie, Birdie Compact, Birdie Plus and Birdie Electrical Mobile Hoists
MHRA
2009/008/017/261/004
FSCA
07-Sep-09
Direct Health LTD
N.A.
Medical Device Control Office
3
Department of Health
The Government of HKSAR
SN090924
IMTEC (a 3M company) ILUMAVision software, version 2.1.0
MHRA
2009/008/020/081/001
FSCA
07-Sep-09
N.A.
N.A.
SN090925
Karma Mobility Karma 20" Self Propel Wheelchair
MHRA
2009/004/023/401/007
FSCA
08-Sep-09
N.A.
N.A.
SN090926
Siemens Immulite 2000 Androstenedione (L2KAO) kit, Immulite 2500
Androstenedione (L5KAO) kit
MHRA
2009/008/028/081/007
FSCA
07-Sep-09
Siemens Healthcare Diagnostic Limited
2810 7533
SN090927
Corin Uniglide Unicondylar Knee System, Zenith Total Ankle System and Modular
Femoral Head
MHRA
2009/008/006/081/015
FSCA
07-Sep-09
N.A.
N.A.
SN090928
Medtronic Enterra Therapy System
MHRA
2009/008/025/081/001
FSCA
07-Sep-09
Medtronic International Ltd.
2919 1362
SN090929
Trinity Biotech Multichannel Discrete Analyzer (MDA) II coiled axis tubing (Product
Number BX34138-901, BX45612568)
MHRA
2009/007/006/081/015
FSCA
07-Sep-09
N.A.
N.A.
SN090930
Medtronic Concerto CRT-D and Virtuoso ICD
Medrronic International
Ltd
N.A.
08-Sep-09
Medrronic International Ltd
2919 1362
SN090931
Conmed PRO5 and PRO6 series handpieces and MC5057 Universal cable
FDA
N.A.
Press Release
10-Sep-09
Anaheim Medical
2527 9929
SN090932
Biomet Kent Hip Twist Drills (Item No. 31-401478 & 31-401479)
MHRA
2009/008/028/081/002
FSCA
10-Sep-09
N.A.
N.A.
SN090933
BD Difco Trypsin 250 (Cat No: 215240 & 215250)
BD
N.A.
10-Sep-09
BD
2803 5320
SN090934
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-Sep-09
N.A.
N.A.
SN090935
Luv N' Care Gel Filled Teethers - Nuby, Cottontails and Playskool
FDA
Z-1878-2009
Class I
10-Sep-09
N.A.
N.A.
SN090936
Dreager Heater Elements for Resuscitaire Infant Radiant Warmers (Model #
RW82, RW82 VHA, WBR82 and WMRW82)
FDA
Z-1693-2009
Class II
10-Sep-09
N.A.
N.A.
SN090937
International Technidyne (ITC) Hemochron Jr. ACT-LR Assay (JACT-LR)
(Recall#: Z-1732-2009)
FDA
Z-1732-2009
Class II
10-Sep-09
N.A.
N.A.
SN090938
Amvex Integrated Flowmeter
FDA
Z-1724-2009
Class II
10-Sep-09
N.A.
N.A.
SN090939
CardioChek PTS panels CHOL+HDL+GLU, panel test strips
MHRA
2009/008/028/081/009
FSCA
17-Sep-09
N.A.
N.A.
SN090940
Siemens Immulite 1000 / 2000 / 2500 hsCRP (high sensitivity CRP)
MHRA
2009/009/009/291/005
FSCA
17-Sep-09
2810 7533
SN090941
Siemens Immulite 1000 Total T4, LKT4 kit
MHRA
2009/009/003/291/009
FSCA
17-Sep-09
2810 7533
SN090942
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-Sep-09
Baxter Healthcare Ltd
2807 8516
SN090943
GE Healthcare Seno Advantage 1.x, 2.0 & 2.1
MHRA
2009/009/004/291/015
FSCA
17-Sep-09
2783 1838
SN090944
IMPAC Medical Systems (Elekta) SEQUENCER for MOSAIQ
MHRA
2009/009/001/291/012
FSCA
17-Sep-09
N.A.
N.A.
SN090945
Maquet Harness Safety System for transport of CS300 Intra-Aortic Balloon Pump
MHRA
2009/009/001/291/021
FSCA
17-Sep-09
Maquet Hong Kong LTD.
2393 9511
SN090946
GE Healthcare Image Diagnost MammoWorkstation
MHRA
2009/009/004/291/016
FSCA
17-Sep-09
2783 1838
SN090947
GE Healthcare Uni-Circuit Kit, Adult, Disposable
FDA
Z-1870-2009
Class II
18-Sep-09
2783 1838
SN090948
Stryker 100ml Autofuser PainPump
FDA
Z-1823-2009 to Z-1868-2009
Class II
18-Sep-09
Stryker China Ltd
2518 6915
SN090949
Bard Access System Gauderer Genie II, Ponsky, Bard, FASTRAC
FDA
Z-2179-2009 to Z-2207-2009
Class II
18-Sep-09
N.A.
N.A.
4
SN090950
Smith & Nephew Orthopaedics PIP Fixation Hinge Kit (Ref 101638)
FDA
Z-2027-2009
Class II
18-Sep-09
Smith & Nephew LTD
9651 5523
SN090951
American Optisurgical Horizon Phacoemulsification System (Model HZN-2030)
FDA
Z-1808-2009
Class II
18-Sep-09
N.A.
N.A.
SN090952
Gyrus Acmi (Olympus) PKS SEAL Open Forceps, product codes 3103PK,
3104PK, 3105PK, 915000PK, 915005PK & 915010PK
MHRA
2009/008/019/601/002
FSCA
18-Sep-09
Olympus Hong Kong and China Ltd
2170 5678
SN090953
Boston Scientific LATITUDE communicator (model: 6468, 6476)
MHRA
2009/009/009/291/009
FSCA
18-Sep-09
Boston Scientific Hong Kong Ltd
2960 7136
SN090954
Beckman Coulter SYNCHRON Systems Phenobarbital (PHE) Reagent
MHRA
2009/009/001/601/001
FSCA
18-Sep-09
2240 6150
SN090955
Ventana Medical Systems (Roche) PATHWAY HER-2/neu (4B5) Rabbit
Monoclonal Primary Antibody
MHRA
2009/009/010/291/005
FSCA
18-Sep-09
2485 7510
SN090956
Fenwal AMICUS Separator
MHRA
2009/009/007/291/015
FSCA
18-Sep-09
N.A.
N.A.
Boston Scientific Hong
Kong Ltd
N.A.
18-Sep-09
2960 7136
SN090957
Boston Scientific Swiss LithoClast Pneumatic Probes
SN090958
Picis Anesthesia Manager (Model# 4220), PACU Manager (Model # 4245) and
Critical Care Manager
Health Canada
50507
Type II
21-Sep-09
N.A.
N.A.
SN090959
Beckman Coulter Synchron CX Immuno-Protein Calibrator (Model# 442840)
Health Canada
50657
Type II
21-Sep-09
2240 6150
SN090960
Carl Zeiss Meditec Stratus OCT Tomographer Vers. 6.0 Software (Model# Stratus
OCT, Software Version 6.0.0)
Health Canada
50625
Type II
21-Sep-09
Carl Zeiss Far East Co. Ltd
2332 0402
SN090961
Coloplast InterDry Ag (Model# 7910, lot# 1789435)
Health Canada
50228
Type II
21-Sep-09
Coloplast (HK) LTD
3628 7427
SN090962
Hurricane Medical Hydrodissector Cannulas (Model# 4027, lot# 90402)
Health Canada
50440
Type II
21-Sep-09
N.A.
N.A.
SN090963
Philips Medical HeartStart MRx, Defibrillator/Monitor (Model# M3535A, M3536A)
Health Canada
50623
Type II
21-Sep-09
2821 5226
SN090964
Immucor Galileo 500ul Syringes (Model# 64999, 65050)
Health Canada
50526
Type II
21-Sep-09
Uninet Technology LTD
2838 8423
GE Healthcare Datex Ohmeda Carestations Interface
Health Canada
47422
Type II
21-Sep-09
2783 1838
Health Canada
50601
Type II
21-Sep-09
2960 7136
SN090965
SN090966
SN090967
Boston Scientific Cobra Electrosurgical System (Model# M00448100, M00448110,
M0048400)
Philips Gyroscan Intera ACS 1.5 Tesla MR System and Intera 1.5 T MR SystemsCoils
Health Canada
50623
Type II
21-Sep-09
2821 5226
SN090968
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-Sep-09
N.A.
N.A.
SN090969
Biomimed Aquesure Disposable Filters (Lot# 042709, 042309, 042209)
Health Canada
50420
Type II
21-Sep-09
N.A.
N.A.
SN090970
Cook Sydney IVF Culture Oil (Model# K-SICO-200)
Health Canada
47702
Type II
21-Sep-09
N.A.
N.A.
SN090971
Immucor Capture-R Ready Screen (4) (Model# 0066802, 0066812, lot# K226)
Health Canada
50618
Type II
21-Sep-09
N.A.
N.A.
SN090972
The Anspach Effort Emax 2 Plus System - Foot Pedal (Model# EPLUS-FP, Lot#
SN C08301701901)
Health Canada
50456
Type II
21-Sep-09
N.A.
N.A.
SN090973
Tyco CT9000ADV
MHRA
2009/009/014/291/019
FSCA
21-Sep-09
Tyco Healthcare (HKSAR) LTD
3157 7220
SN090974
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
BrainLAB Ltd
N.A.
22-Sep-09
BrainLAB Ltd
2417 1881
SN090975
Boston Scientific Liberte Bare-Metal Coronary Stents
Kong Ltd
N.A.
23-Sep-09
2960 7136
5
SN090976
ConMed Livatec PowerPro, PowerProMax and Mpower I handpieces
MHRA
2009/008/024/081/010
FSCA
23-Sep-09
N.A.
N.A.
SN090977
ConMed Linvatec Universal Cable (3.6 metres / 12 feet)
MHRA
2009/008/024/081/009
FSCA
23-Sep-09
N.A.
N.A.
SN090978
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-Sep-09
N.A.
N.A.
SN090979
Boston Scientific CircuCool Fluid Circulation Pump
Kong Ltd
N.A.
23-Sep-09
2960 7136
SN090980
Wright Medical CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH. (Ref 38AM3604, 38AM-3635)
FDA
Z-1715-2009 to Z-1716-2009
Class II
24-Sep-09
N.A.
N.A.
SN090981
Med Tec Foot Lok Cushion (Part no. MTAFS01)
FDA
Z-1721-2009
Class II
24-Sep-09
N.A.
N.A.
SN090982
Varian VARiS LINK
MHRA
2009/009/011/291/003
FSCA
24-Sep-09
Varian Medical Systems Pacific Inc.
2724 2836
SN090983
Mölnlycke ProcedurePak (Lap Chole Pack)
MHRA
2009/009/015/291/010
FSCA
24-Sep-09
N.A.
N.A.
SN090984
Arcoma OrbixTop, ArcoSphere
MHRA
2009/009/015/291/003
FSCA
24-Sep-09
N.A.
N.A.
SN090985
Zimmer Magna -FX Cannulated Screw Fixation
Zimmer PTE Ltd (Hong
Kong branch)
N.A.
24-Sep-09
2992 0968
SN090986
Penumbra Neuron Delivery Catheter 070
Synapse Therapeutics
Limited
N.A.
24-Sep-09
Synapse Therapeutics Limited
9106 1836
SN090987
BD Probetec ET CT/GC Endocervical Speciment Collection and Dry Transport
System-Pink (Cat no. 440476)
BD
N.A.
24-Sep-09
BD
2575 8668
SN090988
Draeger Medical Sola 500, Sola 500 Mobil, Sola 700 and Stella
MHRA
2009/006/017/291/019
FSCA
25-Sep-09
Draeger Medical Hong Kong Ltd
28773077
SN090989
Mölnlycke ProcedurePak (Lap Chole Pack)
MHRA
2009/009/021/081/012
FSCA
25-Sep-09
N.A.
N.A.
SN090990
Phadia Varelisa U1RNP Antibodies, 17096
MHRA
2009/008/007/081/016
FSCA
29-Sep-09
Science International Corporation
2543 7442
Philips Electronic Hong
Kong Ltd
SN090991
Philips HeartStart FR2 M3860A/M3861A, M3840A/M3841A
N.A.
29-Sep-09
Philips Electronic Hong Kong Ltd
2821 5364
SN090992
Immucor Echo Blood Grouping Analyser
MHRA
2009/009/022/081/019
FSCA
30-Sep-09
2838 8423
SN090993
Sigma-Aldrich Histopaque 1077-1 reagent
MHRA
2009/009/021/081/010
FSCA
30-Sep-09
Sigma-Aldrich China Inc.
N.A.
SN090994
Trinity Biotech MDA Auto Dimer (Product code: T3103)
MHRA
2009/009/023/081/015
FSCA
30-Sep-09
N.A.
N.A.
SN090995
BD BBL Lactophenol Cotton Blue Stain Droppers (Cat no 26118)
BD
N.A.
30-Sep-09
BD
2575 8668
Kong Ltd
N.A.
30-Sep-09
2960 7136
SN090996
Boston Scientific Equalizer Occlusion Balloon Catheter
6
Monthly Summary of Medical Device Safety Alerts - August 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Boston Scientific Guidant Contak Renewal 3 CRT-D, 3HE CRT-D,
SN090801 4CRT-D, 4HE CRT-D, 4AVT CRT-D, 4AVT HE CRT-D and Vitality
Z-1620-2009 to Z-1621-2009
Class II
2009/08/03
FDA
DS VR
Philips TumorLoc software application (software versions: 23.1.1,
SN090802 20.7.13 and 20.8.15) and TumorLoc Software Application for the
Z-1578-2009 to Z-1580-2009
Class II
2009/08/03
FDA
EBW
Stryker Triathlon Revision Instruments (1,2,7,8 TGC Upper Tray and
SN090803
Z-1618-2009 to Z-1619-2009
Class II
2009/08/03
Stryker China Ltd
FDA
3-6 TGC Upper Tray)
Agent Contact
Telephone No
2960 7136
2821 5480
2518 6915
SN090804
Stryker Amico E-Cylinder Canister Holder (Catalog/Product Number:
0682-001-111 & 0682-000-449)
FDA
Z-1569-2009
Class II
2009/08/03
Stryker China Ltd
2518 6915
SN090805
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.
SN090806
Steris ACS2000 Ambulatory Surgical Table (Model # MTS110003)
FDA
Z-1597-2009
Class II
2009/08/03
Swedish Trading Co., Ltd
N.A.
SN090807
XoranConnect Software version 4.1.0.6
FDA
Z-1577-2009
Class II
2009/08/03
N.A.
N.A.
SN090808
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
SN090809
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.
SN090810
Barrington Healthcare (supplied by Hill-Rom) Thermo contour
mattress for hospital beds
MHRA
MDA/2009/051
MDA
2009/08/04
N.A.
N.A.
SN090811
Siemens Diagnostic Ultrasound System Acuson S2000 (software
VA10A, VA10B, VA10C, VA15 & VA15A)
MHRA
2009/007/008/291/002
FSCA
2009/08/04
2810 7533
SN090812
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.
SN090813
Invacare REA Assist wheelchairs
MHRA
2009/001/020/401/015
FSCA
2009/08/04
N.A.
N.A.
SN090814
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.
SN090815
BD Beaver Optimum Blade, 15 Straight
BD
N.A.
2009/08/04
BD
3575 8668
SN090816
Newdeal Large Qwix Measurer (Ref./Cat. no. 119150)
MHRA
2009/007/029/081/006
FSCA
2009/08/05
N.A.
N.A.
SN090817
Minerva Dental Silverfil
MHRA
2009/004/029/061/012
FSCA
2009/08/05
N.A.
N.A.
SN090818
Roche Diagnostics Lightcycler Capillaries (100μL, M-Grade, ID/Cat
No. 03612066001)
MHRA
2009/007/009/081/002
FSCA
2009/08/05
2485 7510
SN090819
ThermoFisher PO0794A Brilliance U.T.I. Medium
MHRA
2009/007/024/601/001
FSCA
2009/08/05
N.A.
N.A.
SN090820
Siemens Immulite 2000 & 2500 AlaTOP Allergy Screen (Cat.No.
L2KAT2 & L5KAT2 resp.)
MHRA
2009/007/021/081/002
FSCA
2009/08/05
2810 7533
SN090821
Beckman Coulter Tube Assembly #142, V2, V12 Wash
MHRA
2009/007/030/601/003
FSCA
2009/08/05
2240 6150
SN090822
Cardinal Health Alaris System
FDA
N.A.
Press Release
2009/08/05
N.A.
N.A.
SN090823
GE Datex-Ohmeda ADU Carestation, Datex-Ohmeda AS/3
Anesthesia Delivery Unit and Datex-Ohmeda S/5 Anesthesia
Delivery Unit
FDA
Z-1633-2009 to Z-1635-2009
Class II
2009/08/06
2783 1838
7
SN090824
Abbott StarClose Vascular Closure System (Part no 14677-01)
FDA
Z-1657-2009
Class II
2009/08/06
Abbott Laboratories LTD.
2593 2211
SN090825
Philips IntelliVue Clinical Information Portfolio Software Version D.0
FDA
Z-1654-2009
Class II
2009/08/06
2821 5480
SN090826
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
N.A.
N.A.
SN090827
Siemens Somatom Definition Model AS/AS+ (Model no. 8098027)
FDA
Z-1675-2009
Class II
2009/08/06
2810 7533
FDA
Z-1650-2009
Class II
2009/08/06
2810 7533
FDA
Z-1655-2009
Class II
2009/08/06
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
2009/08/06
2960 7136
SN090828
SN090829
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)
SN090830
Boston Scientific HTA Procedure Set
SN090831
Dynex Technologies DS2 automated microplate processing system
MHRA
MDA/2009/052
MDA
2009/08/06
N.A.
N.A.
SN090832
GE AdvantageSim MD versions 7.4 through 7.6 inclusive
MHRA
2009/004/016/061/001
FSCA
2009/08/06
2783 1838
SN090833
Penumbra Separator for Neuron Intracranial Access System
PSS032 and PSS041
MHRA
2009/007/031/081/003
FSCA
2009/08/06
N.A.
N.A.
SN090834
Accuray Cyberknife Robotic Radiosurgery System (Systems SN#128
and higher with 2005 Edition Robot Controller)
SN090835
Boston Scientific Neurovascular Spinnaker Elite Flow Directed
Microcatheter
SN090836
SN090837
MHRA
2009/007/028/081/004
FSCA
2009/08/06
Accuray Asia Ltd
2247 8628
Boston Scientific
Hong Kong Ltd
N.A.
2009/08/07
2960 7136
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
2724 2836
Beckman Coulter Synchron Rheumatoid Factor (RF) Reagent
(Model/Catalog # 475136)
Health Canada
49912
Type II
2009/08/10
2240 6150
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
Philips PCR AC-500/PCR AC-5000 Basic System (model/catalog#
MCR1511)
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
Health Canada
46769
Type II
2009/08/10
2821 5480
SN090841
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
2821 5480
SN090842
GE AW Volumeshare -CT Perfusion 4 (Model # 5189396)
Health Canada
48164
Type II
2009/08/10
2783 1838
SN090843
GE CIC Pro Clinical Information Centre
Health Canada
46547
Type II
2009/08/10
2783 1838
SN090844
Cardinal Health Bypass TGH Kit and Valve TGH Kit
Health Canada
49952
Type II
2009/08/10
N.A.
N.A.
SN090845
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.
SN090838
SN090839
SN090840
SN090846
SN090847
Trinity Biotech Trinclot APTT HS (Product Code: T1204, Lot no
R324001)
Arrow (Teleflex Medical) Central Venous Catheterization Set (Model
# CS-12123-E, CS-15123-E) and Central Venous Catheter (Model #
MC-12123, MC-15123)
8
SN090848
SN090849
Posey Soft Belt With Crotch Strap (Model# 4125C) and Breezeline
Pelvi Holder (Model#4411)
Kuschall K-Junior Manual Wheelchair (Model # K-Junior, Lot#
806135534)
Health Canada
49840
Type II
2009/08/10
N.A.
N.A.
Health Canada
49293
Type II
2009/08/10
N.A.
N.A.
SN090850
Breg Kodiak Power Supply (Lot # 3508, 3908, 4308, 4808)
Health Canada
49511
Type II
2009/08/10
N.A.
N.A.
SN090851
Immucor Fetal Bleed Screening Test (Model # 7892, Lot # 17411)
Health Canada
49726
Type II
2009/08/10
2838 8423
SN090852
Smith & Nephew Disposable Blade
Smith & Nephew LTD
N.A.
2009/08/10
Smith & Nephew LTD
9651 5523
SN090853
Boston Scientific Wiseguide Guide Catheter, Impulse Angiographic
(Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter
Boston Scientific
Hong Kong Ltd
N.A.
2009/08/10
2960 7136
SN090854
Aesculap Targon PFT Depth Stop KH535R for Drill KH536R
MHRA
2009/008/004/081/015
FSCA
2009/08/10
N.A.
N.A.
SN090855
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.
SN090856
Immucor Gamma Benelux Gamma ELU-KIT II Buffering Solution
MHRA
2009/007/030/081/002
FSCA
2009/08/10
2838 8423
SN090857
Wyeth ReFacto AF
MHRA
2009/006/002/081/001
FSCA
2009/08/10
N.A.
N.A.
MHRA
2009/007/030/601/004
FSCA
2009/08/10
2593 2211
MHRA
2009/008/003/291/016
FSCA
2009/08/11
N.A.
N.A.
SN090858
SN090859
Abbott ARCHITECT i2000 & i2000SR Analyser (List numbers 8C89,
1G17 & 3M74)
Teleflex Medical Multifit Nebulizer and Multifit Nebulizer with BOC
Adapter (Cat.No.922800 & 922820)
SN090860
GE Ventri
MHRA
2009/008/011/291/005
FSCA
2009/08/13
2783 1838
SN090861
Toshiba Multi-plane transoesophageal transducer, model PET511BTM
MHRA
2008/012/003/291/010
FSCA
2009/08/13
238400688
SN090862
Stryker Accolade TMZF Hip Stem
FDA
Z-1354-2009 to Z-1684-2009
Class II
2009/08/14
Stryker China Ltd
2518 6915
SN090863
Stryker Offset Adaptor Trial 2MM, 4MM, 6MM and 8MM
FDA
Z-1607-2009 to Z-1610-2009
Class II
2009/08/14
Stryker China Ltd
2518 6915
SN090864
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
2992 0968
SN090865
Medtronic INTREPID Spinal System and Coverplate
FDA
Z-1796-2009 to Z-1802-2009
Class II
2009/08/14
Medronic International Ltd
2919 1300
SN090866
Steris Cmax 110v Surgical Table Hand Control
FDA
Z-1599-2009
Class II
2009/08/14
N.A.
SN090867
Raytec Yan X-Ray Detectable Gauze
HA
N.A.
N.A.
2009/08/14
Winner Medical (Hong Kong) Ltd
3170 7000
SN090868
Roche Diagnostics cobas e 411
MHRA
2009/008/005/081/010
FSCA
2009/08/17
2485 7510
SN090869
Stryker MIS Diamond Burs
MHRA
2009/008/010/291/001
FSCA
2009/08/17
Stryker China Ltd
2518 6915
SN090870
ConMed Linvatec UltraPower Diamond Wheel Burs
MHRA
2009/008/011/291/001
FSCA
2009/08/17
ConMed Limited
N.A.
SN090871
Linet Eleganza 3 and Latera bedframes
MHRA
2009/007/020/601/004
FSCA
2009/08/17
N.A.
N.A.
SN090872
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.
MHRA
2009/008/007/081/015
FSCA
2009/08/17
2992 0968
MHRA
2009/008/006/081/004
FSCA
2009/08/17
N.A.
SN090873
SN090874
Zimmer Various targeting components for the Zimmer Natural Nail
Aesculap NN340 Columbus RP Gliding Surface T4/4+ 10mm (lot
51405551)
NN222 Columbus DD Tibial Insert SZ 2/2+ 14mm (lot 51400343)
9
SN090875
Stryker Scorpio femoral components (Cat.No. 70-3007R, 80-4405L,
80-4407R)
MHRA
2009/007/029/081/004
FSCA
2009/08/17
Stryker China Ltd
2518 6915
Medtronic
International Ltd.
N.A.
2009/08/17
2919 1362
SN090876
Medtronic LIFEPAK 15 Defibrillator/Monitor
SN090877
Invacare REA Azalea base
MHRA
2009/001/007/401/001
FSCA
2009/08/19
Direct Health LTD
N.A.
SN090878
Hospira AC Power Cords
FDA
N.A.
Press Release
2009/08/20
Hospira Limited
2898 2886
SN090879
Stryker Trident Hemispherical Acetabular Shell (Part no 508-11-72J)
FDA
Z-1685-2009
Class II
2009/08/20
Stryker China Ltd
2518 6915
SN090880
Boston Scientific EndoVive Safety PEG Kit and Standard PEG Kit
FDA
Z-1625-2009 to Z-1632-2009
Class II
2009/08/20
2960 7136
SN090881
Arjo Huntleigh Passive Clip Slings and Flite Clip Slings
FDA
Z-1636-2009 to Z-1637-2009
Class II
2009/08/20
Arjo Huntleigh (Hong Kong) Ltd.
2508 1416
SN090882
Johnson & Johnson Spine Expedium SFX Cross Connector System
Torque Driver Shaft (REF: 2894-10-300)
FDA
Z-1670-2009
Class II
2009/08/20
Johnson & Johnson Medical (HK)
2738 6027
SN090883
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
2810 7533
SN090884
Zimmer ITST Intertorchanteric/Subtrochanteric fixation tapered
reamer (REF 2258-50-00)
FDA
Z-1701-2009 to Z-1702-2009
Class II
2009/08/20
2992 0968
SN090885
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
SN090886
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.
SN090887
Arrow Large-Bore Central Venous Catheters
FDA
Z-1671-2009 to Z-1672-2009
Class II
2009/08/20
N.A.
N.A.
SN090888
TomoTherapy Hi-Art system
MHRA
2009/008/013/081/025
FSCA
2009/08/20
N.A.
N.A.
SN090889
Teleflex Medical Sher-I-Swiv, Sher-I-Bronch
MHRA
2009/008/013/081/024
FSCA
2009/08/20
N.A.
N.A.
SN090890
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.
SN090891
ConMed Linvatec Lightwave Suction Ablator
MHRA
2009/008/010/291/012
FSCA
2009/08/20
ConMed Ltd
N.A.
SN090892
Gyrus Acmi (Olympus) PlasmaKinetic SuperSect / PK SuperSect
Instrument
MHRA
2009/007/013/601/001
FSCA
2009/08/20
2170 5678
SN090893
Maquet Servo 300 ventilator (SV300)
MHRA
MDA/2009/056
MDA
2009/08/20
N.A.
N.A.
SN090894
Pride Riser Recliner
MHRA
2008/006/024/401/014
FSCA
2009/08/21
N.A.
N.A.
SN090895
ConMed Linvatec Arthro-Knife Sheathed Knife
MHRA
2009/008/012/291/012
FSCA
2009/08/21
N.A.
N.A.
SN090896
Spacelabs Healthcare ECG cable with integrated leadwires (PNs:
700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25)
MHRA
2009/008/004/291/002
FSCA
2009/08/21
N.A.
N.A.
SN090897
GE N-DISVENT-02
MHRA
2009/008/011/601/003
FSCA
2009/08/21
2783 1838
SN090898
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.
2009/08/21
BrainLAB Ltd
2417 1881
SN090899
GE Instatrak 3500 System (Model # 1006236-001)
Health Canada
49926
Type II
2009/08/24
2783 1838
10
SN0908100 GE Compax 40E Table (Model # 2208203, 2225864, 2225881)
Health Canada
49649
Type II
2009/08/24
2783 1838
GE Innova 4100 IQ - Main Unit (Model # 2335129) & Innova 2000
SN0908101
Cardiovascular System (Model no S1872LC)
Health Canada
50099
Type II
2009/08/24
2783 1838
GE Innova 4100 IQ - Main Unit (Model # 2335129) & Innova 2000
SN0908102
Cardiovascular System (Model no S1872LC)
Health Canada
49983
Type II
2009/08/24
2783 1838
SN0908103 GE Reusable Metal Needle Guides & Bushings
Health Canada
48986
Type I
2009/08/24
2783 1838
Health Canada
50100
Type II
2009/08/24
Stryker China Ltd
2518 6915
Health Canada
49969
Type II
2009/08/24
Smith & Nephew LTD
2648 7700
SN0908106 Siemens Easylink Informatics System (Model# 100034941)
Health Canada
49974
Type II
2009/08/24
2810 7533
SN0908107 Welch Allyn Vital-Signs Monitor
Health Canada
49917
Type II
2009/08/24
N.A.
N.A.
SN0908108 Vascular Solutions Twin-Pass Access Catheter (Model# 5200)
Health Canada
Celki Medical
Company
49872
Type I
2009/08/24
N.A.
N.A.
N.A.
2009/08/24
2268 9201
o Healthcare (HKSAR)
N.A.
2009/08/24
3157 7220
SN0908111 Gebrüder MARTIN Acrobat 2000 Spring Arm
MHRA
2009/008/017/081/011
FSCA
2009/08/24
N.A.
N.A.
SN0908112 Cellestis QuantiFERON-TB Gold TB-Antigen Tubes
MHRA
2009/008/017/081/021
FSCA
2009/08/24
N.A.
N.A.
SN0908113 One Lambda HLA B27 FITC Conjugated Monoclonal Antibody
MHRA
2009/008/014/081/012
FSCA
2009/08/24
N.A.
N.A.
SN0908114 Trinity Biotech Auto D Dimer Kit (Product Number CRS126B)
MHRA
2009/008/017/081/026
FSCA
2009/08/24
N.A.
N.A.
SN0908115 Arjo Maxi Move Scoop Stretcher (model # KRA2210-20)
MHRA
2009/007/022/291/009
FSCA
2009/08/24
2508 1416
Stryker (Howmedica Osteonics) Delta Ceramic Ball Heads (Model #
18-3200)
Smith & Nephew 4.0mm Direct Measuring Gauge (Model #
SN0908105
71117083)
SN0908104
SN0908109 Philips Respironics M Series Humidifier
SN0908110 Tyco (Nellcor, Puritan Bennett) PediCap End-Tidal CO2 Detectors
SN0908116 Össur Hiptric Frame (Item # 980121, 980122, 980123)
MHRA
2009/007/029/401/003
FSCA
2009/08/24
N.A.
N.A.
SN0908117 Össur Total Knee Junior (Serial numbers: 8573-8792)
MHRA
2009/007/022/301/001
FSCA
2009/08/24
N.A.
N.A.
BD
N.A.
2009/08/25
BD
2575 8668
Medtronic
International Ltd.
N.A.
2009/08/25
2919 1362
MHRA
2009/008/019/081/011
FSCA
2009/08/26
N.A.
N.A.
FDA
Z-1590-2009 to Z-1595-2009
Class II
2009/08/27
2485 7510
FDA
Z-1713-2009 to Z-1714-2009
Class II
2009/08/27
N.A.
N.A.
FDA
Z-1730-2009
Class II
2009/08/27
2783 1838
FDA
Z-1731-2009
Class II
2009/08/27
2810 7533
FDA
Z-1694-2009
Class II
2009/08/27
N.A.
N.A.
SN0908118
BD CLAY ADAMS Dynac III Centrifuge 120V (Cat/Model no.:
420104)
SN0908119 Medtronic LIFEPAK CR Plus Defibrillator
SN0908120
Ortho-Clinical Diagnostics Veridex LLC CellSearch Circulating
Tumor Cell (CTC) Kit (product code 7900001)
Roche ACCU-Chek Softclix Lancing Device, Active Meter Kit,
SN0908121 Voicemate Meter, Aviva Meter Kit, Compact Plus Meter Kit and
Coaguchex XS Systems for Patient Self-testing
SJM (St. Jude Medical) Peel Away Introducer (REF 405116,
SN0908122
405153)
SN0908123 GE Drapes and Sterile Covers
Siemens Dimension Cardiac Tropnin I Flex Reagent cartridge
SN0908124
(CTNI)
SN0908125 X Spine Systems Capless Li Pedicle Screw System
11
Source Production & Equipment M-19 (Iridium 192): Brachytherapy
SN0908126
source
SN0908127 Suarez Foot Choice Therapeutic Foot Massager (Model no YS-322)
Johnson & Johnson STERRAD CYCLESURE and CYCLESURE 24
SN0908128
Biological Indicator(s)
FDA
Z-1717-2009
Class II
2009/08/27
N.A.
N.A.
FDA
Johnson & Johnson
Medical (HK)
Z-1697-2009
Class II
2009/08/27
N.A.
N.A.
N.A.
2009/08/27
2738 6027
Medtronic Sutureless Connector (SC) Intrathecal Catheters Cot
SN0908129
Compatible with IsoMed Constant - Flow Infusion Pumps
Smith Medical Portex Tracheal Tube and Portex Paediatric Tracheal
SN0908130
Tube
SN0908131 Biomerica EZ PSA and Fortel PSA (Part number 1081)
Medtronic
International Ltd.
N.A.
2009/08/28
2919 1362
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
SN0908132
Renegade Hi-Flo Microcatheter
Boston Scientific Renegade Fiber Braided Microcatheters,
SN0908133 Renegade Hi-Flo Microcatheter and Renegade Hi-Flo Microcatheter
Kits
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
N.A.
2009/08/31
2960 7136
N.A.
2009/08/31
2960 7136
N.A.
2009/08/31
2960 7136
SN0908134 Boston Scientific Contour SE Microspheres
Boston Scientific
Hong Kong Ltd
12
Monthly Summary of Medical Device Safety Alerts - July 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Siemens E.CAM Patient Handling System (PHS) Field of View
SN090701
Z-1505-2009
Class II
2009/07/02 Siemens Healthcare Diagnostic Limited
FDA
(FOV) indicator bars (Part no 43 66 618 and 43 81 088)
Agent Contact
Telephone No
2810 7533
SN090702
Arrow Embolectomy Catheters
FDA
Z-1471-2009 to Z-1473-2009
Class II
2009/07/02
Cemma Enterprise Co., Ltd
2412 2310
SN090703
Inverness Medical BioSrar Strep A OIA MAX (Product Code 90003)
FDA
Z-1506-2009
Class II
2009/07/02
N.A.
N.A.
SN090704
Edwards LifeSciences BM25
MHRA
2009/006/018/081/010
FSCA
2009/07/02
N.A.
N.A.
SN090705
GE CT Perfusion 4
MHRA
2009/003/019/061/005
FSCA
2009/07/02
2783 1838
SN090706
Cardinal Health Alaris GP volumetric pump and Alaris GP Guardrails
volumetric pump
MHRA
2009/006/017/291/018
FSCA
2009/07/02
Cardinal Health
N.A.
Bausch & Lomb
(Hong Kong ) Ltd
N.A.
2009/07/02
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
SN090707
Bausch & Lomb Boston Conditioning Solution Original Formula
SN090708
Agfa NX software
MHRA
2009/006/029/081/013
FSCA
2009/07/06
AGFA Hong Kong Limited
2555 9421
SN090709
Edwards Lifesciences Fogarty Occlusion Catheter
MHRA
2009/006/026/081/006
FSCA
2009/07/06
N.A.
N.A.
SN090710
GE Signa Excite 1.5T MR systems
MHRA
2009/006/024/291/013
FSCA
2009/07/06
2783 1838
SN090711
Likoscale Adaptor
MHRA
2009/006/022/301/001
FSCA
2009/07/06
Solutions Health Care Products
2688 2933
SN090712
Karomed COMM-METAL Supreme Profiling Bed
MHRA
2009/001/028/301/003
FSCA
2009/07/06
N.A.
N.A.
SN090713
Sidhil Bradshaw Bariatric Bed
MHRA
2009/006/016/261/001
FSCA
2009/07/06
N.A.
N.A.
SN090714
Wescott Medical Sae-Flo
MHRA
2009/004/014/401/004
FSCA
2009/07/06
N.A.
N.A.
SN090715
Philips Dental Application v4.0.0 to v4.0.1.9999 on the Extended
Brilliance Workspace
MHRA
2009/006/010/291/008
FSCA
2009/07/06
2821 5480
SN090716
Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion
Pump Battery Performance
Medtronic
International Ltd.
N.A.
2009/07/06
2919 1362
SN090717
Philips Intellivue MP70 Patient Monitor System (Model # M8007A)
Health Canada
48839
Type II
2009/07/07
2821 5480
SN090718
Philips Mulitdiagnost Eleva-Flat Detector and Allura XPER FD10/10Main Unit
Health Canada
48595
Type II
2009/07/07
2821 5480
SN090719
Philips Achieve 3.0T MRI System-Main Unit and Achieva 1.5T MRI
System-Main Unit
Health Canada
49149
Type II
2009/07/07
2821 5480
SN090720
Philips Brilliance 6/10/16 Slice CT-SERTWR Dent
Health Canada
49151
Type II
2009/07/07
2821 5480
SN090721
Zimmer ZMR Hip System-Stems
Health Canada
48913
Type II
2009/07/07
2992 0968
SN090722
Zimmer Alumina Ceramic Femoral Head
Health Canada
48988
Type II
2009/07/07
2992 0968
SN090723
Zimmer 2.7mm Cortical Screw Self-Tapping
Health Canada
48914
Type II
2009/07/07
2992 0968
SN090724
Smith & Nephew Disposable Endoscopic Surgery Blades
Health Canada
48408
Type II
2009/07/07
Smith & Nephew LTD
2992 0968
13
SN090725
GE Muse Cardiology Information System
Health Canada
46833
Type II
2009/07/07
2783 1838
SN090726
GE Carescape V100
Health Canada
46236
Type II
2009/07/07
2783 1838
SN090727
Varian Aria Radiation Oncology
Health Canada
49074
Type II
2009/07/07
2724 2836
SN090728
Getinge Washer Disinfectors with transformer
Health Canada
48035
Type II
2009/07/07
N.A.
N.A.
SN090729
Data Innovations Instrument Manager
Health Canada
48997
Type II
2009/07/07
N.A.
N.A.
SN090730
Picis OR Manager, Preop Manager, Anesthesia Manager, PACU
Manager, Critical Care Manager
Health Canada
48937
Type II
2009/07/07
N.A.
N.A.
SN090731
Boston Scientific Flexima Biliary Catheter System
Boston Scientific
Hong Kong Ltd
N.A.
2009/07/08
2960 7136
SN090732
Respironics BiPAP Focus Noninvasive Ventilator System
FDA
Z-1606-2009
Class I
2009/07/09
2268 9258
SN090733
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate
(Model no. 6420-00-002, 6420-01-002, 6420-00-200, 6420-01-200)
FDA
Z-1482-2009 to Z-1485-2009
Class II
2009/07/09
2992 0968
SN090734
Zimmer Steinmann Pins (Model no. 00-0187-03-69)
FDA
Z-1481-2009
Class II
2009/07/09
2992 0968
SN090735
Zimmer Gender Solutions Natural Knee Flex System (Product No.
00-5410-017-01)
FDA
Z-1477-2009
Class II
2009/07/09
2992 0968
SN090736
Philips Brilliance iCT software v2.5.0 (Model 728306)
FDA
Z-1582-2009
Class II
2009/07/09
2821 5480
SN090737
GE Centricity PACS Software
FDA
Z-1549-2009
Class II
2009/07/09
2783 1838
SN090738
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System;
Innova 3100/3100IQ Cardiovascular Imaging System and Innova
4100/4100IQ Cardiovascular Imaging System
FDA
Z-1474-2009 to Z-1476-2009
Class II
2009/07/09
2783 1838
SN090739
Stryker Xia Dual Anterior Staple (Catalog no. 03820115)
FDA
Z-1525-2009
Class II
2009/07/09
Stryker China Ltd
2518 6915
SN090740
Biomet OSS FINN Proximal Femoral Trial, OSS Letson Proximal
Femoral Trial, OSS Elliptical Proximal Femoral Tral
FDA
Z-1526-2009 to Z-1531-2009
Class II
2009/07/09
N.A.
N.A.
SN090741
Bard StartLock Intravenous (IV) Catheter Stabilization Kit (Catalog
no IVK0124)
FDA
Z-1539-2009
Class II
2009/07/09
N.A.
N.A.
SN090742
Arrow various devices
FDA
Z-1489-2009 to Z-1503-2009
Class II
2009/07/09
N.A.
N.A.
SN090743
Ascension Normed TX8 Driver (Catalog no 503004268)
FDA
Z-1524-2009
Class II
2009/07/09
N.A.
N.A.
FDA
Z-1247-2009
Class II
2009/07/09
N.A.
N.A.
BD
N.A.
2009/07/09
BD
2575 8668
SN090744
SN090745
SN090746
SN090747
SN090748
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
MHRA
MDA/2009/043
MDA
2009/07/10
2960 7136
Medtronic
International Ltd.
N.A.
2009/07/10
2919 1362
Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT397, MMT-398 and MMT-399
Medtronic
International Ltd.
N.A.
2009/07/10
2919 1362
14
Boston Scientific
Hong Kong Ltd
N.A.
2009/07/10
2960 7136
Zimmer Intertrochanteric / Subtrochanteric Fixation Tapered Reamer
00-2258-050-00
MHRA
2009/006/008/291/011
FSCA
2009/07/13
2992 0968
SN090751
Smith & Nephew Disposable Impactor Cap 74120152 for use with
BHR Acetabular Cups
MHRA
2009/006/019/601/002
FSCA
2009/07/13
Smith & Nephew LTD
2648 7700
SN090752
Aidapt VB539 Solo Deluxe Shower Seat and VB535 Solo Deluxe
Shower Seat with Pads
MHRA
2009/006/029/261/001
FSCA
2009/07/13
N.A.
N.A.
SN090753
Unipath Clearview hCG Pregnancy Test 506788
MHRA
2009/005/011/291/018
FSCA
2009/07/13
N.A.
N.A.
SN090754
Zimmer Dynesys Top Loading Spacer Cutter
MHRA
2009/006/018/291/006
FSCA
2009/07/13
2992 0968
SN090755
Microm (a part of ThermoFisher Scientific) STP 420D Tissue
Processor
MHRA
2009/006/023/291/002
FSCA
2009/07/13
N.A.
N.A.
SN090756
Biodiagnostics MPO QuickCard
MHRA
2009/006/023/601/001
FSCA
2009/07/13
N.A.
N.A.
SN090757
Nopac Healthcare Chelmer 200
MHRA
2009/006/002/301/001
FSCA
2009/07/14
N.A.
N.A.
SN090758
Siemens Stratus CS Acute Care Troponin I CalPak.
FDA
Z-1246-2009
Class II
2009/07/20
2810 7533
SN090759
Genicon Suction irrigation device (Cat no. 700-005-010, 700-010005)
FDA
Z-1406-2009 to Z-1407-2009
Class II
2009/07/20
N.A.
N.A.
SN090760
Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling
Tube Mount (DTCM)
FDA
Z-1247-2009
Class II
2009/07/20
N.A.
N.A.
SN090761
RSW International First Steps medicine feeder
MHRA
MDA/2009/045
MDA
2009/07/21
N.A.
N.A.
SN090762
Vital Signs Broselow / Hinkle Pediatric Emergency System
Intraosseus Modules
MHRA
2009/007/006/081/012
FSCA
2009/07/21
N.A.
N.A.
SN090763
Aqua Joy Premier Plus and Junior Plus bathlifts
MHRA
2008/005/007/401/005
FSCA
2009/07/21
N.A.
N.A.
SN090764
Zimmer Nexgen Rotating Hinge Knee-Femoral Component and
Nexgen Rotating Hinge Knee-Tibial Component
Health Canada
49105
Type II
2009/07/22
2992 0968
SN090765
Baxter Isolex 300 and 300I Magnetic Cell Separator
Health Canada
48344
Type II
2009/07/22
2807 8516
SN090766
Abbott Stat G3+ Cartridges (Model no.: 06F03-01 and 06F03-02;
Lot: P08321C)
Health Canada
48497
Type II
2009/07/22
2593 2211
SN090767
Brainlab M3 Micro-MLC for Varian with MLC (Model: 41600-3,
41600-5, 41600-6)
Health Canada
47235
Type II
2009/07/22
BrainLAB Ltd
2417 1881
SN090768
Litecure LCT-1000 Therapy Laser
Health Canada
49192
Type II
2009/07/22
N.A.
N.A.
SN090769
Nobel Biocare Impression Coping Closed Tray Regular Platform
05x9mm (Lot 687218)
Health Canada
48621
Type II
2009/07/22
Nobel Biocare Asia Ltd
2845 1266
SN090770
Hill-Rom Flexicair (Model I3000, M4000)
Health Canada
49146
Type II
2009/07/22
N.A.
N.A.
SN090771
Wallac Delfia Xpress PAPP-A Kit (Model no. 6003-0020)
Health Canada
48607
Type II
2009/07/22
N.A.
N.A.
SN090749
Boston Scientific LeVeen Needle Electrodes - 5.0cm
SN090750
15
SN090772
Gyrus Acmi (Olympus) Sur-Catch No Tip Nitinol Stone Basket
(Model no. 5711222)
SN090773
Health Canada
49030
Type II
2009/07/22
2170 5678
Vygon Neonatal / Paediatric 96 hour I.V. Filter 0807.204
MHRA
2009/007/010/601/002
FSCA
2009/07/22
N.A.
N.A.
SN090774
Penumbra Neuron Delivery Catheter 053
MHRA
2009/007/010/081/010
FSCA
2009/07/22
N.A.
N.A.
SN090775
Elekta Desktop Pro
MHRA
2009/003/010/291/010
FSCA
2009/07/22
N.A.
N.A.
SN090776
Bemis Quick Fit 3000cc Suction Liner
MHRA
2009/006/019/601/003
FSCA
2009/07/22
N.A.
N.A.
SN090777
Medos Medizintechnik Hilite Oxygenators (models 7000, 7000LT,
2800, 2400LT, 1000 & 800LT)
MHRA
2009/006/025/081/008
FSCA
2009/07/22
N.A.
N.A.
SN090778
Siemens Stratus CS Acute Care Troponin I CalPak
FDA
Z-1555-2009
Class II
2009/07/23
2810 7533
SN090779
Medtronic One Source Pack, One Source Pack Magellan and Ideal
MAXPAC Total System
FDA
Z-1550-2009 to Z-1552-2009
Class II
2009/07/23
Medtronic Internation Ltd
2919 1362
FDA
Z-1543-2009
Class II
2009/07/23
2783 1838
FDA
Z-1542-2009
Class II
2009/07/23
2821 5480
SN090780
SN090781
SN090782
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)
FDA
Z-1570-2009
Class II
2009/07/23
Johnson & Johnson Hong Kong Ltd
2738 6027
SN090783
Sybaritic Hydration Station with Pedestal (Part # E30003-01 and
E30003-01D)
FDA
Z-1245-2009
Class II
2009/07/23
N.A.
N.A.
SN090784
Gendex VixWin Platinum Imaging Software, versions 1.0, 1.1 and
1.2
FDA
Z-1548-2009
Class II
2009/07/23
N.A.
N.A.
SN090785
Radiometer Waste bottles Part No/Article no. a) 905-590/D512 and
b) 905-802/D513
FDA
Z-1554-2009
Class II
2009/07/23
N.A.
N.A.
SN090786
Biomet 3i ACT3020 Twist Drills
MHRA
2009/007/017/081/002
FSCA
2009/07/23
Ositek (Hong Kong) Inc. Ltd
N.A.
SN090787
One Lambda Flow Class I and Flow Class II Positive Control Serum
MHRA
2009/007/003/081/001
FSCA
2009/07/24
N.A.
N.A.
SN090788
Oxoid Oxidase Identification Sticks BR0064A
MHRA
2009/007/006/601/008
FSCA
2009/07/24
N.A.
N.A.
SN090789
Intuitive Surgical Da Vinci S Surgical System
MHRA
2009/007/006/081/011
FSCA
2009/07/24
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
2009/07/24
2960 7136
SN090790
Boston Scientific Prolieve Thermodilatation System Kit
SN090791
Stryker E-Cylinder Canister Holder (Model# 0682-000-449, 0682001-111)
Health Canada
49172
Type II
2009/07/27
Stryker China Ltd
2518 6915
SN090792
Stryker Dall Miles Trochanter Cable Grip System (Model # 6704-0210; Serial # 29233201)
Health Canada
49278
Type II
2009/07/27
Stryker China Ltd
2518 6915
SN090793
Stryker S3 Med/Surg Bed Fowler (Model# 302S3-000-000) and
Secure II Med/Surg Bed Fowler (Model# 3002-000-000)
Health Canada
49199
Type II
2009/07/27
Stryker China Ltd
2518 6915
SN090794
Stryker Trident Acetabular Surgical Protocol
Health Canada
49269
Type II
2009/07/27
Stryker China Ltd
2518 6915
SN090795
Smith & Nephew Genesis II Femorals (Model # 71420026, Lot #
08HM17084)
Health Canada
49201
Type II
2009/07/27
Smith & Nephew LTD
2648 7700
16
SN090796
Smith & Nephew Exogen Bone Healing System (Model # 71034101)
Health Canada
49177
Type II
2009/07/27
Smith & Nephew LTD
2648 7700
SN090797
Smith & Nephew BHR Acetabular Cups (Model#74120152)
Health Canada
49557
Type II
2009/07/27
Smith & Nephew LTD
2648 7700
SN090798
Toshiba Digical Radiography Imaging System (Model# TFD3000A1/WV)
Health Canada
49202
Type II
2009/07/27
238400688
SN090799
Zimmer Coonrad/Morrey Total Elbow System (Model # 32-8105-03800; Lot# 61249897, 61249899)
Health Canada
49362
Type II
2009/07/27
2992 0968
SN0907100
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
2485 7510
SN0907101
Cardiac Science Quinton QStress TM55 Stress Treadmill (Serial #
11040079567, 11040079568)
Health Canada
49032
Type II
2009/07/27
N.A.
N.A.
SN0907102
Advanced Bionics Removable Magnet Hires 90K (Model# CI 140001, CI-1400-01, CI-1400-02H)
Health Canada
49409
Type II
2009/07/27
N.A.
N.A.
Vastec Medical
Limited
N.A.
2009/07/27
Vastec Medical Limited
2897 1912
Medtronic
International Ltd.
N.A.
2009/07/27
2919 1362
SN0907103
Trinity Biotech Mumps IgM 1 Plate (Trinity Elisa Kit Model# 2325960)
SN0907104
Medtronic Integrated Power Console System (Ref# 1898001 &
EC300)
SN0907105
Innogenetics INNO-LIA HCV Score (product code: 80538)
MHRA
2009/007/017/081/005
FSCA
2009/07/27
N.A.
N.A.
SN0907106
Innogenetics Innotest hPLAP (product code: 80326)
MHRA
2009/007/017/081/001
FSCA
2009/07/27
N.A.
N.A.
SN0907107
Philips BrightView Gamma Camera
MHRA
2009/007/020/291/020
FSCA
2009/07/27
2821 5480
MHRA
2009/007/021/081/008
FSCA
2009/07/27
N.A.
N.A.
MHRA
2009/007/021/301/001
FSCA
2009/07/27
N.A.
N.A.
N.A.
N.A.
SN0907108
SN0907109
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)
SN0907110
Össur Icelock Expulsion Valve 551
MHRA
2009/006/025/081/007
FSCA
2009/07/27
SN0907111
Stryker Various titanium bone screws and modular join prostheses
MHRA
2009/007/008/081/004
FSCA
2009/07/27
Stryker China Ltd
2518 6915
MHRA
MDA/2009/048
MDA
2009/07/29
2555 9421
MHRA
2009/006/015/291/028
FSCA
2009/07/29
N.A.
N.A.
SN0907112
SN0907113
SN0907114
SN0907115
SN0907116
Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D
5.1.
Applied Medical Resources 15x100mm Kii Optical Access System,
non-threaded
Remploy Access heavy duty manual wheelchair
Boston Scientific RF Ablation System Foot Switch used with EPT1000 Cardiac Ablation Systems (Cat#840)
Abbott Clinical Chemistry Total Bilirubin (List number: 6L45-20 &
6L45-40)
MHRA
2009/004/029/401/010
FSCA
2009/07/29
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
2009/07/29
2960 7136
MHRA
2009/007/010/601/001
FSCA
2009/07/30
2593 2211
SN0907117
Roche Diagnostics CoaguChek XS, CoaguChek XS Plus
MHRA
2009/007/016/081/002
FSCA
2009/07/31
2485 7510
SN0907118
DePuy LCS Duofix Femoral Component
MHRA
2009/007/024/081/003
FSCA
2009/07/31
2738 6027
SN0907119
Trulife RM512700 extra long double adjustable soft handle elbow
crutches
MHRA
2009/007/007/401/005
FSCA
2009/07/31
N.A.
N.A.
SN0907120
Roche Diagnostics Factor V Leiden Kit
MHRA
2009/007/015/081/009
FSCA
2009/07/31
2485 7510
SN0907121
Maxter Cathéters Oral / enteral feeding syringe
MHRA
2009/001/016/401/004
FSCA
2009/07/31
N.A.
N.A.
17
Monthly Summary of Medical Device Safety Alerts - June 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
SN090601
Agent Contact
Telephone No
Hologic Discovery and Explorer X-ray Bone Densitometer Systems
MHRA
2009/004/029/061/013
FSCA
2009/06/01
N.A.
N.A.
SN090602
CME McKinley T34 Syringe Driver
MHRA
2009/004/028/291/009
FSCA
2009/06/01
N.A.
N.A.
SN090603
GE Signa Ovation systems with CTL Array, XL Body Flex and Open
Body Coils
MHRA
2009/003/012/061/013
FSCA
2009/06/01
2783 1838
SN090604
ThermoFisher Scientific Salmonella Chromogenic medium PO0958A
MHRA
2009/005/008/601/004
FSCA
2009/06/01
N.A.
N.A.
SN090605
DePuy PFC Sigma Cruciate Retaining Non-Porous Size 5 Left
Femoral Component
MHRA
2009/005/014/081/001
FSCA
2009/06/01
N.A.
N.A.
SN090606
KeyMed, Olympus, Aloka WM-NP1 (Workstation)
MHRA
2009/005/007/061/003
FSCA
2009/06/01
N.A.
N.A.
SN090607
Stryker Triathlon TS Knee System Offset Adapter Trial
MHRA
2009/005/013/081/011
FSCA
2009/06/01
Stryker China Ltd
2518 6915
SN090608
Teleflex Medical (Athlone) Arrow 12 French Triple-Lumen 20cm &
16cm Large-Bore Central Venous Catheters
MHRA
2009/005/014/081/003
FSCA
2009/06/01
N.A.
N.A.
SN090609
Moria Evolution 3E
MHRA
2009/003/023/401/006
FSCA
2009/06/01
N.A.
N.A.
SN090610
Welch Allyn Vital Signs Monitor VSM 300
MHRA
2008/012/005/601/002
FSCA
2009/06/01
N.A.
N.A.
SN090611
Aerocrine NIOX and NIOX Flex, 03-1000 resp 03-1000-F
MHRA
2009/005/014/051/012
FSCA
2009/06/01
N.A.
N.A.
SN090612
Siemens Medical Acuson X300 System with Swiftlink Connector
DL260
MHRA
2009/005/014/081/012
FSCA
2009/06/01
2810 7533
SN090613
Medical Devices Group Computer treatment planning
MHRA
2009/005/017/601/002
FSCA
2009/06/01
N.A.
N.A.
SN090614
Smith & Nephew Legion Pressfit Stems 71424053 & 71424043
MHRA
2009/004/016/051/009
FSCA
2009/06/01
N.A.
N.A.
SN090615
Stryker Mantis Rod Inserter Shaft
MHRA
2009/005/006/061/001
FSCA
2009/06/01
N.A.
N.A.
SN090616
ThermoFisher PB0378A
MHRA
2009/005/006/601/001
FSCA
2009/06/01
N.A.
N.A.
SN090617
ThermoFisher PO1110A
MHRA
2009/005/006/601/002
FSCA
2009/06/01
N.A.
N.A.
SN090618
Roche Diagnostics Elecsys Folate III
MHRA
2009/004/029/061/008
FSCA
2009/06/01
2485 7510
SN090619
Merit Medical Systems Prelude Short Sheath Introducer
MHRA
2009/004/024/051/002
FSCA
2009/06/01
King Health Limited
2481 3787
SN090620
CalMed Op-Flex Poole (Handle Set) contained within Procedure
Packs
MHRA
2009/005/014/291/013
FSCA
2009/06/01
N.A.
N.A.
SN090621
Siemens Medical ACUSON Sequoia, auxiliary CW transducer
MHRA
2009/005/014/081/013
FSCA
2009/06/01
2810 7533
SN090622
Medmont E300 Corneal Topographer, DV2000 Digital Imaging
Software and M700 Automated Perimeter
Health Canada
45746
Type II
2009/06/02
Park World Development Ltd
2880 9689
SN090623
Ethicon (JNJ) Endopath Endoscopic Linear Cutters (Model #
LONG45A; ATB45, ATW45; NAW45)
Health Canada
47966
Type II
2009/06/02
N.A.
N.A.
SN090624
CMS Focal Software CD
Health Canada
48015
Type II
2009/06/02
N.A.
N.A.
SN090625
Immucor Gallileo Echo Blood Analyzer (Model 87000)
Health Canada
47888
Type II
2009/06/02
2838 8423
18
SN090626
FisherDiagnostics Infinity Glucose Hexokinase Reagent (Catalog #
TR15498)
Health Canada
47989
Type II
2009/06/02
N.A.
N.A.
SN090627
Premier Dental Integra CEM (Model# 3001410)
Health Canada
48059
Type II
2009/06/02
N.A.
N.A.
SN090628
Leckey Four-point Pelvic Harness (Model no 122-719)
Health Canada
47922
Type II
2009/06/02
Otto Bock Asia Pacific Limited
2598 9772
Health Canada
47380
Type II
2009/06/02
N.A.
N.A.
Health Canada
47835
Type II
2009/06/02
2240 6150
Health Canada
47987
Type II
2009/06/02
N.A.
N.A.
Health Canada
47031
Type II
2009/06/02
2960 7136
SN090629
SN090630
SN090631
SN090632
Sunrise Mobility Quickie LXI Manual Wheelchair (Model# LXI034741, LXI-034609, LXI-034740, LXI-034500)
Beckman Coulter Synchron Systems Ammonia (AMM) Reagent
(Model#439770)
Sonomed Vumax Ophthalmic Ultrasound Scanner (Model#SHFS35S)
Boston Scientific Contak Renewal 4 CRT-D and Vitality 2 Acid
SN090633
MEDEX SBI Injector
MHRA
2009/003/010/601/001
FSCA
2009/06/03
N.A.
N.A.
SN090634
Promotal SAS Quest and Duolys exam couches and Ambéo, 3181
and 3185 chairs
MHRA
2009/005/011/291/012
FSCA
2009/06/03
N.A.
N.A.
SN090635
GE Healthcare Definium 5000 digital X-ray systems
MHRA
2009/005/007/051/002
FSCA
2009/06/03
N.A.
N.A.
SN090636
Siemens Medical Symbia S and Symbia T
MHRA
2009/003/016/291/004
FSCA
2009/06/03
2810 7533
SN090637
Marflow AG - Medical Equipment Grabit 3 prong grasping forcep
MHRA
2009/002/027/401/005
FSCA
2009/06/03
N.A.
N.A.
SN090638
Corin Uniglide Unicondylar Knee - femoral component
MHRA
2009/004/023/061/002
FSCA
2009/06/03
N.A.
N.A.
SN090639
Varian Clinacs with C Series version 7.x and the SRS Motion
Disable Option
Varian Medical
Systems Pacific Inc.
N.A.
2009/06/03
2724 2836
SN090640
Depuy (JNJ) Knee Replacement Implant
MHRA
MDA/2009/037
MDA
2009/06/04
2738 6027
SN090641
Arjo Maxilift
MHRA
2009/004/016/261/001
FSCA
2009/06/05
ArjoHuntleigh (Hong Kong) Ltd
2508 9553
SN090642
Beckman Coulter AutoMate Sample Processing Systems
MHRA
2009/005/014/601/001
FSCA
2009/06/05
2240 6150
SN090643
BD Syringe 10ml Luer-Lok
BD
N.A.
2009/06/05
BD
2575 8668
SN090644
GE Healthcare ApexPro Telemetry System
FDA
Z-1227-2009
Class II
2009/06/08
2783 1838
SN090645
Alcon 25 GA Total Plus Pak and Vitrectomy 25 GA Custom Pak
FDA
Z-1412-2009 to Z-1413-2009
Class II
2009/06/08
Alcon Hong Kong Ltd
2568 0636
SN090646
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
Kimberly-Clark (Hong Kong) Limited
2334 3361
SN090647
Abbott ARCHITECT Reaction Vessel (List no 7C15-01)
FDA
Z-1398-2009
Class II
2009/06/08
2593 2211
SN090648
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
2593 2211
SN090649
Siemens Medical Immulite 2000 and Immulite 2500 digital Fluidics
PC Board (Part no. 450116-0002)
FDA
Z-1399-2009
Class II
2009/06/08
2810 7533
SN090650
MEDRAD Sterile Disposable Syringe Kit (Catalog. no DSK 130-Q)
FDA
Z-1228-2009
Class II
2009/06/08
Medrad Asia Pte.Ltd
65-6752 5318
SN090651
Synthes Spine Square Nut MR Safe (Catalog no. 03.311.060)
FDA
Z-1324-2009
Class II
2009/06/08
Synthes (Hong Kong) Ltd
2724 2032
19
SN090652
Synthes Spine InSitu Bender Cutter Kit Wide Sterile (Cat. No.
530.521S) and InSitu Bender Cutter Kit Narrow Sterile (Cat. No.
530.522S)
FDA
Z-1248-2009 to Z-1249-2009
Class II
2009/06/08
2724 2032
SN090653
Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire
FDA
Z-1267-2009 to Z-1307-2009
Class II
2009/06/08
N.A.
N.A.
SN090654
Zimmer TM-400 Broach Handle
MHRA
2009/005/011/291/010
FSCA
2009/06/08
2992 0968
SN090655
AGA Medical Amplatzer Cardiac Plug
MHRA
2009/002/018/291/006
FSCA
2009/06/08
N.A.
N.A.
SN090656
Zimmer TransFx External Fixation System drill bit, quick connect
MHRA
2009/005/007/061/017
FSCA
2009/06/08
2992 0968
SN090657
Ortho-Clinical Diagnostics Veridex LLC CellTracks AutoPrep System
MHRA
2009/005/012/081/014
FSCA
2009/06/08
Ortho Clinical Diagnostics
2737 5504
SN090658
Biomet Microfixation Arthrosimplicity and OnPoint Scope kits, Becton
Dickinson syringe component
MHRA
2009/004/002/601/001
FSCA
2009/06/08
N.A.
N.A.
SN090659
Siemens Medical Immulite 2000 / Immulite 2500 Chemiluminescent
Substrate Module
MHRA
2009/005/027/081/003
FSCA
2009/06/08
2810 7533
SN090660
Trinity Biotech TriniCAL Reference Plasma and TriniCHECK Control
Levels 1, 2 & 3
MHRA
2009/005/027/291/008
FSCA
2009/06/08
N.A.
N.A.
SN090661
Beckman Coulter UniCel DxC 880i, 860i, 680i & 660i Synchron
Access Clinical Systems
MHRA
2009/005/021/601/001
FSCA
2009/06/09
2240 6150
SN090662
Invacare Harrier Plus, HD & XHD
MHRA
2007/005/024/061/002
FSCA
2009/06/09
N.A.
N.A.
SN090663
Philips Synergy Flex-M / Shoulder Coil
MHRA
2009/005/028/051/005
FSCA
2009/06/09
2821 5480
SN090664
Mölnlycke Phaco Pack Shepton Mallet JAV 17177
SN090665
Gambro AK200 S equipped with UFD and AK 200 ULTRA S in
combination with BiCart Select
MHRA
2009/005/029/081/003
FSCA
2009/06/09
N.A.
N.A.
Gambro Hong Kong
Ltd
N.A.
2009/06/10
Gambro Hong Kong Ltd
2839 9710
SN090666
Allergan Medical FloWatch-PAB
MHRA
2009/005/028/051/010
FSCA
2009/06/11
N.A.
N.A.
SN090667
GE Healthcare Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ,
2121IQ & 3131IQ
MHRA
2009/006/002/081/006
FSCA
2009/06/11
2783 1838
SN090668
Tosoh Bioscience Hemoglobin F&A2 control set
MHRA
2009/005/014/051/010
FSCA
2009/06/11
N.A.
N.A.
SN090669
Trinity Biotech TriniCLOT aPPT HS
MHRA
2009/005/022/081/001
FSCA
2009/06/11
N.A.
N.A.
SN090670
EBI Titanium Cannulated Screws and Bone Screws
MHRA
2009/004/024/601/004
FSCA
2009/06/11
N.A.
N.A.
SN090671
Philips MD Allura FD
MHRA
2009/006/003/291/017
FSCA
2009/06/12
2821 5480
SN090672
Varian Eclipse Treatment planning System, version 8.6 and earlier
(Product Code: H48)
Varian Medical
N.A.
2009/06/12
2722 8122
SN090673
Stryker Gamma3 Plus Obese Targeting System, Gamma3S
Trochanteric Nail 170 and Gamma 3
FDA
Z-1349-2009 to Z-1351-2009
Class II
2009/06/15
Stryker China Ltd
2518 6915
SN090674
Stryker Surgical Table Headrest (Catalog/Part # 0788-300-012)
FDA
Z-1418-2009
Class II
2009/06/15
Stryker China Ltd
2518 6915
SN090675
Terumo Advanced Perfusion System 1 Central Control Monitor
(Catalog no 802100)
FDA
Z-1224-2009
Class II
2009/06/15
TERUMO CHINA (H.K.) LTD.
2866 0811
SN090676
Biomet Dual Offset Broach Handle, Clamping Style, Left (REF 31555403) and Right (REF 31-555404)
FDA
Z-1352-2009 to Z-1353-2009
Class II
2009/06/15
N.A.
N.A.
SN090677
Spectranetics SLS II Lasr Sheath Kit, 14F (REF 500-012)
FDA
Z-1264-2009
Class II
2009/06/15
N.A.
N.A.
20
SN090678
Varian CLINAC Software Versions 6.X and 7.X (Remote Auto
Motions)
Varian Medical
N.A.
2009/06/15
2722 8122
SN090679
Zimmer Nexgan LPS and Nexgen LPS-Flex Femoral Components
Health Canada
48206
Type II
2009/06/15
2992 0968
SN090680
Roche PSM with Validation Module (Model# 03009696001,
03265439001)
Health Canada
47890
Type II
2009/06/15
2485 7510
SN090681
Abbott i-STAT 1 Analyzer System-Instrument (Model/Catalog #
06F16-10)
Health Canada
48245
Type II
2009/06/15
2593 2211
SN090682
Stryker Austin Moore Stems - Curved 43mm (Model/Catalog# 69390-430)
Health Canada
48207
Type II
2009/06/15
Stryker China Ltd
2518 6915
SN090683
Siemens Acuson S2000 VA10 (Model / Catalog# 10041461)
Health Canada
48077
Type II
2009/06/15
2810 7533
SN090684
Cook Zenith Renu AAA Converter, Zenith Renu AAA Main Body and
Zenith AAA Main Body Bifurcated Stent
Health Canada
47349
Type II
2009/06/15
N.A.
N.A.
SN090685
Medline Penrose Drain
Health Canada
48072
Type II
2009/06/15
N.A.
N.A.
SN090686
Ansell Healthcare Derma Prene Ultra Surgical Glove (Model/Catalog
# 851365 / 851470)
Health Canada
48229
Type II
2009/06/15
N.A.
N.A.
SN090687
Motion Concepts Tilt/Elevating Seating System and
Tilt/Elevate/Recline Seating System
Health Canada
46283
Type II
2009/06/15
N.A.
N.A.
SN090688
Walter Lorenz Surgical (Biomet Microfixation) Dean Scissors (Model:
09-0142)
Health Canada
47701
Type II
2009/06/15
N.A.
N.A.
SN090689
Viewsonic VGM 19" Monitor
Health Canada
48079
Type II
2009/06/15
ViewSonic Hong Kong
3690 1398
N.A.
2009/06/16
2481 3387
N.A.
2009/06/16
2593 2211
SN090690
Roche Accu-chek Performa
SN090691
Abbott POWERSAIL Coronary Dilatation Catheter
Roche Diagnostics
(Hong Kong) Ltd
Abbott Laboratories
LTD.
SN090692
ThermoFisher PO0171A brilliant green agar
MHRA
2009/006/004/601/002
FSCA
2009/06/17
N.A.
N.A.
SN090693
Heliosphere Bag Intragastric Balloon
MHRA
MDA/2009/040
MDA
2009/06/19
N.A.
N.A.
SN090694
GE Healthcare Ge Signa Hdx 3T MR Systems, Ge Signa Hdxt 3T
MR Systems
MHRA
2009/006/008/291/012
FSCA
2009/06/19
2783 1838
SN090695
Edwards Lifesciences Introflex Tuohy-Borst Valve Introducer
MHRA
2009/005/028/051/012
FSCA
2009/06/19
N.A.
N.A.
SN090696
Ortho-Clinical Diagnostics VITROS 3600 immunodiagnostic system,
VITROS 5600 integradeted system
MHRA
2009/006/002/051/003
FSCA
2009/06/22
Ortho Clinical Diagnostics
N.A.
SN090697
Philips CareVue Chart Release C.O. (Part Number 862246)
FDA
Z-1436-2009
Class II
2009/06/22
2821 5480
SN090698
Synthes Zero-P StarDrive Screwdriver Shaft, T8 (Catalog#
03.617.902)
FDA
Z-1348-2009
Class II
2009/06/22
2724 2032
SN090699
Innovative Neurotronics WalkAide Stimulator System Control Module
(Part No. 20-0100)
FDA
Z-1435-2009
Class II
2009/06/22
N.A.
N.A.
SN0906100
TEVA Medical Device TEVADAPTOR Closed Drug Reconstitution
and Transfer System (Model no. MG412110)
FDA
Z-1244-2009
Class II
2009/06/22
N.A.
N.A.
BD
N.A.
2009/06/22
BD
2575 8668
Cemma Enterprise
Co., Ltd
N.A.
2009/06/22
Cemma Enterprise Co., Ltd
2412 2310
SN0906101 BD Beaver Arthro-Lok Pointed Tip 4mm Blade (Cat no. 376780)
SN0906102
Arrow International Pediatric Two-Limen Central Venous
Catheterization Set with Blue FlexTip Catheter (Cat no. CS-14502)
21
SN0906103 Select Healthcare Locomotor lifting slings for adults and children
SN0906104 Philips Avalon Fetal Monitor
SN0906105 Boston Scientific Resolution Clip
Philips Respironics MicroElite Nebulizer Compressors (Medel
SN0906106 Product No. 91709 to 91716, Respironics Product No. 1053626,
1053677 to 1053683)
SN0906107 Terumo Advanced Perfusion System 1 (Catalog no 802100)
MHRA
MHRA
Boston Scientific
Hong Kong Ltd
MDA/2009/041
2009/006/010/291/016
MDA
FSCA
2009/06/23
2009/06/23
N.A.
N.A.
N.A.
N.A.
N.A.
2009/06/22
2960 7136
MHRA
2009/005/013/081/008
FSCA
2009/06/24
2821 5480
Health Canada
46444
Type II
2009/06/25
2866 0811
Health Canada
47925
Type II
2009/06/25
N.A.
N.A.
Health Canada
45984
Type II
2009/06/25
2783 1838
SN0906110 Stryker Vertier Table Headrest Attachment (Model # 0788-300-012)
Health Canada
48498
Type II
2009/06/25
Stryker China Ltd
2518 6915
SN0906111 ACIST Angiographic System - Manifold Kit (Model # BT2000)
Health Canada
48480
Type II
2009/06/25
N.A.
N.A.
SN0906112 CMS XIO Radiation Treatment Planning System
Health Canada
48447
Type II
2009/06/25
N.A.
N.A.
R&D Systems Quantikine IVD Human B2-Microglobulin (Lot #
260980)
Health Canada
48674
Type II
2009/06/25
N.A.
N.A.
SN0906114 MedovationsInsufflation Tubing With Filter (Model no SU1101)
Health Canada
48488
Type II
2009/06/25
N.A.
N.A.
Medical Devices Group Computer treatment planning release
SN0906115
4.34.00 through 4.40.00
MHRA
2009/006/011/601/001
FSCA
2009/06/25
N.A.
N.A.
Bard Vacora Vacuum Biopsy System (Model# VC10118P) and
Vacora Vacuum Biopsy System-Cannula (Model# VC10118MR)
GE Healthcare AW Volumeshare2 - Software Options (Model#
SN0906109
B79011MA)
SN0906108
SN0906113
SN0906116
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
2810 7533
SN0906117
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
2810 7533
SN0906118
PENTAX Suction Valve (Types, Of-B136, Of-B140, Of-B163, OfB179 in endoscopy)
MHRA
2009/005/020/291/005
FSCA
2009/06/25
N.A.
N.A.
SN0906119 Siemens Mavig Portegra 2
FDA
Z-1437-2009 to Z-1443-2009
Class II
2009/06/26
2810 7533
Advanced Sterilization Products (JNJ) STERRAD 50 Sterilization
SN0906120 System (Product Code 10050) and STERRAD NX Sterilization
System (Prodoct Code 10033)
FDA
Z-1419-2009 to Z-1420-2009
Class II
2009/06/26
Johnson & Johnson Hong Kong Ltd
2738 6027
FDA
Z-1416-2009
Class II
2009/06/26
AR Burkill & Sons (HK) Ltd
2541 1041
SN0906121
Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology
Sampler (REF J-ES-090500-BL)
SN0906122 Bard E LUMINEXX Biliary Stent
FDA
Z-1453-2009 to Z-1469-2009
Class II
2009/06/26
N.A.
N.A.
MHRA
2009/006/002/081/003
FSCA
2009/06/26
2783 1838
MHRA
2009/006/009/081/006
FSCA
2009/06/26
2866 0811
2009/006/011/291/002
FSCA
2009/06/26
2810 7533
2008-011-013-301-001
FSCA
2009/06/26
N.A.
N.A.
2009/006/012/291/005
FSCA
2009/06/29
2738 6027
MHRA
2009/005/028/051/014
FSCA
2009/06/29
N.A.
N.A.
SN0906129 ThermoFisher Scientific PO0287A Yersinia Agar (CIN Med)
MHRA
2009/006/017/601/003,
2009/006/024/601/001
FSCA
2009/06/29
N.A.
N.A.
SN0906130 Possum HC603C IR Mains Switch
MHRA
2009/004/023/301/001
FSCA
2009/06/29
N.A.
N.A.
SN0906123 GE Signa Ovation 0.35T, GE Signa Openspeed 0.7T
Terumo pre-connected haemoconcentrator with drainage bag (adult
SN0906124
or paediatric)
SN0906125 Siemens Advia Centaur Hepatitis B Core Total (HBcT) Assay
MHRA
SN0906126 Ormesa New Bug
MHRA
SN0906127 Ethicon (JNJ) Endoloop Ligature Pds II Suture
MHRA
SN0906128 DxS Therascreen: EGFR29 Mutation Kit
22
SN0906131 Maquet Servo 300 ventilator (SV300)
MHRA
MDA/2009/042
23
MDA
2009/06/30
N.A.
N.A.
Monthly Summary of Medical Device Safety Alerts - May 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
SN090501
Roche ACCU-CHEK Spirit Insulin Pump
SN090502
Agent Contact
Telephone No
FDA
N.A.
Press Release
04-May-09
2485 7510
Accuray Synchrony Respiratory Tracking System
MHRA
2009/004/017/061/012
FSCA
04-May-09
Accuray Asia Ltd
2247 8628
SN090503
Sunrise Medical Breezy 100 and Breezy 300
MHRA
2008/006/025/261/001
FSCA
04-May-09
N.A.
N.A.
SN090504
Elekta XVI (Synergy® kV Detector)
MHRA
2009/003/011/061/002
FSCA
04-May-09
N.A.
N.A.
SN090505
Great Bear cubCATH Intermittent Catheter AVP10
MHRA
2009/003/025/061/007
FSCA
04-May-09
N.A.
N.A.
SN090506
Maquet MEDAP BORA UP 2080 Universal suction pump
MHRA
2009/003/025/061/017
FSCA
04-May-09
Maquet Hong Kong Ltd
2393 9511
SN090507
Nucletron Oncentra Prostate CT/MR option
MHRA
2009/004/022/291/006
FSCA
04-May-09
N.A.
N.A.
SN090508
Medtronic Sprinter OTW Product (TPL 970)
Medtronic
International Ltd
N.A.
05-May-09
2919 1362
SN090509
Stryker PainPump2
FDA
Z-1182-2009 to Z-1194-2009
Class II
07-May-09
Stryker China Ltd
2518 6915
SN090510
Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module
(Model 8120)
FDA
Z-1237-2009
Class II
07-May-09
Cardinal Health
N.A.
SN090511
Siemens Syngo Imaging (Model# 10 014 063)
FDA
Z-1235-2009
Class II
07-May-09
2810 7533
SN090512
Tri-State Centurion Products
FDA
Z-1319-2009 to Z-1322-2009
Class II
07-May-09
N.A.
N.A.
SN090513
Wright Medical Screwdriver for 3.5mm Screws (DARCO System,
REF: DC4261)
FDA
Z-1208-2009
Class II
07-May-09
Starry Medical Technology, Ltd
2961 4503
SN090514
Hill-Rom TotalCare Bed (Model P1900)
FDA
Z-1317-2009
Class II
07-May-09
N.A.
N.A.
Medtronic
International Ltd
N.A.
07-May-09
2919 1362
Smiths & Nephew Ltd
N.A.
07-May-09
Smith & Nephew LTD
9651 5523
MHRA
2008/011/010/061/017
FSCA
08-May-09
N.A.
N.A.
FDA
Z-1391-2009
Class I
11-May-09
Biosite Incorporated
2855 6883
SN090515
Medtronic Model 37085 Restore 1x4 DBS Extension Kit
SN090516
Smith & Nephew Blades
SN090517
Invacare XLT Self Propelling Wheelchair with rear wheels set back anti tipper
SN090518
Biosite Triage Cardiac Panel
SN090519
Boston Scientific Safety and Standard Push PEG Kits
Boston Scientific
Hong Kong Ltd
N.A.
11-May-09
2960 7136
SN090520
Boston Scientific Neuroform3 Microdelivery Stent System
Boston Scientific
Hong Kong Ltd
N.A.
11-May-09
2960 7136
SN090521
Smith & Nephew Reflection Microstable Acetabular Liner (REF
71740250)
Smiths & Nephew Ltd
Z-1004-2009
11-May-09
Smith & Nephew Ltd
2648 7700
SN090522
BD Insuline Syringe (Cat no. 328420)
BD
N.A.
13-May-09
BD
2575 8668
SN090523
Molift Smart
MHRA
2009/001/020/301/001
FSCA
13-May-09
N.A.
N.A.
24
SN090524
ThermoFisher TPHA Test Kit.
SN090525
Johnson & Johnson
Cordis Cypher Select Sirolimus Eluting Coronary Stents (Hub Crack)
Medical (HK)
2009/004/028/061/014
FSCA
13-May-09
N.A.
N.A.
N.A.
13-May-09
2738 6027
SN090526
Siemens Mammomat Novation DR (Model No. 06646900)
SN090527
GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6, 5.0.7, 5.0.8
and 4.1
FDA
Z-1233-2009
Class II
14-May-09
2810 7533
FDA
Z-1232-2009
Class II
14-May-09
2783 1838
SN090528
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
14-May-09
N.A.
N.A.
SN090529
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
Varian Medical
N.A.
15-May-09
2724 2836
SN090530
Bard Truguide Coazial Biopsy Needle (Model: C4140A, C1810B,
C1813B, C1816B, C1820B, C2013B, C2016B, C2020B)
Health Canada
47695
Type II
14-May-09
N.A.
N.A.
SN090531
Stryker Restoration Modular Cone Bodies (Model: 6276-1-121,
6276-1-125, 6276-1-219, 6276-1-325)
Health Canada
47576
Type II
14-May-09
Stryker China Ltd
2518 6915
SN090532
Boston Scientific Percutaneous combination stent (Model: 410-111,
112, 126, 202-207, 304-305)
Health Canada
47581
Type II
14-May-09
2960 7136
SN090533
UNOMEDICAL Paradigm Silhouette Infusion Set (Model: MMT377600, 378600, 381600, 382600)
Health Canada
47734
Type II
15-May-09
N.A.
N.A.
SN090534
Norwex Silvercare Toothbrush (Model: 22963)
Health Canada
47238
Type II
15-May-09
N.A.
N.A.
SN090535
Spacelabs Medical Medical Flat Panel Power Supply (Model: 0101619-00, 010-1655-00)
Health Canada
47582
Type II
15-May-09
N.A.
N.A.
SN090536
Beckman Coulter Flow-set Fluorospheres (Model: 6607007)
Health Canada
47347
Type II
15-May-09
2240 6150
SN090537
Biomet Orthopedics C2A Ringloc Acetabular System - 28 mm
(Model: 12-115112)
Health Canada
47389
Type II
15-May-09
N.A.
N.A.
SN090538
Biomet Microfixation Byrd Screw 2.0x6mm Self Drilling (Model: 010267)
Health Canada
46721
Type II
15-May-09
N.A.
N.A.
SN090539
Bard Max-Core Disposable Bipsy Instr. (Model: MC1810, MC1816,
MC1820)
Health Canada
47251
Type II
15-May-09
N.A.
N.A.
Health Canada
47348
Type II
15-May-09
2240 6150
Health Canada
46908
Type II
15-May-09
N.A.
N.A.
Health Canada
47632
Type II
15-May-09
N.A.
N.A.
SN090540
SN090541
SN090542
Beckman Coulter Access Systems Total BHCG Reagent Kit (Model:
33500)
Arrow International A) Percutaneous Sheet, B) Central Venous
Catheterization Set/Kit, C) Temporary Pacing Catheter, D) Twolumen 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.
Thrombolytic Kit
Medxi Heparin pre-filled syringes (Model: 3706, 3780, 3781, 3786,
3787), Saline pre-filled syringes )3704, 37043, 37043B, 37043B,
37043BNC, 3705C, 3705NC, 3706)
MHRA
25
SN090543
Ace Surgical Supply 5/0 Polyglycolic Acid Absorbable Suture (Model:
34630)
Health Canada
47393
Type II
15-May-09
N.A.
N.A.
SN090544
Wallac OYT Neogram Amino Acids Mass Spec Kit
Health Canada
47714
Type II
15-May-09
N.A.
N.A.
SN090545
Philips Holter
Health Canada
47704
Type II
15-May-09
2821 5480
SN090546
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-May-09
2277 6125
Health Canada
47789
Type II
15-May-09
2508 1416
Health Canada
47936
Type II
15-May-09
2960 7136
SN090547
SN090548
BMH Medical Combi Sling (626002), Sling Deluxe Child (626002C),
Sling Mesh Deluxe Child (626002C-M), Sling Deluxe Oversize
(626003), Sling
Cardiac Pacemakers Cognis CRT-D HE (N106), Cognis CRT-D
(N107), Teligen ICD (VR-HE DF1)(E110), Teligen ICD (DR-HE IS1)(E110)
SN090549
ALL Models Bioprosthetic Heart valves
MHRA
MDA/2009/032
MDA
18-May-09
N.A.
N.A.
SN090550
Medtronic Kappa 600/700/900 Series and Sigma 100/200/300 Series
Pacemakers
Medtronic
International Ltd.
N.A.
19-May-09
2919 1362
SN090551
Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and
4003)
FDA
Z-1411-2009
Class I
19-May-09
2268 9258
SN090552
BD 20ml Luer-Lok Syringe (Recorder Number 309661)
BD
N.A.
19-May-09
BD
2575 8668
SN090553
Roche MagNA Pure LC Workstation
FDA
Z-1255-2009
Class II
21-May-09
2485 7510
SN090554
GE Centricity TriWin Laboratory Information System
FDA
Z-1397-2009
Class II
21-May-09
2783 1838
N.A.
21-May-09
2724 2836
SN090555
Varian Acuity (Auto-fit MLC feature)
Varian Medical
SN090556
Varian Acuity (Changes to Asymmetric and Symmetric Field Axis
Properties During Verification Simulation
Varian Medical
N.A.
22-May-09
2724 2836
SN090557
Boston Scientifc FORTE GUIDE WIRE
Boston Scientific
Hong Kong Ltd
N.A.
22-May-09
2960 7136
SN090558
Radiometer Medical ABL800 Flex analyser
MHRA
2009/004/021/061/004
FSCA
25-May-09
N.A.
N.A.
SN090559
ThermoFisher Scientific Columbia Blood Agar PB0122A
MHRA
2009/004/023/601/001
FSCA
25-May-09
N.A.
N.A.
SN090560
Trinity Biotech TriniCLOT aPTT S
MHRA
2009/004/028/061/018
FSCA
25-May-09
N.A.
N.A.
SN090561
Biomet Orthopedics Offset tibial tray adaptor 5.0mm
MHRA
2009/003/005/601/002
FSCA
25-May-09
N.A.
N.A.
SN090562
Unisurge OP-Flex Poole (handle set) contained within Procedure
Packs
MHRA
2009/003/020/061/016
FSCA
25-May-09
N.A.
N.A.
SN090563
Integra LifeScience Licox Oxygen Catheter Micro-Probes (models
CC1 and CC1.2)
MHRA
2009/004/024/051/001
FSCA
25-May-09
N.A.
N.A.
SN090564
Oxoid (Ely) ProSpecT Adenovirus R240096
MHRA
2009/004/023/601/003
FSCA
25-May-09
Hong Kong South East Chemicals &
Instruments Ltd
2802 6333
SN090565
Siemens Dimension Enzymatic Creatinine Flex Reagent Cartridge
MHRA
2009/004/027/291/022
FSCA
25-May-09
2810 7533
SN090566
Biomet Microfixation Lactosorb Pectus Stabiliser
MHRA
2009/004/015/601/003
FSCA
25-May-09
N.A.
N.A.
26
SN090567
Trinity Biotech Captia Measles IgM ELISA test kit
MHRA
2009/004/017/061/009
FSCA
25-May-09
N.A.
N.A.
SN090568
Stanmore Implants METS Modular Tumour System
MHRA
2009/004/009/061/008
FSCA
25-May-09
N.A.
N.A.
SN090569
KeyMed, Olympus, Aloka Endoscope - MU-1
MHRA
2008/012/023/601/003
FSCA
25-May-09
N.A.
N.A.
SN090570
Edwards Lifesciences Aquarius systems GEF08200, GEF09500,
GEF09600, GEF09700
MHRA
2009/004/006/291/009
FSCA
25-May-09
N.A.
N.A.
FDA
Z-1393-2009 to Z-1394-2009
Class II
29-May-09
2485 7510
FDA
Z-1195-2009
Class II
29-May-09
2783 1838
FDA
Z-1395-2009
Class II
29-May-09
N.A.
FDA
Z-1400-2009
Class II
29-May-09
Instruments Ltd
2802 6333
BD
N.A.
29-May-09
BD
2575 8668
Smiths & Nephew Ltd
N.A.
29-May-09
Smith & Nephew LTD
2648 7700
Cardinal Health Esteem Blue with Neu-Thera Polyisoprene Surgeon
Gloves
MHRA
2009/005/007/051/005
FSCA
29-May-09
N.A.
N.A.
SN090578
Wright Medical Darco Cannulated Hex Driver
MHRA
2009/003/003/291/016
FSCA
29-May-09
Starry Medical Technology, Ltd
2961 4503
SN090579
Rocialle InHealth Procedure Packs containing Suction Catheter
MHRA
2009/005/013/291/002
FSCA
29-May-09
N.A.
N.A.
SN090571
SN090572
SN090573
SN090574
SN090575
SN090576
SN090577
Roche cobas 6000 analyzer series (including cobas c 501 and cobas
e601 modules) Middleware Solutions instrument Manager Standard
and Middleware Solutions instrument Manager Server
GE Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging
System
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0
(model no 270-2000)
Remel Staphaurex Plus Kit (Catalog. no. R30950102 and
R30950201)
BD Insyte Autoguard IV Catheter (Cat. No. 381812; Lot no.
8171780)
Smith & Nephew DYONICS 25 tubeset kits (Cat no. 7211005;
7211006)
27
Monthly Summary of Medical Device Safety Alerts - April 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Agent Contact
Telephone No
SN090401
Tri-State Centurion Products
FDA
N.A.
Class I
2009/04/02
N.A.
N.A.
SN090402
Roche COBAS c 11 Analyzer with ISE Module option, GMMI No.
04777433001
FDA
Z-1009-2009
Class II
2009/04/02
2485 7510
SN090403
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
N.A.
SN090404
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901300 and 5400-300
FDA
Z-1052-2009
Class II
2009/04/02
Stryker China Ltd
2518 6915
SN090405
Lecia QCA and iQCA software
FDA
Z-1040-2009
Class II
2009/04/02
Leica Microsystems Ltd
2564 6699
SN090406
DiaSorin LIASON ® Chemiluminescence Analyzer Model #15970
Colorimeter, Photometer, Spectrophotometer for clinical use
FDA
Z-1042-2009
Class II
2009/04/02
N.A.
N.A.
SN090407
Medtronic Physio-Control Bisphasic LIFEPAK® 12
Defibrillator/monitor
Medtronic
International Ltd
N.A.
2009/04/02
2919 1362
SN090408
3M No Sting Barrier Film (Model 3346E)
3M
N.A.
2009/04/03
3M
2806 6349
SN090409
GE Healthcare ViewPoint Image Archiving and Reporting System
MHRA
2009/001/007/401/004
FSCA
2009/04/06
2783 1838
SN090410
Gas Control Equipment Sabre Therapy Probe Regulator
MHRA
2009/003/024/291/011
FSCA
2009/04/06
N.A.
N.A.
SN090411
CODAN Burette Sets
MHRA
2009/003/023/291/013
FSCA
2009/04/06
N.A.
N.A.
SN090412
Roche Ambulatory insulin infusion pump. Accu-Chek Spirit
MHRA
MDA/2009/024
MDA
2009/04/07
2485 7510
SN090413
Biomet Biolox Delta Ceramic Heads 28mm, +5mm (T1 taper)
MHRA
2009/003/017/061/004
FSCA
2009/04/07
N.A.
N.A.
SN090414
ThermoFisher Columbia blood agar - PB0122A
MHRA
2009/003/024/601/003
FSCA
2009/04/07
N.A.
N.A.
SN090415
GE Healthcare S/5 iCentral and iCentral Client (L-NET05 and LNETC05)
FDA
Z-1039-2009
Class II
2009/04/14
2783 1838
SN090416
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
SN090417
Stelkast Dual Taper Wedge Pressed Fit Femoral Component
FDA
Z-1073-2009
Class II
2009/04/14
N.A.
N.A.
SN090418
Zues Scientific Sm ELISA Test System (Product no.: 2Z2831G and
43270CE)
FDA
Z-1089-2009
Class II
2009/04/14
N.A.
N.A.
SN090419
Trumpf Medical ILED Surgical Light (Model no ILED3, ILED5 and
ILED5K)
FDA
Z-1122-2009
Class II
2009/04/14
TRUMPF China (Hong Kong) Ltd.
2880 9808
SN090420
Theragenics Spacers of varying lengths
FDA
Z-1020-2009
Class II
2009/04/14
N.A.
N.A.
SN090421
Johnson and Johnson Ethicon Endo-Surgery Device - Ets-FLEX45
Johnson & Johnson
Medical (HK)
N.A.
2009/04/14
2738 6027
SN090422
Tepnel Quick-Type for LIFEMATCH Update CD
MHRA
2009/003/026/601/014
FSCA
2009/04/15
N.A.
N.A.
SN090423
Teleflex Medical (Arrow) 30, 40 and 50 cc Intra-Aortic Ballloon
FDA
Z-1210-2009 to Z-1222-2009
Class I
2009/04/16
N.A.
N.A.
28
SN090424
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
Cardinal Health
N.A.
SN090425
Biomet Offset Tibial Tray Adaptor, 5.0 MM, Sterile, REF 141491
FDA
Z-1061-2009
Class II
2009/04/16
N.A.
N.A.
SN090426
Abbott CELL-Dyn Ruby Hematology Analyzer (List no 08H67-01)
FDA
Z-1064-2009
Class II
2009/04/16
2593 2211
SN090427
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
2485 7510
SN090428
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
2960 7136
SN090429
GE Healthcare Infinia Hawkeye and Hawkeye 4
FDA
Z-1094-2009 to Z-1095-2009
Class II
2009/04/16
2783 1838
SN090430
GE Healthcare Infinia, Hawkeye for Infinia and Infinia Hawkeye 4
FDA
Z-1119-2009 to Z-1121-2009
Class II
2009/04/16
2783 1838
SN090431
Cardinal Health ReadyMed Elastomeric Ambulatory Pump
FDA
Z-1170-2009
Class II
2009/04/16
Cardinal Health
N.A.
FDA
Z-1171-2009
Class II
2009/04/16
2919 1362
FDA
Z-1096-2009 to Z-1117-2009
Class II
2009/04/16
N.A.
N.A.
SN090432
SN090433
SN090434
Medtronic Physio Control Internal Sterilizable Paddles and Handles
without discharge control for use with LIFEPAK 9 and LIFEPAK 9P
defibrillators/monitors
Bard Dual Port Wizard Low Profile Replacement Gastrostomy
Device
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.
SN090435
diaDexus PLAC Test Reagent Kit (Catalog no 90110)
FDA
Z-1204-2009
Class II
2009/04/16
N.A.
N.A.
SN090436
Teleflex Medical Pilling Coronary Scissors (Cataolg no 352164352169 & 352178)
FDA
Z-1175-2009 to Z-1181-2009
Class II
2009/04/16
N.A.
N.A.
SN090437
Siemens HM Reaction Vessels (RXV1A)
MHRA
2008/012/002/061/010
FSCA
2009/04/16
2810 7533
SN090438
i-sens Caresens II BGM
Others
N.A.
N.A.
2009/04/17
BioScan Ltd
3589 6670
SN090439
Sybron Pitt Easy Implant
MHRA
2008/012/002/061/010
FSCA
2009/04/20
N.A.
N.A.
SN090440
James Leckey EAS Floor Mat
MHRA
2009/003/016/301/002
FSCA
2009/04/22
N.A.
N.A.
SN090441
Homecraft Rolyan Frimley folding stool model AA1550
MHRA
2009/001/030/401/010
FSCA
2009/04/22
N.A.
N.A.
SN090442
Stryker Modular Replacement System (MRS) Cemented Stems
Stryker AxSOS T8 Screwdriver and AxSOS Torque Limiting
Screwdriver
Stryker Trio Small Offset Connector Non Sterile (Catalog no
48902015)
FDA
Z-1251-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
FDA
Z-1062-2009 to Z-1063-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
FDA
Z-0986-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
GE Healthcare Infinia, Infinia Hawkeye and Infinia Hawkeye 4
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
Maquet ALM Prismatic Surgical Light 9551 DF and ALM Prismatic
Surgical Light 54004 SF
FDA
Z-1001-2009 to Z-1003-2009
Class II
2009/04/23
2783 1838
FDA
Z-1046-2009 to Z-1051-2009
Class II
2009/04/23
2593 2211
FDA
Z-1153-2009 to Z-1154-2009
Class II
2009/04/23
2393 9511
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.
SN090443
SN090444
SN090445
SN090446
SN090447
SN090448
Cardiovascular System DiamondBack 360, CSI ViperWire Orbital
Atherectomy Guide Wire (REF: GW14335FRM)
SN090449
St.Jude Medical EP-4 Stimulator 2 and 4 channels and EP
WorkMate containing the EP4 stimulator
29
SN090450
Philips HeartStart XL M4735A Defibrillator/Monitor
Philips Health Care
(Great China)
N.A.
2009/04/23
2821 5226
SN090451
Philips HeartStart MRx/MRxE M3535A/M3536A/M3536J
Defibrillator/Monitor
Philips Health Care
(Great China)
N.A.
2009/04/23
2821 5226
SN090452
ThermoFisher BO0332D Ringers Solution 1/4 Strength lot 1067747
MHRA
2009/001/029/601/001
FSCA
2009/04/29
N.A.
N.A.
SN090453
Stryker Restoration Modular Cone Bodies
MHRA
2009/003/025/291/008
FSCA
2009/04/29
Stryker China Ltd
2518 6915
SN090454
Abbott Hematology Reagent Syringe (List no 08H49-02)
FDA
Z-1069-2009
Class II
2009/04/30
2593 2211
SN090455
Berchtold Operon Electrical Operating Room Table
FDA
Z-1123-2009
Class II
2009/04/30
N.A.
N.A.
SN090456
Pointe Scientific Liquid Auto HDL CHolesterol Reagent Set
DiaDexus PLAC Test Calibrator Kit (Catalog No. 90108 and 100108)
FDA
Z-1200-2009 to Z-1201-2009
Class II
2009/04/30
N.A.
N.A.
FDA
Z-1205-2009
Class II
2009/04/30
N.A.
N.A.
SN090457
30
Monthly Summary of Medical Device Safety Alerts - March 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
SN090301
Draeger Medical Oxylog 3000 Ventilator (2M86955)
Health Canada
44596
Type II
2009/03/03
SN090302
Oxoid Limited Oxoid Fraser Broth Base (CM0895B)
Health Canada
45182
Type II
2009/03/03
SN090303
Biomet Modular Microplasty Cup Inserter
Health Canada
43310
Type II
SN090304
Miltex Stainless Steel Surgical Blades
Health Canada
46242
SN090305
Ohio Willow Wood Duralite Pyramid Receiver Proximal Adapter
(FND-136102)
Health Canada
SN090306
GE Diamond Mammography X-Ray Equipment (81000)
SN090307
GE Datrex-Ohmeda Network and Icentral (M1113714, M1113715)
SN090308
SN090309
SN090310
SN090311
SN090312
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
Agent Contact
Telephone No
2009/03/03
N.A.
South East Chemicals & Instruments
Ltd
N.A.
N.A.
N.A.
Type II
2009/03/03
N.A.
N.A.
44165
Type II
2009/03/03
N.A.
N.A.
Health Canada
44731
Type II
2009/03/03
2783 1838
Health Canada
44822
Type II
2009/03/03
2783 1838
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
Health Canada
44335
Type II
2009/03/03
2783 1838
N.A.
Health Canada
46193
Type II
2009/03/03
2810 7533
Philips Gemini GXL 6/10/16 Slice PET/CT, Gemini TF 16 PET?CT
system, Gemini TF 64 PET/CT System
Health Canada
46137
Type II
2009/03/03
2821 5480
Health Canada
42978
Type II
2009/03/03
N.A.
N.A.
MHRA
MDA/2009/017
MDA
2009/03/04
N.A.
N.A.
SN090313
Draeger Evita 4, Evita 2 Dura, Evita XL
SN090314
DORC international MembraneBlue© 0.5ml syringe
SN090315
Philips Diagnostic Ultrasound System (Model HD3 and HDI4000)
FDA
Z-0522-2009 to Z-0523-2009
Class II
2009/03/05
2821 5480
SN090316
Medtronic Surgical Membrane Oxygenator
FDA
Z-0975-2009
Class II
2009/03/05
2919 1362
SN090317
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
SN090318
Abbott ACCELERATOR APS Centrifuge Module (Hettich Robotic
centrifuge) (List no: 07L02-01)
FDA
Z-0951-2009
Class II
2009/03/05
2593 2211
SN090319
Abbott Architect / Aeroset Clinical Chemistry Iron/Magnesium
Calibrator (List No. 1E69-03)
FDA
Z-0950-2009
Class II
2009/03/05
2593 2211
SN090320
Terumo Advanced Perfusion System 1
FDA
Z-0909-2009 to Z-0910-2009
Class II
2009/03/05
2866 0811
SN090321
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.
SN090322
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.
SN090323
Welch Allyn AED 10 and former MRL Jumpstart Automated External
Defibrillators
Welch Allyn
N.A.
2009/03/05
N.A.
N.A.
SN090324
Medtronic Physio-Control Lifepak 20 defibrillator/monitor - Keypad
Medtronic
International Ltd
N.A.
2009/03/10
2919 1362
SN090325
Sunrise Medical Quickie Groove battery powered wheelchairs
MHRA
MDA/2009/018
MDA
2009/03/10
N.A.
N.A.
31
SN090326
CMS Software 4.3.1 through 4.40.00
MHRA
2009/002/015/601/001
FSCA
2009/03/10
N.A.
N.A.
SN090327
Cardiac Science Powerheart and First Save AED
FDA
Z-0916-2009 to Z-0922-2009
Class II
2009/03/12
N.A.
N.A.
SN090328
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.
SN090329
Johnson and Johnson (Animas) Meter Remote for OneTouch Ping
Glucose Management System
FDA
Z-0955-2009
Class II
2009/03/12
2738 6027
SN090330
Zimmer Orthosoft Navitrack, OS Unicodylar Knee 1.0- Universal
Stryker Triathlon X3 Posterior Stabilized Tibial Insert Use with
Triathlon PS Femoral Components (Catalog no 5532-G-713 & 5532G-813)
Medtronic VARI-STIM III Nerve Locator/Stimulator
FDA
Z-0985-2009
Class II
2009/03/12
2992 0968
FDA
Z-1013-2009
Class II
2009/03/12
Stryker China Ltd
2518 6915
FDA
Z-0947-2009
Class II
2009/03/12
2919 1362
SN090333
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
SN090334
GE Healthcare Innova Biplane 3131
MHRA
2008/006/013/601/413
FSCA
2009/03/13
2783 1838
SN090335
Zimmer NCB cancellous screw 4.5mmx 48mm Self tapping
MHRA
2009/002/020/291/022
FSCA
2009/03/13
2992 0968
SN090336
VYGON PROTECT-A-SPIRAL – 300CM
MHRA
2009/002/026/601/003
FSCA
2009/03/13
N.A.
N.A.
SN090337
IPSOGEN JAK2 MutaScreen Kit
MHRA
2009/002/010/291/016
FSCA
2009/03/16
N.A.
N.A.
SN090338
Philips Multi Diagnost Eleva FD - Leaking X-Ray Tube Grid
SN090331
SN090332
SN090339
Boston Scientific Wiseguide Guide Catheter
SN090340
BD Falcon 100 x 20 mm Tissue Culture - Treated Dish (BD Cat no
353003)
MHRA
2008/011/020/061/028
FSCA
2009/03/16
2821 5226
Boston Scientific
Hong Kong Ltd
N.A.
2009/03/16
2960 7136
BD
N.A.
2009/03/17
BD
2575 8668
SN090341
Unihoist University Bath Hoist and University Bath Hoist Transporter
MHRA
2008/011/006/301/002
FSCA
2009/03/18
N.A.
N.A.
SN090342
Stryker Triathlon Primary
Health Canada
46302
Type II
2009/03/18
Stryker China Ltd
2518 6915
SN090343
Stryker Triathlon Primary Cemented Baseplate (5520-B-400)
Health Canada
46208
Type II
2009/03/18
Stryker China Ltd
2518 6915
SN090344
Smith & Nephew Tandem Unipolar 46 mm Femoral Heads (126646)
Health Canada
46556
Type II
2009/03/18
Smith & Nephew LTD
N.A.
SN090345
Zimmer Minimally Invasive Solutions Technology Offset RASP
Handles
Health Canada
46270
Type II
2009/03/18
2992 0968
SN090346
Technidata Logiciel TDHIsto/CytoSoftware
Health Canada
44729
Type II
2009/03/18
N.A.
N.A.
SN090347
Computerized Medical Systems Focal Software CD
Health Canada
46521
Type II
2009/03/18
N.A.
N.A.
SN090348
Bard Fantrac "Paul" Gastric Access Port Kit (Model 5729)
Health Canada
45860
Type II
2009/03/18
N.A.
N.A.
SN090349
Genzyme Diagnostics Enzymatic Creatinine Assay
Health Canada
46641
Type II
2009/03/18
N.A.
N.A.
SN090350
Nipro Blood Tubing Set for Hemodialysis (A230TR/V810TR)
Health Canada
45627
Type II
2009/03/18
N.A.
N.A.
Health Canada
46652
Type II
2009/03/18
N.A.
N.A.
Health Canada
46636
Type II
2009/03/18
Cardinal Health
N.A.
Health Canada
46404
Type II
2009/03/18
2738 6027
SN090351
SN090352
SN090353
Armstrong Medical Amsorb Plus Prefilled Bubble-Can Universal
WTOV
Cardinal Health Sterile Pacemaker and Defibrillator Pack
(SAN30PAXXX), Sterile Shoulder Pack (SOP30ASXXX)
PDSII Monofilament suture, Coated Vicryl Absorable Suture, PDS II
Suture, Monocryl Plus Antibacterial Suture, Coated Vicryl Plus
Antibacterial Ethicon Suture
32
SN090354
SN090355
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
Biomet Sports Medicine 9-10mm Ezloc Femoral Fixation Device
(904781)
Health Canada
45280
Type II
2009/03/18
2807 8516
Health Canada
44280
Type II
2009/03/18
N.A.
N.A.
SN090356
GE Innova 3100/3100IQ and Innova 4100 /4100IQ
FDA
Z-1092-2009 to Z-1093-2009
Class II
2009/03/19
2783 1838
SN090357
Medtronic PROSTIVA RE Model 8929 Hand Piece
FDA
Z-1060-2009
Class II
2009/03/19
2919 1362
SN090358
FDA
Z-1014-2009 to Z-1017-2009
Class II
2009/03/19
2919 1362
FDA
Z-1021-2009 to Z-1030-2009
Class II
2009/03/19
Stryker China Ltd
2518 6915
SN090360
Medtronic TSRH 3DX Implant Set and TSRH Spinal System
Stryker Cordless Driver 3 Handpiece, Rotary Handpiece,
Reciprocating Saw, Sternum Saw, Sagittal Saw and Precision
Oscillating Tip Saw
Zimmer Most Hinged Tibia Baseplate Spacer (REF 5020-06-001)
FDA
Z-0996-2009
Class II
2009/03/19
2992 0968
SN090361
Integra Mosail Putty and Dermal Regeneration Template-TS
FDA
Z-1034-2009 to Z-1035-2009
Class II
2009/03/19
N.A.
N.A.
SN090362
Pointe Scientific Glucose Oxidase Reagent
FDA
Z-1091-2009
Class II
2009/03/19
N.A.
N.A.
SN090363
Remel Wellcolex colour salmonella Kits, R30858301 (50
tests)/R30858302
MHRA
2009/003/006/051/003
FSCA
2009/03/19
Instruments Ltd
2802 6333
SN090364
ConMed Fortis II
ConMed Limited
N.A.
2009/03/19
ConMed Limited
N.A.
SN090359
SN090365
Philips GXR RF Systems with DI (EasyDiagnost Eleva)
Philips Health Care
(Great China)
N.A.
2009/03/19
2821 5226
SN090366
CORONA MEDICAL Patient Beds (Side Rails)
CORONA MEDICAL
N.A.
2009/03/20
N.A.
N.A.
SN090367
GE AS/3 Anaesthesia Delivery Unit, S/5 Anaesthesia Delivery Unit,
and ADU Carestation
MHRA
2009/002/013/601/003
FSCA
2009/03/23
2783 1838
Medtronic
International Ltd
N.A.
2009/03/23
2919 1362
SN090368
Medtronic Sprint Fidelis Lead
SN090369
Maquet Servo ventilators 300 and 300A
MHRA
MDA/2009/020
MDA
2009/03/25
2393 9511
SN090370
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
2332 4455
SN090371
GE Datex-Ohmeda Aisys and GE Datex-Ohmeda Avance
Anesthesia Machines
MHRA
2009/002/017/601/001
FSCA
2009/03/25
2783 1838
SN090372
Draeger Medical Patient monitor bracket
MHRA
2009/003/010/051/014
FSCA
2009/03/25
Draeger Medical Hong Kong Ltd.
2877-3077
SN090373
Aidapt VR231 Lenham adjustable height commode
MHRA
2009/001/007/401/004
FSCA
2009/03/25
N.A.
N.A.
SN090374
Abbott Xience V Everilimus Eluting Coronary Stent System, 2.5 x
28mm
Abbott Laboratories
LTD.
N.A.
2009/03/25
2593 2211
SN090375
BD PrepStain System (Model no.: 799-14000-00)
FDA
Z-1090-2009
Class II
2009/03/26
BD
2575 8668
SN090376
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
2738 6027
SN090377
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.
SN090378
Biosite Triage Drugs of Abuse Panel (Model No 95000)
FDA
Z-1088-2009
Class II
2009/03/26
Biosite Incorporated
2855 6883
SN090379
BD Insyte Autoguard Shielded IV Catheter
BD
N.A.
2009/03/26
BD
2575 8668
33
SN090380
Boston Scientific Flexima and Percuflex Drainage Catheter Family
(Pigtail Style)
SN090381
GE Mobile Care Server L-WEB05 and iCentral L-NET05
SN090382
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide and
Snap Shunt Ventricular Catheter, BioGlide
SN090383
Novo Nordisk NovofineR Needles 31G, 0.25 mm x 6 mm lot number
08J02S
Boston Scientific
Hong Kong Ltd
N.A.
2009/03/27
2960 7136
MHRA
2008/009/018/601/004
FSCA
2009/03/27
2783 1838
FDA
N.A.
Class I
2009/03/30
2919 1362
MHRA
MDA/2009/021
MDA
2009/03/30
N.A.
N.A.
N.A.
2009/03/30
Astrazeneca Hong Kong Ltd
2491 5206
N.A.
Urgent Safety Information
2009/03/31
Suburfarm Investment & Trading Co.
2780 9421
SN090384
AstraZeneca Nebuchamber
Astrazeneca Hong
Kong Ltd
SN090385
ZOLL AED Plus Defibrillator
Health Canada
34
Monthly Summary of Medical Device Safety Alerts - February 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Medtronic
SN090201 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor
N.A.
2009/02/02
International Ltd
Beckman Coulter UniCel DxC 880i Synchron Access Clinical
SN090202
2009/001/023/601/001
FSCA
2009/02/02
MHRA
Systems
SN090203 Xcelens IDEA 613XC
2009/001/026/291/003
FSCA
2009/02/02
N.A.
MHRA
SN090204
Agent Contact
Telephone No
2919 1350
2240 6150
N.A.
Stryker GAMMA3 Trochanteric Nail 180 Operative Technique
MHRA
2009/001/008/291/002
FSCA
2009/02/02
Stryker China Ltd
2518 6915
SN090205
Activate Patron Bohemia TOM Cross Country Chassis
MHRA
2008/009/016/401/009
FSCA
2009/02/02
N.A.
N.A.
SN090206
James Leckey Advanced, Contoured Advanced, Squiggles Saddle
and Squiggles Early Sitting Seating Sytems
MHRA
2008/011/027/061/008
FSCA
2009/02/02
N.A.
N.A.
SN090207
ThermoFisher BO0471D, 0.1% Peptone Water + 0.85% Salt
MHRA
2009/001/026/601/005
FSCA
2009/02/02
N.A.
N.A.
SN090208
ThermoFisher EB0348D, Maximum Recovery Diluent
MHRA
2009/001/026/601/006
FSCA
2009/02/02
N.A.
N.A.
MHRA
2009/001/028/601/002
FSCA
2009/02/02
Smith & Nephew LTD
N.A.
Johnson & Johnson
Medical (HK)
N.A.
2009/02/03
2738 6027
N.A.
2009/02/03
BD
886-2722-5660
SN090209
SN090210
Smith & Nephew BHR BRIDGING CUP, 66MM PRODUCT CODE
74120366
Johnson and Johnson DePuy Vac-Mix plus pre-packed with
Endurance Bone Cement
SN090211
BD FACS Sample Prep Assistant (SPA or SPA II)
BD
SN090212
GE Centricity PACS RA1000 Workstation
FDA
Z-0836-2009
Class II
2009/02/05
2783 1838
SN090213
iCAD 3TP TheraMap Software and 3TP PrecisionPoint Software
FDA
Z-0653-2009 to Z-0654-2009
Class II
2009/02/05
N.A.
N.A.
SN090214
Virtus Expressaire, Disposable Tourniquet Cuff (Cuff type
A70107010, A70107011)
FDA
Z-0907-2009 to Z-0908-2009
Class II
2009/02/05
N.A.
N.A.
SN090215
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 Ltd.
2802 2900
SN090216
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.
N.A.
SN090217
Coloplast EasiCath intermittent urinary catheters
MHRA
MDA/2009/007
MDA
2009/02/05
N.A.
SN090218
MHRA
MDA/2009/008
MDA
2009/02/09
N.A.
N.A.
MHRA
2009/001/026/291/007
FSCA
2009/02/09
N.A.
N.A.
SN090220
Teleflex Medical Ligating clips
Johnson and Johnson (DePuy) DNP Anatomic Fracture Repair
System
Smith & Nephew Compass PIP Hinge
Smiths & Nephew Ltd
N.A.
2009/02/09
Smiths & Nephew Ltd
9651 5523
SN090221
Doddmed Metrax Primedic HeartSave AED, HeartSave AED-M
MHRA
2008/011/010/061/024
FSCA
2009/02/10
N.A.
N.A.
SN090222
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
BD
886-2722-5660
SN090223
Zimmer Coonrad/Morrey Total Elbow System Surgical Technique
MHRA
2009/002/005/291/017
FSCA
2009/02/10
2992 0968
SN090224
Johnson and Johnson STERRAD 50 Sterilization System
MHRA
2009/001/030/291/010
FSCA
2009/02/10
2738 6027
SN090219
SN090225
ThermoFisher BO0348N Maximum Recovery Diluent
SN090226
Medtronic LIFEPAK 20 Defibrillator / Monitor
MHRA
2009/001/029/601/002
FSCA
2009/02/10
N.A.
N.A.
Medtronic
International Ltd
N.A.
2009/02/11
2919 1362
SN090227
Medtronic O-Arm Intraoperative Imaging System (Catalog no.: BI700-0027)
FDA
Z-0624-2009
Class II
2009/02/12
2919 1362
SN090228
FDA
Z-0670-2009 to Z-0674-2009
Class II
2009/02/12
2866 0811
SN090229
Stryker Restoration Modular Conical Distal Stem, Titanium Alloy
(Catalog no 6276-7-017 (17mm); 6276-7-014 (14mm))
FDA
Z-0884-2009
Class II
2009/02/12
Stryker China Ltd
2518 6915
35
SN090230
Stryker various modular components
FDA
Z-0888-2009 to Z-0902-2009
Class II
2009/02/12
Stryker China Ltd
2518 6915
SN090231
Biomet MicrofixationLactosorb System (REF: 915-1006); Lactosorb,
Office Fixation Kit (REF: 915-1000); MF Set (REF: 01-6871); Office
System (REF: 01-6851)
FDA
Z-0864-2009 to Z-0867-2009
Class II
2009/02/12
N.A.
N.A.
SN090232
Activate Hi-Lo Powered Wheelchair
MHRA
2008/010/001/061/003
FSCA
2009/02/12
N.A.
N.A.
SN090233
Invacare Flamingo Hoist
MHRA
2009/001/022/301/001
FSCA
2009/02/12
N.A.
N.A.
SN090234
SN090235
Mecall UNISTAT L floor stand
Vitech Scientific Starrsed Compact Interrliner
2008/012/030/401/007
2008/007/023/401/007
FSCA
FSCA
2009/02/12
2009/02/12
N.A.
N.A.
N.A.
N.A.
SN090236
BrainLAB Radiolucent Spine Reference Clamp
MHRA
MHRA
BrainLAB Ltd
N.A.
2009/02/12
BrainLAB Ltd
2417 1881
SN090237
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
SN090238
Baxter Healthcare Rear Case Assembly For Auto Syringe (Model:
1M8560R)
Health Canada
43803
Type II
2009/02/13
2807 8516
SN090239
Problem Solving Concepts Prosolv Cardiovascular Image and
Information Management
Health Canada
46106
Type II
2009/02/13
N.A.
N.A.
SN090240
Encore Medical Modular Femoral Neck
Health Canada
44847
Type II
2009/02/13
N.A.
N.A.
SN090241
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.
SN090242
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.
SN090243
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
45821
Type II
2009/02/13
2838 8423
SN090244
Medtronic Durepair Dura Regeneration Matrix
Health Canada
45672
Type II
2009/02/13
2919 1362
SN090245
Health Canada
45218
Type II
2009/02/13
N.A.
Health Canada
45219
Type II
2009/02/13
N.A.
SN090247
Bio-Rad Laboratories Bioplex 2200 Detector Calibration Packs
Bio-Rad Laboratories Liquicheck Cardiac Markers Control LT Trilevel (145), Level 1(146), Level 2 (147), Level 3 (148), Trilevel
Minipak (145x)
ThermoFisher BO0351G, Tryptone soya broth, lot number 1066679
MHRA
2009/001/026/601/003
FSCA
2009/02/13
N.A.
N.A.
SN090248
TRB Chemedica Visiol Syringe 20mg/ml
MHRA
2008/012/023/291/008
FSCA
2009/02/13
N.A.
N.A.
SN090246
SN090249
BD Insyte Autogard I.V Catheter
MHRA
2009/001/030/291/009
FSCA
2009/02/16
BD
886-2722-5660
SN090250
Elekta Precise Treatment Table
MHRA
2009/002/011/291/007
FSCA
2009/02/16
N.A.
N.A.
SN090251
BioMerieux Bacteriology culture medium. Chocolate agar +
PolyViteX VCAT3 agar
MHRA
MDA/2009/011
MDA
2009/02/17
Biomerieux China Ltd. (HK office)
2356 7033
SN090252
Mast Laboratories V Factor Catridges
MHRA
2009/002/009/601/001
FSCA
2009/02/18
N.A.
N.A.
SN090253
STAAR Surgical Aquaflow collagen glaucoma drainage device
MHRA
2008/011/024/291/008
FSCA
2009/02/18
N.A.
N.A.
SN090254
Spacelabs Healthcare Blease 700/900 Ventilator
MHRA
2009/002/005/291/006
FSCA
2009/02/18
N.A.
N.A.
SN090255
Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact
Suction Unit
FDA
Z-0863-2009
Class II
2009/02/19
N.A.
N.A.
SN090256
Stryker PainPump (Prodcut no.: 0500-166-025, 0500-166-050, 0500200-000; REF: 500-166-25; 500-166-50, 500-200
FDA
Z-0923-2009 to Z-0925-2009
Class II
2009/02/19
Stryker China Ltd
2518 6915
FDA
Z-0926-2009
Class II
2009/02/19
Stryker China Ltd
2518 6915
FDA
Z-0936-2009
Class II
2009/02/19
Stryker China Ltd
2518 6915
FDA
Z-0928-2009
Class II
2009/02/19
2783 1838
SN090257
SN090258
SN090259
Stryker PainPump 2 Blockaid (REF 575-100)
Stryker AVS AL Spacer Trial Inserter; Non Sterile (Catalog no
48329800)
GE Centricity PACS RA1000 Workstation (for diagnostic image
analysis)
36
SN090260
Siemens Artiste MV Digital Linear Accelerator System equipped with
160 MCL Accessory Holder
FDA
Z-0949-2009
Class II
2009/02/19
2810 7533
SN090261
AGFA IMPAX Cardiovascular Polling Procedure version 1.00.09
FDA
Z-0945-2009
Class II
2009/02/19
2555 9421
SN090262
Posey Connecting Straps and Belts/Locking Cuffs
FDA
Z-0934-2009
Class II
2009/02/19
N.A.
N.A.
SN090263
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.
SN090264
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
2724 2032
SN090265
Teleflex Medical CC IAB Catheters/Volume Connectors
MHRA
2009/002/010/291/018
FSCA
2009/02/20
N.A.
N.A.
SN090266
Maquet Heartstring II Proximal Seal System
MHRA
2009/002/013/051/002
FSCA
2009/02/23
2393 9511
SN090267
Blatchford Endolite 30mm Pyramid Adapt
MHRA
2008/009/008/401/012
FSCA
2009/02/23
SN090268
Siemens Sireskop SX and AXIOM Sireskop SD
MHRA
2009/002/013/051/003
FSCA
2009/02/23
2810 7533
SN090269
Tyco Shiley 3.0 Cuffless Paediatric Tracheostomy
MHRA
2009/001/023/291/001
FSCA
2009/02/24
3157 7220
SN090270
Johnson and Johnson (DePuy) Total knee replacement implant
femoral components – PFC SIGMA
MHRA
MDA/2009/016
MDA
2009/02/25
2738 6027
SN090271
Edwards Lifesciences Swan-Ganz Thermodilution Catheters
MHRA
2009/002/018/291/008
FSCA
2009/02/25
N.A.
N.A.
SN090272
Abbott RealTime HIV-1 Assay
MHRA
2009/002/019/291/015
FSCA
2009/02/25
2593 2211
SN090273
ConMed Endoscopic Disposable Polypectomy Snares and
Gastrostomy Feeding Systems - EnTake PEG
MHRA
2009/002/018/291/007
FSCA
2009/02/25
N.A.
N.A.
SN090274
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
2724 2836
SN090275
Boston Scientific Atlantis PV Peripheral Imaging Catheter (Model no
H749364560)
FDA
Z-0837-2009
Class II
2009/02/26
2960 7136
SN090276
Philips M8000-64100 Table Mount
FDA
Z-0817-2009
Class II
2009/02/26
2821 5480
SN090277
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
2810 7533
SN090278
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
2810 7533
SN090279
SN090280
SN090281
Zoll Monitor portion of the LifeVest device (Model no. WCD3000 and
WCD3100)
Ossur 3" Titanium Skull Pin, 3" Ceramic Tip Pin,2 1/4" Ceramic Tip
Pin
Mako Surgical Femoral Array (Model no 0150ARR00001) and Tibial
Array (Model no 0150ARR00002)
FDA
Z-0883-2009
Class II
2009/02/26
N.A.
N.A.
FDA
Z-0594-2009 to Z-0596-2009
Class II
2009/02/26
N.A.
N.A.
FDA
Z-0915-2009
Class II
2009/02/26
N.A.
N.A.
SN090282
Baxter System 1000 and Arena Haemodialysis instruments
MHRA
2009/002/010/291/017
FSCA
2009/02/27
2807 8516
SN090283
Edwards Lifesciences Fem-FlexII Paediatric Catheter
MHRA
2009/002/018/291/010
FSCA
2009/02/27
N.A.
N.A.
SN090284
GE Giraffe Warmer & Panda iRes
MHRA
2009/001/021/601/001
FSCA
2009/02/27
2783 1838
SN090285
Bio-Rad Laboratories Variant II Sytem with CDM 3.5 software, 3.6T
System
Health Canada
46347
Type I
2009/02/27
N.A.
SN090286
Boston Scientific Precision Spinal Cord stimulation system
Health Canada
44523
Type II
2009/02/27
2960 7136
SN090287
Bard Access Ponsky Non-Ballon Gastrostomy tube
Health Canada
42263
Type II
2009/02/27
N.A.
N.A.
37
SN090288
Fresenius Medical Patient On Line
Health Canada
41821
38
Type II
2009/02/27
Fresenius Medical Care Asia Pacific
Ltd.
2802 2900
Monthly Summary of Medical Device Safety Alerts - January 2009
Date of Issue
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
SN090101 Terumo Advanced Perfusion System 1 (Model 801763 and 801764)
Z-0445-2009 to Z-0446-2009
Class II
2009/01/02
FDA
CTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel
SN090102
Z-0476-2009
Class II
2009/01/02
FDA
Harvesting System with VASOVIEW Flexible Endoscopic Tools
FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66Z-0486-2009
Class II
2009/01/02
N.A.
SN090103
FDA
FA-SF)
Smiths Medical Wallace Oocyte Recovery Needles, Oocyte
Z-0593-2009
Class II
2009/01/02
Gold Pacific Enterprises
SN090104
FDA
Recovery sets (Product no. ONS1633LL-750 and ONS1733LL-750)
SN090105 SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)
Z-0524-2009
Class II
FDA
SN090106 Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025)
Z-0480-2009
Class II
2009/01/02
N.A.
FDA
SN090107 Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001)
Z-0500-2009
Class II
2009/01/02
N.A.
FDA
Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation
SN090108
2008/011/028/061/020
FSCA
2009/01/07
Stryker China Ltd
MHRA
Chair Model 6253
SN090109 Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II
2008/012/009/061/007
FSCA
2009/01/07
MHRA
SN090110 ArthroCare Saber 30 with Integrated Cable Wand
2008/012/009/061/003
FSCA
2009/01/08
N.A.
MHRA
EV3 Marathon Flow Directed Micro Catheter Catalog Number 105SN090111
2008/012/009/061/015
FSCA
2009/01/08
N.A.
MHRA
5055
SN090112 GE Centricity Ultra Laboratory System Software
Z-0472-2009
Class II
2009/01/08
FDA
SN090113 Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace
Z-0543-2009 to Z-0545-2009
Class II
FDA
SN090114 Alphatec Spine Novel PEEK VBR XS
Z-0507-2009 to Z-0508-2009
Class II
2009/01/08
N.A.
FDA
SN090115 Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K
Z-0604-2009
Class II
2009/01/08
N.A.
FDA
SN090116 Stryker Leibinger New Generation/Universal Mandibular System
Z-0610-2009
Class II
2009/01/08
Stryker China Ltd
FDA
SN090117 Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator
Z-0617-2009
Class II
2009/01/08
N.A.
FDA
CovaTec Flexi-Seal Fecal Management System Advanced Odor
SN090118
Z-0618-2008
Class II
2009/01/08
N.A.
FDA
Control Kit. Rx only
SN090119 Edwards Lifesciences EndoClamp aortic catheter
Z-0644-2009 to Z-0645-2009
Class II
2009/01/08
N.A.
FDA
SN090120 Hyphen BioMed Biophen Heparin 6 (various lots)
2008/012/003/061/001
FSCA
2009/01/09
N.A.
MHRA
SN090121 Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay
2008/012/023/051/001
FSCA
MHRA
SN090122 Arcomedical Infusion Syramed SP6000 Syringe Pumps
2008/011/005/601/004
FSCA
2009/01/09
N.A.
MHRA
Boston Scientific
SN090123 Boston Scientific Safety and Standard Push PEG Kits
N.A.
2009/01/13
Hong Kong Ltd
Zimmer NexGen® Complete Knee Solution Provisional Articular
SN090124
2008/012/016/061/007
FSCA
2009/01/14
MHRA
Surface
SN090125 ThermoFisher BO0366G Brain heart infusion, lot number 1070312
2008/012/015/601/005
FSCA
2009/01/14
N.A.
MHRA
GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP
SN090126
Z-0341-2009 to Z-0342-2009
Class II
2009/01/14
FDA
Fluoroscopic x-Ray System
Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and
SN090127
Z-0439-2009 to Z-0440-2009
Class II
2009/01/14
N.A.
FDA
RL 01
SN090128 Innovative Implant Sinu-Lift System (Model SLS-1)
Z-0505-2009
Class II
2009/01/14
N.A.
FDA
SN090129 Biomet Compress Instrument Anchor Plug Holders
Z-0517-2009 to Z-0521-2009
Class II
2009/01/14
N.A.
FDA
Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared
SN090130
Z-0600-2009 to Z-0603-2009
Class II
2009/01/14
N.A.
FDA
and Pro 2000
Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no
Z-0542-2009
Class II
2009/01/14
SN090131
FDA
04522320190)
SN090132 GE Solar 8000M System
Z-0285-2009
Class II
2009/01/14
FDA
SN090133 Siemens CT syngo Dual Energy Viewer (Model 10094833)
Z-0647-2009
Class II
FDA
SN090134 Hitachi CXR4 Computed Tomography Scanner
Z-0608-2009
Class II
2009/01/14
N.A.
FDA
ACIST CVi Angiographic Injection System (Model: CVi Toshiba
SN090135
Z-0643-2009
Class II
2009/01/14
N.A.
FDA
interface Cable)
SN090136 Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX)
Z-0607-2009
Class II
2009/01/14
N.A.
FDA
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate
SN090137
Z-0871-2009
Class II
2009/01/14
FDA
(Ref 6420-01-230)
SN090138 Frontier Medical Repose Mattress and Cushion
2008/009/015/301/001
FSCA
2009/01/15
N.A.
MHRA
39
Agent Contact
Telephone No
2866 0811
2960 7136
N.A.
2544 2602
2810 7533
N.A.
N.A.
2518 6915
2738 6027
N.A.
N.A.
2783 1838
2810 7533
N.A.
N.A.
2518 6915
N.A.
N.A.
N.A.
N.A.
2810 7533
N.A.
2960 7136
2992 0968
N.A.
2783 1838
N.A.
N.A.
N.A.
N.A.
2485 7510
2783 1838
2810 7533
N.A.
N.A.
N.A.
2992 0968
N.A.
SN090139
SN090140
SN090141
SN090142
SN090143
SN090144
SN090145
SN090146
SN090147
SN090148
SN090149
SN090150
SN090151
SN090152
SN090153
SN090154
SN090155
SN090156
SN090157
SN090158
SN090159
SN090160
SN090161
SN090162
SN090163
SN090164
SN090165
SN090166
SN090167
SN090168
SN090169
SN090170
SN090171
SN090172
SN090173
SN090174
SN090175
SN090176
SN090177
SN090178
SN090179
SN090180
SN090181
SN090182
Boston Scientific Stonetome Single-Use Stone Removal Device
Stryker Intouch Bed Model 2130 with positionpro (model: 2130-000000), Intouch Bed Model 2140 with Positionpro (model: 2140-000Biomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office
Fixation Kit, C) 1.5/IMF Small Office Set
Toshiba Aquilion One (TSX-310A/2)
Invacare Careguard Mattress
Medtronic DLP Pericardial / Intracardiac Sump
Philips Easydiagnost Eleva
Convatec Flexi-Seal FMS Advanced Odor Control
KCI Kinair IV
Maquet Maquet Foot Paddle
Philips Multi Diagnostic Eleva-Flat Detector-IM
Stryker Patient Registration Mask (Box of 5)
Coloplast Philips Bougle
Roche Diagnostics Process System Manager
Smith & Nephew Reflection Hip PE Inlay (7174-0250)
Synthes (Canada) Synfix LR, Low Profile U-Joint Driver
KCI Therapulse ATP
Biomerieux Vitek 2 GN Card
Abbott Voyager RX Coronary Dilation Catheter (1011759-08,
1011759-12)
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
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)
St Jude Medical Epicor LP Connecting Cable
BioMerieux Vironostika HIV Uni-Form II Ag/Ab
Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units)
Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay
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
BioMerieux Chocolate PolyViteX VCAT3 agar
Diagnostica Stago STA - Cuvettes
Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H4902
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
Siemens Sentinel Apolipoprotein B
Otto Bock Blizzard Active Wheelchair
Bausch & Lomb Akreos Advanced Optics Aspheric Lens
Maquet SERVO 300A Automode
Philips Pulmonary Toolkit
Medtronic MicroTargetingTM Drive System and Accessories
Boston Scientific
Hong Kong Ltd
N.A.
2009/01/15
2960 7136
Health Canada
45354
Type II
2009/01/15
Stryker China Ltd
2518 6915
Health Canada
43740
Type II
2009/01/15
N.A.
N.A.
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
44879
45093
45468
45433
45051
45500
44983
44908
45115
45314
44820
45263
45120
44999
44650
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
Type II
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
2009/01/15
Direct Health LTD
Medtronic International, Ltd.
Bristol-Myers Squibb (HK) LTD.
N.A.
Stryker China Ltd
Coloplast (HK) LTD
Smith & Nephew LTD
Synthes International Ltd.
N.A.
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
Health Canada
44757
Type II
2009/01/15
2593 2211
Health Canada
44817
Type II
2009/01/15
2821 5480
Health Canada
45310
Type II
2009/01/15
2821 5480
Health Canada
45351
Type II
2009/01/15
Stryker China Ltd
2518 6915
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
2008/012/010/061/001
2008/011/019/061/001
2008/010/002/401/007
2008/012/001/061/004
2008/012/002/291/002
2008/012/015/601/004
2008/010/017/401/001
2008/012/022/051/001
2008/012/001/601/001
2008/012/030/291/017
2008/012/022/601/003
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
2009/001/005/061/005
2008/012/029/301/002
2008/012/019/291/002
2008/012/016/061/001
2008/012/029/291/001
2008/012/030/291/011
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
2009/01/20
2009/01/20
2009/01/20
2009/01/20
2009/01/20
2009/01/20
2009/01/20
2009/01/20
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/22
2009/01/22
N.A.
N.A.
Goodman Medical Supplies Ltd
N.A.
N.A.
N.A.
Healthpro Technology Co. Ltd
N.A.
N.A.
N.A.
Olympus Hong Kong and China Limited
N.A.
N.A.
2356 7033
N.A.
2810 7533
2332 4455
N.A.
N.A.
N.A.
2356 7033
N.A.
2593 2211
2332 4455
N.A.
N.A.
N.A.
2170 5603
2810 7533
N.A.
2213 3371
2393 9511
2821 5480
2919 1300
40
SN090183
SN090184
SN090185
SN090186
SN090187
SN090188
SN090189
SN090190
SN090191
SN090192
SN090193
SN090194
SN090195
SN090196
SN090197
SN090198
SN090199
SN0101100
SN0101101
SN0101102
SN0101103
SN0101104
SN0101105
SN0101106
SN0101107
SN0101108
SN0101109
SN0101110
SN0101111
SN0101112
SN0101113
SN0101114
SN0101115
SN0101116
SN0101117
SN0101118
SN0101119
SN0101120
SN0101121
SN0101122
SN0101123
SN0101124
SN0101125
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)
GE Centricity Enterprise Web 3.0 software
Stryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630G-108) and Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no:
Siemens Ariste MV Digital Linear Accelerator
Dade Behring (a Siemens Company) Dimension EXL Clinical
Chemistry System
Abbott Clinical Chemistry Bilirubin Calibrator
Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE
Cup
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
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
GE OEC 7600 and OEC 7700
Elekta Leksell GainmaPlan / Leksell SurgiPlan
Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade
Roche Hitachi 917 Modular Analytics
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
Siemens Somatom Definition AS
Siemens syngo Workflow MLR
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
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, 0682-000415 and 0682-000-416)
Stryker Dri-Lok Disposable Cannula
Philips Vertical drive brake on patient supports
Philips NeuViz Dual Multi-Slice Computed Tomography (CT)
Scanner System (software)
Accuray CyberKnife Robotic Radiosurgery System
GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ
MHRA
2009/001/013/291/003
FSCA
2009/01/22
MHRA
2009/001/012/301/001
FSCA
2009/01/22
N.A.
2807 8516
N.A.
FDA
N.A.
Class II
2009/01/22
2724 2836
FDA
Z-0870-2009
Class II
2009/01/22
2783 1838
FDA
Z-0869-2009
Class II
2009/01/22
Stryker China Ltd
2518 6915
FDA
Z-0857-2009
Class II
2009/01/22
2810 7533
FDA
Z-0581-2009
Class II
2009/01/22
2810 7533
FDA
FDA
Z-0580-2009
Z-0532-2009 to Z-0539-2009
Class II
Class II
2009/01/22
2009/01/22
2593 2211
2738 6027
FDA
Z-0129-2009
Class II
2009/01/22
2240 6150
FDA
FDA
FDA
FDA
MHRA
MHRA
Z-0873-2009 to Z-0882-2009
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
Class II
MDA
FSCA
2009/01/22
2009/01/22
2009/01/22
2009/01/22
2009/01/23
2009/01/23
N.A.
Accuray Asia Ltd
N.A.
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
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
2008/010/024/401/007
2009/001/009/061/002
2008/012/017/061/006
2009/001/007/061/008
2008/011/026/291/009
2009/001/012/601/001
2009/001/008/061/005
2008/012/023/401/006
2008/012/012/401/010
2008/012/012/291/003
2008/012/022/051/003
2009/001/016/291/004
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
2009/01/23
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
2009/01/29
N.A.
N.A.
Stryker China Ltd
N.A.
N.A.
N.A.
N.A.
Stryker China Ltd
N.A.
2783 1838
N.A.
2518 6915
2485 7510
N.A.
N.A.
N.A.
N.A.
2810 7533
2810 7533
2518 6915
MHRA
2009/001/014/601/004
FSCA
2009/01/29
N.A.
N.A.
MHRA
MHRA
MHRA
MHRA
2009/001/012/291/017
2008/010/017/061/003
2008/010/020/401/012
2009/001/021/291/004
FSCA
FSCA
FSCA
FSCA
2009/01/29
2009/01/29
2009/01/29
2009/01/29
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2821 5480
Coloplast (HK) Ltd
N.A.
2009/01/30
Coloplast (HK) LTD
3628 7428
Bausch & Lomb
N.A.
2009/01/30
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
FDA
Z-0868-2009
Z-0597-2009
Class II
Class II
2009/01/30
2009/01/30
Stryker China Ltd
2518 6915
2821 5480
FDA
Z-0001-2009
Class II
2009/01/30
2821 5480
FDA
FDA
Z-0629-2009
Z-0473-2009 to Z-0475-2009
Class II
Class II
2009/01/30
2009/01/30
Accuray Asia Ltd
2247 8628
2783 1838
41
SN0101126
SN0101127
SN0101128
SN0101129
SN0101130
SN0101131
SN0101132
SN0101133
SN0101134
SN0101135
SN0101136
SN0101137
SN0101138
SN0101139
SN0101140
SN0101141
SN0101142
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)
Ansell Healthcare Products Conform XT - Gloves (Model: 69318)
Ossur HF ReSolve Open Back Halo Ring
Maquet Reservoirs (BEQ-VHK 2001)
Styker Dri-Lok Disposable Cannulas
BHM Medical Ergolift, Ergolift-2
Roche Diagnostics Process System Manager (Model: 3009696001)
Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K)
Harvest Technologies Autologous Platelet Concentrate System
(Model: APC-201)
Philips A) Multidiagnost Eleva - Image Intensifier (70832), B)
Multidiagnost Eleva - Flat Detector (70834), C) Omnidiagnost Eleva
White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ
Zirconia Disc
MC Healthcare Products QP2508 Hand Pendant (Model: HB43U010-00/01
Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500415)
FDA
FDA
FDA
FDA
FDA
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
Z-0615-2009 to Z-0616-2009
Z-0626-2009
Z-0598-2009
Z-0513-2009 to Z-0516-2009
Z-0506-2009
45563
45100
45565
45616
45626
45358
41402
Class II
Class II
Class II
Class II
Class II
Type II
Type II
Type II
Type II
Type I
Type I
Type II
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Stryker China Ltd
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2393 9511
2518 6915
2508 1416
2485 7510
2807 8516
Health Canada
45706
Type II
2009/01/30
N.A.
N.A.
Health Canada
45311
Type II
2009/01/30
2821 5480
Health Canada
44705
Type II
2009/01/30
N.A.
N.A.
Health Canada
45786
Type II
2009/01/30
N.A.
N.A.
Health Canada
45802
Type II
2009/01/30
N.A.
N.A.
42
Device Safety Alerts - December 2008
s and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Source of
Information*
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-Dec-08
N/A
N/A
SN081202
Liko LikoScale 200
MHRA
2008/005/029/401/009
FSCA
01-Dec-08
N/A
N/A
SN081203
Diamed ID DiaScreen Prophylax
MHRA
2008/011/021/061/012
FSCA
01-Dec-08
DIAMED-CHINA LTD.
251 262 38
SN081204
ThermoFisher Staphaurex Plus
MHRA
2008/011/024/601/002
FSCA
01-Dec-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-Dec-08
Philips Healthcare - Great China
2821 5480
SN081206
Zimmer Silhouette Axial Torque Wrench
MHRA
2008/011/021/061/010
FSCA
01-Dec-08
2992 0968
SN081207
Edwards Lifesciences Aquarius software operating manuals
MHRA
2008/011/024/291/007
FSCA
01-Dec-08
N/A
N/A
SN081208
Siemens Syngo Dynamics version 4.2, 5.x, 6.0
MHRA
2008/009/008/061/001
FSCA
02-Dec-08
2810 7533
SN081209
Integra LifeSciences Uni-CP Compression Forceps (Spreader)
(Catalog no 339001ND)
FDA
Z-0307-2009
Class II
04-Dec-08
N/A
N/A
SN081210
Boston Scientific RF Ablation System Foot Switch
Boston Scientific
Hong Kong Ltd
N/A
05-Dec-08
2960 7136
SN081211
Boston Scientific Flextome Cutting Balloon w/Over-the-Wire Delivery
System
Boston Scientific
Hong Kong Ltd
N/A
05-Dec-08
2960 7136
SN081212
Johnson and Johnson ENDOPATH Electrosurgery Probe Plus II
Johnson & Johnson
Medical (HK)
N/A
05-Dec-08
2738 6027
SN081213
Medtronic EnTrust® Implantable Cardioverter Defibrillators
MHRA
2008/011/021/061/005
FSCA
08-Dec-08
2907 5911
SN081214
Otto Bock Healthcare 3R66 – Modular Polycentric Knee Joint
MHRA
2008/011/006/301/001
FSCA
08-Dec-08
N/A
N/A
SN081215
Varian Linear accelerators other than Clinac
Varian Medical
N/A
10-Dec-08
2722 8123
SN081216
GE Healthcare CT/e and HiSpeed X/I families of Computed
Tomography systems
GE Medical Systems
Hong Kong Ltd.
N/A
10-Dec-08
2783 1888
SN081217
Baxter COLLEAGUE Triple Channel Mono, and CXE Volumetric
Infusion Pumps 2M8153K and 2M9163
MHRA
2008/011/028/061/015
FSCA
15-Dec-08
2807 8555
SN081218
AMO Healon D Ophthalmic Viscosurgical Device (Lot No. UD30654)
FDA
Z-0343-2009
Class I
15-Dec-08
AMO Asia Limited
2480 3330
SN081219
Integra NeuroSciences Gravity Compensating Accessory
FDA
Z-0458-2009
Class I
15-Dec-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-Dec-08
N/A
N/A
SN081221
Siemens AXIOM Artis System
FDA
Z-0312-2009 to Z-0317-2009
Class II
15-Dec-08
2810 7533
SN081222
Siemens syngo MultiModality WorkPlace (MM WP), software product
(Model No 10140720)
FDA
Z-0324-2009
Class II
15-Dec-08
2810 7533
SN081223
Terumo Sarns Sternal Saw II System Power Unit
FDA
Z-0358-2009 to Z-0359-2009
Class II
15-Dec-08
2529 0451
43
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-Dec-08
2907 5911
FDA
Z-0484-2009
Class II
15-Dec-08
2738 6027
SN081226
Radiometer Calibrator 1 Solution for the ABL700 Series
FDA
Z-0457-2009
Class II
15-Dec-08
N/A
N/A
SN081227
Cardinal Health GSI Audera (version 2.6 Software) System
FDA
Z-0195-2009
Class II
15-Dec-08
N/A
N/A
SN081228
Stryker Pain Pump 2 Blockaid (0575-100-000)
Health Canada
44921
Type II
17-Dec-08
Stryker China Ltd
2518 6988
SN081229
Smiths Medical Disposable Norothermic IV Admin. Sets (DI-100, DI50)
Health Canada
44870
Type II
17-Dec-08
Smiths Medical (S.E. Asia) Ltd.
2317 0988
SN081230
Oxoid Filteredhorse Serum (SR0035C)
Health Canada
44449
Type II
17-Dec-08
South East Chemical & Instrument Ltd
28026333
SN081231
BHM Battery Model NDA 0200-20
Health Canada
45060
Type II
17-Dec-08
BHM Medical Inc.
N/A
SN081232
Technidata TD-Synergy Software (TD-SYS-01)
Health Canada
44744
Type II
17-Dec-08
N/A
N/A
SN081233
Orasure Intercept Mirco-Plate EIA Kit (Model: 61452, 61454, 61456)
Health Canada
44505
Type II
17-Dec-08
N/A
N/A
SN081234
Hill-Rom Liko Uno 100, 101, 102 Patient Lift
Health Canada
44701
Type II
17-Dec-08
N/A
N/A
Health Canada
44646
Type II
17-Dec-08
N/A
N/A
Health Canada
44525
Type II
17-Dec-08
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-Dec-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-Dec-08
2240 6150
SN081239
Siemens CT Syngo Dual Energy Viewer
MHRA
2008/010/031/061/006
FSCA
17-Dec-08
2810 7533
SN081240
Fresenius Medical Care 5008 dialysis machine
MHRA
2008/012/001/061/001
FSCA
17-Dec-08
N/A
N/A
SN081241
Smiths Medical Deltec Cozmo Insulin Pump Model number 1800
MHRA
2008/011/027/061/013
FSCA
17-Dec-08
2317 0988
SN081242
Terumo Sarns Level Sensor II Pads (Ref 195240)
FDA
Z-0311-2009
Class II
18-Dec-08
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-Dec-08
2866 0811
SN081244
GE Centricity PACS RA1000 Workstation
FDA
Z-0460-2009
Class II
18-Dec-08
2783 1888
SN081245
Siemens Dade Behring Dimension Enzymatic Creatinine Flex
reagent cartridge, DF270
FDA
Z-0485-2009
Class II
18-Dec-08
2810 7533
SN081246
Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit
FDA
Z-0414-2009
Class II
18-Dec-08
N/A
N/A
SN081247
Acumed Modular Shoulder Body Assembly
FDA
Z-0477-2009
Class II
18-Dec-08
N/A
N/A
SN081248
Promega RNAgents Total RNA Isolation System (Cat. #Z5110)
FDA
Z-0483-2009
Class II
18-Dec-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-Dec-08
2907 5911
SN081250
Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades
FDA
N/A
Class I
22-Dec-08
N/A
N/A
SN081237
44
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
22-Dec-08
Bard Pacific Health Care Co Ltd
886-2-2503-1900
N/A
23-Dec-08
2907 5911
MHRA
MDA/2008/088
MDA
23-Dec-08
N/A
N/A
FDA
N/A
Class I
29-Dec-08
Stryker China Ltd
2518 6988
FDA
Z-0338-2009
Class II
30-Dec-08
2960 7136
FDA
Z-0412-2009 to Z-0413-2009
Class II
30-Dec-08
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
SN081257
Beckman Coulter Vidiera NsP Nucleic Sample Preparation
FDA
Z-0454-2009
Class II
30-Dec-08
2240 6150
SN081258
Alfa Wassermann ACE and ACE Alera Hemoglobin A1C
FDA
Z-0482-2009
Class II
30-Dec-08
N/A
N/A
SN081259
FHC MicroTargeting Electrode
FDA
Z-0497-2009 to Z-0498-2009
Class II
30-Dec-08
N/A
N/A
SN081260
Arjo Maxi Move, Model NDA0200-20 Batteries Pack
FDA
Z-0503-2009
Class II
30-Dec-08
2508 9553
SN081261
Bk Medical Single-use sterile puncture attachment UA1256-U
FDA
Z-0504-2009
Class II
30-Dec-08
N/A
N/A
SN081262
Boston Scientific Convoy Advanced Delivery Sheath Kits
Boston Scientific
Hong Kong Ltd
N/A
30-Dec-08
2960 7136
SN081263
Boston Scientific Gold Probe Single-Use Bi-Polar Electrohemostasis
Catheters
Boston Scientific
Hong Kong Ltd
N/A
30-Dec-08
2960 7136
SN081264
Wescott Medical Sae-Flo MD Extension Set with Y-Connector
MHRA
2008/010/022/601/001
FSCA
31-Dec-08
N/A
N/A
SN081265
Siemens Leonardo Workstation
MHRA
2008/004/010/061/006
FSCA
31-Dec-08
2810 7533
SN081266
Biotronik EDP 30/A
MHRA
2007/002/007/401/009
FSCA
31-Dec-08
N/A
N/A
45
Device Safety Alerts - November 2008
MDCO Ref.
No.
Source of
Information*
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
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
2008/11/05
Abbott Laboratories Ltd.
2593 2211
SN081112
Tyco Healthcare (Covidien) ReliOn Insulin Syringes
FDA
N/A
Press Release
2008/11/06
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
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
FDA
Z-0163-2009
Class II
2008/11/07
2810 7533
FDA
Z-0086-2009
Class II
2008/11/07
2810 7533
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
SN081117
Siemens Coherence Therapist Systems
FDA
Z-0089-2009 to Z-0099-2009
Class II
2008/11/07
2810 7533
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
2810 7533
SN081119
Siemens Acuson X300 Ultrasound Systems (Model no. 10037409,
10038837, 10348531, 10132987, 10133170, 10348532, 10348533)
FDA
Z-0111-2009
Class II
2008/11/07
2810 7533
SN081120
Siemens Artiste MV System (Part no 8139789)
FDA
Z-0116-2009
Class II
2008/11/07
2810 7533
SN081121
Stryker Osteosynthesis Reduction Spoon (Product Code 1806-0125)
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
46
SN081123
GE Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision Software
FDA
Z-0112-2009
Class II
2008/11/10
2783 1838
SN081124
Baxter Auto Syringe AS50 Infusion Pump (Product Code 1M8550)
FDA
Z-0152-2009
Class II
2008/11/10
2807 8500
SN081125
Roche Diagnostic LDL_C, IRON2, CREP2, STFR, HDLC3, ALBT2,
NAPA2
FDA
Z-0006-2009 to Z-0012-2009
Class II
2008/11/10
2485 7510
SN081126
Roche/Hitachi Modular E Module immunoassay analyzer (GMMI
Nos. 04998642001 and 03617505001)
FDA
Z-0165-2009
Class II
2008/11/10
2485 7510
SN081127
Philips Respiratory Gating System (Model # 455011203131 and
455011203191)
FDA
Z-0132-2009
Class II
2008/11/10
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
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
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
Tosoh Bioscience TSKgel G8 Variant HSi
MHRA
2008/011/003/061/010
FSCA
2008/11/10
N/A
N/A
SN081143
Roche Diagnostics MODULAR ANALYTICS Software version 08.03
MHRA
2008/010/030/061/016
FSCA
2008/11/10
2485 7510
SN081144
Siemens Syngo Imaging
MHRA
2008/010/031/061/003
FSCA
2008/11/10
2810 7533
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
47
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
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
2781 0232
SN081152
Maquet Pedal 1009.81 for operating tables
MHRA
2008/011/003/061/013
FSCA
2008/11/12
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
2332 4455
SN081159
Siemens AG Syngo Imaging (Model 10014063)
Health Canada
44245
Type II
2008/11/14
2810 7533
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
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
2332 4455
SN081166
GE Centricity PACS Software
Health Canada
42408
Type II
2008/11/14
2783 1838
SN081167
Medtronic Synchromed EL, Synchromed II infusion pumps
Health Canada
44005
Type II
2008/11/14
2907 5911
SN081168
Health Canada
42752
Type II
2008/11/14
2866 0811
SN081169
Synthes sternal Fixation System - Cable Ferrule
Health Canada
44393
Type II
2008/11/14
N/A
N/A
SN081170
Siemens Somatom Sensation / Cardiac 64
Health Canada
44298
Type II
2008/11/14
2810 7533
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
2866 0811
SN081174
TomoTherapy Hi-Art System
Health Canada
44265
Type II
2008/11/14
N/A
N/A
48
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
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
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
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
2866 0811
SN081193
Siemens AXIOM Artis and Artis zee
FDA
Z-0193-2009 to Z-0194-2009
Class II
2008/11/17
2810 7533
SN081194
Animas (Johnson & Johnson ) One Touch Ping Glucose Monitoring
System
FDA
Z-0283-2009
Class II
2008/11/17
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
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
49
SN0811100
B Braun Diacap Ultra Dialysis Fluid and Online Filter, 7107366 and
7107365
SN0811101 Stryker V40 ORTHINOX femoral head 28/-4 mm & 28/0 mm
MHRA
2008/010/007/061/011
FSCA
2008/11/18
2277 6125
MHRA
2008/010/030/061/008
FSCA
2008/11/18
Stryker China Ltd
2518 6988
Johnson & Johnson
Medical (HK)
N/A
2008/11/19
2738 6027
N/A
2008/11/19
2807 8516
SN0811104 Beckman Coulter Power Processor with LX Connections, 6605741
MHRA
2008/011/005/601/001
FSCA
2008/11/20
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
2960 7136
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
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
2821 5480
SN0811115 GE Giraffe OmniBed (Cleaning & Care Guidelines)
MHRA
2008/011/018/601/002
FSCA
2008/11/24
2783 1838
SN0811113
SN0811116 Phadia Varelisa U1RNP Antibodies Kit (model 17096)
Health Canada
44383
Type II
2008/11/24
N/A
N/A
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
Foxwood Medical Supplies
2770 6877
SN0811119 Smiths Potex Blue Line Ultra Tracheostomy Kit (Model 100/812/070)
Health Canada
44440
Type II
2008/11/24
2317 0988
SN0811120 Siemens Symbia T Series (Model 10275009)
Health Canada
44551
Type II
2008/11/24
2810 7533
Health Canada
44535
Type II
2008/11/24
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
2738 6027
FDA
Z-2388-2008
Class II
2008/11/28
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
2866 0811
Abbott CELL-DYN Sapphire Hematology Analyzer (List no 08H00SN0811126
01, 08H00-03)
FDA
Z-0306-2009
Class II
2008/11/28
2593 2211
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
50
SN0811127
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
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
51
Monthly Summary of Medical Device Safety Alerts - October 2008
MDCO Ref.
No.
Medtronic INDURA 1P Intrathecal Catheter (Model 8709SC),
Intrathecal Catheter (Model 8731SC), Sutureless Pump Connector
SN081001
Revision Kit (Model 8678) and Intrathecal Catheter Pump Segment
Revision Kit (Model 8596SC)
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
FDA
Z-2380-2008 to Z-2383-2008
Class I
02-Oct-08
2907 5911
SN081002
Medtronic IsoMed Refill Kit (Model 8553)
FDA
Z-1903-2008
Class II
02-Oct-08
2907 5911
SN081003
Stryker Osteonics Scorpio Total Knee
FDA
Z-2079-2008
Class II
02-Oct-08
Stryker China Ltd
2518 6988
SN081004
Stryker Hoffman II compact Sterile Wrist Kit
FDA
Z-2080-2008
Class II
02-Oct-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-Oct-08
Stryker China Ltd
2518 6988
SN081006
GE Healthcare Definium 8000 Digital Radiographic System
FDA
Z-1822-2008
Class II
02-Oct-08
2783 1838
SN081007
GE Healthcare Definium 8000 Digital Radiographic System
FDA
Z-1882-2008
Class II
02-Oct-08
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-Oct-08
2783 1838
SN081009
GE OEC 9600 C-arm Fluoroscopy System
FDA
Z-1709-2008
Class II
02-Oct-08
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-Oct-08
2783 1838
SN081011
Siemens Radiation Therapy Systems
FDA
Z-2095-2008 to Z-2104-2008
Class II
02-Oct-08
2810 7533
SN081012
Siemens Ultrasound Transducer 17L5HD
FDA
Z-2230-2008
Class II
02-Oct-08
2810 7533
SN081013
Accuray CyberKnife Ronotic Radiosurgery System radiation therapy
device
FDA
Z-2056-2008
Class II
02-Oct-08
Accuray Asia Ltd
2247 8628
SN081014
Varian VariSource CT/MR Ring & Tandem Applicator Set
FDA
Z-2081-2008
Class II
02-Oct-08
2724 2836
SN081015
Smith & Nephew TRIGEN Hind Foot Fusion Nail
FDA
Z-2082-2008 to Z-2088-2008
Class II
02-Oct-08
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-Oct-08
N/A
N/A
2645 8703
SN081017
Naviscan PEM Flex Solo II PET Scanner
FDA
Z-2229-2008
Class II
02-Oct-08
N/A
N/A
SN081018
Biogenex Laboratories Xmatrx FISH Automated Staining System
FDA
Z-1471-2008
Class II
02-Oct-08
N/A
N/A
SN081019
Abbott Total Bilirubin
MHRA
2008/009/018/601/005
FSCA
02-Oct-08
2806 4021
SN081020
Immucor Galileo Echo
MHRA
2008/009/022/061/013
FSCA
02-Oct-08
N/A
N/A
SN081021
ConMed VCareR Uterine Manipulators
MHRA
2008/009/002/061/001
FSCA
02-Oct-08
N/A
N/A
SN081022
Sendal 3101-TJ Transfusion Set
MHRA
2008/009/011/061/010
FSCA
02-Oct-08
N/A
N/A
52
SN081023
Diagnostica Stago (STA) Neoplastine CI (Plus) 10
MHRA
2008/009/025/061/010
FSCA
02-Oct-08
Healthpro Technology Co. Ltd
N/A
SN081024
Spacelabs Ultraview Digital Telemetry Reciever, model 90478
MHRA
2008/008/014/061/012
FSCA
02-Oct-08
N/A
N/A
SN081025
ThermoFisher Tryptone soya broth BO0351G
MHRA
2008/009/023/601/003
FSCA
02-Oct-08
N/A
N/A
SN081026
Nebion, LLC HLX-8 Magnetic Resonance Device
FDA
N/A
Class I
06-Oct-08
N/A
N/A
SN081027
Kimal K-Flow access catheters
MHRA
2008/008/026/401/004
FSCA
06-Oct-08
N/A
N/A
SN081028
Draeger Zeus Anaesthetic machines software version 4.01
MHRA
2008/009/015/051/009
FSCA
06-Oct-08
2877 3077
SN081029
GENICON 5 mm Pyramidal Trocars
MHRA
2008/009/026/061/009
FSCA
06-Oct-08
N/A
N/A
SN081030
GE Healthcare Aisys Anaesthesia machine
MHRA
2008/009/025/061/011
FSCA
06-Oct-08
2783 1838
SN081031
Remploy Access and Accent attendant propelled wheelchairs
MHRA
MDA/2008/070
MDA
08-Oct-08
N/A
N/A
SN081032
Park House Alternating air mattress pumps models PHP198,396,
398 and 399
MHRA
MDA/2008/071
MDA
08-Oct-08
N/A
N/A
SN081033
Hoggi BINGO Rehab Pushchair
MHRA
2008/005/030/061/019
FSCA
08-Oct-08
N/A
N/A
SN081034
Sunrise Medical Breezy Moonlite Wheelchairs
MHRA
2008/005/028/401/006
FSCA
08-Oct-08
N/A
N/A
SN081035
Hologic: ATEC 1212-20 Handpieces
MHRA
2008/009/026/061/014
FSCA
09-Oct-08
N/A
N/A
SN081036
ThermoFisher Columbia Blood Agar, PB0122A
MHRA
2008/010/002/601/002
FSCA
09-Oct-08
N/A
N/A
SN081037
Siemens Medical Solutions Diagnostics ADVIA Chemistry Controls 1
and 2
MHRA
2008/010/001/061/008
FSCA
09-Oct-08
2810 7533
SN081038
Abbott ClearStar model number M771
MHRA
2008/010/001/061/012
FSCA
09-Oct-08
2806 4021
SN081039
Baxter FLOGARD 6201 Volumetric Infusion Pump (Product Code
2M8063)
N/A
Firm Initiated Field
Action
10-Oct-08
2807 8500
SN081040
NeoMedix Trabectome I/A Console, Model Number 550014, surgical
aspirator
FDA
Z-0071-2008
Class II
13-Oct-08
N/A
N/A
SN081041
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
FDA
Z-0368-2008
Class II
13-Oct-08
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-Oct-08
2783 1838
FDA
Z-1547-2008
Class II
13-Oct-08
N/A
N/A
FDA
Z-1692-2008
Class II
13-Oct-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-Oct-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-Oct-08
2810 7533
SN081047
Siemens Medical Solutions, Mevatron Digital Linear Accelerator
FDA
Z-1753-2008 to Z-1763-2008
Class II
13-Oct-08
2810 7533
SN081048
X-STOP Interspinous Process Decompression (lPD) System
FDA
Z-1765-2008
Class II
13-Oct-08
N/A
N/A
53
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-Oct-08
2783 1838
SN081050
Cook Vital Port Vascular Access System Polysulfone Petite
FDA
Z-2190-2008 to Z-2191-2008
Class II
13-Oct-08
2781 0232
SN081051
Brainlab VectorVision (VV) Sky Navigation Platform
FDA
Z-2209-2008
Class II
13-Oct-08
BrainLAB Ltd. (Hong Kong)
FDA
Z-2213-2008 to Z-2214-2008
Class II
13-Oct-08
N/A
N/A
FDA
Z-2219-2008 to Z-2224-2008
Class II
13-Oct-08
N/A
N/A
FDA
Z-2235-2008
Class II
13-Oct-08
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-Oct-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-Oct-08
2821 5480
SN081057
Varian Medical Systems Eclipse device, model H48, Version 6.5
FDA
Z-2308-2008
Class II
13-Oct-08
2724 2836
FDA
Z-2329-2008
Class II
13-Oct-08
N/A
N/A
FDA
Z-2347-2008
Class II
13-Oct-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-Oct-08
N/A
N/A
SN081061
Boston Scientific Platinum Plus Guidewire
FDA
Z-2362-2008 to Z-2365-2008
Class II
13-Oct-08
2960 7136
SN081062
BD Ace Heat Therapy
FDA
Z-2431-2008
Class II
13-Oct-08
N/A
N/A
SN081063
Zimmer Universal Optical Tracker Fixation, not sterile, REF 111.031
FDA
Z-2445-2008
Class II
13-Oct-08
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-Oct-08
SN081065
Siemens SOMATOM Emotion 6 and Emotion 16 Computed
tomography X-ray system
FDA
Z-2452-2008 to Z-2453-2008
Class II
13-Oct-08
2810 7533
SN081066
ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500
FDA
Z-2458-2008
Class II
13-Oct-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-Oct-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-Oct-08
N/A
N/A
SN081069
BD Anaesthesia Kits and Epidural Filter
MHRA
2008/010/006/061/006
FSCA
14-Oct-08
2575 8668
SN081070
GE Healthcare Advantage Workstation Suite-Card IQ
MHRA
2008/010/006/061/010
FSCA
14-Oct-08
2783 1838
2645 8703
SN081071
GE Healthcare AMX Series Mobile RAD System(AMX 4 and AMX 4+
MHRA
2008/010/002/061/004
FSCA
14-Oct-08
2783 1838
SN081072
Thomas Medical Products SafetSheath family
MHRA
2008/009/029/061/018
FSCA
14-Oct-08
N/A
N/A
SN081073
ThermoFisher Xpect Giardia/ Cryptosporidium Kit
MHRA
2008/008/014/061/008
FSCA
14-Oct-08
N/A
N/A
SN081074
CASMED 500cc Single Patient Use Infusion Cuffs
MHRA
2008/010/001/061/001
FSCA
14-Oct-08
N/A
N/A
SN081075
Boston Scientific Atlantis PV 15 MHz Imaging Catheter
Boston Scientific
Hong Kong Ltd
N/A
Action
15-Oct-08
2960 7136
54
Boston Scientific
Hong Kong Ltd
Medtronic
International Ltd
N/A
Action
Action
15-Oct-08
2960 7136
15-Oct-08
2907 5911
Class II
16-Oct-08
N/A
N/A
Z-1931-2008 to Z-2001-2008
Class II
16-Oct-08
N/A
N/A
FDA
Z-1896-2008 to Z-1900-2008
Class II
16-Oct-08
N/A
N/A
ArthroCare ArthroWand Covator with Integrated Cable Wand
(Catalog no AC4340-01)
FDA
Z-2309-2008
Class II
16-Oct-08
ArthoCare Asia Pacific
2159 7436
SN081082
Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00
FDA
Z-2314-2008
Class II
16-Oct-08
N/A
N/A
SN081083
Propper short gas-chex EO sterilization indicators (Recorder no
269001)
FDA
Z-2330-2008
Class II
16-Oct-08
N/A
N/A
SN081084
Oscor Permanent Pacing Lead
FDA
Z-2333-2008
Class II
16-Oct-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-Oct-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-Oct-08
N/A
N/A
SN081087
Stryker Rejuvenate Broach
FDA
Z-2349-2008
Class II
16-Oct-08
Stryker China Ltd
2518 6988
FDA
Z-2007-2008
Class II
16-Oct-08
Stryker China Ltd
2518 6988
FDA
Z-2310-2008
Class II
16-Oct-08
AMO Asia Limited
2480 3330
FDA
Z-2305-2008
Class II
16-Oct-08
2806 4021
FDA
Z-2212-2008
Class II
16-Oct-08
2810 7533
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
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)
SN081090
Abbott Flexiflo Quantum Pump Set (List # 50604)
SN081091
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)
SN081096
SN081092
N/A
FDA
Z-2241-2008
Class II
16-Oct-08
2907 5911
FDA
Z-2356-2008 to Z-2361-2008
Class II
16-Oct-08
2783 1838
FDA
Z-2145-2008
Class II
16-Oct-08
2783 1838
FDA
Z-1883-2008
Class II
16-Oct-08
2783 1838
GE Datex-Ohmeda Engstrom Carestation
FDA
Z-1829-2008
Class II
16-Oct-08
2783 1838
SN081097
GE Proteus XR/a Eclipse Collimator (Model # 2379827)
FDA
Z-1713-2008
Class II
16-Oct-08
2783 1838
SN081098
GE Precision 500D and Advantx Legacy Radiographic and
Fluoroscopic systems
FDA
Z-1610-2008 to Z-1611-2008
Class II
16-Oct-08
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-Oct-08
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-Oct-08
2783 1838
SN0810101
Siemens Dimension Clinical Chemistry System - Enzymatic
Creatinine Flex Reagent Cartridge DF270
MHRA
2008/010/007/061/010
FSCA
17-Oct-08
2810 7533
SN081093
SN081094
55
SN0810102
Spacelabs Healthcare 90496 and 91496 Command Module NIBP
Option
MHRA
2008/010/003/061/005
FSCA
17-Oct-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-Oct-08
2738 6027
SN0810104
Varian C-Series Clinac Linear Accelerator
Health Canada
44028
Type I
17-Oct-08
27242836
SN0810105
Varian Acuity, Ximatron
Health Canada
43747
Type I
17-Oct-08
27242836
SN0810106
Immucor Galileo / Capture-R Ready test wells
Health Canada
43677
Type I
17-Oct-08
N/A
N/A
SN0810107
Immucor Galileo Echo / CaptureR Ready Scrn strip
Health Canada
43678
Type I
17-Oct-08
N/A
N/A
SN0810108
Ferno 35-A Mobile Transporter
Health Canada
43920
Type II
17-Oct-08
2332 4455
SN0810109
Anspach effort A) 12.6mm Boring Tool, B) 9.5mm Boring Tool
Health Canada
43458
Type II
17-Oct-08
N/A
N/A
SN0810110
Cardinal Health Custom Sterile Procedure Pack
Health Canada
43591
Type II
17-Oct-08
N/A
N/A
SN0810111
Sirona Dental System GMBH Galileos 3D X-Ray with Galaxis 1.5
Health Canada
43380
Type II
17-Oct-08
N/A
N/A
SN0810112
Siemen Axiom Artis, Axiom Artis DMP
Health Canada
43745
Type II
17-Oct-08
2810 7533
SN0810113
Roche Cobas Integra System-Smphetamines, Roche Hitachi-Online
Amphetamines
Health Canada
43716
Type II
17-Oct-08
2485 7510
SN0810114
Welch Allyn Fiber Optic Sigmoidoscope, Insufflation Bulbs
Health Canada
43629
Type II
17-Oct-08
2764 5208
SN0810115
Cybernius Medical Nepfrocare Software
Health Canada
43736
Type II
17-Oct-08
N/A
N/A
SN0810116
Biomerieux Oberva Data Management System
Health Canada
42986
Type II
17-Oct-08
Biomerieux China Ltd (HK)
2356 7033
SN0810117
Stryker Communication Ophit DVI Extender
Health Canada
43879
Type II
17-Oct-08
Stryker China Ltd
2518 6988
SN0810118
Immco Diagnostic West Nile Virus IGG Indirect Elisa
Health Canada
43722
Type II
17-Oct-08
N/A
N/A
SN0810119
Griener Bio One Vacuette Lithium Heparin Blood Collection Tube
Health Canada
43583
Type II
17-Oct-08
Mekim Ltd
2774 8300
Bausch & Lomb
(Hong Kong) Limited
N/A
Action
21-Oct-08
2213 3371
SN0810120
SN0810121
SN0810122
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
MHRA
2008/010/007/601/002
FSCA
23-Oct-08
N/A
N/A
MHRA
2008/010/010/061/004
FSCA
23-Oct-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-Oct-08
N/A
N/A
SN0810124
Radiometer ABL700 Series Calibration 1 Solution
MHRA
2008/009/008/061/002
FSCA
23-Oct-08
N/A
N/A
N/A
SN0810125
Nucletron Oncentra Prostate System (with option CT/MRI imaging)
MHRA
2008/006/027/401/003
FSCA
23-Oct-08
N/A
SN0810126
BD Vacutainer Blood Collection Tubes
MHRA
2008/009/006/601/001
FSCA
23-Oct-08
Homecraft Rolyan 2” and 4” Savanah raised toilet seats
MHRA
MDA/2008/075
MDA
24-Oct-08
N/A
N/A
MHRA
MDA/2008/076
MDA
24-Oct-08
N/A
N/A
24-Oct-08
2960 7136
24-Oct-08
2960 7136
27-Oct-08
SN0810127
SN0810128
SN0810129
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)
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
FDA
N/A
N/A
Z-2462-2008
56
Action
Action
Class II
SN0810132
Philips Ultraview Digital Telemetry Transmitter (Model 91341-09)
FDA
Z-2336-2008
Class II
27-Oct-08
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-Oct-08
2992 0968
FDA
Z-2339-2008
Class II
27-Oct-08
N/A
N/A
FDA
Z-2370-2008 to Z-2373-2008
Class II
27-Oct-08
N/A
N/A
SN0810134
SN0810135
SN0810136
Cardinal Health NicoletOne photic adapter cable 085-463700
FDA
Z-2389-2008
Class II
27-Oct-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-Oct-08
N/A
N/A
SN0810138
Arjo Kwiktrak Gate System
FDA
Z-2434-2008
Class II
27-Oct-08
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-Oct-08
2277 6125
SN0810140
ACIST BRACCO AT P54 AngioTouch Kit
FDA
Z-2406-2008
Class II
27-Oct-08
Pacific Medical (Hong Kong) Ltd.
2343 8009
2240 6150
SN0810142
Beckman Coulter Synchron Acetaminophen (ACTM) Reagent (Part
No. 472169)
Cardinal Health NicoletOne 5.30.2 Software
SN0810143
Boston Scientific easy Core Biopsy Device (Peripheral Interventions)
SN0810144
Baylis Medical BMC RF Cannula - Part # PMF20-100-10CS; Lot
PFFA211107
MHRA
2008/010/002/061/003
FSCA
27-Oct-08
N/A
N/A
SN0810145
GE Healthcare Giraffe and Panda Warmers
MHRA
2008/010/014/601/001
FSCA
27-Oct-08
2783 1838
MHRA
2008/010/016/061/016
FSCA
27-Oct-08
2919 1300
MHRA
2008/008/018/301/001
FSCA
27-Oct-08
N/A
N/A
FDA
N/A
Press Release
27-Oct-08
N/A
N/A
2008/010/010/061/012
FSCA
28-Oct-08
N/A
N/A
SN0810141
FDA
Z-2405-2008
Class II
27-Oct-08
FDA
Z-2459-2008
Class II
27-Oct-08
Cardinal Health
Boston Scientific
Hong Kong Ltd
N/A
Action
27-Oct-08
2960 7136
SN0810146
Medtronic OptiVol CareAlert and CareLink Transmissions Issue
SN0810147
Invacare Typhoon 1 & 2 Power Wheelchairs
SN0810148
Thoratec HeartMate II LVAS
SN0810149
Helena Laboratories Manual D-dimer 5250
MHRA
SN0810150
Metrax Primedic DefiMonitor XD Series
MHRA
2008/010/006/061/011
FSCA
29-Oct-08
N/A
N/A
SN0810151
Tryton Side Branch Stent
MHRA
2008/010/014/061/023
FSCA
29-Oct-08
N/A
N/A
SN0810152
Inverness Panbio West Nile Virus IgM Capture ELISA
MHRA
2008/010/022/061/008
FSCA
29-Oct-08
N/A
N/A
SN0810153
Biomet 2.00mm Crimp Sleeve, item: 350805, lot 568400
MHRA
2008/010/013/601/004
FSCA
29-Oct-08
N/A
N/A
SN0810154
Edwards Lifesciences Vigilance II Monitor VIG2/VIG2E
MHRA
2008/010/010/061/011
FSCA
29-Oct-08
N/A
N/A
SN0810155
Stryker Circlip retaining system
MHRA
2008/010/009/061/007
FSCA
29-Oct-08
Stryker China Ltd
2518 6988
2518 6988
SN0810156
Stryker System 6 and Cordless Driver 3 Handpiece
MHRA
2008/010/015/061/013
FSCA
29-Oct-08
Stryker China Ltd
SN0810157
Respironics BIPAP Focus Ventilator System
MHRA
2008/010/009/061/028
FSCA
29-Oct-08
CELKI Medical Company
SN0810158
Siemens IMMULITE® 2000/2500 Substrate Module L2SUBM 252
MHRA
2008/010/023/061/015
FSCA
29-Oct-08
2810 7533
SN0810159
DLS Medical Wound dressing pack avm3550, Woundcare pack
avm3633, Basic care pack avm3757
MHRA
2008/009/026/601/002
FSCA
30-Oct-08
N/A
N/A
SN0810160
BRAHMS PAPP-A Kryptor Lots 566034 and 566036
MHRA
2008/010/010/061/007
FSCA
30-Oct-08
N/A
N/A
SN0810161
Ergolet Luna Track Hoist Handset
MHRA
2008/004/004/401/002
FSCA
30-Oct-08
N/A
N/A
SN0810162
Sidhil Universal Standard and High Siderails
MHRA
2008/008/018/401/004
FSCA
30-Oct-08
N/A
N/A
SN0810163
R82 X-Panda size 2 High-Low Frame
MHRA
2008/004/025/401/012
FSCA
30-Oct-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-Oct-08
N/A
N/A
57
SN0810165
Zimmer Durom cup, Metasul Durom acetabular compenent
FDA
Z-2415-2008 to Z-2426-2008
Class II
30-Oct-08
2992 0968
SN0810166
Medtronic BI-700-00027 0-arm 1000 Imaging System mobile X-ray
System
FDA
Z-2034-2008
Class II
30-Oct-08
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-Oct-08
2810 7533
SN0810168
GE Precision MPi (Model 5126893 -, 2385125, 2398238)
FDA
Z-2142-2008 to Z-2144-2008
Class II
30-Oct-08
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-Oct-08
2783 1838
58
MDCO Ref.
No.
Source of
Information*
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
2008/09/03
Boston Scientific HK Limited
2960 7136
2008/09/03
2907 5911
SN080904
Boston Scientific Platinum PlusT Guidewire (Peripheral)
SN080905
Medtronic Adjustable Valve Model 6248VAL and Attain 6216A and
6218A System Kits
SN080906
Physio Control LIFEPAK CR Plus
SN080907
Boston Scientific
Hong Kong Ltd
Medtronic
International Ltd
N/A
N/A
Action
Action
Medtronic
International Ltd
N/A
Action
2008/09/03
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
2508 9553
SN080910
Smiths Medical CADD-MS"3 Ambulatory Infusion Pumps (Model
7400, Rx only)
FDA
Z-1641-2008
Class II
2008/09/04
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
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
2907 5911
SN080915
Medtronic Physio Control, FASTPAK batteries
FDA
Z-1567-2008
Class II
2008/09/04
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
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
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
59
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/09/05
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
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
2738 6027
SN080935
Bausch & Lomb AMVISC and AMVISC PLUS - Viscoelastic (Ref:
DV-2007-8041)
Bausch & Lomb
(Hong Kong) Limited
N/A
Action
2008/09/10
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
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
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
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
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
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
2821 5480
N/A
Action
Action
60
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
2821 5480
SN080955
Philips Healthcare HD3 Diagnostic Ultrasound System
MHRA
2008/009/010/061/010
FSCA
2008/09/16
2821 5480
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
2008/09/16
2575 8668
2008/09/16
2738 6027
2008/09/17
2960 7136
SN080958
Boston Scientific iLabR Ultrasound Imaging Systems
SN080959
GE Healthcare Responder 2000 Defibrillator
MHRA
2008/008/013/061/012
FSCA
2008/09/18
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
MHRA
2008/009/010/061/008
FSCA
2008/09/19
2821 5480
FDA
Z-2192-2008 to Z-2193-2008
Class II
2008/09/19
2806 4021
SN080963
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
FDA
Z-1813-2008
Class II
2008/09/19
2806 4021
SN080964
Abbott PathFinder Cannulated T-Handle Bone Awl (Part No. 1155-2)
FDA
Z-1784-2008
Class II
2008/09/19
2806 4021
FDA
Z-1526-2008
Class II
2008/09/19
2783 1838
FDA
Z-1825-2008
Class II
2008/09/19
2783 1838
SN080962
SN080965
SN080966
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
Action
Action
Action
SN080967
Medtronic CD Horizon Agile Dynamic Stabilization Device
FDA
Z-1408-2008 to Z-1441-2008
Class II
2008/09/19
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
2907 5911
SN080969
Medtronic Suction Jar Lid for Medela Vario 18 Vacuum Pump
FDA
Z-2168-2008
Class II
2008/09/19
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
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
61
SN080979
Varian Medical Varis Aria Radiation Oncology Version 8.1
FDA
Z-2194-2008
Class II
2008/09/19
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
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
2555 9421
FDA
Z-1893-2008 to Z-1894-2008
Class II
2008/09/19
2807 8500
FDA
Z-1588-2008 to Z-1589-2008
Class II
2008/09/19
2789 3300
SN080983
SN080984
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)
SN080985
Allez Spine Laguna Pedicle Screw System (IT-FN1001 and ITFN1007)
FDA
Z-1819-2008 to Z-1820-2008
Class II
2008/09/19
N/A
N/A
SN080986
Galil Medical Warming Catheter
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
Action
2008/09/22
2575 8668
FDA
Z-1827-2008
Class II
2008/09/22
N/A
N/A
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
SN080987
SN080988
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
SN080990
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
2821 5480
MHRA
2008/009/011/601/601/002
FSCA
2008/09/24
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
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
2821 5480
FDA
Z-1374-2008
Class II
2008/09/26
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
62
SN081007
Zimmer 4.5 Compression plate-broad (REF 4945-10-01)
FDA
Z-2179-2008
Class II
2008/09/26
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
2907 5911
SN081009
Medtronic VNUS Medical U-CLIP Remocal Tool (UREM 1860)
FDA
Z-1609-2008
Class II
2008/09/26
2907 5911
SN081010
Johnson and Johnson Depuy LCS Knee
FDA
Z-1812-2008
Class II
2008/09/26
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
SN081020
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
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
2821 5480
SN081023
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
2821 5480
SN081027
Philips Brilliance 64 Slice CT System-Main Unit
Health Canada
43322
Type II
2008/09/29
2821 5480
SN081028
Philips Essenta DR
Health Canada
43360
Type II
2008/09/29
2821 5480
SN081029
Philips Isite Pacs
Health Canada
43324
Type II
2008/09/29
2821 5480
SN081030
Philips HDI 4000 System
Health Canada
43395
Type II
2008/09/29
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
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
2992 0968
SN081036
Porex Surgical Ocular Conformers (Non-Vented and Vented)
Health Canada
43459
Type II
2008/09/29
N/A
N/A
63
SN081037
Medilab Beautytek Premium Edition
Health Canada
41783
Type II
2008/09/29
N/A
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
N/A
N/A
SN081042
Coloplast Folysil Xtra Silicone Indwelling Catheters
MHRA
2008/008/028/401/010
FSCA
2008/09/29
Coloplast (Hong Kong) Ltd
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
2722 5660
SN081047
Johnson and Johnson Animas™ 2020 and IR 1200 Insulin Pump
MHRA
2008/009/022/061/015
FSCA
2008/09/30
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
Action
2008/09/30
SN081055
FDA
Boston Scientific
Hong Kong Ltd
2008/09/30
2960 7136
N/A
64
MDA/2008/059
MDA
Date of Issue
(YYYY/MM/DD)
2008/08/01
MHRA
2008/002/026/401/001
FSCA
2008/08/01
N/A
N/A
Stryker Scorpio Series 7000 Tibial Impactor/Extractor
MHRA
2008/007/007/061/017
FSCA
2008/08/01
Stryker China Ltd
2518 6915
ThermoFisher Scientific BO0348V Maximum recovery diluent
MHRA
2008/007/018/601/501
FSCA
2008/08/01
N/A
N/A
N/A
Action
2008/08/04
2807 8500
2008/08/05
N/A
N/A
MDCO Ref.
No.
SN080801 Bayer Ascensia Contour blood glucose meters
SN080802
Levitronix CentriMag Systems
SN080803
SN080804
Source of
Information*
MHRA
Local Agent
Bayer Healthcare
Agent Contact
Telephone No
2814 4836
SN080805
Baxter FLOSEAL Endoscopic Applicator (#1500181)
SN080806
Arjo Carendo multi-purpose hygiene chair
MHRA
MDA/2008/060
MDA
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
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
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
2724 2836
SN080816
Varian High-Definition 120 MultiLeaf Collimator (Product code: H56)
FDA
Z-1459-2008
Class II
2008/08/07
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
N/A
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
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
2393 9511
65
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
2876 7525
SN080830
Philips Digital Diagnost
Health Canada
43190
Type II
2008/08/13
2876 7525
SN080831
Draeger Fabius Titro Anesthesia System
Health Canada
43160
Type II
2008/08/13
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
Data Innovations Instrument Manager (Part no 626553 and
6605628)
FDA
Z-1529-2008
Class II
2008/08/14
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
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
2722 8123
SN080841
Apline Microtargeting Electrode Cable
Apline BioMed
N/A
Varian Medical
N/A
Action
Action
SN080842
Varian Exact Couch Pinch Point
SN080843
GE Healthcare Solar 8000/i/M
MHRA
2008/007/024/601/510
FSCA
2008/08/18
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
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
66
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
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
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
2919 1300
FDA
Z-1621-2008
Class II
2008/08/21
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
2722 8123
FDA
Z-1525-2008
Class II
2008/08/21
2722 5660
FDA
Z-1527-2008 to Z-1528-2008
Class II
2008/08/21
2722 5660
FDA
Z-1830-2008 to Z-1853-2008
Class II
2008/08/21
N/A
N/A
SN080863
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom
Carestation (Model# 1505-3272-00)
FDA
Z-1526-2008
Class II
2008/08/21
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
2919 1300
SN080866
BrainlabVectorVision Sky and/or BrainSUITE NET system
MHRA
2008/008/004/051/009
FSCA
2008/08/25
SN080867
Varian Exact Couch with Exact Couch Top
MHRA
2008/008/007/061/015
FSCA
2008/08/25
2722 8123
SN080868
Maquet Expiratory Valve Coils
MHRA
2008/007/016/061/004
FSCA
2008/08/25
2393 9511
SN080869
GE Healthcare CT/SPECT Studies of Brain Scans
MHRA
2008/008/011/051/011
FSCA
2008/08/25
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
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
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
2575 8668
SN080880
Tyco Argyle Suction Catheter (Model: 1180-851121, 1180-851147)
Health Canada
43260
Type II
2008/08/27
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
2876 7525
67
SN080882
Philips Achieva 1.5T MRI System - Sense Torso Coil, Intera 1.5T
MRI System - Sense XL Torso Coil
Health Canada
43296
Type II
2008/08/27
2876 7525
SN080883
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
2738 2818
SN080885
Medtronic Deep Brain Stimulator lead kit with cap
MHRA
2008/008/015/061/004
FSCA
2008/08/27
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
2240 6150
FDA
Z-1513-2008 to Z-1514-2008
Class II
2008/08/28
2960 7136
FDA
Z-2139-2008
Class II
2008/08/28
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
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
FDA
Z-1770-2008 to Z-1772-2008
Class II
2008/08/28
N/A
N/A
Class II
2008/08/28
N/A
N/A
SN080898
Medline Bariatric Wheelchair
SN080899
EKOS EndoWave Infusion System
FDA
Z-1773-2008
SN080900
Acumed Osteo-Clage Cable System Package Assembly (01-0001-S)
FDA
Z-2140-2008
Class II
2008/08/28
N/A
N/A
SN080901
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
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
2919 1300
SN080907
Baxter HOMECHOICE/HOMECHOICE PRO Automated Peritoneal
Dialysis System
MHRA
2008/005/028/061/023
FSCA
2008/08/29
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
2876 7525
SN080910
GE Voluson E8 Ultrasound Systems
MHRA
2008/005/019/601/350
FSCA
2008/08/29
2783 1838
SN080911
BrainlabExac TRac Infrared Tracking Platform 5.0, 5.5
MHRA
2008/008/011/061/001
FSCA
2008/08/29
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
68
MDA/2008/044
MDA
Date of Issue
(YYYY/MM/DD)
2008/07/02
N/A
Agent Contact
Telephone No
N/A
MHRA
2008/006/002/601/380
FSCA
2008/07/02
2806 4021
Anspach Sterile Single-use Cuting Burrs
MHRA
2008/006/011/291/004
FSCA
2008/07/02
N/A
N/A
Arrow International Cannon catheter , Cannon catheter II and Edge
catheter
MHRA
2008/006/018/061/010
FSCA
2008/07/02
N/A
N/A
MDCO Ref.
No.
SN080701 Invacare Action³ manual wheelchair
SN080702
Abbott Diagnostics ARCHITECT c8000 System
SN080703
SN080704
Source of
Information*
MHRA
Local Agent
SN080705
TerumoTubing packs for extracorporeal circulation of blood
MHRA
2008/005/021/401/005
FSCA
2008/07/02
2866 0811
SN080706
BioMerieux Agars 43001, 43041, and 43401
MHRA
2008/006/018/601/425
FSCA
2008/07/02
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
2919 1300
SN080713
Remploy Access & Accent wheelchair
MHRA
2007/010/023/261/001
FSCA
2008/07/03
N/A
N/A
SN080714
Beckman Coulter Access Ultra sensitive Insulin Assay Kit (Part
Number 33410)
FDA
Z-1160-2008
Class II
2008/07/03
2240 6150
SN080715
Stryker Solar HA Humeral Stem with Plasma Coating 7mm to 17mm
FDA
Z-1236-2008
Class II
2008/07/03
Stryker China Ltd
2518 6915
SN080716
AGFA HeartLabCardiovascular DICOMstore (Model # L9M8E)
FDA
Z-1241-2008
Class II
2008/07/03
2555 9421
SN080717
AGFA HeartLab Cardiovascular Results Management Product
(Model No.: L58RZ and L9MWQ)
FDA
Z-1242-2008
Class II
2008/07/03
2555 9421
SN080718
AGFA IMPAX 6.2.1 Network Gateway Server, License Key (Catalog
# ABC)
FDA
Z-1306-2008
Class II
2008/07/03
2555 9421
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/07/03
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
2332 4455
N/A
Action
2008/07/07
Alcon Hong Kong Ltd
2161 0844
2008/001/010/401/007
FSCA
2008/07/07
N/A
N/A
2008/006/025/181/011
FSCA
2008/07/07
2877 3077
SN080724
SN080725
SN080726
Alcon MONARCH II IOL Delivery System - Cartridge Model B ( Pat #
Alcon Hong Kong Ltd
8065977758; Lot#: 174244, 174250)
Park House Healthcare PHP 198, PHP396, PHP398 & PHP399
MHRA
Pumps
Draeger Medical Intensive Care ventilators
MHRA
69
SN080728
TherapostureTheracare Beds supplied with Mesh Linked Padded
Rails
Medtronic SynchroMed® II Implantable Infusion Pump
SN080729
Liko AB Universal SlingBar
SN080730
Invacare Harrier Heavy Duty (HD) battery powered wheelchair
SN080731
Quest 88 Kaye Posture Control Walkers
MHRA
2007/011/015/401/003
FSCA
2008/07/08
N/A
SN080732
Steris Quick Connect (Model QXCXXXX)
Health Canada
38366
Type II
2008/07/10
N/A
Type II
2008/07/10
Cardinal Health
N/A
SN080727
MHRA
2007/009/027/401/001
FSCA
2008/07/07
N/A
N/A
MHRA
2008/005/029/291/001
FSCA
2008/07/07
2919 1300
MHRA
2008/006/024/071/002
FSCA
2008/07/07
N/A
N/A
MHRA
MDA/2008/050
MDA
2008/07/08
N/A
N/A
N/A
Health Canada
39224
SN080734
Cardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal Pack,
C) Sterile Cardiovascular Universal
Siemens Oncor Expression (Model 7360717, 8139839)
Health Canada
39313
Type II
2008/07/10
Siemens Ltd.
2810 7533
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
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
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
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
2485 7510
SN080747
AGFA Drystar AXYS
Health Canada
42393
Type II
2008/07/10
2555 9421
SN080748
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
Edwards LifeStent FlexStar Biliary Stent System
FDA
Z-1246-2008 to Z-1296-2008
Class II
2008/07/10
N/A
N/A
SN080751
AGFA Impax 4.5, 5.1, 5.2 ans 5.2x Picture Archiving System (PACs)
FDA
Z-1307-2008
Class II
2008/07/10
2555 9421
SN080752
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
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
SN080756
Siemens Mevatron Primus, Mevatron MX-2, Oncor Expression,
Oncor Impression IMRT Plus
Health Canada
42781
Type II
2008/07/11
Siemens Ltd.
2810 7533
SN080757
Lomax Mobility Kid Active Folding Frame with Swing Away Footrests
MHRA
2007/012/006/061/004
FSCA
2008/07/14
N/A
N/A
70
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
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
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
2992 0968
Boston Scientific HK Ltd
SN080767
Boston Scientific Platinum PlusT Cononary Guidwire
MHRA
2008/007/001/061/022
FSCA
2008/07/14
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
2806 4021
SN080770
ArthroCare Covator Arthro Wand
MHRA
2008/004/016/401/009
FSCA
2008/07/16
N/A
N/A
2821 5480
SN080771
Philips Medical Systems Biopsy Guide Starter Kits
SN080772
BD Vacutainer Blood Collection Tubes Containing Heparin
SN080773
Respironics PLV100 Ventilator (#RCA200802)
MHRA
2008/007/003/061/008
FSCA
2008/07/17
BD
N/A
Action
2008/07/21
2722 5660
CELKI Medical
Company
N/A
Action
2008/07/21
2268 9258
SN080774
Kimal safety fistula needle
MHRA
MDA/2008/051
MDA
2008/07/22
N/A
N/A
SN080775
SN080776
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
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
2806 4021
SN080782
Beckman Coulter GEN.S and LH SlideMakers
MHRA
2008/007/002/601/459
FSCA
2008/07/24
2240 6150
SN080783
Roche cobas b 221 Software version 7.0
MHRA
2008/007/007/061/008
FSCA
2008/07/24
2485 7510
SN080784
Applied Medical 15mm SeparatorR access systems
MHRA
2008/007/008/061/006
FSCA
2008/07/24
N/A
N/A
SN080785
GE Healthcare Innova ® single plane cardiovascular Xray imaging
systems
MHRA
2008/006/018/601/424
FSCA
2008/07/24
2783 1838
SN080786
Q’Straint Wheelchair QLK-100 Docking System
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
71
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
2555 9421
SN080798
BD 60ml Luer-Lok Syringe (Recorder no. 309653)
BD
N/A
Action
2008/07/28
2722 5660
SN080799
Abbott Sequoia Spinal System Surgical Kits
FDA
Z-1479-2008
Class II
2008/07/28
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
Medtronic International Ltd
2919 1300
SN080806
Abbott ARCHITECT AFP assay
MHRA
2008/007/011/601/482
FSCA
2008/07/28
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
2821 5480
SN080811
SN080812
SN080813
Philips Axis and Irix Gamma Cameras
MHRA
SN080814
Beckman Coulter Acetaminophen Reagent
MHRA
2008/007/024/601/509
FSCA
2008/07/31
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
CXP Software version 2.1 and 2.2
FDA
Z-2016-2008 to Z-2033-2008
Class II
2008/07/31
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
2821 5480
2008/007/014/061/004
72
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
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
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
2839 7010
Health Canada
42939
Type II
2008/07/31
Stryker China Ltd
2518 6915
Health Canada
42974
Type II
2008/07/31
2783 1838
Health Canada
42906
Type II
2008/07/31
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
2821 5480
SN080829
Maquet Cardipulmonary AG Remote Control Unit (Model 939401)
Health Canada
41063
Type II
2008/07/31
2393 9511
SN080830
Zimmer Miller Bone Cement Injector Front Cartridge Kit (Model 005069-052-00)
Health Canada
43002
Type II
2008/07/31
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
2722 5660
73
Monthly Summary of Medical Device Safety Alerts -June 2008
MDCO Ref.
No.
Baush and Lomb Zyoptix Treatment Calculator (Versions 1.1 and
SN080601
1 2)
SN080602 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
SN080609
Stryker Kinemax Plus Revision TS Tibial Insert
Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E6903)
AGA Medical Amplatzer PFO Occluder
SN080610
Arrow Balloon Temporary Pacing Catheter Kit
SN080611
BHM Ergiscake Scake abd Swivel Bar
SN080608
SN080612
SN080613
Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and
minipak
Bio-Rad Varient B-Thalassemia Short Program
Source of
Information*
Bausch and Lomb
Boston Scientific
Hong Kong Ltd
MHRA
MHRA
MHRA
Affaps
MHRA
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
2008/06/02
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
Health Canada
42116
Type II
2008/06/05
2806 4021
Health Canada
41996
Type II
2008/06/05
AGA Medical Corporation (Asia Pacific)
N/A
Health Canada
41991
Type II
2008/06/05
N/A
N/A
Health Canada
41995
Type II
2008/06/05
Arjo Far East Ltd
2508 9553
Health Canada
41858
Type II
2008/06/05
2789 3300
Health Canada
42066
Type II
2008/06/05
2789 3300
Health Canada
42115
Type II
2008/06/05
Cardinal Health
N/A
Health Canada
Health Canada
42174
Type II
2008/06/05
2781 0232
41708
Type II
2008/06/05
N/A
N/A
N/A
N/A
SN080614
Cardinal Health Sterile Mammoplasty Pack, Sterile Total Knee Pack
and Othopedie-Fusion Posterieure
SN080615
Cook Hilal Embolization Coils
SN080616
Hill-Rom 100 Low Beds
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
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
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
Local Agent
Kong
Kong
2738 2818
2738 2818
Health Canada
40792
Type II
2008/06/05
2919 1300
SN080621
Nova Biomedical Statstrip Glucose Hospital Meter
Health Canada
42078
Type II
2008/06/05
N/A
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
Philips Suresigns VS3 Vital Signs Monitor
Health Canada
42049
Type II
2008/06/05
2876 7525
SN080625
Pulmonetic Systems LTV 800, 950, 900 and 1000 Series Ventilators
Health Canada
41278
Type II
2008/06/05
N/A
N/A
SN080626
Randox Triglycerides
Health Canada
41875
Type II
2008/06/05
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
2518 6988
3157 7220
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
74
N/A
2485 7510
SN080632
Zimmer Dermacarriers Skin Graft Carriers and Dermacarriers II Skin
Graft Carriers
SN080633
SN080634
Health Canada
42114
Type II
2008/06/05
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
2876 7525
MHRA
2008/005/021/061/004
FSCA
2008/06/10
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
2008/06/12
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
2008/06/16
Accuray Asia Ltd
2247 8628
MHRA
2008/005/022/061/020
FSCA
2008/06/17
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
SN080654
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, L-NET05,
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
Kong
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
2876 7525
SN080662
Siemens ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems
MHRA
2008/005/029/061/019
FSCA
2008/06/17
Siemens Ltd.
2810 7533
SN080659
SN080660
75
N/A
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
2277 6125
N/A
2008/06/19
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
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
2789 3300
SN080676
Boston Scientific Platinum PlusT Coronary Guidewire
N/A
2008/06/23
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
SN080679
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
MHRA
N/A
2008/06/23
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
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
2008/06/25
3628 7428
N/A
2008/06/26
2960 7136
SN080687
Coloplast (Hong
Kong) Ltd
Boston Scientific
Hong Kong Ltd
SN080692
Boston Scientific implantables devices, ICD and CRT-D
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
2821 5480
76
SN080695
Gambro cartridge blood set (Model 003410-510, 003410-710,
0141080XXXC)
Health Canada
42069
Type II
2008/06/27
2839 7010
SN080696
Maquet HL 30 Perfusion System
Health Canada
41066
Type II
2008/06/27
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
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
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
77
Monthly Summary of Medical Device Safety Alerts -May 2008
MDCO Ref.
No.
Source of
Information*
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
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
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
Action
2008/05/05
Baush and Lomb
2213 3371
Accuray Asia Ltd
N/A
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
2919 1300
SN080517 Medtronic Bravo PH Capsule With Delivery System
Health Canada
39316
Type II
2008/05/08
2919 1300
SN080518 Varian Medical Clinac High and Low Engery
Health Canada
41305
Type II
2008/05/08
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
78
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
Action
2008/05/08
2919 1300
Health Canada
41574
Type II
2008/05/08
Biomerieux (Hong Kong)
2356 7033
Health Canada
41659
Type II
2008/05/08
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
2789 3300
MHRA
2008/004/009/301/001
FSCA
2008/05/08
N/A
N/A
Convatec
N/A
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
2992 0968
2008/05/14
2960 7128
2008/05/14
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
Action
Action
N/A
N/A
Smiths Medical BCI Mini-Torr Plus NIBP Monitor with SpO2 & BuiltSN080536
in 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
2332 4455
FDA
Z-1594-2008 to Z-1602-2008
Class II
2008/05/15
COVIDIEN
3157 7244
2008/05/16
2960 7128
2008/05/16
2960 7128
SN080545 Tyco Healthcare Monoject Prefill
Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation
SN080546
Device
SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Action
Action
N/A
N/A
79
SN080548
Baxter HomeChoice Automated Peritoneal Dialysis System
(Software v.10.210)
SN080549 Boston Scientific iLab UltraSound Imaging System
N/A
Action
2008/05/16
MHRA
2008/004/024/061/011
FSCA
2807 8500
2008/05/19
2960 7128
2738 6000
SN080550 Johnson and Johnson Codman ARCHIMEDES Drug Pumps
MHRA
2008/004/021/061/008
FSCA
2008/05/19
Kong
SN080551 Respironics Humidifier Chambers
MHRA
2008/003/028/401/001
FSCA
2008/05/19
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
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
Siemens Syngo US Workplace Picture Archiving and
SN080561
Communication System, software version 2.0, 94043
FDA
Z-1138-2008
Class II
2008/05/22
Siemens Ltd.
2810 7533
FDA
Z-1105-2008
Class II
2008/05/22
Stryker China Ltd
2518 6988
FDA
Z-1103-2008
Class II
2008/05/22
2806 4021
SN080564 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitor
MHRA
2008/004/024/061/014
FSCA
2008/05/22
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
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
N/A
Company
Company
Company
SN080562
Stryker Triathlon Baseplate Impactor Extractor (Catalog no. 6541-4805)
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
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
80
2810 7533
2810 7533
2810 7533
SN080574
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
Health Canada
2008/05/23
2877 3077
2008/05/23
Kong
2738 6000
SN080578 Draeger Medical Oxylog 3000
41844
Type II
Johnson & Johnson
Medical Hong Kong
N/A
Action
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/05/26
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
SN080579 Johnson and Johnson STERRAD Sterilization Systems Oil Mist
SN080580 Boston Scientific RotaWire Guidewire
SN080583 Pointe Scientific Liquid ALT (SGPT) reagent set
81
cal Device Safety Alerts -April 2008
and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Source of
Information*
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
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
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
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
SN080415 Leica Bond maX systems with cversion 03.05.08 Software instaled
MHRA
2008/003/013/291/008
FSCA
2008/04/10
N/A
N/A
Stryker Scorpio Knee Femoral Component (Catalog No. 70-5211R,
71-5211R, Lot Code: KNAMED, V8WMED)
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
2806 4021
SN080411 Hospira Butterfly winged needle infusion set
SN080416
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)
82
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
Boston Scientific Epic Over-The-Wire Self-Expanding Nitinol Stent
SN080427
with Delivery System Stent System
SN080428 Boston Scientific Smash Balloon Dilation Catheter
SN080429 Boston Scientific Various Products
SN080430 Zimmer Hemovac Wound Drainage Device Infection Control Kits
SN080431
Medtronic AneuRx AAAdvantage Endovascular Stent Graft with the
Xcelerant Delivery System
MHRA
2008/003/013/601/181
FSCA
2008/04/14
N/A
N/A
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/16
2960 7128
2008/04/16
2960 7128
2008/04/16
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
Action
Action
Action
Action
Action
Action
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
2992 0968
FDA
Z-0689-2008
Class II
2008/04/17
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
2806 4021
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
9656 7000
SN080444
Biohorizons Single-Stage Implant System 122-800 Kit (Model 122800)
83
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 Glenoid)
SN080448 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
Medfor S400 and S227 Femoral Head Storage Pot, Labelled,
SN080453
double wrapped
MHRA
2008/002/029/601/140
FSCA
2008/04/23
N/A
N/A
MHRA
SN080454 Merlin Medical Disposable pen torch (Model no. W2137)
MDA/2008/028
MDA
2008/04/23
N/A
N/A
GE Medical Systems
Hong Kong Ltd.
N/A
Action
2008/04/24
2783 1838
SN080456 Cook Peel-Away Introducer set and Cook TPN Lumen Catheter set
FDA
Z-0892-2008 to Z-0904-2008
Class II
2008/04/24
2781 0232
SN080457 BioRad BioPlex 2200 Instrument
FDA
Z-0575-2008
Class II
2008/04/24
2789 3300
SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes)
84
Monthly Summary of Medical Device Safety Alerts -March 2008
MDCO Ref.
No.
Source of
Information*
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
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
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
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
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
85
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
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
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
2992 0968
SN080333
Zimmer Hemovac Infection Control Kits
Health Canada
40972
Type II
2008/03/19
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
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
2960 7128
SN080339
Draeger Medical Fabius GS (Model# 8604700)
Health Canada
40720
Type II
2008/03/19
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
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
86
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
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
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
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
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
Action
2008/03/26
2919 1300
Cryocath
Technologies Inc.
N/A
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
2877 3077
SN080368
Smith & Nephew CALAXO Bioabsorbable Interference Screw
FDA
Z-0593-2008 to Z-061612008
Class II
2008/03/27
2648 7700
87
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
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
Boston Scientific
Hong Kong Ltd
N/A
2008/03/27
2960 7128
Action
Action
SN080375
Boston Scientific COGNIS CRT-D device
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
2332 4455
SN080380
Philips Brilliance CT Systems
Health Canada
39694
Type II
2008/03/31
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
2876 7525
SN080382
Steris Tenzor Carbon Fiber Orthopedic Traction
Health Canada
41089
Type II
2008/03/31
N/A
SN080383
Steris C1160 Tray used with Steris System 1
Health Canada
41078
Type II
2008/03/31
N/A
SN080384
Steris Amsco Remanufactured Prevacuum Sterilizers
Health Canada
41256
Type II
2008/03/31
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
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
88
Monthly Summary of Medical Device Safety Alerts -February 2008
MDCO Ref.
No.
Source of
Information*
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-Feb-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-Feb-08
N/A
N/A
SA080203 Hoana LifeBed Patient Vigilance System (Model# 010135-01)
FDA
Z-0592-2008
Class II
01-Feb-08
N/A
N/A
SA080204 AADCO Rayshield Frame Mounted Overhead X-Ray Barrier
FDA
Z-0552-2008
Class II
01-Feb-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-Feb-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-Feb-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-Feb-08
N/A
N/A
FDA
Z-0120-2008
Class II
01-Feb-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-Feb-08
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-Feb-08
Kong
2738 2818
SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01)
FDA
Z-0551-2008
Class II
01-Feb-08
2806 4021
SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20)
FDA
Z-0127-2008
Class II
01-Feb-08
2806 4021
FDA
Z-0529-2008
Class II
01-Feb-08
N/A
N/A
Health Canada
40047
Type II
04-Feb-08
Sanko Medical System (HK) Ltd
2384 0688
MHRA
2008/001/024/291/004
FSCA
04-Feb-08
2876 7525
MHRA
2008/001/024/601/003
FSCA
04-Feb-08
2806 4021
MHRA
2008/001/014/291/020
FSCA
04-Feb-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-Feb-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-Feb-08
Limited
2485 7510
89
SA080220 Corin Cormet Head Trial Size 4/44
SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups
MHRA
2008/001/023/291/002
FSCA
Action
Action
04-Feb-08
N/A
N/A
04-Feb-08
Stryker China Ltd
2518 6988
06-Feb-08
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-Feb-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-Feb-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-Feb-08
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-Feb-08
2876 7525
SA080227 Philips Page Writer Touch Cardiograph (Model # 860284)
FDA
Z-0124-2008
Class II
11-Feb-08
2876 7525
SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ
FDA
Z-0690-2008 to Z-0692-2008
Class II
11-Feb-08
2783 1838
Blackstone Hallmark Anterior Cervical Plate System (REF#62SA080229
3140)
FDA
Z-0478-2008
Class II
11-Feb-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-Feb-08
N/A
N/A
SA080231 Spacelabs Medical, Ultraview Multigas Anaylzer (Model 91518)
FDA
Z-0660-2008
Class II
11-Feb-08
N/A
N/A
SA080232 Molnycke Health Care Laparoscopic Cholecysectomy
MHRA
2008/001/031/291/002
FSCA
12-Feb-08
N/A
N/A
SA080233 Schiller FRED Easy Defibrillator
MHRA
2008/001/024/291/003
FSCA
12-Feb-08
2764 5208
SA080234 Days Healthcare Viper & Viper Plus Powerchairs
MHRA
2008/001/022/301/002
FSCA
13-Feb-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-Feb-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-Feb-08
2332 4455
SA080237 Inotech Brand Heparin Adsobent (Catalog# HA-1)
FDA
Z-0934-2008
Class II
18-Feb-08
N/A
N/A
SA080238 Horizon Cardiology Hemo Monitoring System
FDA
Z-0710-2008
Class II
18-Feb-08
N/A
N/A
FDA
Z-0738-2008
Class II
18-Feb-08
Fresenius Medical Care Asia-Pacific
Ltd.
2802 2900
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
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2)
A.R. Burkhill & Sons (Hong Kong) Ltd.
2541 1041
FDA
Z-0135-2008
Class II
18-Feb-08
FDA
Z-0948-2008 to Z-0949-2008
Class II
18-Feb-08
886-22183-6130
FDA
Z-0727-2008
Class II
18-Feb-08
886-22183-6130
MHRA
2008/002/005/061/014
FSCA
20-Feb-08
Siemens Ltd.
2810 7533
90
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
MHRA
2007/004/030/261/002
FSCA
20-Feb-08
N/A
N/A
MHRA
2008/002/011/061/008
FSCA
21-Feb-08
2783 1838
MHRA
2008/002/006/601/033
FSCA
21-Feb-08
2783 1838
SA080247
Abbott Comfort T-handle Hudson Connector with Impactor Cap
(Part # 1006-1)
FDA
Z-0880-2008
Class II
22-Feb-08
2806 4021
SA080248
Siemens Mevatron KD2 Medical Charged-Particle Radiation
Therapy System
FDA
Z-0677-2008 to Z-0687-2008
Class II
22-Feb-08
Siemens Ltd.
2810 7533
SA080249
Roche LIPC Lipase Colorimetric Reagent (Catalog No.:
03029590322)
FDA
Z-0688-2008
Class II
22-Feb-08
Limited
2485 7510
SA080250
Varian VARiS 1.4g; Linear Accelerator with RTP Exchange v6.2,
v6.6 and v8.0 (Models : ALL)
FDA
Z-0718-2008
Class II
22-Feb-08
2724 2836
SA080251
Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24)
(Product Code: 866.2500; Part No. 173400)
FDA
Z-0718-2008
Class II
22-Feb-08
N/A
N/A
SA080252
Rockwell Medical RenalPure Liquid Acid Concentrate R-006, R-235
and R-259 ; Glacial Acidic Acid and Dri-Sate Glacial Acidic Acid
FDA
Z-0871-2008 to Z-0875-2008
Class II
22-Feb-08
N/A
N/A
SA080253 ConMed Electrosurgical blades and Needles
MHRA
2008/002/011/061/011
FSCA
22-Feb-08
N/A
N/A
SA080254 Unipath SmartCheck INR POC Meter and Consumables
MHRA
2008/002/020/061/008
FSCA
22-Feb-08
N/A
N/A
SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX
MHRA
2008/002/006/291/001
FSCA
22-Feb-08
Limited
2485 7510
SA080256 Philips General X-Ray System
MHRA
2008/002/012/061/007
FSCA
22-Feb-08
2876 7525
SA080257 Philips X-Ray System Types Omni Diagnost Eleva
MHRA
2008/002/013/061/004
FSCA
22-Feb-08
2876 7525
FDA
N/A
Press Release
26-Feb-08
N/A
N/A
MHRA
2008/002/012/061/008
FSCA
27-Feb-08
2876 7525
MHRA
2008/002/015/061/001
FSCA
27-Feb-08
886-22183-6130
MHRA
2008/002/014/601/063
FSCA
27-Feb-08
N/A
N/A
Bausch and Lomb
N/A
Action
27-Feb-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-Feb-08
2807 8555
Siemens Primus Linear Accelerator System and Mevatron Linear
SA080264
Accelerator Systems
FDA
Z-0850-2008 to Z-0852-2008
Class II
29-Feb-08
Siemens Ltd.
2810 7533
FDA
Z-0732-2008
Class II
29-Feb-08
Siemens Ltd.
2810 7533
FDA
Z-0731-2008
Class II
29-Feb-08
Carestream Health Hong Kong Limited
2564 9759
MHRA
MDA/2008/008
MDA
29-Feb-08
N/A
N/A
FDA
Z-0581-2008 to Z-0584-2008
Class II
29-Feb-08
N/A
N/A
Chattem Icy Hot Heat Therapy Air Activated Heat adhesive heating
SA080258
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
Siemens Syngo Imaging System with VB30A version of software
(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
SA080265
SA080268 Hill-Rom Affinity Birthing Bed (Model P3600, P3700A, P3700B)
91
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-Feb-08
Chindex
2892 0301
FDA
Z-0151-2008 to Z-0152-2008
Class II
29-Feb-08
N/A
N/A
FDA
Z-0724-2008 to Z-0726-2008
Class II
29-Feb-08
N/A
N/A
SA080272 Philips Digital Diagnost Family
MHRA
2008/002/019/063/003
FSCA
29-Feb-08
2876 7525
SA080273 Philips EasyVision RAD
MHRA
2008/002/020/061/007
FSCA
29-Feb-08
2876 7525
Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No
SA080274
1320-0231)
MHRA
2008/002/006/061/001
FSCA
29-Feb-08
Stryker China Ltd
2518 6988
MHRA
2008/002/019/061/020
FSCA
29-Feb-08
2876 7525
29-Feb-08
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
MHRA
2007/010/031/061/010
92
FSCA
Monthly Summary of Medical Device Safety Alerts -January 2008
MDCO Ref.
No.
Source of
Information*
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
2919 1362
SA080102
Smiths Medical Graseby 500 and 505 volumetric infusion pumps
(Models: ALL)
MHRA
MDA/2007/100
MDA
2008/01/02
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
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
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
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
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)
2007/012/017/051/003
FSCA
2008/01/09
Ltd.
BD
N/A
Action
2008/01/09
BD
2575 8668
FDA
Z-0457-2008
Class II
2008/01/11
2356 7033
FDA
Z-0301-2008
Class II
2008/01/11
2806 4201
MHRA
93
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
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
Action
2008/01/16
2960 7128
SA080133
Boston Scientific Slimline 200 Micron Delivery System
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/01/16
2960 7128
SA080134
Boston Scientific Galaxy 2 and ClearView Systems
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/01/16
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
Action
2008/01/16
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
Action
2008/01/16
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
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: SSA-790A
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
2807 8555
SA080148
Baxter Healthcare Infusor 2mL/HR
Health Canada
39388
Type II
2008/01/18
2807 8555
94
2645 8703
N/A
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
2876 7525
SA080153
Philips Medical BV Endura and BV Pulsera (Model# MMC 2011,
MMC 2011)
Health Canada
39582
Type II
2008/01/18
2876 7525
SA080154
Varian RPM Respiratory Gating System
Health Canada
39358
Type II
2008/01/18
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
Limited
2485 7510
SA080156
Bio-Rad Amplicheck Swab CT/GC Control A positif (Model # 133,
133X)
Health Canada
39423
Type II
2008/01/18
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
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
2876 7525
MHRA
2007/012/024/601/003
FSCA
2008/01/21
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
SA080170
Medtronic Synchromed EL, Synchromed II and IsoMed drug
infusion pumps
SA080171
SA080172
2008/001/017/291/013
FSCA
2008/01/24
N/A
N/A
Medtronic
International Ltd
N/A
Action
2008/01/24
2891 4456
ev3 IntraStent Unmounted Balloon Expandable Stents
MHRA
2008/001/011/291/003
FSCA
2008/01/28
Conmed Limited
2854 4413
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
95
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)
MHRA
2008/001/016/121/001
2008/01/30
Stryker China Ltd
2518 6988
FSCA
2008/01/30
Kong
2738 2818
2008/001/003/291/014
FSCA
2008/01/30
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
96
FSCA
Monthly Summary of Medical Device Safety Alerts -December 2007
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
Medtronic
International, Ltd.
N/A
Action
2007/12/03
2919 1362
SA071201
Medtronic Bravo pH capsule with delivery system (Proudct
Numbers 9012B1011 and 9012B1001)
SA071202
Philips Brilliance or MX8000Dual v.EXP CT Couch
MHRA
2007/010/029/061/017
FSCA
2007/12/04
2876 7525
SA071203
Vital PET/CT Visualization option available in ViTALConnect
Version 4.0 and 4.1
MHRA
2007/011/022/061/010
FSCA
2007/12/04
N/A
N/A
MHRA
2007/011/026/061/018
FSCA
2007/12/04
N/A
N/A
MHRA
MDA/2007/090
MDA
2007/12/05
2877 3077
SA071204
SA071205
SA071206
ZOLL LifeVest WCD3000 Battery Pack
Draeger Medical Anaesthetic Gas Scaverging System (AGSS)
receiver
Procare Privac set (Product code 24760)
MHRA
MDA/2007/091
MDA
2007/12/05
N/A
N/A
SA071207
Stryker V40+ 16mm Offset Femoral Heads and associated Femoral
Head Trails
MHRA
2007/011/026/061/011
FSCA
2007/12/06
Stryker China Ltd
2518 6988
SA071208
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal
Dialysis System
MHRA
2007/011/030/061/012
FSCA
2007/12/06
2807 8555
SA071209
Ohio Willow Wood Alpha Original Locking Liners (ALL-X0XX / ALLX1XX / ALL-X2XX)
MHRA
2007/008/013/051/014
FSCA
2007/12/06
N/A
N/A
SA071210
Steering Developments Lifestyle JW1, JWII and JWX1 Wheelchair
Power Assist System
MHRA
2007/006/022/261/001
FSCA
2007/12/06
N/A
N/A
SA071211
VIASYS Infant Flow SiPAP Paediatric Respiratory Support Device
MHRA
MDA/2007/093
MDA
2007/12/07
Viasys Healthcare Hong Kong Ltd
2891 8730
SA071212
MI Tech Hanarostent Anti Reflux and Choostent
MHRA
2007/008/014/061/009
FSCA
2007/12/07
N/A
N/A
SA071213
Sunrise Medical Little Gem 2
MHRA
2007/011/016/301/002
FSCA
2007/12/07
N/A
N/A
SA071214
Movingpeople.net Beatle Y.e.S.
MHRA
2007/005/003/401/001
FSCA
2007/12/07
N/A
N/A
SA071215
Philips MD Eleva Flat Detector (Ref XDB087-070515/BW)
MHRA
2007/011/030/061/010
FSCA
2007/12/07
2876 7525
SA071216
Stryker UHR Universal Head Bipolar Component
MHRA
2007/011/027/061/002
FSCA
2007/12/07
Stryker China Ltd
2518 6988
SA071217
Terumo Integrated Centrifugal System Control Unit (Model 801046,
Lot: 0049, 0079)
Health Canada
38444
Type II
2007/12/10
2866 0811
SA071218
Terumo Ultrasonic Air Sensor (Model: 5773, 5785, 5791)
Health Canada
39116
Type II
2007/12/10
2866 0811
SA071219
Philips M3170 Intellivue Patient Link (Model: M3170, LOT: S/A
4721A01711)
Health Canada
38975
Type II
2007/12/10
2876 7525
SA071220
Smith & Nephew Genesis II femoral sets
Health Canada
39055
Type II
2007/12/10
Smith & Nephew Ltd.
2648 7700
SA071221
Depuy PFC Sigma Knee System - ALL Polyethlen, PS RP Bearing,
Stabilized TIBI and Preservation Unicondylar Knee -ALL POL
Health Canada
38472
Type II
2007/12/10
DePuy Inc (J&J)
Health Canada
38915
Type II
2007/12/10
2806 4021
Health Canada
38840
Type II
2007/12/10
N/A
N/A
Health Canada
37977
Type II
2007/12/10
N/A
N/A
Health Canada
38921
Type II
2007/12/10
2384 0688
FDA
Z-0293-2008
Class II
2007/12/10
2384 0688
SA071224
Abbott AxSYM Gentamicin and TDx/TDxFLx Gentamicin (Model
7A65-20 and 9512-60)
Radiometer Pump tubes for ABL800 Series (Model: 842-326, 842327, 842-328, 902-754, 905-671)
Sigma 8002 Dual Channel Infusion Pump (Model 35061)
SA071225
Toshiba Asteion M/S4, Asteion S/S (Mode TSX-021A)
SA071226
Toshiba-Interventional Angiography System, Infinix i (Model DFP8000D)
SA071222
SA071223
97
2738 2894
SA071227
SA071228
SA071229
SA071230
SA071231
Medtronic 0-arm Imaging System (Product Code B1-700-00027)
Zimmer Durom Hip Resurfacing Systems, Femoral Component 54
Code T and 46 Code L (Cat no. 01.00211.154 and 01.00211.146)
Edwards Lifesciences LifeStent FlexStar Bilary Stent System
Application (Model EX080801CD)
Teleflex Pilling Center-Action Forceps with Insulated Shafts (Cat
no. 505015, 505039 and 505045)
Wright Medical Technology Odyssey Femoral Holder/Driver (Part
no. K001-7410)
FDA
Z-0294-2008
Class II
2007/12/10
2919 1362
FDA
Z-0275-2008 to Z-0276-2008
Class II
2007/12/10
2992 0968
FDA
Z-0179-2008
Class II
2007/12/10
N/A
N/A
FDA
Z-0266-2008 to Z-0268-2008
Class II
2007/12/10
N/A
N/A
FDA
Z-0290-2008
Class II
2007/12/10
Starry Medical Technology Ltd
2381 0279
SA071232
Xoran MiniCAT for ENT
FDA
Z-0296-2008
Class II
2007/12/10
N/A
N/A
SA071233
Oridion Capnostream20 Monitor with Nellcor Pulse Oximetry
Module (Part no. CS08657) and Capnostream20 Monitor with
Masiomor Pulse Oximetry Module (Part no. CS08659)
FDA
Z-0177-2008 to Z-0178-2008
Class II
2007/12/10
N/A
N/A
SA071234
Sunrise Medical Sapphire 2 and Sapphire LS 2
MHRA
2007/010/024/261/001
2007/010/009/261/001
FSCA
2007/12/11
N/A
N/A
SA071235
Philips Cardiac Viewer and Pulmonary Viewer Application
MHRA
2007/011/030/061/009
FSCA
2007/12/12
2876 7525
MHRA
2007/011/022/601/005
FSCA
2007/12/14
N/A
N/A
MHRA
2007/010/001/291/003
FSCA
2007/12/14
Medisource
MHRA
2007/011/008/291/006
FSCA
2007/12/14
Limited
2485 7510
SA071236
SA071237
Henry Schein EasyCam Eurolite, Eurolite II and Eurodoc Intra-oral
Cameras
ConMed Frazier and Poole Suction Intruments (Cat no. 0031030,
0033080, 0033120, 0031100, 0031070, 0033180, 0031050,
0033110, 0035040, 0033100)
SA071238
Roche Elecsys HBsAgII and Elecsys Anti-HBs
SA071239
Siemens Mevatron M2/PRIMUS Plus, Oncor Impresson Plus.
Oncor Impression, ONCOR Avante Garde, Mevatron M2 Primus
FDA
Z-0380-2008 to Z-0384-2008
Class II
2007/12/14
Siemens Ltd.
2810 7533
SA071240
Biomet Orthopedics Vanguard PS Open Femoral (Ref. no.: 183130;
Lot no. 395450)
FDA
Z-0123-2008
Class II
2007/12/14
2332 4455
SA071241
Straumann Palatal Implant (Article No. 042.335S and 042.336S)
Frenius Kabi Applix Smart pump (all models)
N/A
Ltd.
N/A
SA071242
SA071243
SA071244
SA071245
SA071246
SA071247
SA071248
SA071249
CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment
(CME Code: 120-112SFV) (Lot no. 2856-7, 3173-7, 3226-7, 33437, 3344-7, 3345-7, 3346-7, 3347-7, 3397-7, 3398-7)
Sysmex SF-3000 Haematology Analyser, software version 00-01 on
CPSU-4 sampler
Radiometer Medical ABL77 Cal Packs
Stryker Hipstar V40 Femoral Stem-127 degrees (Cat. No. 7850-5001 - 7850-5-012)
Stryker Hipstar TMZF Cementless Hip Stem Protocol (Product no.
LSP60)
Stryker Triathlon MIS AP Sizer Body-left and Right, Triathlon MIS
Femoral Adjustment Block and Triathlon MIS Modular Capture
Stryker inTouch Critical Care bed (Model 2130) and Stryker
inTouch Zoom Critical Care bed (Model 2140)
FDA
Z-0277-2008 to Z-0278-2008
Class II
2007/12/14
MHRA
MDA/2007/098
MDA
2007/12/18
MHRA
2007/012/005/061/022
FSCA
2007/12/19
N/A
N/A
MHRA
2007/011/005/401/011
FSCA
2007/12/19
N/A
N/A
MHRA
2007/009/003/061/009
FSCA
2007/12/19
N/A
N/A
FDA
Z-0463-2008 to Z-0474-2008
Class II
2007/12/20
Stryker China Ltd
2518 6988
FDA
Z-0475-2008
Class II
2007/12/20
Stryker China Ltd
2518 6988
FDA
Z-0448-2008 to Z-0450-2008
Class II
2007/12/20
Stryker China Ltd
2518 6988
FDA
Z-0356-2008 to Z-0357-2008
Class II
2007/12/20
Stryker China Ltd
2518 6988
SA071250
B. Braun Excia Cemented Hip Stems (Size 9mm to 18mm)
FDA
Z-0436-2008 to Z-0445-2008
Class II
2007/12/20
B. Braun Medical (Hong Kong) Ltd.
2277 6125
SA071251
Abbott ARCHITECT c8000 Processing Module (List no 106-01) and
ARCHITECT c16000 Processing Module (List no 3L77-01)
FDA
Z-0146-208 to Z-0147-2008
Class II
2007/12/20
2806 4021
98
SA071252
SA071253
Roche Diagnostics LightCycler Capillaries (100uL) (Catalog #
03337090001, 04391039001, 03603946001, 03531414201)
ConMed Accessory Electrode, Universal Electrodes and Ultra
Clean Accessory Electrode
FDA
Z-0459-2008
Class II
2007/12/20
Limited
2485 7510
FDA
Z-0452-2008
Class II
2007/12/20
N/A
N/A
SA071254
BD Visitec Nucleus Hydrodissector (Catalog # 585155, 585793)
FDA
Z-0453-2008 to Z-0454-2008
Class II
2007/12/20
BD
2575 8668
SA071255
Accuray Multiplan Treatment Planning Software
FDA
Z-0364-2008
Class II
2007/12/20
Accuray Asia Ltd
2247 8688
SA071256
Cardinal Health Alaris Pump modules, model 8100 (Medley Pump
modules)
FDA
Z-0460-2008
Class I
2007/12/20
N/A
N/A
SA071257
Axya Bone Anchor
FDA
Z-0331-2008 to Z- 0355-2008
Class II
2007/12/21
N/A
N/A
SA071258
Mizuho OSI Allegro 6800 Imaging Table (Operating) and OSI ProFx
Operating Room Table 6850
FDA
Z-0241-2008 to Z-0242-2008
Class II
2007/12/21
N/A
N/A
SA071259
VNUS ClosureFAST catheters (Model no. CL7-7-100)
FDA
Z-0132-2008
Class II
2007/12/21
N/A
N/A
FDA
Z-0316-2008 to Z-0317-2008
Class II
2007/12/21
2992 0968
FDA
Z-0363-2008
Class II
2007/12/21
N/A
N/A
FDA
Z-0359-2008
Class II
2007/12/21
N/A
N/A
SA071260
SA071261
SA071262
Zimmer Minimally Invasive Solutions Technology Offset Rasp
Handles (REF/Catalog# 7712-35-01 and 7712-35-02)
Blackstone Medical Ascent POCTS (Posterior Occipital Cervical
Thoracic System)
ACIST Multi-Use Syringe Kit (Model A2000; SKU# 014612,
Catalog#800061-003)
SA071263
VKS Tibial Trial, Right/Left, Prep Guide
FDA
Z-0362-2008
Class II
2007/12/21
N/A
N/A
SA071264
Haemonetics cardioPAT System (Product list no 02050)
FDA
Z-0358-2008
Class II
2007/12/21
Haemonetics (Hong Kong) Limited
2868 9218
SA071265
Single Use Surgical Tibbs cannula - S044 all batches
MHRA
2007/011/028/601/002
FSCA
2007/12/21
N/A
N/A
SA071266
Liko Sabina II 350-slingbar (prod no. 2027002)
MHRA
2007/011/021/291/001
FSCA
2007/12/21
N/A
N/A
SA071267
Baxter Infusor 2ml/hr with Tubing Flow Restrictor (Product Code:
2C1071KJP)
MHRA
2007/012/010/061/003
FSCA
2007/12/21
2807 8555
SA071268
OPTI LION E-Plus Cassettes(Model: BP7507)
MHRA
2007/011/026/061/019
FSCA
2007/12/21
N/A
N/A
2007/12/21
Cyberonics
2007/12/21
2866 0811
SA071269
Cyberonics VNS Therapy Lead (Model 302)
SA071270
Terumo Artifical vascular graft - Triplex
SA071271
Bayer Contour TS blood glucose test strips
SA071272
SA071273
SA071274
SA071275
Action
Action
Cyberonics
N/A
Terumo China (H.K.)
Ltd.
N/A
FDA
Press Release
N/A
2007/12/21
Bayer Healthcare Ltd. (Hong Kong)
2814 7337
Toshiba Aquilion 32 and Aquilion 64
Health Canada
39250
Type II
2007/12/31
2384 0688
TD-Synergy Software (TD-SYN-01)
Health Canada
39374
Type II
2007/12/31
N/A
N/A
Health Canada
39288
Type II
2007/12/31
2814 0481
2814 0481
Instrumentation Laboratory HemosIL RecombiPlasTin and
Hemoliance RecombiPlasTin
Beckman Coulter Cytomics FC 500 Flow Cytometer and Cytomics
FC 500 MPL
Health Canada
39286
Type II
2007/12/31
SA071276
Beckman Coulter Cytomics FC 500 Flow Cytometer
Health Canada
37157
Type II
2007/12/31
2814 0481
SA071277
Beckman Coulter Sychron CX Systems salicylate reagent
Health Canada
39284
Type II
2007/12/31
2814 0481
SA071278
Freedom Designs TriPod w/Anti tipper Manual Wheelchair (Model
no.: TriPod, Tripod LT and TriPod Pediatric LT with Trailing AntiTipper-Caster- Axle Link)
FDA
Z-0137-2008
Class II
2007/12/31
N/A
N/A
99
SA071279
Medtronic Prestige Cervical Disc System, Implant Trial
(REF/Catalog#: 6972226, 6972246, 6972266, 6972247, 6972267,
6972287)
FDA
Z-0138-2008 to Z-0143-2008
Class II
2007/12/31
2919 1362
SA071280
Gen-Probe Accuprobe Group B Streptococcus Culture Identification
Test (Catalog.: 2820B and Batch no.: 531379)
FDA
Z-0145-2008
Class II
2007/12/31
N/A
N/A
FDA
Z-0184-2008 to Z-0185-2008
Class II
2007/12/31
N/A
N/A
FDA
Z-0286-2008 to Z-0287-2008
Class II
2007/12/31
N/A
N/A
FDA
Z-0136-2008
Class II
2007/12/31
N/A
N/A
SA071284
Encore Reverse Shoulder Prothesis(RSP) System (Catalog #: 50800-036 and 508-00-040)
Ellex Solitarie Opthalmic Laser System (Model no : LP4532-DGS
P/N303896; Solitaire-SGS P/N 3038960) and Ellex Integre Duo
(Model no. LP1RG-S P/N 3040000)
OrthoHelix Surgical Designs DRLock Bone Fixation Plates, Pegs
and Screw Systems, Distal Screw and Distal Peg
Sultan Brand Mirror Defogger
Health Canada
39364
Type II
2007/12/31
N/A
N/A
SA071285
Hudson Action forceps with insulated shafts
Health Canada
38922
Type II
2007/12/31
N/A
N/A
SA071286
Span-America Medical Systems Pressureguard Easy Air Mattress
Health Canada
39236
Type II
2007/12/31
N/A
N/A
SA071281
SA071282
SA071283
100
Month
*Note: FDA
F d Ref.
d
MDCO
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
Smith & Nephew Ltd.
2648 7700
SA071101
Smith & Nephew, Birmingham Hip Resurfacing Acetabular Cup
FDA
Z-0017-2008 to Z-0033-2008
Class II
2007/11/01
SA071102
Remington Medical Disposable Urinary Leg Bags (Order no. 500-D
and 1000-D)
FDA
Z-0058-2008
Class II
2007/11/01
N/A
N/A
SA071103
Philips Heartstart XL Monitor/Defibrillator (Model : M4735A)
FDA
Z-0062-2008
Class II
2007/11/01
2876 7525
SA071104
SA071105
BD Microkeratome K3000 and K4000 (Cat No. 378660)
Steris QFC1728 and QFC1729 Quick Connects
Stryker Trident PSL HA Cluster Acetabular Shell and HA solid back
acetabular shell
FDA
FDA
Z-0062-2008
Z-0101-2008
Class II
Class II
2007/11/01
2007/11/01
BD
2575 8668
FDA
Z-0072-2008 to Z-0073-2008
Class II
2007/11/01
Stryker China Ltd
2518 6988
SA071107
SA071106
Integra Flat Foot Implant KALIX II (Ref141 0xx)
MHRA
2007/008/010/061/008
FSCA
2007/11/02
N/A
N/A
SA071108
Innovacon Strep A Rapid Test Strip and Strep A Rapid Test Device
MHRA
2007/007/019/291/002
FSCA
2007/11/02
N/A
N/A
SA071109
Welch Allyn AED10 Automatic External Defibrillators
FDA
N/A
Class I
2007/11/05
Umedco
2765 8222
SA071110
Beckman Coulter FC500 Flow Cytometry Systems with CXP
Acquisition Software and FC500 MPL Cytometry Systems with MXP
Acquisition Software
MHRA
2007/010/026/601/002
FSCA
2007/11/07
2240 6260
SA071111
Boston Scientific RepliformR Tissue Regenration Matrix
Boston Scientific(HK)
Ltd
N/A
2007/11/07
Boston Scientific (HK) Ltd
2960 7128
SA071112
Bio-logic System Corp - Telescoping Camera Pole Assembly (part
no 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART
and 580PNCART, model 580-VIDPOL)
FDA
Z-0001-2008
Class II
2007/11/08
Schmidt BioMed Tech (HK) Ltd
2620 8320
SA071113
Thoratec Implantable Ventricular Assist Devices (Catalogue No.:
10012-2555-001)
Thoratec Corporation
N/A
Action
2007/11/08
N/A
N/A
SA071114
Roche High Pure System (Product Numbers 03502295001 and
03702995001)
MHRA
2007/010/029/061/009
FSCA
2007/11/09
Roche Diagnostics (Hong Kong) Limited
2485 7510
SA071115
GE Healthcare Flexi-DT Mobile Radiographic Table
MHRA
2007/010/025/061/006
FSCA
2007/11/09
2783 1838
SA071116
Unomedical umbilical cord clamp clipper (Ref: 84006182)
MHRA
2007/010/003/291/012
FSCA
2007/11/09
N/A
N/A
SA071117
Vernon-Carus Products containing 10x10 16ply X-Ray Detectable
Swabs (49335)
MHRA
2007/010/023/601/003
FSCA
2007/11/09
N/A
N/A
SA071118
Terumo Advanced Perfusion System 1 (Model no. 801046, Lot:
0049 AND 0079)
Health Canada
38444
Type II
2007/11/12
2866 0811
SA071119
Toshiba Aplio XG (SSA-790A)
Health Canada
38432
Type II
2007/11/12
2384 0688
SA071120
Baxter Healthcare Duoject EASY-Prep System
Health Canada
38628
Type II
2007/11/12
2807 8517
SA071121
Abbott Aeroset System-Creatine Kinase Assay (Model 7D63-30)
Health Canada
38476
Type II
2007/11/12
2806 4021
SA071122
Abbott Accelerator APS System Input/Output Module (IOM) (Model:
7L01-01)
Health Canada
38529
Type II
2007/11/12
2806 4021
SA071123
Siemens Mevatron Linear Accelerators, Oncor Expression Digital
Linear Accelerator and Oncor Care Systems
Health Canada
34805
Type II
2007/11/12
Siemens Ltd.
2810 7533
SA071124
Siemens Mevatron Linear Accelerators and Oncor Impression
Health Canada
38601
Type II
2007/11/12
Siemens Ltd.
2810 7533
SA071125
Beckman Coulter Immunoassay Analyzers
Health Canada
38546
Type II
2007/11/12
2240 6260
101
SA071126
Remel Wellcogen N Meningitidis B/E Coli K
Health Canada
37147
Type II
2007/11/12
Wenline Company
2521 2439
SA071127
Respironics Various Devices and Accessories
Health Canada
38678
Type II
2007/11/12
2332 3366
SA071128
Medtronic Sofamor Danek METRx System Bayonet Electrosurgical
Pencil (REF (P/N) 9560575)
FDA
Z-0114-2008
Class II
2007/11/19
2919 1362
SA071129
Philips Brilliance CT Big Bore (Model No. 728243)
FDA
Z-0121-2008
Class II
2007/11/19
2876 7525
SA071130
GE Voluson E8 ultrasound scanner (version 6.2.0 and 6.2.1)
FDA
Z-0113-2008
Class II
2007/11/19
2783 1838
SA071131
Siemens Medical charge-particle radiation therapy system
(Mevatron, Oncor and Primus)
FDA
Z-0155-2008 to Z-0169-2008
Class II
2007/11/19
Siemens Ltd.
2810 7533
SA071132
GE Signa MFO/I Magnetic Resonance System
FDA
Z-0170-2008
Class II
2007/11/19
2783 1838
SA071133
GE Sunisa Flexi-DT S0014115 Digital Table Flexi-DT
FDA
Z-0075-2008
Class II
2007/11/19
2783 1838
SA071134
Abbott AxSYM Digoxin III Reagent Pack (List 6L07-20)
Smiths Medical Portex Perfit Percutaneous Tracheostomy Tube
Replacement Kit (Sterile Ref: 536090)
FDA
Z-0064-2008
Class II
2007/11/19
2806 4021
FDA
Z-0100-2008
Class II
2007/11/19
2648 7700
SA071135
SA071136
Encore Medical Foundation Hip System Bipolar Modular
FDA
Z-0082-2008 to Z-0099-2008
Class II
2007/11/19
N/A
N/A
SA071137
Cardinal Health Texium Closed Male Luer (CML) (Model No.:
10012241)
FDA
Z-0218-2008
Class II
2007/11/19
N/A
N/A
SA071138
Varian Ximatron Digital Imaging (Ximavision)
FDA
Z-0213-2008
Class II
2007/11/19
2724 2836
SA071139
Karl Storz Fluid Management Stand (Product No. 26601EQ-KT)
FDA
Z-0144-2008
Class II
2007/11/19
Karl Storz Endoscopy China Ltd
2865 2411
SA071140
B Braun FT420T and FT430T CASPAR
MHRA
2007/011/066/291/003
FSCA
2007/11/20
B. Braun Medical (HK) Ltd
2277 6611
SA071141
APC Medical Bedside Temporary Cardiac Pacemaker (Model 4170)
MHRA
2007/006/005/401/014
FSCA
2007/11/20
N/A
N/A
SA071142
P3 Medical Robertshaw Endobronchial tubes (Rubber, Disposable)
MHRA
2007/010/030/601/002
FSCA
2007/11/20
N/A
N/A
SA071143
Respironics Esprit Ventilator
MHRA
2007/077/077/291/004
FSCA
2007/11/20
2268 9258
SA071144
Olympus KeyMed BML-V232QR-26, BML-V232QR-30, BMLV242QR-30 and BML201Q
MHRA
2007/009/025/601/002
FSCA
2007/11/22
2376 1805
MHRA
2007/008/008/301/001
FSCA
2007/11/22
N/A
N/A
MHRA
SA071145
SA071146
Pride Mobility Quantum 6000, 6000Z, 600, R-4000 and 1420, Pride
LX Power wheelchair
DiaSorin LIAISON Toxo IgM (Cat no 310710, lot no: 035052,
035052/1, 035052/2)
2007/009/027/601/003
FSCA
2007/11/22
N/A
N/A
N/A
Action
2007/11/26
2960 7128
SA071147
Boston Scientific LeVeen SuperSlim Needle Electrodes
Ltd
SA071148
Boston Scientific Impulse Angiographic Catheter
Ltd
N/A
Action
2007/11/26
2960 7128
SA071149
Ethicon Endopath 5mm Curved Dissector with Monopolar Cautery
(Product Code: 5DCD, Lot no. D4HZ9Y)
MHRA
2007/011/014/291/006
FSCA
2007/11/26
Johnson & Johnson Medical Hong Kong
2738 2818
SA071150
Invacare Typhoon Power Wheelchairs
MHRA
2007/004/020/261/001
FSCA
2007/11/26
N/A
N/A
SA071151
Bio-Rad Variant II Turbo Hemoglobin Testing System
MHRA
2007/011/014/061/010
FSCA
2007/11/26
2789 3300
SA071152
Kavo Estertica E80 Treatment Unit
MHRA
2007/011/013/061/011
FSCA
2007/11/26
N/A
N/A
SA071153
GE AW 4.2, AW Volumeshare and AW Volumeshare 2
Health Canada
38214
Type I
2007/11/27
2783 1838
SA071154
BD BBL Fluid Thioglycollate Medium and BBL Trypticase Soy Broth
(Model no 299108 and 299107)
Health Canada
38700
Type II
2007/11/27
BD
2575 8668
102
SA071155
SA071156
SA071157
GE Definium 8000 Table and Revolution XR/d Table
Abbott i-STAT Cartridges
Philips Intellivue Patient Monitor System - Multi Measurement
Server (Model no. M3001A)
Health Canada
Health Canada
36689
38822
Type II
Type II
2007/11/27
2007/11/27
2783 1838
2806 4021
Health Canada
32105
Type II
2007/11/27
2876 7525
SA071158
Medline Septoplasty Pack (Lot # 07CD1090 and 07DD3113)
Health Canada
38314
Type II
2007/11/27
N/A
N/A
SA071159
Zimmer Trilogy Cluster Hole Shell, Non Coated (Model 620006022,
lot 26208600)
Health Canada
38744
Type II
2007/11/27
2992 0968
SA071160
Bard Atlas PTA Balloon Dilation Catheter (Model AT-120124, Lot
GFRF1789)
Health Canada
38941
Type II
2007/11/27
N/A
N/A
SA071161
Patterson Dental Mirror Defogger / Solution (Lot 25622)
Health Canada
38884
Type I
2007/11/27
N/A
N/A
Health Canada
38502
Type II
FDA
Z-0240-2008
Class II
2007/11/27
N/A
N/A
FDA
Z-0183-2007
Class II
2007/11/27
2783 1838
SA071162
Hill-Rom Versacare Hospital Beds (model P3200 and P3201)
SA071163
GE OEC Insta Trak 3500 Plus with the Cranial Application
SA071164
GE OEC Insta Trak 3500 Plus Fluoro Trak and Fluoro CAT Spinal
Applications
FDA
Z-0181-2007
Class II
2007/11/27
2783 1838
SA071165
Stryker wheeled stretcher (various models)
FDA
Z-0219-2008 to Z-0239-2008
Class II
2007/11/27
Stryker China Ltd
2518 6988
SA071166
Stryker T2 Locking Screw (Cat no 1896-5070S)
FDA
Z-0214-2008
Class II
2007/11/27
Stryker China Ltd
2518 6988
SA071167
Clarisonic Skin care system
FDA
Z-0182-2008
Class II
2007/11/27
N/A
N/A
SA071168
Coloplast Elefant Suction- Irriagtion Device ASP1
MHRA
2007/011/013/061/021
FSCA
2007/11/28
N/A
SA071169
Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin
Calibrator (List no 1E66-03 & 1E66-04)
FDA
Z-0288-2008
Class II
2007/11/29
2806 4021
SA071170
B. Braun Vena Tech LP Vena Cava Filter System (Item no/REF
05010024, Model no 40DLP)
FDA
Z-0264-2008
Class II
2007/11/29
2277 6162
FDA
Z-0255-2008
Class II
2007/11/29
2332 4455
FDA
Z-0263-2008
Class II
2007/11/29
2807 8517
FDA
Z-0289-2008
Class II
2007/11/29
N/A
N/A
Ltd
N/A
Action
2007/11/30
2960 7117
MHRA
2007/008/009/061/014
FSCA
2007/11/30
N/A
N/A
MHRA
2007/011/029/291/001
FSCA
2007/11/30
Smith & Nephew Ltd.
2648 7700
SA071171
SA071172
SA071173
SA071174
SA071175
SA071176
Biomet Interlok 67mm Fixed Cruciate Tibial Plate with Locking Bar;
CO-CR-MO/TI 6AL 4V Alloy (Product ref 141232)
Baxter Duploject Easy Prep, Fibrin Sealant Preparation and
Application System ISO (Product codes: 1500949 - 1500952)
Metrika A1CNOW+ Sampler 10-Test Kits (Product no.: 3022)
Boston Scientific PATHWAY Balloon Expandable Ureteral Access
Sheath
CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment
(CME Code: 120-112SFV) (Lot no. 3399-7, 3400-7, 3401-7, 34027, 3403-7, 3404-7, 3405-7)
Smith & Nephew Femoral and Tibial Components of TC Plus, VKS
and RT Plus Knee Implants
103
MDCO Ref.
No.
Source of
Information*
Ltd
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
N/A
Action
2007/10/02
2960 7128
SA071001
Boston Scientific Advanced Bionics Electrode Insertion Tool for
HiRes 90KR with HiFocus HelixR Electrode
SA071002
Cardinal Health Procedure Pack
MHRA
2007/008/024/061/003
FSCA
2007/10/02
N/A
N/A
SA071003
CODAN PVB (Product Code STP 85, Lot No. 700265 & 700995)
MHRA
2007/009/003/051/002
FSCA
2007/10/02
N/A
N/A
SA071004
Pride Mobility Power Chairs
2005/011/016/301/004
N/A
N/A
Varian Acuity radiation therapy simulation systems
FSCA
Action
2007/10/03
SA071005
MHRA
Varian Medical
2007/10/03
2724 2836
SA071006
Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073) Pharmacy
Compounding System
SA071007
GE Healthcare OEC9900, OEC9800 and OEC8800
SA071008
Philips Gemini 16, Gemini GXL, Precedence and Brilliance
SA071009
SA071010
SA071011
SA071012
SA071013
SA071014
SA071015
Philips Bucky, Digital and Easy Diagnost X-Ray System & Easy,
Omni and Multi Diagnost Eleva
Philips Pinnacle3 Radiation Therapy Planning (RTP) System and its
associated Software
Intuitive brand Da Vinci Surgical System (Model No. IS2000, Part
no. 351040-04)
Intuitive brand Da Vinci Surgical System Endoscopic Instrument
Control System (Model IS1200, A4.3 SW Level)
GE Innova 2100-IQ Digital Fluoroscopic Imaging System
Cerner Millennium RadNet Auto Launch Study and Auto Launch
Report Software functionalilites
Davol Salute Fixation Reusable Handle, Fixation Reusable Shaft,
Laparoscopic Sterile Implant Cartridge and Short Sterile Implant
Cartridge
CP-2007-001
FDA
Z-1238-2007
Class I
2007/10/04
Jaspo Limited
2713 0007
MHRA
2007/008/029/291/017
FSCA
2007/10/04
2783 1838
FDA
Z-0013-2007 to Z-0014-2007
Class II
2007/10/04
2876 7525
FDA
Z-0907-2007 to Z-0912-2007
Class II
2007/10/04
2876 7525
FDA
Z-1212-2007
Class II
2007/10/04
2876 7525
FDA
Z-1245-2007
Class II
2007/10/04
N/A
N/A
FDA
Z-1244-2007
Class II
2007/10/04
N/A
N/A
FDA
Z-1088-2007
Class II
2007/10/04
2783 1838
FDA
Z-1243-2007
Class II
2007/10/04
N/A
N/A
FDA
Z-1266-2007 to Z-1273-2007
Class II
2007/10/04
N/A
N/A
SA071016
Cardinal Health Pyxis Anesthesia System 3500 (Model 3500)
FDA
Z-0555-2007
Class II
2007/10/04
N/A
N/A
SA071017
Stryker Trident PSL Acetabular Shell
FDA
Z-1261-2007
Class II
2007/10/04
Stryker China Ltd
2518 6988
SA071018
Hitachi Medical Altaire Shoulder Coil
FDA
Z-1263-2007
Class II
2007/10/04
N/A
N/A
SA071019
DeRoyal Assorted sterile surgical kits/trays
FDA
Z-1205-2007
Class II
2007/10/04
N/A
N/A
SA071020
FDA
Z-1228-2007
Class II
2007/10/04
N/A
N/A
FDA
Z-1216-2007 to Z-1218-2007
Class II
2007/10/04
N/A
N/A
SA071022
NxStage Cartridge Express (CAR-170)
Summit LX125 Swivel Collimator (Model D800), LX125V Swivel
Collimator (Model E600) and PCS125 Swivel Collimator (Model
F100)
Merit Medical Surgical Convenience Kits, Custom and SPPT
FDA
Z-1262-2007
Class II
2007/10/04
N/A
N/A
SA071023
BD Neisseria Meningitidis Antisera Group Y
Health Canada
37610
Type II
2007/10/04
BD
2575 8668
SA071024
Siemens Biograph Duo LSO, Biograph 6 and Biograph 16
Health Canada
37227
Type II
2007/10/04
Siemens Ltd.
2810 7533
SA071025
Boots Blood Glucose Monitoring System (50-53-811)
MHRA
2007/008/030/291/007
FSCA
2007/10/05
N/A
N/A
SA071026
GE Flexi-DT Mobile Radiographic Table
MHRA
2006/008/017/601/229
FSCA
2007/10/05
2783 1838
SA071027
Otto Bock Standard Kimba Spring (Ref TS8423)
MHRA
Ltd
Ltd
2007/004/010/301/001
FSCA
Action
Action
2007/10/08
2598 9772
2007/10/10
2960 7128
2007/10/10
2960 7128
SA071021
SA071028
Boston Scientific Transend EX Standard 0.014" Guidewire
SA071029
Boston Scientific Advanced Bionics PrecisionR Implantable Pulse
Generator -UPNM365SC11100
N/A
N/A
104
SA071030
Varian RTP Exchange software (interface application that supports
the electronic transfer of radiation treatment planning data)
SA071031
GE Disposable Multi Absorber Canister
Varian Medical
CP-2007-093
Action
2007/10/10
FDA
Z-0006-2008
Class II
2724 2836
2007/10/11
2783 1838
2780 9421
SA071032
CVI OZ Palm Injector (Ref: OZ 1035)
FDA
Z-0008-2008
Class II
2007/10/11
Suburfarm Investment and Trading Co.
Ltd.
SA071033
Abbott PathFinder Bone Drill-Awl-Tap (Part no. 1156-50 & 1156-60)
FDA
Z-0004-2008 to Z-0005-2008
Class II
2007/10/11
2806 4021
SA071034
Meretek BreathTek Urea Hydrolysis Rate Calculation CD, Version
1.3.5-January 1, '03
FDA
Z-0003-2008
Class II
2007/10/11
N/A
N/A
SA071035
Invacare REA Wheelchair Pelvic Belt
MHRA
2007/006/025/261/001
FSCA
2007/10/11
N/A
N/A
MHRA
2007/009/028/291/005
FSCA
2007/10/11
N/A
N/A
MHRA
MHRA
2007/010/002/061/003
2007/010/003/291/010
FSCA
FSCA
2007/10/12
2007/10/12
Maquet Hong Kong Limited
2724 2836
2393 9511
MHRA
2007/009/025/291/002
FSCA
2007/10/12
Stryker China Ltd
2518 6988
MHRA
2007/010/004/061/011
FSCA
2007/10/12
N/A
N/A
SA071041
Siemens Mobile Magnetom Harmony, Symphony and Sonata
Systems
MHRA
2007/008/029/291/010
FSCA
2007/10/12
Siemens Ltd.
2810 7533
SA071042
B Braun Aesculap e.motion and Columbus femoral components
MHRA
2007/009/017/291/009
FSCA
2007/10/12
N/A
N/A
SA071043
Baxter Colleague Triple Channel Mono, CX and CXE Volumetric
Infusion Pumps (Product Codes: 2M8153 & 2M9163)
MHRA
SA071036
SA071037
SA071038
SA071039
SA071040
Dale 240 Blue Tracheostomy Tube Holders and Dale 242 Blue
Tracheostomy Tube Holders for Neonates to Infants
Varian Real-time Position Management System (RPM) version 1.7
MAQUET ELS-Cannulae
Stryker Locking Screw, Fully Threaded 5 x 70 mm (Cat. no. 18965070S, Lot/Batch no. K871252)
Karl Storz Morcellator Cutter 12mm
2007/010/004/291/001
FSCA
2007/10/15
2807 8555
Medtronic
International, Ltd.
N/A
Action
2007/10/15
2919 1362
2384 0688
SA071044
Medtronic Sprint Fidelis Defibrillation Leads
SA071045
Toshiba Nemio and Nemio XG Ultrasound systems
MHRA
2007/009/026/061/007
FSCA
2007/10/16
SA071046
BD Multiset software version 2.1, 2.1.1 and 2.2
MHRA
2007/009/027/061/011
FSCA
2007/10/16
BD
2575 8668
SA071047
Otto Bock The Back 2, 3 and 4
MHRA
2006/010/011/301/002
FSCA
2007/10/16
2598 9772
SA071048
Respironics DEAS Heated Wire Circuits
MHRA
2007/009/011/291/007
FSCA
2007/10/16
N/A
N/A
SA071049
Masimo Rad 9 Pulse Oximeters
MHRA
2007/008/014/061/002
FSCA
2007/10/16
N/A
N/A
SA071050
BD CellQuest Pro Software v4.0.2, 5.0.1, 5.1, 5.1.1, 5.2 and 5.2.1
MHRA
2007/009/027/061/010
FSCA
2007/10/16
BD
2575 8668
MHRA
2007/009/027/601/002
FSCA
2007/10/16
2240 6260
MHRA
2007/008/013/051/002
FSCA
2007/10/17
N/A
N/A
MHRA
2007/009/010/291/009
FSCA
2007/10/17
N/A
N/A
MHRA
2006/008/007/401/006
FSCA
2007/10/17
N/A
N/A
Cyberonics
N/A
Action
2007/10/17
N/A
N/A
SA071053
Beckman Coulter Access Immunoassay Systems Ultrasensitive
Insulin Reagent Kit
Park House Healthcare Phase Type 1 Cell (Product code:
PHSP116)
Zeiss Hydromax (batches 6500 and 6271)
SA071054
SensorCare Systems Control Unit
SA071055
Cyberonics VNS Therapy Software, Model 250
SA071051
SA071052
SA071057
GE Healthcare Disposable Multi Absorber Canister with the EZ
change Module
movingpeople.net Trophy 6 electrical scooters
SA071058
Pluss GZL080A Wheelchair restraint belt
SA071059
Boston Scientific IMAGERT II Angiographic Cather
SA071060
Siemens Digital Linear Accelerators
SA071061
SA071056
MHRA
2007/008/001/601/004
FSCA
2007/10/18
2783 1838
MHRA
2007/008/014/061/005
FSCA
2007/10/18
N/A
N/A
MHRA
Ltd
Health Canada
2004/012/008/401/008
2007/10/18
N/A
N/A
2007/10/18
2960 7128
37632
FSCA
Action
Type II
2007/10/22
Siemens Ltd.
2810 7533
Siemens C.Cam Imaging System
Health Canada
37749
Type II
2007/10/22
Siemens Ltd.
2810 7533
SA071062
Siemens Mevatron Linear Accelerators
Health Canada
37825
Type II
2007/10/22
Siemens Ltd.
2810 7533
SA071063
Siemens Troponin Ultra (TNI-ULTRA) Assay
Health Canada
37323
Type II
2007/10/22
Siemens Ltd.
2810 7533
N/A
105
SA071064
SA071066
Baxter Amiscus Separator
Medtronic TSRH Silo Spinal System- Sagittal Adjusting Screw for
Rod - TI
Radiometer Pump waste tube for blood gas analysis kit
SA071067
SA071065
Health Canada
37954
Type II
2007/10/22
2807 8555
Health Canada
37878
Type II
2007/10/22
2919 1362
FDA
Z-0038-2008
Class II
2007/10/22
N/A
N/A
Diagnostica STA Compact and STA Compact CT
FDA
Z-0039-2008
Class II
2007/10/22
N/A
N/A
SA071068
Mallinckrodt Angiomat Illumena Injector with Auxiliary Console
FDA
Z-0056-2008
Class II
2007/10/22
Tyco Healthcare (HKSAR) Limited
3157 7244
SA071069
I-Flow ON-Q PainBuster with OnDemand (Model PMB01)
Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA +
Vancomycin 6MCG/ML for screening for Vancomycin Resistant
Enterococc (Cat# P1174)
Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA +
Vancomycin 6MCG/ML Microbiological media plates (Cat# P1174)
Medtronic Model Model 7428 Kinetra and Model 7426 Soletra
implantable neurostimulators
FDA
Z-0057-2008
Class II
2007/10/22
N/A
N/A
FDA
Z-0014-2008
Class II
2007/10/22
N/A
N/A
FDA
Z-0011-2008
Class II
2007/10/22
N/A
N/A
Medtronic
International, Ltd.
N/A
Action
2007/10/22
2919 1362
Gelita Medical Gelitacel Oxidized Cellulose Haemostat Gauze
MHRA
MHRA
MHRA
2007/009/014/601/003
2007/010/011/061/005
2007/010/015/291/003
FSCA
FSCA
FSCA
2007/10/23
2007/10/23
2007/10/23
N/A
2806 4021
2919 1362
N/A
FDA
Z-0044-2008 to Z-0046-2008
Class II
2007/10/25
BD
2575 8668
SA071077
BD Microtainer Safety Flow Lancets (Cat. No. 366356, 365759,
366357)
Days Healthcare Transportable Wheelchairs
MHRA
2007/005/018/401/005
FSCA
2007/10/25
N/A
N/A
SA071078
SA071079
Siemens Clinitest hCG Cassette
Smiths Medical EMS Ventilator circuits (Product code W196-002)
MHRA
MHRA
2007/010/018/061/010
MDA/2007/080
FSCA
MDA
2007/10/25
2007/10/25
Siemens Ltd.
2810 7533
N/A
SA071070
SA071071
SA071072
SA071073
SA071074
SA071075
SA071076
Abbott ARCHITECT cSystems
Medtronic Nexframe Stereotactic System
106
MDCO Ref.
No.
SA070901
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
N/A
Action
2007/09/03
2960 7128
MHRA
2007-008-024-061-012
FSCA
2007/09/05
N/A
JianXi FDA
N/A
N/A
2007/09/06
Jindun International (HK) Ltd
2851 0879
Varian Medical
N/A
Action
2007/09/11
2724 2836
Health Canada
37021
Type II
2007/09/11
BD
2575 8668
Health Canada
36862
Type II
2007/09/11
BD
2575 8668
FDA
N/A
Press Release
2007/09/11
2806 4021
Smiths Medical Hyperflex (Model 75 FHXL80)
Health Canada
30529
Type II
2007/09/14
N/A
Smiths Medical Epidural Minipack and Epidural Syringe
Health Canada
29940
Type II
2007/09/14
N/A
Terumo Advanced Perfusion System 1 Base and Roller Pumps
Health Canada
36601
Type II
2007/09/14
2866 0811
Siemens Siregraph CF
Health Canada
36799
Type II
2007/09/14
Siemens Ltd.
2810 7533
Health Canada
35983
Type II
2007/09/14
N/A
N/A
Gambro Prisma Continuous Fluid Management System
Health Canada
34788
Type II
2007/09/14
Gambro China Ltd.
2839 7010
Focus Surgery Sonablate 500
Boston Scientific Radial Jaw 4 Large Capacity Foreceps
SA070902 Smith & Nephew Full radius, 4.5 mm Concave Disposable Blade
(Item Code 7205335)
SA070903
Jiangxi Sanxin / "Yixin" Disposable Intravenous Administration Set
SA070904
Varian clinacs
SA070905 BD Epicentre Microbiology Data Management
SA070906
BD FA Stretococcus Group A
SA070907 Abbott Blood Glucose Meter: Precision Xtra, Optium, ReliOn
Ultima, Rite Aid and Kroger
SA070908
SA070909
SA070910
SA070911
SA070912 Randox Laboratories Carbon Dioxide Reagent
SA070913
SA070914
Source of
Information*
Ltd
Health Canada
36419
Type II
2007/09/14
N/A
N/A
SA070915 Conmed Linvatec Ultrapower Burr and Ultrapower Burr Diamond
Health Canada
36844
Type II
2007/09/14
N/A
N/A
SA070916 PreMD PREVU* Point of Care Skin Sterol Test
Health Canada
36800
Type II
2007/09/14
N/A
N/A
Boston Scientific Mach 1 Guide Catheter
Ltd
N/A
Action
2007/09/14
2960 7128
Boston Scientific Renegade HiFlo Microcatheter Kit
Ltd
N/A
Action
2007/09/14
2960 7128
SA070919 BD Vacutainer Safety-Lok Blood Collection Set with Preattached
Holder (Catalog #368652)
FDA
Z-0777-2007
Class II
2007/09/14
BD
2575 8668
FDA
Z-1219-2007
Class II
2007/09/14
N/A
N/A
FDA
Z-1198-2007 to Z-1200-2007
Class II
2007/09/14
2806 4021
FDA
Z-1201-2007
Class II
2007/09/14
N/A
N/A
FDA
Z-1202-2007
Class II
2007/09/14
2806 4021
SA070917
SA070918
SA070920 Molnlycke Biogel Skinsense Polyisoprene Surgical Gloves, NonLatex, Sterile (Size 8)
SA070921 Abbott CELL-DYN 3000, CELL-DYN 3500 and CELL-DYN 3700
Hematology Analyzer
SA070922 Sendx Medical (Radiometer Capenhagen ) ABL8O FLEX Software
Version 1.10 (Model no. 914863)
SA070923
Abbott AxSYM System Digoxin III Reagent Pack
107
SA070924
Abbott Multi-Link Vision RX Coronary Stent System
SA070925 Dade Behring Dimension clinical chemistry system Total Bilirubin
(TBIL) Flex reagent cartridge (Cat# DF67A) (Lot: FC8170)
SA070926
Biomet Austin-Moore and Thompson Endoprotheses
SA070927
Roma Medical Bed Support Handle Model 5423
SA070928 Elekta Synergy Linear accelerator XVI
FDA
Z-1211-2007
Class II
2007/09/14
2806 4021
MHRA
2007/008/022/601/001
FSCA
2007/09/17
N/A
N/A
MHRA
2007/008/028/061/007
FSCA
2007/09/17
N/A
N/A
MHRA
2007/007/005/401/001
FSCA
2007/09/17
N/A
N/A
MHRA
2007/008/009/061/006
FSCA
2007/09/17
N/A
N/A
SA070929 Immucor Galileo
MHRA
2007/008/016/401/005
FSCA
2007/09/17
Uninet Technology Ltd
2838 8423
SA070930 Chas A. Blatchford & Sons Ltd Derby Seat / Moulded Seat Insert
MHRA
2006/009/019/301/001
FSCA
2007/09/17
N/A
N/A
SA070931 Philips MR Systems
MHRA
2007/001/023/081/009
FSCA
2007/09/17
2876 7525
MHRA
2006/010/011/261/001
FSCA
2007/09/17
N/A
N/A
MHRA
2007/006/005/061/010
FSCA
2007/09/17
2806 4021
MHRA
2007/008/014/601/004
FSCA
2007/09/17
2806 4021
2738 2818
2277 6162
SA070932
Cascade Designs Varilite Back Support
SA070933 Abbott Precision Plus Blood Glucose Electrodes / Test Strips (Lot
no. 96425)
SA070934
Abbott Bilirubin Calibrator : 1E66-04
SA070935
SA070936
SA070937
SA070938
SA070939
SA070940
MHRA
2007/007/025/061/016
FSCA
2007/09/17
Kong
FDA
N/A
Press Release
2007/09/18
Stericom STE 4021 Proctoscope
MHRA
2007/007/030/061/008
FSCA
2007/09/18
Roche Online TDM Tobramycin for Modular Analytics {P} System
MHRA
2007/004/017/131/017
FSCA
2007/09/18
Smith & Nephew CALAXO Interference Screw
MHRA
2007/008/024/291/005
FSCA
2007/09/18
BD Plastipak 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes
MHRA
MDA/2007/071
MDA
2007/09/18
BD
2575 8668
MHRA
MDA/2007/070
MDA
2007/09/18
N/A
N/A
MHRA
MDA/2007/073
MDA
2007/09/18
N/A
N/A
FDA
37014
Class I
2007/09/19
N/A
N/A
Abbott Muligent Acetaminophen Assay
Health Canada
37211
Type II
2007/09/19
2806 4021
Abbott Commander System Analyzer Class 4
Health Canada
37035
Type II
2007/09/19
2806 4021
Abbott Architect System - Lipase Assay
Depuy Engage Modular Revision Hip Implant Component
B. Bruan Medical Normal Saline Flush Syringes (Lot no "SFR")
SA070941 Universal Hospital Supplies Sterile suction connecting tubing (ref
no. UN30026FFM)
SA070942
Eschmann Electrosurgery bipolar unit (model TDB 60)
SA070943
SA070944
SA070945
SA070946
Welch Allyn AED20 Automatic External Defibrillators
N/A
Limited
Smiths & Nephew Healthcare (Hong
Kong)
N/A
2485 7510
2648 7700
Health Canada
35873
Type II
2007/09/19
2806 4021
SA070947 Abbott Freestyle Freedom Blood Glucose Monitorinf System,
Freestyle Blood Glucose Monitoring System, Freestyle Mini Blood
Glucose Monitoring System
Health Canada
31983
Type II
2007/09/19
2806 4021
SA070948 Medtronic Export XT Catheter
Health Canada
36691
Type II
2007/09/19
2919 1362
Health Canada
37173
Type II
2007/09/19
2919 1362
Health Canada
37033
Type II
2007/09/19
Siemens Ltd.
2810 7533
SA070949
Medtronic Paceart System Software - 2006 1st Edition
SA070950 Siemens Biograph 2, Biograph 6 and Biograph 16
108
SA070951
Smiths Medical Portex Perfit Percutaneous Dilational
SA070952 Smiths Medical Portex Epidural and Spinal Needle Set
SA070953
28486
Type II
2007/09/19
2648 7700
Health Canada
30639
Type II
2007/09/19
2648 7700
Health Canada
24935
Type II
2007/09/19
2648 7700
SA070954 Siemens Lithoskop
Health Canada
37262
Type II
2007/09/19
Siemens Ltd.
2810 7533
SA070955 Draeger Medical Babylog 8000
Health Canada
36919
Type II
2007/09/19
2877 3077
Health Canada
37229
Type II
2007/09/19
2877 3077
SA070957 Agfa Healthcare Impax DS3000 Diagnostic Pacs, Impax ES (5.0)
for Cardiology, Impax for Cardiology, MA3000 Mammographic
Workstation, Impax OT3000 Orthopaedic Workstation, Web 1000
Health Canada
35889
Type II
2007/09/19
Agfa Hong Kong Limited
2555 9421
SA070958 Remel Wellcogen Bacterial Antigen Test
Health Canada
37147
Type II
2007/09/19
N/A
N/A
SA070959 Ivoclar Vivadent Odyssey Diode Laser
Health Canada
37057
Type II
2007/09/19
N/A
N/A
MHRA
MDA/2007/074
MDA
2007/09/19
N/A
N/A
MHRA
MDA/2007/075
MDA
2007/09/19
N/A
N/A
FDA
SA070956
Smiths Medical Graseby MS26 Syringe Driver
Health Canada
Draeger Medical D-Vapor
SA070960 Invacare Action 2000 wheelchairs (blue frame)
SA070961
Invacare Action 3 wheelchairs
SA070962 Philips Isolation Transformer
SA070963 Boston Scientific Advanced Bionics Patient Controller SC-5400
(Joystick Controller)
Z-1234-2007
Class II
2007/09/20
2876 7525
Ltd
N/A
Action
2007/09/21
2960 7128
N/A
SA070964 Bard Guidewire 70 cm x 1 mm (0.038") (Product Code: 5583705)
MHRA
2007/009/010/291/012
FSCA
2007/09/21
N/A
SA070965 Vertec, Hologic Fluoroscan Premier and Encore Image Intensifiers
MHRA
2007/008/003/601/006
FSCA
2007/09/21
N/A
N/A
SA070966 Cyberonics VNS Therapy Leads
MHRA
2007/008/010/061/010
FSCA
2007/09/21
GM Medical (Hong Kong) Ltd
2783 1838
MHRA
2007/007/030/051/009
FSCA
2007/09/21
Limited
2485 7510
MHRA
2007/009/010/291/015
FSCA
2007/09/21
2919 1362
MHRA
2007/008/028/061/009
FSCA
2007/09/24
N/A
N/A
MHRA
2007/006/014/601/002
FSCA
2007/09/24
Arjo Far East Ltd (Hong Kong)
2508 9553
MHRA
2007/007/024/061/008
FSCA
2007/09/24
2648 7700
SA070972 Stryker Radius Lcoking Caps (Cat. No. 486610000)
FDA
Z-1239-2007
Class II
2007/09/27
Stryker China Ltd
2518 6988
SA070973 Stryker Wheeled Electric Stretcher Model 1550
FDA
Z-1009-2007
Class II
2007/09/27
Stryker China Ltd
2518 6988
SA070974 Biomet 3i LTX XP Miniplant, Dental Implant, Sterile (Model No
LTX3211 and Model LTX3213)
FDA
Z-1221-2007
Class II
2007/09/27
N/A
N/A
FDA
Z-1224-2007
Class I
2007/09/27
N/A
N/A
FDA
Z-1222-2007
Class II
2007/09/27
2806 4021
FDA
Z-1226-2007
Class II
2007/09/27
BD
2575 8668
SA070967 Roche LightCycler 2.0 Instrument Software v 4.05.415 Deficiency
and LightCycler SeptiFast Test M
SA070968
Medtronic Spinal Implants: Colorado II Locking Nut#8634111
SA070969 Metrax Primedic - DefiMonitor Models DX1, XD3, XD10, XD30,
XD100, XD300, XD110, XD330
SA070970 Arjo Otter lift and Arjo Pool Lift
SA070971 Smiths CADD Medication Cassette Reservoir
SA070975 Baxter Colleague CX Single Channel Volumetric Infusion Pumps,
product code 2M8161
SA070976
Abbott ARCHITECT Prolactin MasterCheck
SA070977 BD ReliOn 0.5cc 3g x 8mm Bilster Pak U-100 Syringe
109
SA070978
Kimberly Clark BALLARD BAL CATH Kit
Kimberly Clark Health
Care
N/A
Action
2007/09/27
N/A
N/A
SA070979 Medtronic Intersept 3608 Sterile tubing (Lot 7626621)
FDA
Z-1227-2007
Class II
2007/09/27
2919 1362
SA070980 Nicolet Biomedical BMSI " MicroJack" PN672-510000
FDA
Z-1225-2007
Class II
2007/09/27
N/A
N/A
SA070981 Newport HT50 Ventilator (all Models)
FDA
Z-1192-2007
Class II
2007/09/27
N/A
N/A
SA070982 Sorin SR Single Chamber Pacemakers
MHRA
2007/009/012/291/004
FSCA
2007/09/27
N/A
N/A
SA070983 G & S Smirthwaite SAMBA Supportive Seating System
MHRA
2006/010/012/301/001
FSCA
2007/09/27
N/A
N/A
SA070984 Roma Medical Aids Bed Grab Handle (Model 5425)
MHRA
2007/007/030/051/005
FSCA
2007/09/28
N/A
N/A
SA070985 Pegasus Euro Adaptor (Part No. MSM14337)
MHRA
2007/003/008/081/010
FSCA
2007/09/28
N/A
N/A
SA070986 Varian Clinacs with Type 3 accessories
MHRA
2007/009/012/061/006
FSCA
2007/09/28
2724 2836
SA070987 R82 Vests and Belts
MHRA
2006/010/012/301/004
FSCA
2007/09/28
N/A
N/A
SA070988 Gambro Spectra Optia System
MHRA
2007/009/019/061/002
FSCA
2007/09/28
Gambro China Ltd.
2576 2688
SA070989 B BRAUN Excia Hip Endoprosthesis, cementless, NC410T (LOT
51283009)
MHRA
2007/009/017/291/010
FSCA
2007/09/28
N/A
N/A
110
MDCO Ref.
No.
SA070801
BCI Autocorr Plus patient monitor
SA070802 Cousin Biotech Intrmesh TI - FBIOT12020, FBIOT12025,
FBIOT13030, FBIOT13050
SA070803 Philips X-Ray System BV Pulsera and Endura rel.2 with Remote
Control
SA070804
GE Healthcare OEC InstaTrak 3500 Plus System
SA070805 GE Healthcare CardioLab/Mac-Lab IT/ComboLab IT
Electrophysiology and Haemodynamic Systems
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
N/A
Action
2007/08/02
Goodwin Healthcare Ltd.
2408 8838
MHRA
2007/006/012/291/002
FSCA
2007/08/06
N/A
N/A
MHRA
2007/007/023/061/018
FSCA
2007/08/06
2876 7525
MHRA
2007/007/025/061/013
FSCA
2007/08/06
2783 1838
MHRA
2007/007/019/601/002
FSCA
2007/08/06
2783 1838
MHRA
2007/007/027/291/008,
2007/007/027/291/007
FSCA
2007/08/06
2783 1838
Source of
Information*
Goodwin Healthcare
Ltd.
SA070806 GE Healthcare Extended Range Transmitter (Catalog Part 1004070
, 1003991)
SA070807
Tyco Kendall Curity Suprapubic Catheter Sets
MHRA
2007/007/012/051/003
FSCA
2007/08/06
3157 7244
SA070808 Fresenius Medical Care HD Catheters
MHRA
2007/007/019/291/018
FSCA
2007/08/06
Ltd.
2802 2900
Teleflex Medical Hudson RCI Large Volume Nebuliser
MHRA
2007/006/012/401/015
FSCA
2007/08/06
N/A
N/A
Abbott ACCELERATOR APS System (7L01-01)
MHRA
2007/005/023/601/001
FSCA
2007/08/06
2806 4021
Trinity Biotech Captia Measles IgM ELISA Test Kit
MHRA
2007/007/009/061/003
FSCA
2007/08/06
N/A
N/A
FDA
Z-1110-2007
Class II
2007/08/06
2919 1362
FDA
Z-1096-2007 to Z-1098-2007
Class II
2007/08/06
2806 4021
FDA
Z-1100-2007 to Z-1101-2007
Class II
2007/08/06
N/A
N/A
FDA
Z-1080-2007 to Z-1085-2007
Class II
2007/08/06
N/A
N/A
FDA
Z-1057-2007 to Z-1062-2007
Class II
2007/08/06
N/A
N/A
SA070809
SA070810
SA070811
SA070812
Medtronic Intersept Filtered Cardiotomy Reservior (Model 1351)
SA070813 Abbott Architect AUSAB Assay
SA070814 Sunnex Celestial Star MR-16 and Tri-Star Surgical Exam Light MR16 (Lamp Holder)
SA070815 Allez Medical Applications 4Closure Surgical Fascia Closure
System
SA070816 Gebauer Pain Ease Mist Spray
SA070817 Gambro Prismaflex Hemodialysis Unit
SA070818
Performance Health Products AXXIS, Comfort and V-Trak
MHRA
2007/007/018/061/005
FSCA
2007/08/06
Gambro China Ltd.
2839 7010
MHRA
2006/010/011/301/001
FSCA
2007/08/07
N/A
N/A
SA070819 Philips Brilliance 40/64 CT Scanners
MHRA
2007/007/024/291/007
FSCA
2007/08/07
2876 7525
SA070820 Pelican Proctoscope (Product Code 400340)
MHRA
2007/007/030/061/008
FSCA
2007/08/07
N/A
N/A
SA070821 Medtronic SynchroMed EL Pump
MHRA
2007/007/025/291/008
FSCA
2007/08/07
2919 1362
MHRA
2007/008/002/061/011
FSCA
2007/08/08
N/A
FDA
Z-1020-2007
Class II
2007/08/09
Vita Company Limited
N/A
FDA
Z-1078-2007
Class II
2007/08/09
Vita Company Limited
N/A
Health Canada
32026
Type II
2007/08/09
2992 0968
SA070822 Beckman Coulter Cytomics FC 500 Flow Cytometer with CXP
Software
SA070823
Cardinal Health Alaris IV Administration Infusion Sets
SA070824 Cardinal Health Alaris IV Administration Infusion Sets, Low Sorbing
Extension Set
SA070825
Zimmer M/DN Intramedullary Fixation System
111
SA070826
SA070827
Cook Fixed Core Stainless Stell Wireguide
Health Canada
35942
Type II
2007/08/09
Cook Asia Ltd
(1) 2781 0232; (2)
2541 1041
(1) 2781 0232; (2)
2541 1041
Cook Black Silicone Filiform Double Pigtail Stent Set
Health Canada
36639
Type II
2007/08/09
Cook Asia Ltd
SA070828 Boston Scientific Amplatz, CLS Cure, Internal Mamnary, Kimmy,
Multipurposse and Voda Guide Catheters
Health Canada
36465
Type II
2007/08/09
2960 7128
SA070829 Siemens ECAT
Health Canada
36463
Type II
2007/08/09
Siemens Ltd.
2810 7533
SA070830
Health Canada
36560
Type II
2007/08/09
Siemens Ltd.
2810 7533
SA070831 Siemens Biograph 6 and Biograph 16
Health Canada
36426
Type II
2007/08/09
Siemens Ltd.
2810 7533
SA070832 Stryker Peek Electrosurgical Handle
Health Canada
34278
Type II
2007/08/09
Stryker China Ltd
2518 6988
Health Canada
36506
Type II
2007/08/09
N/A
N/A
SA070833
Siemens Sonoline Antares and Acusion Antares Premium Edition
Radiometer D711 Reference Membrane ABL7XX
SA070834 Getinge Castle Steam Sterilizers
Health Canada
35738
Type II
2007/08/09
N/A
N/A
Sensor Health Products Cary Blair Enteric Pathogen Transport
Health Canada
36355
Type II
2007/08/09
N/A
N/A
Cybernius Nephroncare Software 5.1 Full and 5.1A5
Health Canada
34861
Type II
2007/08/09
N/A
N/A
Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit
Health Canada
36279
Type II
2007/08/09
N/A
N/A
BHM Medical Nautica Patient Lift
Health Canada
34044
Type I
2007/08/09
N/A
N/A
Health Canada
36188
Type I
2007/08/13
N/A
N/A
MHRA
2007/005/009/061/011
FSCA
2007/08/14
N/A
N/A
MHRA
2007/008/007/051/007
FSCA
2007/08/15
2877 3077
MHRA
2007/007/027/291/009
FSCA
2007/08/15
N/A
N/A
MHRA
MDA/2007/062
MDA
2007/08/15
2877 3077
MHRA
2007/008/010/061/012
FSCA
2007/08/16
2876 7525
MHRA
2007/008/001/291/016
FSCA
2007/08/16
N/A
N/A
NMPE ISOLOC Software Versions 4.2, 6.0 and 6.5
FDA
Z-1145-2007 to Z-1147-2007
and Z-1152-2007 to Z-11552007
Class II
2007/08/17
N/A
N/A
Biomet Straight Magnum Inserter Handle
FDA
Z-1151-2007
Class II
2007/08/17
N/A
N/A
ACT VS-1000 Senator Prosthetic Foot
FDA
Z-1149-2007
Class II
2007/08/17
N/A
N/A
FDA
Z-1156-2007 to Z-1158-2007
Class II
2007/08/17
N/A
N/A
Abbott Embrace Enteral Pump
FDA
Z-1141-2007
Class II
2007/08/17
2806 4021
SA070851 Possis AngioJet XVG Thrombectomy Sets
FDA
Z-1131-2007
Class II
2007/08/17
N/A
N/A
SA070835
SA070836
SA070837
SA070838
SA070839 Georg Kramer GES.M.B.H. & Co. KG - Atlantis Patient Lift Model
9500
SA070840
Specialised Orthotic Services Stroller buggies
SA070841 Draeger Medical Anaesthesia Machine with additional monitor
(device combination)
SA070842
Cardinal Health Propofol-Schnider Upgrade Kit
SA070843 Draeger Medical Falcon single-use paediatric Miller blades size 00,
0&1
SA070844
Philips X-Ray System Allura Xper FD20/10 Rel. 1.2., FD20 Rel.2.2.
SA070845
Finsbury Orthopaedics ADEPT Acetabular Cups
SA070846
SA070847
SA070848
SA070849 Accellent Precision Bipolar Device ClearGlide EVH Small
SA070850
112
SA070852
FDA
Z-1162-2007
Class II
2007/08/17
Cook Asia Ltd
(1) 2781 0232; (2)
2541 1041
MHRA
2007/008/013/061/003
FSCA
2007/08/20
2876 7525
ThermoFisher Scientific Infinity Ammonia Liquid Stable Reagent
MHRA
2007/004/003/291/010
FSCA
2007/08/20
N/A
N/A
MAQUET Vessel Cannulae Product Code GK03 and S 1184
MHRA
2007/008/010/061/004
FSCA
2007/08/20
2393 9511
Ltd
N/A
Action
2007/08/22
2960 7128
Abbott CELL-DYN 1700 Hematology Analyzer
FDA
Z-1170-2007 to Z-1171-2007
Class II
2007/08/23
2806 4021
Lifescan One Touch SureSoft Lancing Device
FDA
Z-1165-2007
Class II
2007/08/23
Kong
2738 2818
FDA
Z-1173-2007
Class II
2007/08/23
FDA
Z-1132-2007 to Z-1134-2007
Class II
2007/08/23
2783 1838
FDA
Z-1172-2007
Class II
2007/08/23
N/A
N/A
COOK PTFE Wire Guide with 3 cm flexible tip
SA070853 Philips Medical System Information Centre
SA070854
SA070855
SA070856
SA070857
SA070858
Boston Scientific Precision Spare Suture Sleeve
SA070859 Sendx Medical ABL77 Cal Pack, Model No. 944-069
SA070860 GE Medical System Mac-Lab System, CardioLab System,
ComboLab System
SA070861
Sisus- Bath Helper / Sisus All In One
SA070862 Louisville ApI Diagnostics APhL HRP IgG & IgM ELISA Kit, APhL
HRP IgG ELISA Kit and APhL HRP IgM ELISA Kit
FDA
Z-1175-2007 to Z-1177-2007
Class II
2007/08/23
N/A
N/A
SA070863 Hill-Rom TotalCare Duo 2
MHRA
MDA/2007/065
MDA
2007/08/23
N/A
N/A
SA070864 Femcare Nikomed Unimax Disposable Shielded Trocar and
Cannula
SA070865 North Eos single-use Cusco screw type vaginal specula
MHRA
2007/008/020/051/005
FSCA
2007/08/23
N/A
N/A
MHRA
MDA/2007/066
MDA
2007/08/23
N/A
SA070866 Depuy SmartSeal Pressurisers
MHRA
2007/007/016/061/005
FSCA
2007/08/27
2798 6080
SA070867 Biomet Optigun 4195
MHRA
2007/008/014/061/008
FSCA
2007/08/27
N/A
Kong
N/A
Health Canada
36667
Type I
2007/08/28
Gambro China Ltd.
2839 7010
Health Canada
33984
Type II
2007/08/28
2866 0811
Terumo Advanced Perfusion System - Modules
Health Canada
33985
Type II
2007/08/28
2866 0811
Terumo Advanced Perfusion System 1 and Central Control Monitor
Health Canada
33982
Type II
2007/08/28
2866 0811
Health Canada
33981
Type II
2007/08/28
2866 0811
Health Canada
36673
Type II
2007/08/28
2866 0811
Health Canada
36696
Type II
2007/08/28
2866 0811
SA070868
Gambro AK-95
SA070869 Terumo Advanced Perfusion System - Roller Pump and
Centrifugual Control Unit
SA070870
SA070871
SA070872 Terumo Advanced Perfusion System 1 (Model 801041)
SA070873 Terumo Advanced Perfusion System 1 (Model 801040, 801041)
SA070874 Terumo Sarns Modular Perfusion System 9000, 8000 and
Centrifugal System
SA070875 Biomerieux AacT/Alert 3D, BacT/Alert 3D 240, BacT/Alert 3D
Combi
SA070876 Kodak Direct View DR3000 System 80kW Generator
SA070877 BD Procount Progenitor Cell
SA070878 BD Difco Shigella Antiserum Poly A1
SA070879 Steris Amsco Century Medium Steam Sterilizer & SFPP Steam
Sterilizer
N/A
Health Canada
36531
Type II
2007/08/28
2356 7033
Health Canada
36629
Type II
2007/08/28
Care Stream Health
2564 9751
Health Canada
33951
Type II
2007/08/28
BD
2575 8668
Health Canada
28852
Type II
2007/08/28
BD
2575 8668
FDA
Z-1193-2007
Class II
2007/08/30
N/A
113
SA070880
Dade Behring EasyLink Informatics System Software version 3.0
FDA
Z-1174-2007
Class II
2007/08/30
N/A
N/A
SA070881 Carmel PhaSeal Protector 14, 21 and 50 (Item No. P14, P21 and
P50)
FDA
Z-1178-2007 to Z-1181-2007
Class II
2007/08/30
N/A
N/A
114
MDCO Ref.
No.
SA070701 Abbott m2000sp Instrument and m1000 Instrument
Source of
Information*
MHRA
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
2007/006/020/601/002
FSCA
2007/07/03
2806 4201
Ltd
N/A
Action
2007/07/03
2960 7128
SA070703 Roche Cortisol Reagent
FDA
Z-0977-2007
Class II
2007/07/05
2485 7510
SA070704 GE Healthcare Diamond Mannographic X-Ray System
FDA
Z-0976-2007
Class II
2007/07/05
2783 1838
SA070705 Varian Medical LINAC Scapel Treatment Planning System
FDA
Z-0978-2007
Class II
2007/07/05
2724 2836
SA070706 Toshiba Aplio 80 and Aplio 50 Digital Ultrasound System
FDA
Z-0985-2007 to Z-0986-2007
Class II
2007/07/05
2384 0688
SA070707 Oasis Disposable Bimanuals Irrigation and Aspiration Set
FDA
Z-0740-2007 to Z-0742-2007
Class II
2007/07/05
N/A
N/A
SA070708 Philips Masimo SPO2 modules
MHRA
2007/002/020/401/006
FSCA
2007/07/05
2876 7525
SA070709 Abbott ClearStar enteral feeding pump
MHRA
2007/006/025/061/002
FSCA
2007/07/05
2806 4201
SA070710 Baxter CS3000 Apheresis Kits
MHRA
2007/006/029/291/010
FSCA
2007/07/06
2807 8517
SA070711 Baxter Sample First Sampling System
MHRA
2007/007/002/291/004
FSCA
2007/07/06
2807 8517
SA070712 Varian Clinacs with Type 3 accessories
MHRA
2007/006/029/291/003
FSCA
2007/07/06
2724 2836
MHRA
SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters
SA070713 Integra Neurosciences Elektrotm ET630 and ET621
Boston Scientific VASOVIEWR UniportR Plus EVH System w/
SA070714
Bisector VasoView 7xB Bisector
SA070715
Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FS
Chemistry System - Software
2007/007/003/291/024
FSCA
2007/07/06
N/A
N/A
Ltd
N/A
Action
2007/07/09
2960 7128
Health Canada
35306
Type II
2007/07/10
2738 2818
Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin Panel
SA070716
System resolve Panel C
Health Canada
35880
Type II
2007/07/10
2738 2818
SA070717 Teleflex Medical Non Absorbable Stainless Steel Suture
Health Canada
35784
Type II
2007/07/10
N/A
N/A
SA070718 Siemens Medical Simview 3000 and Simview NT
Health Canada
34690
Type II
2007/07/10
Siemens Ltd.
2810 7533
SA070719 Siemens Medical Linear Accelerators
Health Canada
34805
Type II
2007/07/10
Siemens Ltd.
2810 7533
SA070720 Bayer Healthcare Ascencia Contour Blood Glucose Meter
Health Canada
35772
Type II
2007/07/10
2814 4829
Abbott Axsym System - Quinidine Assay and X Systems Quinidine
SA070721
Assay
Health Canada
35874
Type II
2007/07/10
2806 4201
SA070722 Abbott Architect System - Analyzer - Class 2
Health Canada
35299
Type II
2007/07/10
2806 4201
SA070723 Elekta Precise Plan
Health Canada
35590
Type II
2007/07/10
N/A
N/A
SA070724 Gyrus CyberWand Ultrasonic Lithotriptor
Health Canada
35779
Type II
2007/07/10
N/A
N/A
115
SA070725 Chiltern Wispa Attachment Handle
Health Canada
34860
Type I
SA070726 Airox Legendair Ventilator
Health Canada
35588
MHRA
2007/006/028/061/010
MHRA
SA070729 AIDAPT Coniston Swivel Bathers
MHRA
SA070730 AIDAPT Solo Bed Rail
SA070727 AMO VISX WaveScan WaveFront Systems
SA070728
Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum
610, 1107
2007/07/10
N/A
N/A
Type I
2007/07/10
Forever Health Medical Instrument Ltd
2770 9922
FSCA
2007/07/10
AMO Asia Limited
2480 3330
2006/008/017/301/002
FSCA
2007/07/10
N/A
N/A
2007/003/002/401/004
FSCA
2007/07/11
N/A
N/A
MHRA
2007/004/024/291/010
FSCA
2007/07/11
N/A
N/A
GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800
SA070731
mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system
FDA
Z-0848-2007 to Z-0852-2007,
Z-0928-2007
Class II
2007/07/12
2783 1838
SA070732 Smiths Medical Pneupac VR1 Standard and VR1 Responder
FDA
Z-0991-2007
Class II
2007/07/12
FDA
Z-1002-2007 to Z-1005-2007
Class II
2007/07/12
2866 0811
SA070734 Terumo Advanced Perfusion System 1 Model 801763 and 801764
FDA
Z-0929-2007 to Z-0930-2007
Class II
2007/07/12
2866 0811
SA070735 Invacare Storm TDX Power Wheelchair
FDA
Z-0966-2007
Class II
2007/07/12
N/A
N/A
SA070736 Diagnostica Stago STA Liatest VWF: Ag
FDA
Z-0853-2007
Class II
2007/07/12
N/A
N/A
SA070737 Philips Medical HDIIXE Diagnostic Ultrasound System
FDA
Z-0987-2007
Class II
2007/07/12
2876 7525
SA070738 Kodak Direct View DR7500 System
FDA
Z-0738-2007
Class II
2007/07/12
Kodak (Hong Kong) Ltd
SA070739 Radiometer Medical SafeClinitubes
FDA
Z-0975-2007
Class II
2007/07/12
N/A
N/A
MHRA
2007/007/009/061/005
SA070733
Terumo Perfusion System 8000 Roller Pump, Model 8000 and
Perfusion System 9000 Roller Pump Model 9000
SA070740 Instersurgical Solus Flexible Wire-Reinforced Airway
SA070741 Boston Scientific 6 French Guider Catheter
Arizant Ranger Standard Flow Blood/Fluid Warming Disposable
SA070742
Sets
Ltd
MHRA
2007/006/029/601/004
SA070743 Siemens CENTRA Active BTE Hearing Instrument
MHRA
2007/004/018/601/810
SA070744 BD Trypticase Soy Agar dehydrated culture media
BD
SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth
SA070746 Boston Scientific Mach 1 Guide Catheter
MHRA
2007/007/005/051/003
Ltd
FSCA
2007/07/13
N/A
N/A
Action
2007/07/13
2960 7128
FSCA
2007/07/17
N/A
N/A
FSCA
2007/07/17
Siemens Ltd.
2810 7533
Action
2007/07/17
BD
2575 8668
FSCA
2007/07/18
N/A
N/A
Action
2007/07/18
2960 7128
SA070747 Terumo TenderFlow Pediatric Arterial Cannulae
FDA
Z-0874-2007 to Z-0885-2007
Class II
2007/07/19
2866 0811
SA070748 Abbott Patrol Enteral Pump Set
FDA
Z-0888-2007
Class II
2007/07/19
2806 4201
SA070749 Abbott AxSYM Troponin-I ADV Reagent Pack
FDA
Z-1023-2007 to Z-1040-2007
Class II
2007/07/19
2806 4021
SA070750 Ossur Total Knee Model Number 2100
FDA
Z-1076-2007
Class II
2007/07/19
N/A
N/A
FDA
Z-0989-2007 to Z-0990-2007
Class II
2007/07/19
2783 1838
SA070751
GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 CArm Fluoroscopic X-Ray System
116
SA070752
GE Healthcare Innova 2100 IQ and Innova 3100/3100IQ
Fluoroscopic Imaging System
FDA
Z-1043-2007 to Z-1044-2007
Class II
2007/07/19
2783 1838
SA070753 Cardinal Health AirLife nCPAP System Driver
FDA
Z-1075-2007
Class II
2007/07/19
N/A
N/A
SA070754 Anspach Single Use, Sterile Bone Cutting Burrs
FDA
Z-1008-2007
Class II
2007/07/19
N/A
N/A
Ltd
N/A
Action
2007/07/20
2960 7128
FDA
N/A
Press Release
2007/07/23
2807 8555
2007/07/24
N/A
N/A
SA070755
Boston Scientific AccuStick II with 0.38" Stainless Steel J Tip and
.18" Nitinol Guidewire
SA070756 Baxter Colleague Triple Channel Volumetric Infusion Pumps
SA070757 Teleflex Infant Nasal CPAP Cannulae/Systems
SA070758 Roche Elecsys Digoxin (Product No. 1182079322)
Health Canada
35510
Type II
2007/07/25
2485 7510
SA070759 Roche PSM QC and Validation Modules
Health Canada
35915
Type II
2007/07/25
2485 7510
SA070760 Philips Heartstart XL Monitor/Defibrillator
Health Canada
36081
Type II
2007/07/25
2876 7525
AGFA OT3000 Orthopaedic Workstation, MA3000 Mammographic
SA070761
Workstation, Impax DS3000
Health Canada
36232
Type II
2007/07/25
2555 9421
SA070762 Cryolife Bioglue Rigid Applicator Tips
Health Canada
35406
Type II
2007/07/25
N/A
N/A
SA070763 Agfa Heartlab Cardiovascular
Health Canada
36244
Type II
2007/07/25
2555 9421
SA070764 Instrumentation Laboratory ACL TOP Coagulation Analyzer
Health Canada
36144
Type II
2007/07/25
N/A
N/A
SA070765 Varian RadioCamera System
Health Canada
35986
Type II
2007/07/25
2724 2836
SA070766 Roche Amplilink
Health Canada
35912
Type II
2007/07/25
2485 7510
SA070767 Elekta Precise Destop Release 4.2/5.0
Health Canada
35828
Type II
2007/07/25
N/A
N/A
Health Canada
36080
Type II
2007/07/25
N/A
N/A
Health Canada
35473
Type II
2007/07/25
N/A
N/A
SA070770 Maquet KION/KION-I Anasthesia Workstation
MHRA
2007/011/021/401/007
FSCA
2007/07/25
2393 9511
SA070771 Universal Hospital Supplies Ltd Sterile Suction Connecting Tubing
MHRA
2007/007/016/291/007
FSCA
2007/07/25
N/A
N/A
SA070772 nSpire Gas Delivery hoses
MHRA
2007/006/004/601/001
FSCA
2007/07/27
N/A
N/A
SA070773 Stapeline circular stapler and hemorrhoidal stapler
MHRA
2007/007/006/061/008
FSCA
2007/07/27
N/A
N/A
SA070774 HemoCue Glucose 201 RT System
MHRA
2007/007/019/291/007
FSCA
2007/07/27
Science International Corp
2543 7442
MHRA
2007/002/001/401/009
FSCA
2007/07/27
2919 1362
Class I
2007/07/27
2807 8555
SA070768
Teleflex Medical Capio PGA Suture and Polyester Non-Absorbable
Suture
Walter Lorenz Dual Rail Distractor, Flex QC Shaft Extension,
SA070769 Pediatric Distractor, QC Patient Driver, QC Removal Tool, QC
Shaft Extension, QC Solid Shaft Removal Tool
SA070775
Medtronic N'Vision InterStim-B Software, N'Vision Clinician
Programmer, InterStim iCon Patient Programmer, InterStim
Implantatble Neurostimuator, InterStim II Implantable
Neurostimulator
SA070776
Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD
volumetric infusion pumps
FDA
117
Monthly Summary of Medical Device Safety Alerts - June 2007
MDCO Ref.
No.
SA070601 Invacare Flamingo mobile patient hoists
Source of
Information*
MHRA
MDA/2007/043
MDA
Date of Issue
(YYYY/MM/DD)
2007/06/01
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal
Dialysis System
MHRA
2007/005/024/061/012
FSCA
SA070603
Olympus CRP Latex OSR6x99 and Ferritin OSR6x50/OSR6x138
Reagents
MHRA
2007/002/019/401/010
FSCA
SA070604
BD BBL Trypticase Soy Agar w/5% Sheep Blood (TSA II) //
MacConkey II Agar I Plate
BD
N/A
Action
2007/06/04
SA070605
Kimberly Clark Health Care Microcuff Pediatric Oral/Nasal Magill
endotracheal tube
Kimberly Clark Health
Care
N/A
Action
2007/06/04
MHRA
2007/005/031/061/014
FSCA
MHRA
2007/004/011/051/001
FSCA
MHRA
2007/005/031/051/010
FSCA
SA070607
Smiths Medical Level 1 H-1200 Fast Flow Fluid Warmer User and
H-31B Air Detector/Clamp User
SA070608 MAQUET Mobile O.R. table 1131.12XO, BETASTAR
SA070609
Kensey Nash TriActiv FX Embolic Protection System, FX Spare
Shieldwire Inflators, ProGuard Spare Shieldwire Inflators
SA070610 Medtronic Strata NSC Lumboperitoneal Shunt Kit
SA070611
Clearview HCG Test Kits (Product Code 500158, Kit Lot no.
HG0050)
SA070612 Siemens AG Sienet Magicstore
SA070613 Fujifilm FCR Velocity U and DR Velocity UFP
Agent Contact
Telephone No
N/A
N/A
2807 8556
2376 1805
BD
2575-8668
2332 4455
Limited
2485 7510
2317 0988
2393 9511
N/A
N/A
2919 1362
Zenith Medical Co. Ltd
2720 2727
Siemens Ltd.
2810 7533
Fujifilm Hong Kong Limited
2317 0848
N/A
N/A
N/A
N/A
N/A
2789 3300
N/A
N/A
N/A
N/A
BD
2575 8668
2007/06/04
SA070602
SA070606 Roche COBAS Taqman HCV and HIV-1 Test
Local Agent
2007/06/04
2007/06/05
2007/06/05
2007/06/06
2007/06/07
FDA
Z-0833-2007 to Z-0835-2007
Class II
MHRA
2007/006/004/051/016
FSCA
MHRA
2007/006/006/061/002
FSCA
Health Canada
Health Canada
35431
Type II
35223
Type II
SA070614 Electric Mobility Rascal Power Chair and Turnabout Power Chair
Health Canada
34829
Type II
SA070615 Sendx Medical (Radiometer Capenhagen ) ABL80 Flex Analyzer
Health Canada
34820
Type II
SA070616 Biohorizons Implant Systems Complete OP & OS Surgical Kit
Health Canada
34533
Type II
2007/06/08
2007/06/11
2007/06/12
2007/06/12
2007/06/12
2007/06/12
2007/06/12
2007/06/12
SA070617 Bio-Rad Gelose MRSA Select REF63747, LOT7C1025
SA070618
Invivo Precess (3160 Series) MRI Compatible Patient Monitoring
System
SA070619 WALLACH T-00337 Anorectal Tip
SA070620 BD Microtainer Safety Flow Lancets
Health Canada
35132
Type II
MHRA
2007/005/009/061/008
FSCA
MHRA
MHRA
2007/005/031/051/005
MDA/2007/049
118
FSCA
MDA
2007/06/12
2007/06/12
2007/06/12
N/A
Action
2007/06/12
Ltd
N/A
Action
2007/06/12
MHRA
2007/006/006/061/023
FSCA
Class II
SA070621 Boston Scientific SwissLithoclast Ultra Sound Handpiece Kit
Ltd
SA070622 Boston Scientific Impulse Angiographic Catheter
SA070623 ev3 Amplatz Goose Neck Snare Kit
SA070624 Wright Medical Profemur R, Revision Hip System
FDA
Z-0867-2007 to Z-0868-2007
SA070625 Surge Medical Solutions 15 Fr. Retrograde Cardioplegia Cannula
FDA
Z-0892-2007 to Z-0904-2007
Class II
SA070626 Roche VANC2 Online TDM Vancomycin
FDA
Z-0919-2007 to Z-0920-2007
Class II
SA070627 Varian Medical FramelessArray Software version 1.0
FDA
Z-0905-2007
Class II
SA070628 Siemens Medical c.cam Gamma Camera, Model 9VIR1200
FDA
Z-0906-2007
Class II
SA070629 Hawaii Medical NeatNick Sweeping Action Hell Lancet
SA070630 Sunrise Medical Groove Power Wheelchairs
SA070631 Schiller Easyport Defibrillators
SA070632 B Braun Intrapur Neonat Lipid I.V. Filter
SA070633
Smith & Nephew PERI-LOC 2.5mm Self Tapping Locking Cortex
Screw
SA070634 Boston Scientific Transend EX Guidewire
SA070635 Biomet 3i EP Healing Abutment
SA070636 Biomet 3i disposable twist drills
FDA
MHRA
MHRA
MHRA
MHRA
Ltd
FDA
FDA
Z-0926-2007 to Z-0927-2007
2007/004/017/601/805
2007/006/005/051/020
2007/006/012/061/008
2007/005/018/601/919
Class II
FSCA
FSCA
FSCA
FSCA
Action
N/A
Z-0922-2007
Z-0959-2007
Class II
Class II
SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement
FDA
Z-0960-2007 to Z-0965-2007
Class II
SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier
FDA
Z-0935-2007
Class II
SA070639 Zoll Lifecor Electrode Belt
SA070640 Bio-Diagnostics GBM Quantitative ELISA Kit
SA070641 Thoratec TLC-II Portable VAD Driver
SA070642 Bausch & Lomb Zyoptix Epi Separator and Zyoptix XP Epi Head
SA070643 Smiths Medical Pneupac VR1 Ventilatory Resucitator
SA070644 Sunrise Quickie
SA070645 Airox Legendair Ventilator Single/Double Bran
FDA
MHRA
Z-0936-2007
2007/005/025/061/005
Class II
FSCA
MHRA
2007/006/013/061/001
FSCA
Bausch & Lomb
(Hong Kong) Ltd.
N/A
Action
MHRA
2007/003/029/601/731
FSCA
Health Canada
Health Canada
35442
Type II
35427
Type I
119
2960 7128
2960 7128
2007/06/13
Conmed Ltd
2854 4413
2007/06/14
2381 0279
N/A
N/A
Limited
2485 7510
2724 2836
Siemens Ltd.
2810 7533
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
2007/06/14
2007/06/14
2007/06/14
2007/06/14
2007/06/14
2007/06/14
2007/06/15
2007/06/15
2007/06/20
2007/06/20
2007/06/21
2007/06/21
2007/06/21
2007/06/21
2007/06/21
2007/06/21
2007/06/21
2007/06/21
2007/06/22
2007/06/25
2007/06/25
2645 8703
2960 7128
N/A
N/A
N/A
N/A
Suntime Technology Ltd
2758 8075
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Bausch & Lomb (Hong Kong) Ltd.
2213 3178
2317 0988
N/A
N/A
Forever Health Medical Instrument Ltd
2770 9922
SA070646 Walter Lorenz Bone File
SA070647 Beckman Coulter Flow Count Fluorospheres
Health Canada
Health Canada
35636
Type II
35682
Type II
Beckman Coulter Cytomics FC 500 Flow Cytometer (CXP Version
SA070648
2.1 and 2.2)
Health Canada
35691
Type II
SA070649 BD Multivisc 2.5% Viscoadaptive solution
Health Canada
34172
Type II
2007/06/25
2007/06/25
2007/06/25
2007/06/25
N/A
N/A
2240 6260
2240 6260
BD
2575 8668
N/A
N/A
SA070650 Inpeco Accelerator Aps System
Health Canada
35448
Type II
2007/06/25
SA070651 Oxoid Metronidazole 10ug disc
Health Canada
35291
Type II
2007/06/25
N/A
N/A
SA070652 Apex Hoy-advance-e
Health Canada
34534
Type II
2007/06/25
N/A
N/A
MHRA
2007/006/013/061/012
FSCA
N/A
N/A
N/A
N/A
SA070653 Edwards Lifesciences Vigilance II Monitor
Horiba ABX Pentra Myoglobin CP Reagent, ABX Pentra Ferritin CP
SA070654
Reagent
MHRA
2007/006/020/061/001
FSCA
SA070655 Fresenius Medical Care AV Set FMC (FA404E/FV404E)
MHRA
2007/005/008/601/880
FSCA
SA070656 Mediplus Coventry Valve Triple IV Peripheral Connector Set
MHRA
2006/012/007/601/455
FSCA
FDA
Z-0950-2007 to Z-0953-2007
Class II
SA070657
Abbott ARCHITECT i2000 Processing Module (List# 08C89-01,
3M74-01, 1G06-01 & 3L77-01)
SA070658 Steris QFC1728 and QFC1729 Quick Connects
SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit
FDA
Z-0967-2007
Class II
2007/07/26
2007/06/27
Ltd.
N/A
2007/06/27
N/A
N/A
2007/06/28
2806 4201
2007/06/28
N/A
2007/06/28
Limited
2485 7510
N/A
N/A
2960 7128
2919 1362
N/A
N/A
GM Medical (Hong Kong) Ltd
2521 9799
FDA
Z-0956-2007
SA070660 Invacare Scanbed 750 (SB750)
MHRA
MDA/2007/056
MDA
2007/06/28
SA070661 Boston Scientific Capio Sutures
Ltd
N/A
Action
2007/06/28
MHRA
2007/006/026/291/010
FSCA
SA070662 Medtronic Biphasic LIFEPAK 500 AEDs
SA070663 Oasis Medical Premier Edge Disposable Knives
SA070664 Cyberonics VNS Therapy Leads (Model 300, 302, 303)
MHRA
Cyberonics
2007/006/026/291/013
Class II
2007/06/25
FSCA
Action
N/A
120
2007/06/29
2007/06/29
2007/06/29
Monthly Summary of Medical Device Safety Alerts - May 2007
MDCO Ref.
No.
Source of
Information*
SA070501 ResMed S8 CPAP Devices
MHRA
2007/004/025/291/009
SA070502 Medi Prosthetic Knee Joint
FDA
Z-0759-2007
MHRA
2007/004/020/291/007
SA070503 Endoart EasyBand
Boston Scientific NexStentR Carotid Stent and Monorail Delivery
SA070504
System
Boston Scientific (HK)
Ltd
N/A
Local Agent
FSCA
N/A
N/A
Class II
2007/05/03
N/A
N/A
FSCA
2007/05/03
N/A
N/A
Action
2007/05/03
2960 7128
Kong
2738 2818
2240 6260
SA070505
Ortho- Clinical Diagnostics VITROS troponin I reagent packs (Cat.
No.: 194 9882)
FDA
N/A
N/A
SA070506
Beckman Coulter COULTER LH750 Analyzer, COULTER LH780,
COULTER LH500 Series System, COULTER GEN.S
MHRA
2007/004/027/291/017
FSCA
SA070507
Smith & Nephew Reflection All Poly Acetabular Cup (Product Code
71353255 06DT97293)
MHRA
2007/003/030/601/744
FSCA
MHRA
2007/005/002/061/009
FSCA
SA070508 Baxter UV Flash Compact Device
SA070509 Hill-Rom AvantGuard Electtic Bed
BioMerieux BacT/ALERT Classic System Software, Blood Culturing
SA070510
System
Toshiba Nemio XG, Ultrasound system SSA-590A with version 1.5
software
B.Braun HyperFormer Pump Dispensing Set (Catalog No V9900SA070512
02)
SA070511
SA070513 Instrumentation Laboratory GEM Premier 4000 Laboratory Analyzer
SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator
American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitro
SA070515
diagnostic
SA070516
SA070517
Tyco Healthcare SealGuard TracheoSoft and SealGuard
TracheoSoft PERC
Edwards Lifesciences CO-Set + Closed Injectate Delivery System
for Cold Injectate (Model 93600)
SA070518 AFOS All endoscope storage facilities (ESF)
SA070519 Olympus Flexible endoscopes
SA070520 Medtronic MiniMed insulin infusion pumps
SA070521 JCM Supportive seating system
SA070522 Thoratec - Paracorporeal ventricular assist device
MHRA
2006/009/004/291/005
FSCA
FDA
Z-0773-2007 to Z-0776-2007
Class II
FDA
Z-0771-2007
Class II
FDA
Z-0783-2007
Class II
FDA
Z-0778-2007
Class II
FDA
Z-0772-2007
Agent Contact
Telephone No
Date of Issue
(YYYY/MM/DD)
2007/05/02
Class II
FDA
Z-0779-2007
Class II
MHRA
2006/011/016/291/003
FSCA
2007/05/04
2007/05/07
2007/05/07
2007/05/09
2007/05/09
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2645 8703
28078556
N/A
N/A
2356 7033
Sanko Medical Systems (H.K.) Ltd.
2384 0688
2277 6125
Vastec medical Ltd
2897 1912
N/A
N/A
N/A
N/A
3157 7244
N/A
N/A
N/A
N/A
2376 1805
2919 1362
N/A
N/A
GM Medical Pacific Ltd
2783 1838
2007/05/10
MHRA
2007/003/029/291/013
FSCA
MHRA
MDA/2007/035
Medical Device Alert
MHRA
Medtronic
International, Ltd.
2007/05/11
MDA/2007/034
2007/05/11
N/A
Action
2007/05/11
MHRA
2006/010/012/301/003
FSCA
Health Canada
34992
Type I
121
2007/05/11
2007/05/14
SA070523 Datex-Ohmeda TEC 6 Plus Desflurane Vaporizer
Health Canada
33552
Type II
SA070524 GE Healthcare Revolution XR/D
Health Canada
34525
Type II
SA070525 GE Medical System CIC Pro Central Station
Health Canada
34840
Type II
SA070526 Conmed PET Eliminator Balloon Dilator
SA070527 AMG Medpro Lubricating Gel
SA070528 Stryker 3.5mm 90-S Serfas Energy Suction Probe
Health Canada
Health Canada
Health Canada
34868
Type II
34958
Type II
Ltd
N/A
Action
MHRA
2007/005/003/061/014
FSCA
SA070534 CIBASoft Visitint Soft Contact Lenses
SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor
SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp
SA070537 BD FACSCanto and FACSCanto II Software
SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A
SA070539 Olympus Triglyceride Reagent
DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-18-90SA070540
180 & NDC-18-110-180)
SA070541 Conor Medsystems CoStar drug-eluting coronary stents
FDA
Z-0796-2007 to Z-0799-2007
Z-0795-2007
Class II
Class II
FDA
Z-0793-2007
Class II
MHRA
2007/005/002/061/006
FSCA
MHRA
MHRA
MHRA
MHRA
2007/05/14
2007/05/14
2007/05/15
N/A
Boston Scientific System Drape (IVUS motor drive sterile plastic
SA070530
cover)
SA070533 Ethicon Gynecare PROLIFT Total Pelvic Repair System
2007/05/14
2007/05/15
SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter
FDA
2007/05/14
Type II
Action
SA070532 Arjo Maxi Move Patient Lift with Scale
2007/05/14
34918
Ltd
SA070531 Medical Wire and Equipment Customers Microrings
2007/05/14
2007/005/011/291/002
2007/005/010/291/006
2007/005/010/061/013
2007/005/010/061/009
FSCA
FSCA
FSCA
FSCA
MHRA
2007/004/025/291/018
FSCA
Johnson & Johnson
N/A
N/A
2007/05/15
2783 1838
2783 1838
2783 1838
N/A
N/A
N/A
N/A
Stryker China Ltd
2518 6988
2960 7128
2960 7128
N/A
N/A
2007/05/17
2508 9553
2007/05/17
Kong
2738 2818
Ciba Vision (Hong Kong) Ltd.
2814 2121
2919 1362
N/A
N/A
BD
2575 8668
2376 1805
2376 1805
N/A
N/A
Biotronik Hong Kong
2877 6787
N/A
N/A
2007/05/17
2007/05/18
2007/05/18
2007/05/18
2007/05/18
2007/05/18
2007/05/18
2007/05/18
2007/05/22
Homecraft Rolyan Bathmaster 2000, Bathmaster Classic,
SA070542
Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls)
MHRA
MDA/2007/039
SA070543 Nightingale Pro Axis and Pro Axis Plus
MHRA
MDA/2007/038
2007/05/22
N/A
N/A
2007/05/22
2317 0988
N/A
N/A
2893 0873
2806 4201
Umedco
2765 8222
SA070544 MEDEX DPS Kids Kit (Pediatric) Secure System
MHRA
2007/005/016/291/014
FSCA
SA070545 BREAS PV403 PEEP
MHRA
2007/005/014/061/009
FSCA
Viasys all paediatric ventilator breathing systems containing water
SA070546
trap
MHRA
MDA/2007/037
SA070547 Abbott FLEXIFLO DURA-PEG Kit
MHRA
2007/005/014/061/019
FSCA
SA070548 Cranex Tome panoramic x-ray unit
FDA
Z-0816-2007
Class II
122
2007/05/22
2007/05/22
2007/05/23
2007/05/25
SA070549
GE Americas Signa 3.0T EXCITE Whole Body Magnetic
Resonance System
SA070550 BioMerieux BacT/VIEW Software, all versions.
FDA
FDA
Z-0815-2007
Z-0814-2007
Class II
Class II
2007/05/25
2007/05/25
SA070551 Diagnostic Stago STA Compact and STA Compact CT
FDA
Z-0812-2007
Class II
2007/05/25
SA070552 Roche PTH (Parathyroid Hormone Test system )
FDA
Z-0810-2007
Class II
2007/05/25
MHRA
2007/004/010/301/003
FSCA
2007/05/25
SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs
2007/05/25
SA070554 Draeger Medical Primus anaesthetic workstation
MHRA
MDA/2007/040
SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger
MHRA
2007/002/001/301/001
FSCA
2007/05/25
N/A
Action
2007/05/25
SA070556 Abbott ARCHITECT STAT Troponin-I test products
Abbott Laboratories
Ltd.
FDA
N/A
CDC
2007/05/28
SA070558 Roche COBAS Integra System Valproic Acid
Health Canada
34875
Type I
2007/05/28
SA070559 T.H.E. Medical Reacher Bar with Small Carabiner
Health Canada
34511
Type I
2007/05/28
SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution
2783 1838
2356 7033
N/A
Limited
N/A
2485 7510
2877 3077
GNB Technologies (China) Ltd
N/A
2806 4201
AMO Asia Limited
Limited
N/A
2480 3330
N/A
N/A
2485 7510
N/A
SA070560 Randox Laboratories Assayed Bovine Serum
Health Canada
34276
Type II
2007/05/28
N/A
N/A
SA070561 B.Braun Ultrasite Horizon Pump IV Set
Health Canada
34874
Type II
2007/05/28
2277 6125
SA070562 Dentsply Protper Obturators
Health Canada
34652
Type II
2007/05/28
N/A
N/A
2876 7525
2876 7525
N/A
N/A
2240 6260
N/A
N/A
2919 1362
BD
2575 8668
N/A
N/A
2007/05/28
Philips Medical (1) Achieve 1.5T MRI System (2) Gyroscan
SA070563 Magnetic System ACS-NT (3) Gyroscan Magnetic System T10-NT
(4) Intera 3.0T MRI System (5)Intera 1.5 Master MR
Health Canada
35215
Type II
SA070564 Philips HD11 Ultrasound System
Health Canada
35094
Type II
Conmed Linvatec Medical Devices Packaged within certain Peel
SA070565
Pouch Sterile Packages
Health Canada
35032
Type II
Beckman (1) Synchro LX20Pro (2) Synchron LX20 System
SA070566 Analyzer (3) Synchron LXI725 (4) Unical DXC 600 (5) Unical DXC
6001 Analyzer (6) Unical DXC80.
Health Canada
35003
Type II
MHRA
2007/003/026/291/004
FSCA
SA070567 BIODIS VerifyNow P2Y12
SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760
SA070569 BD Infusion Therapy System (Angiocath Catheter)
2007/05/28
2007/05/28
2007/05/28
Medtronic
International, Ltd.
BD
Action
Action
N/A
N/A
2007/05/29
2007/05/29
2007/05/29
2007/05/31
Inverness Medical BinaxNOW (a) Influenza A&B 10 Test Kit (b)
SA070570 Influenza A&B 22 Test kit (c) RSV 10 Test kit (d) Nasopharyngeal
Accessory pak (e) A&B Kit 10 Test kit (Japan)
FDA
Z-0822-2007 to Z-0826-2007
Class II
SA070571 GE Medical Definium AMX 700 Digital mobile x-ray system
FDA
Z-0821-2007
Class II
2007/05/31
2783 1838
SA070572 Abbott Precision Link Software (version 2.1 - 2.6)
FDA
Z-0709-2007
Class II
2007/05/31
2806 4201
SA070573 CP Medical Surgical Suture
FDA
Z-0807-2007
Class II
2007/05/31
N/A
N/A
FSCA
2007/05/31
N/A
N/A
SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem
MHRA
2007/005/022/061/006
123
Monthly Summary of Medical Device Safety Alerts - April 2007
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
MHRA
2007/003/028/601/729
FSCA
2007/04/02
Siemens Ltd.
2870 7533
SA070402 GE Healthcare OEC 9900
MHRA
2007/003/029/181/004
FSCA
2007/04/03
2783 1838
SA070403 Smith & Nephew - Birmingham Hip Resurfacing Acetabular Cups
MHRA
2007/002/006/081/001
FSCA
2007/04/03
2645 8703
SA070404 Baxter Haemodialysis Instruments Addenda
MHRA
2007/003/016/291/002
FSCA
2007/04/04
Baxter Healthcare Ltd.
2807 8556
MHRA
2007/003/022/601/706
FSCA
2007/04/04
N/A
N/A
SA070406 GE Healthcare Smart Box
Health Canada
32004
Type II
2007/04/10
2783 1838
SA070407 GE Healthcare Lightspeed VCT and Lightspeed VCT Select
Health Canada
33345
Type II
2007/04/10
2783 1838
Health Canada
345,133,451,434,517
Type II
2007/04/10
2783 1838
Health Canada
34484
Type II
2007/04/10
2783 1838
2783 1838
MDCO Ref.
No.
SA070401
SA070405
Siemens Medical Solutions IMMULITE One TNF-Alpha Lot 147
(LKNF 147)
Arcomedical Infusion Ltd - 3101-PVJ (FSB502) Needlefree solution
set (Batch C8227)
GE Healthcare - OEC Uroview 2800, OEC Miniview 6800, OEC
Flexiview 8800
GE Healthcare OEC Radiographic/Fluoroscopic Systems, Model (1)
SA070409 Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800 (5)
9800
SA070410 GE Healthcare - Instatrak 3500 System
SA070408
Health Canada
33329
Type II
2007/04/10
SA070411 Depuy Asr Acetabular Cup System
Health Canada
34519
Type II
2007/04/10
DePuy Inc (J&J)
SA070412 Smiths Medical - Fluid Warming System
Health Canada
34536
Type II
2007/04/10
2317 0988
SA070413 Smiths Medical - Medfusion 3500 Syring Infusion Pump
Health Canada
34277
Type II
2007/04/10
2317 0988
SA070414 Siemens Medical - Lithoskop
Health Canada
34448
Type II
2007/04/10
Siemens Ltd.
2810 7533
SA070415 Conmed Padpro Adult Radiotranslucent Pad
Health Canada
34510
Type I
2007/04/10
Conmed Limited
2854 4413
SA070416 Trudell Medical Marketing Limited - ABG kit
Health Canada
34214
Type II
2007/04/10
N/A
N/A
SA070417 Stentor (Philips Medical Systems) - Isite Pacs
Health Canada
34305
Type II
2007/04/10
2876 7525
SA070418 Cryocath Flexcath Steerable Sheath
Health Canada
34518
Type II
2007/04/10
N/A
N/A
SA070419 Dentalez Inc - End Cup
Health Canada
34543
Type II
2007/04/10
N/A
N/A
SA070420 Physio-Control LIFEPAK 20 Defibrillator/Monitor
Medronic
International Ltd
N/A
Action
2007/04/10
2919 1362
124
2738 2894
SA070421 Philips Medical - Brilliance Computed Tomography System
Health Canada
34499
Type II
2007/04/10
2876 7525
SA070422 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System
Health Canada
33615, 33616
Type II
2007/04/10
Gambro China Ltd.
2576 2688
Johnson & Johnson
Medical Hong Kong
N/A
N/A
2007/04/10
2738 2818
Ltd
N/A
Action
2007/04/11
2690 7218
SA070425 Remington Medical Prostate Biopsy needle
FDA
Z-0673-2007
Class II
2007/04/11
N/A
N/A
SA070426 Intuitive brand Da Vinci S Surgical System
FDA
Z-0670-2007
Class II
2007/04/11
N/A
N/A
SA070427 Aspyra Inc CyberMed Version 2.1 Pharmacy Software
FDA
Z-0686-2007
Class II
2007/04/11
N/A
N/A
SA070428 NDO Surgical Plicator EPS Plication System
FDA
Z-0685-2007
Class II
2007/04/11
N/A
N/A
Zimmer Trabecular Metal Reserse Shoulder System
SA070429
Instrumentation Conical Reamer
FDA
Z-0675-2007
Class II
2007/04/11
2992 0968
SA070423
Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circular
stapler
SA070424
Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITY
and VITALITY 2 (ICD)
SA070430 Siemens syngo Dynamics 5.0 Workplace
Zimmer NexGen Complete Knee Solution Minimally Invasive
Solutions MIS Technology Femoral Finishing Guid
SA070432 Terumo Perfusion System 8000 Base, Model 8000
SA070431
FDA
Z-0652-2007
Class II
2007/04/11
Siemens Ltd.
2810 7533
FDA
Z-0647-2007 to Z-0651-2007
Class II
2007/04/11
2992 0968
2866 0811
2541 1041
FDA
Z-0655-2007 to Z-0659-2007
Class II
2007/04/11
SA070433 Cook ATB Advance PTA Dilation Catheter, REF G26887
FDA
Z-0665-2007
Class II
2007/04/11
SA070434 BD 366358 LANSCET SFL GREEN
BD
N/A
Action
2007/04/11
BD
2575 8668
MHRA
2007/003/028/081/005
FSCA
2007/04/11
2317 0988
FDA
Z-0660-2007
Class II
2007/04/11
N/A
N/A
FDA
Z-0722-2007
Class II
2007/04/12
2806 4201
SA070438 BD 30ml Syringe Luer-Lok tip Sterile (Reorder number 309650)
FDA
Z-0719-2007
Class II
2007/04/12
BD
2575 8668
Abott CELL-DYN 3200 Dilutent / Sheath Reagent (List number
SA070439
03H79-01)
FDA
Z-0706-2007
Class II
2007/04/12
2806 4201
Smiths Medical Level 1 H-1200 H31-B Fast flow fluid warmer users
and Level 1 H31-B Air Detector/ Clamp User
Intuitive Surgical 8mm EndoWrist Bipolar Maryland Instrument Part
SA070436
Number: 400172-04
SA070435
SA070437
SA070440
Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no
7D71-30 and 7D71-20)
Integra Biotechnical ProWord Shoulder Postoperative Dressing and
Cold Therapy System (Model number AR-1625)
FDA
Z-0714-2007
Class II
2007/04/12
N/A
N/A
Cenorin ThermaSure Medical Device Drying Cabient series 130,
SA070441
300 AND 1000
FDA
Z-0711-2007 to Z-0713-2007
Class II
2007/04/12
N/A
N/A
SA070442
Radiometer America ABL800 FLEX Series analyzer with FLEXQ
module-equipped with software version 5.2 to 5.27
FDA
Z-0705-2007
Class II
2007/04/12
N/A
N/A
SA070443
Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001761)
FDA
Z-0701-2007
Class II
2007/04/12
N/A
N/A
FDA
Z-0720-2007 to Z-0721-2007
Class II
2007/04/12
N/A
N/A
Ltd
N/A
Action
2007/04/16
2960 7128
Ltd
N/A
Action
2007/04/16
2960 7128
SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0
SA070445
Boston Scientific Percutaneous Track Kit with Amplaz Dilator and
Sheath Kit
SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System
125
SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators
Ltd
Action
N/A
2007/04/16
2960 7128
SA070448 HemoCue Glucose Systems
MHRA
2007/033/019/291/006
FSCA
2007/04/16
2543 7442
SA070449 Abbott TDx/TDxFLx Methotrexate Reagent (List no 07A12-60)
MHRA
2007/004/002/601/745
FSCA
2007/04/16
2806 4201
LifeScan United
Kingdom and Ireland
N/A
N/A
2007/04/17
2738 2818
MHRA
2007/004/011/291/009
FSCA
2007/04/18
N/A
N/A
MHRA
2007/002/008/601/580
FSCA
2007/04/18
N/A
N/A
2007/04/18
N/A
N/A
SA070450 LifeScan One Touch Ultra blood glucose test strips
BIOMET 3i Conical 17 Degree Angeled Abutment 4.1mm (D) x
2mm (H) (AC4217 Lot No 639098F-5)
Dade Bethring Syva Emit 2000 Phenobarbital Assay, 4D019UL, lot
SA070452
W6
SA070453 All Shelhigh medical devices
SA070451
FDA
Ortho- Clinical Diagnostics VITROS Immunodiagnostics Products
SA070454
HBsAg Reagent Pack (Cat# 6801322)
FDA
Z-0747-2007
Class II
2007/04/19
Healthcare Diagnositcs
N/A
SA070455 Roche CoaguChek Brand PT Test Strips
FDA
Z-0737-2007
Class II
2007/04/19
2485 7510
SA070456 Roche COBAS Integra DIG, Digoxin Reagent (Cat# 20737836322)
FDA
Z-0736-2007
Class II
2007/04/19
2485 7510
FDA
Z-0734-2007 to Z-0735-2007
Class II
2007/04/19
2485 7510
SA070457
Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP
450 Test, CE-IVD, M/N4381866190
SA070458 Bio-Rad tox/See Drug Screen Test
FDA
Z-0733-2007
Class II
2007/04/19
2789 3300
FDA
Z-702-2007 to Z-703-2007
Class II
2007/04/19
N/A
N/A
SA070460 Joerns Healthcare Sunrise Medical-Hoyer Advance Patient Lifts
FDA
Z-0727-2007
Class II
2007/04/19
N/A
N/A
SA070461 Coloplast Sea-Clens Wound Cleanser (#11701-159-36, #1063)
Dade Bethring Microgenics MAS Controls Cardiolmmune XL
SA070462
Control (CAI-XL1. CAI-XL2, CAI-XL3, CAI-XL4)
Mckinley Medical MicroSet NDEHP with 1.2 flter and SR segment
SA070463
(Product code 120-112XSFV)
AngioDynamics Starburst 25cm, Starburst XL 25cm and Starburst
SA070464
SemiFlex 25cm
FDA
Z-0710-2007
Class II
2007/04/19
3628 7488
MHRA
2007/004/003/601/746
FSCA
2007/04/20
N/A
N/A
MHRA
2007/004/010/131/012
FSCA
2007/04/20
N/A
N/A
SA070459
AMS DURA-II Distal Tips and Universal Tips (Product no 72009340
and 72009361)
MHRA
2007/004/010/131/006
FSCA
2007/04/20
N/A
N/A
MHRA
2007/004/013/051/003
FSCA
2007/04/20
CONMED LTD
2854 4413
SA070466 Teleflex Medical Infant Nasal CPAP System
Health Canada
34613
Type II
2007/04/23
SA070467 GE Healthcare Infinia Gamma Camera
Health Canada
33213
Type II
2007/04/23
2783 1838
SA070468 Alcon LADAR6000TM Excimer Laser
Health Canada
34303
Type II
2007/04/23
Alcon Hong Kong Ltd
2568 0636
SA070469 Medtronic U-Clip -Removal Tool
Abbott ARCHITECT i2000 and i2000 SR Systems (list no. 8C89-01
SA070470
and 3M74-01) and Folate Reagents (List no. 7K60-20, 7K60-25,
Unomedical Drain-Fix 680M and 685M, Central Gard 667M and
SA070471
668M , Epi-Fix 670M
Health Canada
34068
Type II
2007/04/23
2919 1362
MHRA
2007/004/012/601/784
FSCA
2007/04/23
2806 4201
MHRA
2007/003/016/081/007
FSCA
2007/04/23
N/A
N/A
Ltd
N/A
Action
2007/04/23
2960 7128
Varian Medical
N/A
Action
2007/04/23
2724 2836
MHRA
2007/004/017/601/800
FSCA
2007/04/24
2806 4201
FDA
Z-0767-2007
Class II
2007/04/27
N/A
N/A
FDA
Z-0761-2007
Class II
2007/04/27
N/A
N/A
FDA
Z-0752-2007 to Z-0754-2007
Class II
2007/04/27
N/A
N/A
FDA
Z-0749-2007 to Z-0751-2007
Class II
2007/04/27
Siemens Ltd.
2810 7533
SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200)
SA070472 Boston Scientific SypGlassT Light Source
SA070473
SA070474
SA070475
SA070476
SA070477
Varian OBI with cone beam computed tomography (Versions 1.2
and 1.3)
AxSYM Total β - Hcg Reagent (List no. 7A59-21, 7A59-22, 1A0622) and Speciment Diluent (List no. 9C21-50)
Miltex Stainless Steel Disposable Scalpel #22 Part No 4-422
Bio-Logic-Ceegraph/Sleepscan Netlink Traveler Model 580T2ASM2
RITA Starburst XL, Starburst, Starburst MRI SemiFlex
SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363)
126
SA070479
Sunrise Medical DeVibiss PD1000A Pulse Dose Oxygen
Conserving Cylinder and 535D-X CF Continuous Flow Cylinder
FDA
Z-0731-2007 to Z-0732-2007
Class II
2007/04/27
N/A
N/A
MHRA
2007/004/016/121/001
FSCA
2007/04/27
2789 3300
SA070481 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System
Health Canada
34562
Type I
2007/04/30
Gambro China Ltd.
2576 2688
SA070482 Gambro Cartridge Blood Tubing 003409410
Health Canada
34726
Type II
2007/04/30
Gambro China Ltd.
2576 2688
SA070483 Phillips Medical Voxel Q Field Upgrade to ACQSIM
Baxter Healthcare Colleague 3 Volumetric Infusion Pump,
SA070484
Colleague Guardian 3 CXE Color Pump, Colleague Volumetric
SA070485 Toshiba Aplio XV Ultrasound System
Siemens Linear Accelerators, Digital Linear Accelerator and Oncor
SA070486
Impression IMRT
Health Canada
34838
Type II
2007/04/30
2876 7525
Health Canada
34787
Type II
2007/04/30
2807 8556
Health Canada
34318
Type II
2007/04/30
2384 0688
Health Canada
34725
Type II
2007/04/30
Siemens Ltd.
2810 7533
SA070480 BIO-RAD EVOLIS SYSTEMS
SA070487 Maquet HL30 Perfusion System
SA070488
Smiths Medical CADD Administration Sets and CADD Prizm
Administration Sets
SA070489 Dade Behring BEP2000 ADV System Release Kit 1.23.3
SA070490 Zerusa Guardian Hemostasis Valve FH100
SA070491 西安西京醫療用品有限公司"希健醫用" Extracorporeal circulating set
Health Canada
34587
Type II
2007/04/30
2393 9511
Health Canada
34794
Type II
2007/04/30
2317 0988
Health Canada
Health Canada
34859
34684
Type II
Type II
2007/04/30
2007/04/30
N/A
N/A
N/A
N/A
SFDA
N/A
N/A
2007/04/30
N/A
N/A
127
Monthly Summary of Medical Device Safety Alerts - March 2007
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
SA070301 Taut Intraducer Peritoneal Catheter
FDA
Z-0428-2007
Class II
2007/03/01
N/A
Agent Contact
Telephone No
N/A
Abbott - Imx Sirolimns Reagent Pack (Lots# 053389, 053457,
SA070302
063650, 063973, 064459, 064772, 064750, 065076)
FDA
Z-0501-2007
Class II
2007/03/01
2806 4201
SA070303 Siemens Medical Solutions- Symbia S Series SPECT & SPECT-CT
FDA
Z-0548-2007 to Z-0549-2007
Class II
2007/03/01
Siemens Ltd.
2870 7533
FDA
Z-0554-2007
Class II
2007/03/01
N/A
N/A
FDA
Z-0424-2007 to Z-0426-2007
Class II
2007/03/01
MHRA
2007/001/025/081/004
MDCO Ref.
No.
SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625
SA070305 Arjo - Sara Active Sling, patient Lift
SA070306 Edwards Lifescience - Aquarius Haemofiltration Machine
SA070307 BD - Sensi- Disc Ticarcillin (Cat# 231619; Lot# 6167435)
SA070308 Kjaerulff Lift Stand Aid (art no: 400640434)
BD
N/A
2508 9553
Field Safety Corrective
Action
Action
Action
2007/03/01
N/A
N/A
2007/03/01
BD
2575 8668
2007/03/02
N/A
N/A
MHRA
2006/09/006/401/013
SA070309 AGFA - Impax 6.X DS3000, 5.1 and 5.2MA3000
Health Canada
34055
Type II
2007/03/05
2555 9421
SA070310 Olympus - PK7200 Microplate System (Software)
Health Canada
34196
Type II
2007/03/05
United Tecnica Limited
N/A
SA070311 Waverleyglen Systems Ltd - Portable Reacher 24" and 36"
Health Canada
34150
Type I
2007/03/05
N/A
N/A
SA070312 Hospira - Enteral Plumset with Integral Container
Health Canada
33456
Type II
2007/03/05
N/A
N/A
MHRA
2006/011/027/291/008
Action
2007/03/05
N/A
N/A
MHRA
2007/002/014/081/006
Action
2007/03/06
2919 1362
Health Canada
N/A
Alert to Hospital
2007/03/06
N/A
N/A
SA070316 Bausch & Lomb ReNu MultiPlus contact lens care solutions
Bausch & Lomb
(Hong Kong) Ltd.
N/A
Action
2007/03/06
Bausch & Lomb (Hong Kong) Ltd.
2213 3176
SA070317
Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS
defibrillators
Medtronic
International, Ltd.
N/A
Action
2007/03/07
SA070318
Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill
Systems (Parts 01-15400; 01-15401 & 01-15407)
FDA
Z-0521-2007
Class II
2007/03/08
Stryker China Ltd
2518 6988
SA070319
BD Integra 1ml Syringe with Retracting Guide Needle 1 ml 29g 1/2'
(0.33 x 13mm) Re-Order No. 305282 U-100 insulin (Lot# 6073436)
FDA
Z-0582-2007
Class II
2007/03/08
BD
2575 8668
SA070320
Hospira - LifeShield Latex-Free Primary I.V. Pump Set (List 1216301, lot 39-126-5H)
FDA
Z-0542-2007
Class II
2007/03/08
N/A
N/A
SA070321
Exactech Optetrak All Poly Tibial PS Component, Knee prothesis
catalog # 204-11-13, serial numbers 0900529 - 0900532
FDA
Z-0522-2007
Class II
2007/03/08
N/A
N/A
FDA
Z-0550-2007 to Z-0553-2007
Class II
2007/03/08
N/A
N/A
FDA
Z-0546-2007
Class II
2007/03/08
N/A
N/A
SA070313 Huntleigh Healthcare Contoura 880 beds
SA070314
Medtronic Ltd - GATEKEEPER Reflux Repair System Model
3770GK
SA070315 Pine Medical Rotating Waist Restraint
Clark Biocompatible Hemoperfusion Cartridge, Sorbent:
SA070322 Heparinized polymer over activated carbon, 50ml, 100ml, 175ml &
250ml (Lot # 564 - 577)
SA070323
LifeSync ECG System- Disposable Leadwear Ls-222, Ls-223 (Code
C6310, C6324 and C6297)
128
Medronic International Ltd
2919 1362
SA070324
Preservation Uni-Compartmental Knee fixed-bearing Tibial Tray
Components (size 1 - 5 )
MHRA
2006/011/022/081/001
SA070325 ULTIMA TPS femoral stem and ULTIMA Metal-on Metal articulation
MHRA
2007/002/001/081/014
SA070326 ConMed Frazier and Poole Suction Instruments
MHRA
2006/011/023/081/011
SA070327 KaVo. Dental Ltd. - QUATTROcare Spray Cans
MHRA
2006/012/007/081/004
Ltd
N/A
SA070328 Umimplanted PRECISION Implantable Pulse Generators (IPGs)
SA070329 Timesco Optima XL Stubby Laryngoscope Handles
MHRA
2006/012/001/291/002
SA070330 Vygon Lectro Cath Plus 200 cm ext. Line (batch: 0623618A)
MHRA
2007/003/001/181/002
SA070331 Vygon Lectro Cath Plus150 cm ext. Line (batch: 0624291A)
SA070332
VBM Medizintechnik GmbH - 13g Jet Ventilation Catheter Ref 3002-013-1 and 30-02-913-1
MHRA
MHRA
2007/003/008/081/001
2006/011/001/081/009
Action
Action
Action
2007/03/08
DePuy Inc (J&J)
2007/03/08
DePuy Inc (J&J)
2007/03/08
N/A
N/A
Action
2007/03/08
N/A
N/A
Action
2007/03/09
2960 7128
2007/03/09
N/A
N/A
2007/03/09
N/A
N/A
2007/03/12
N/A
N/A
2007/03/13
N/A
N/A
2007/03/14
2240 6260
Action
Action
Action
Action
Action
2738 2894
2738 2894
SA070333 Beckman Coulter FP1000 Cell Preparation System
MHRA
2007/003/006/081/015
Timesco Callisto Macintosh size 3 (adult) single-use laryngiscope
SA070334 blade (part # DS.3940.150.20/21) (Affected lots: GE, GF, GG, GH,
GI, GJ, GK, GL, HA)
MHRA
MDA/2007/021
2007/03/14
N/A
N/A
Hamilton Medical
N/A
Action
2007/03/14
N/A
N/A
FDA
Z-0578-2007 to Z-0579-2007
Class II
2007/03/15
Siemens Ltd.
2870 7533
FDA
Z-0597-2007
Class II
2007/03/15
N/A
N/A
FDA
Z-0577-2007
Class II
2007/03/15
N/A
N/A
FDA
Z-0545-2007
Class II
2007/03/15
Siemens Ltd.
2870 7533
Alcon Custom-Pak (Part# 10975-02; 2638-17; 4917-54; 6515-51;
11148-02)
FDA
Z-0560-2007 to Z-0564-2007
Class II
2007/03/15
Alcon Hong Kong Ltd
2568 0636
Wright Medical Technology Gladiator Bipolar Hip Prothesis (REF:
SA070341 GLBP-2241; GLBP-3650; GLBP-3651L GLBP-3652; GLBP-3653;
GLBP-3654; GLBP-3655)
FDA
Z-0567-2007 to Z-0573-2007
Class II
2007/03/15
2381 0279
FDA
Z-0574-2007
Class II
2007/03/15
N/A
N/A
2007/03/15
N/A
N/A
2007/03/15
2960 7128
2007/03/16
2960 7128
Action
2007/03/16
SA070335 Hamilton Medical Galileo Classic and Gold ventilators
Siemens Medical Solutions AXIOM Artis MP, Angiographic x-ray
SA070336
system (model number 5904466& 7555365)
Kensey Nash Corp. - ThromCat Thrombectomy Catheter System
7F2.5-7.0MM 150CM (Lot#54877, 55318, 55218, 54821)
EKOS EndoWave Infusion System and EKOS Lysus Infusion
SA070338 System (All models with Serial no. greater than and equal to
0610XXXX-XXX)
Siemens Medical Solutions Sample Management System Software
SA070339
for in vitro diagnostic testing Product # 030102-03
SA070337
SA070340
Abiocor AB5000 Console Circulatory Support System (Catalog no.
0015-000)
Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3,
SA070343
length tubing (batches C8237)
SA070342
SA070344 Boston Scientific Carotid Wallstent endoprosthesis
Boston Scientific Ltd: Vitality and Assure implantable cardioverter
SA070345 defibrillator (ICD) families and Contak Renewal cardiac
resynchronisation therapy defibrillator (CRT-D) Families
SA070346
Smith & Nephew RF DENERVATION PROBE (ITEM CODE
7210271; DESCRIPTOR 10 CM, LOT# 602561)
MHRA
Ltd
2007/003/007/601/661
N/A
Action
Action
MDA/2007/023
MHRA
MHRA
2007/003/012/081/010
129
2645 8703
SA070347 B. Braun Medical Ltd - MANDRIN/STYLET INTROCAN
SA070348
SA070349
SA070350
SA070351
SA070352
SA070353
SA070354
SA070355
SA070356
SA070357
SA070358
SA070359
SA070360
SA070361
Abbott - AxSYM Toxo LgG (List no 9K08-20; Lot no 42249HN00,
42249HN01, 43528HN00, 43528HN01)
Gyrus ACMI Tripolar Ultra Cutting Foreceps (Ref no. TRU5-32,
006689-901, 006689-903)
Remel MacConkey Agar w/Sorbitol, growth medium, catalog
R01556 (Lot#506069)
StayFix Fixation Device (REF 680ME, REF 685ME, REF670M)
Cook Triple Lumen Central Venous Catheter Tray with Cook
Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic
Coating (Recorder no. C-UTLMY-701J-RSC-ABRM-HC-FST-A)
iSight PACS version 3.5
Abbott -CELL-DYN 4000 Diluent/Sheath Reagent (List#01H73-01)
Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System
(Catalog # 164268)
Baxter Healthcare Corp - Clearlink Paclitaxel IV Admin Set and
Interlink Paclitaxel IV Admin Set
Haemodialysis Machine: Integra manufactured by Gambro
DePuy ASR Taper Sleeve Adaptor 9/10 (-3) and DePuy ASR Taper
Sleeve Adaptor (Code no 999800313 and 999800300)
Arcomedical Infusion Ltd - 3110-J (FSB499) Burette Set (Batch
H24563)
Biomerieux BacT/ALERT FN Culture Bottle (Product no 259793, lot
no 1015145)
Maquet Cardiopulmonary AG - Product Code H7101 (Lot 218333,
221734, 223245)
SA070362 Karma Mobility - Martin (KM-8520 series)
SA070363 Clearview Simplify D- Dimer( Kit lot no. PX018A, Batch no 682-024)
BD human IL-15 recombinant protein (Mat. No. 554630) and
SA070364
recombinant soluble dimeric human HLA-A2:Ig (Mat. No. 551263)
SA070365 Boston Scientific Expo Selective Angiographic Catheter
SA070366
Varian FastPlan treatment planning system for stereotactic
radiosurgery (versions 5.1 and below)
SA070367 Medicare Technology 716 Wheelchair Lap Belt
Smith & Nephew InterTan Subtrochanteric Lag Screw Driver
SA070368
(Product Code: 71674068)
SA070369 GE Healthcare OEC 9800
Zeiss Reusable Sensor 2PS20 or EPS01 used with Pentasys
SA070370
Phacoemulsificator
BD Vacutainer Safety-Lock Blood Collection Set with Pre-Attached
SA070371
Holders
SA070372 Puritan Bennett 840 Ventilator System
Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3,
SA070373
length tubing (batches C8218)
Boston Scientific Polarcath Peripheral Dilatation System Inflation
SA070374
Unit
2007/003/013/081/005
Action
2007/03/20
N/A
N/A
2007/003/012/601/683
Action
2007/03/20
2806 4201
FDA
Z-0613-2007 to Z-0615-2007
Class II
2007/03/21
N/A
N/A
FDA
Z-0621-2007
Class II
2007/03/21
N/A
N/A
FDA
Z-0629-2007
Class II
2007/03/21
N/A
N/A
MHRA
MHRA
2541 1041
FDA
Z-0637-2007
Class II
2007/03/21
FDA
FDA
Z-0616-2007
Z-0639-2007
Class II
Class II
2007/03/21
2007/03/21
2876 7525
2806 4201
FDA
Z-0617-2007
Class II
2007/03/21
2866 0811
Class II
2007/03/21
2807 8556
Action
Action
Action
Action
2007/03/21
Gambro China Ltd.
2576 2688
2007/03/21
DePuy Inc (J&J)
2007/03/21
N/A
N/A
2007/03/21
2356 7033
Health Canada
34385
MHRA
MDA/2007/027
MHRA
2007/003/016/081/002
MHRA
2007/003/015/601/689
MHRA
2007/003/001/601/640
MHRA
2007/002/022/291/001
2738 2894
2007/03/21
2393 9511
Action
2007/03/21
N/A
N/A
MHRA
2006/003/014/291/019
FDA
Z-0594-2007
Class II
2007/03/21
N/A
N/A
BD
N/A
Action
2007/03/21
BD
2575 8668
Ltd
N/A
Action
2007/03/22
2960 7128
Varian Medical
N/A
Action
2007/03/22
2724 2836
MHRA
2006/009/019/181/013
Action
2007/03/26
N/A
N/A
2007/03/26
2007/03/26
2783 1838
2007/03/26
N/A
N/A
2007/03/27
BD
2575 8668
2007/03/28
3157 7244
2007/03/28
N/A
N/A
2007/03/29
2960 7128
MHRA
2007/001/017/291/001
MHRA
2006/010/013/291/005
MHRA
2007/001/016/081/010
BD
N/A
MHRA
2007/003/021/081/002
MHRA
2007/003/020/601/694
Ltd
N/A
130
Action
Action
Action
Action
Action
Action
Action
2645 8703
SA070375 Viasys VELA Ventilator
SA070376 BioMerieux BacT/ALERT FA Culture Bottles
BioMerieux BacT/VIEW C.30 a Software update (P/N 514515-1)
SA070377
diagnostic data management system
SA070378 Gebauer - Salivart Oral Moisturizer
Z-0638-2007
Z-0643-2007
Class II
Class II
FDA
Z-0644-2007
Class II
FDA
Z-0497-2007
FDA
FDA
SA070379 Immucor Gamma Capture-R Select plates
MHRA
SA070380 CPS Direct SL slittable outer guide catheter
MHRA
SA070381 Arcomedical Ltd - 3101PNOY (FSB542) (Batch number C7944)
MHRA
SA070382 HoMedics Thera-P Heating Pads
FDA
Class II
2007/001/002/291/001
Action
2007/003/021/081/003
Action
2006/009/029/401/001
Action
Z-0622-2007 to Z-0626-2007
Class I
131
2007/03/29
2007/03/29
2893 0873
2356 7033
2007/03/29
2356 7033
2007/03/29
N/A
N/A
2007/03/29
N/A
N/A
2007/03/29
N/A
N/A
2007/03/30
N/A
N/A
2007/03/30
N/A
N/A
Monthly Summary of Medical Device Safety Alerts - February 2007
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
FDA
Z-0341-2007 to Z0342-2007
Class II
2007/02/01
N/A
N/A
FDA
Z-0350-2007
Class II
2007/02/01
Diagnostic Chemicals Ltd. - Salicylate - SL, in vitro diagnostic, Cat.
No 511-20 (Lot#29892)
FDA
Z-0361-2007
Class II
2007/02/01
N/A
N/A
Suros Surgical ATEC Breast Biopsy System handpiece for use with
SA070204 ATEC Breast Biopsy and Excision System, disposable, sterile, Part
no. 0912-20 (Lot: 611018)
FDA
Z-0362-2007
Class II
2007/02/01
N/A
N/A
SA070205 Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85
FDA
Z-0363-2007
Class II
2007/02/01
Otto Bock Hong Kong
2598 9772
Abbott - i-STAT PT/INR Cartridge prothrombin time rest in vitro
SA070206 diagnostic (product list#04J50-01 & 04J50-02; catalog# 420200;
Ref.: 04J50-01 24)
FDA
Z-0364-2007
Class II
2007/02/01
2806 4201
Terang Nusa Sterile Neolon 2G Latex-Free Powder-Free Neoprene
Surgical Gloves (Item no. MDS207060)
FDA
Z-0365-2007
Class II
2007/02/01
N/A
N/A
Philips Integris Allura System angiographic- Allura 9 F/C, Allura
SA070208 Mono X-Ray System, Allura FD 10 FX, Allura FD20 x-ray, FD 10/10
x-ray system and FD 20/10 x-ray system
FDA
Z-0366-2007 to Z-0371-2007
Class II
2007/02/01
2876 7525
FDA
Z-0373-2007
Class II
2007/02/01
2783 1838
FDA
Z-0376-2007
Class II
2007/02/01
2789 3300
FDA
Z-0377-2007
Class II
2007/02/01
2007/02/02
MDCO Ref.
No.
Cyberonics VNS Therapy System, Model 250-'HAND HELD'
programming software v6.1, v6.1.7, v7.0, v7.1.3 & 2500SA070201
'Handhelds' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0,
v7 1 3
Maquet - Jostra Heater Cooler Unit HCU30, System version 1.02SA070202 Low voltage machin, Article no.: 0704629 (serial no. 101006 101024)
SA070203
SA070207
SA070209
GE Centricity PACS RA 1000 Workstation (Version 2.1.X.X. and
3.0.X.X.)
SA070210 Bio-Rad D-10 Dual Program Calibrator Diluent
SA070211
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ
Coating, sterile REF FUS-095013-DL
SA070212
SypGlassT Lightcable, SypGlassT Camera, SpyGlass T Ocular and Boston Scientific (HK)
SpyGlassT Probe
Ltd
SA070213
Heartsine Technologies Ltd - Defibrillators, Non implantable Samaritan AED Models SAM-001, SAM-002 and SAM-003
MHRA
2006/011/006/291/015
Action
SA070214
BOC Ltd - AZ size aluminium medical nitrous oxide cylinders fitted
with a key operated pin index valve for use in MRI units
MHRA
MDA/2007/011
MHRA
(1) Cook Asia (Hong Kong) Ltd. (2) (1) 2781 0232; (2)
2541 1041
Boston Scientific
2960 7128
2007/02/05
N/A
N/A
2007/02/06
BOC Gases, Hong Kong Oxygen &
Acetylene Co Ltd (HKO)
2372 2288
MDA/2007/013
2007/02/07
2919 1362
MHRA
2007/001/031/121/003
Action
2007/02/07
2783 1838
SA070217 Varian Medical - CT/MR Ring & Tandem Applicator Set
Health Canada
33352
Type II
2007/02/07
2724 2836
SA070218 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/7)
Health Canada
32880
Type II
2007/02/07
2384 0688
SA070219 Walter Lorenz- 2" QC Solid Shaft Extention
Health Canada
33542
Type II
2007/02/07
N/A
N/A
Spacelabs Medical - Ultraview SL Command Module
SA070220
(Model/Catalog#91496)
Health Canada
33638
Type II
2007/02/07
Schmidt BioMed Tech (HK) Ltd
2620 8310
Lucas external cardiac compressor, manufactured by Jolife AB and
distributed by Medtronic Ltd
GE Healthcare - Computed tomography - LightSpeed VCT SA070216 Discovery VCT - LightSpeed Pro32 - LightSpeed Pro 16 LightSpeed RT16/ LightSpeed Xtra
SA070215
N/A
2393 9511
132
SA070221 GE Healthcare - Innova 2100 IQ
Health Canada
33717
Type II
2007/02/07
SA070222 Fisher and Paykel Healthcare - Infant Evaqua Breathing Circuits
Health Canada
33803
Type II
2007/02/07
Tokibo Co. (Hong Kong) Ltd
2783 1838
2418 9698
SA070223 Tyco Healthcare- CT9000 ADV with Console
Biomerieux - Vironostika HIV-1 Microelisa System
SA070224
(Model/Catalog#259605; Lot/Serial#160354)
SA070225 Misys Healthcare System Version 6.1 and 6.2
Health Canada
33834
Type II
2007/02/07
3157 7244
Health Canada
33570
Type I
2007/02/07
2356 7033
Health Canada
32993
Type II
2007/02/07
N/A
N/A
VISX Incorporated - Wavescan Wavefront System (Model/Catalog
SA070226
HS-1)
Health Canada
33201
Type II
2007/02/07
VISX Incorporated (HK)
N/A
Dentalez Inc. Stardental Division - Solara Replacement Turbine
SA070227
(Model/Catalog#263739, Lot#170510)
Health Canada
33350
Type II
2007/02/07
N/A
N/A
SA070228 Siemens AG - Magneton Trio (Model: 7387074)
Health Canada
33837
Type II
2007/02/07
Siemens Ltd.
2870 7533
Health Canada
33121
Type II
2007/02/07
2384 0688
SA070229
Toshiba - Digital Fluorography System (Model or Catalog # DFP8000D)
SA070230
Terumo Advance Perfusion System 1 Integrated Centrifugal
System Control Unit (Catalog#801046)
FDA
Z-0381-2007
Class II
2007/02/08
2866 0811
SA070231
Bard Peripheral Vascular Inc - G2 Filter System Jugular/Subclavian Delivery kit (Catalog# RF-320J & RF-220J)
FDA
Z-0393-2007 to Z-0394-2007
Class II
2007/02/08
N/A
N/A
SA070232
Davol Salute Fixation System 38cm and 18cm Resusable Shaft
with Handle (Ref#113036/9113036 and 0113037/9113037)
FDA
Z-0374-2007 to Z-0375-2007
Class II
2007/02/08
N/A
N/A
SA070233 Rhytec, Inc - Portrait PSR3 System
FDA
Z-0397-2007
Class II
2007/02/08
N/A
N/A
Custom Ultrasonics Inc - Stop manufacturing and distributing
SA070234 System 83 Plus Water/Disinfector and System Plus 83 Mini-Flex
Washer/Disinfector
FDA
N/A
Press Release
2007/02/08
N/A
N/A
SA070235
Baxter Healthcare - Amicus Apheresis Kits F4R2337
(Lot#A06129053)
MHRA
2007/002/005/291/011
Action
2007/02/08
2807 8556
SA070236
Boston Scientific - Urgent Medical Device Recall - Immediate Action Boston Scientific (HK)
Required: Matrix 2
Ltd
Action
2007/02/09
2960 7128
SA070237
Medtronic - Spinal Implants - Colorado 2 Anterior Plates # 8639500
& #8619500
MHRA
2007/002/006/291/007
Action
2007/02/12
2919 1362
SA070238
Abbott - StarClose Vascular Closure System (Catalogue# 14677;
Lot # 43034-6H to 47139-6H)
MHRA
2007/002/005/081/014
Action
2007/02/12
2806 4201
SA070239
Bayer - Benzodiazepine Reagent Lot 56510483 used with ADVIA
1200, 1650, 1800 and 2400 Chemistry System
MHRA
2007/001/015/081/013
Action
2007/02/12
Bayer Healthcare Ltd (Hong Kong)
2814 4829
SA070240
Smiths Medical Level 1 normothermic IV Fluid administration set
(Catalogue # DI-60HL) (NHS Supply Chain code FFF265)
MHRA
MDA/2007/015
2007/02/13
2317 0988
MHRA
MDA/2007/016
2007/02/13
Direct Health Ltd
2528 1109
MHRA
2007/002/001/081/008
Action
2007/02/14
2919 1362
FDA
Z-0415-2007 to Z-0416-2007
Class II
2007/02/15
2806 4201
FDA
Z-0399-2007 to Z-0400-2007
Class II
2007/02/15
Stryker China Ltd
2518 6988
FDA
Z-0418-2007 to Z-0420-2007
Class II
2007/02/15
2240 6260
SA070241 Invacare C800 Series ceiling track
SA070242 Medtronic - Vitatron T and C pacemakers
Abbott - ARCHITECT i2000 Processing Module (List#08C89-01 &
SA070243
3M74-01; Temp Controller Board Par#78560-109&7856-109)
Stryker - Triathlon X3 CR Tibial Bearing Insert for Knee prosthesis
SA070244 size # 2-11MM & 7-11MM (Ref# 5530-G-211 2011-09 & 5330-G711 2011-09)
Cytomics FC500 and FC500 MPL with CXP Software version 2.0 &
SA070245
2.1
133
SA070246
Perry-Kolberg Tiatanium Motility/Support System (Model 100045)
(Lot# M-50021)
FDA
Z-0396-2007
Class II
2007/02/15
N/A
N/A
SA070247 Welch Allyn PIC50 External Defibrillator/ Monitor
MHRA
MDA/2007/017
2007/02/15
Welch Allyn
N/A
SA070248 Draeger Infinity monitor with Infinity docking station(IDS)
MHRA
MDA/2007/018
2007/02/15
2877 3077
SA070249 GE Healthcare - Ventilator - Engstom Ventilator
MHRA
2007/002/008/601/579
2007/02/15
2783 1838
SA070250 Thoratec Corporation - thoratec VAD Dual Drive Console
MHRA
2007/002/005/081/012
2007/02/15
N/A
N/A
Action
Action
SA070251
Ascent Healthcare Solutions - AutoSuture Bladed Trocar (Model #
179094)
FDA
Z-0414-2007
Class II
2007/02/15
N/A
N/A
SA070252
Belcher Pharmaceuticals Inc - Mucotrol Conc. Oral Gel Wafer
contained in HDPE Bottle
FDA
Z-0398-2007
Class II
2007/02/15
N/A
N/A
SA070253 Fisher and Paykel Healthcare - Cosycot Infant Warmer
Health Canada
33376
Type II
2007/02/21
Tokibo Co. (Hong Kong) Ltd.
2418 9698
SA070254 Wilson-Cook Medical, Inc. - Quantum Biliary Dilation Balloon
Health Canada
33986
Type II
2007/02/21
N/A
N/A
SA070255 Medex Inc. - Pressure Transducer Cartridge
Health Canada
33633
Type II
2007/02/21
Smith Medical (S.E. Asia) Ltd.
23170988
Health Canada
33908
Type II
2007/02/21
Adaltis Healthcare (HK) Ltd
3123 8000
Type II
2007/02/21
2876 7525
SA070256
Adaltis Inc. - Detect-HCV V.3 (Model/Catalog# HCA-702B;
Lot/Serial# 6770192, 6770192F)
SA070257 Philips Medical System - Brilliance CT Big Bore System, Main Unit
Health Canada
33815
Resonant Medical Inc. - Restitu U/S Guide & Restitu U/S-SIM
SA070258
(Model# 9100-00015-2 & 9100-00015-1)
Health Canada
33905
Type II
2007/02/21
N/A
N/A
SA070259 Linvatec - E9000 Bur Products and Ultrapower Bur Products
Health Canada
33634
Type II
2007/02/21
N/A
N/A
SA070260 Skytron - Infinity Series Surgical Lights
Health Canada
33902
Type II
2007/02/21
N/A
N/A
Cardinal Health - Custom Sterile Cardiovascular Packs
SA070261 (Model/Catalog#SCV30OHXXX, SCV30PCXXX)
(Lot/Serial#769528, 781014, 778976, 787188)
Health Canada
33870
Type II
2007/02/21
N/A
N/A
Health Canada
32633
Type II
2007/02/21
2783 1838
Health Canada
32382
Type II
2007/02/21
2783 1838
Health Canada
33595
Type II
2007/02/21
Kong
2738 6162
2007/002/014/401/013
Action
2007/02/21
N/A
N/A
2007/02/21
Cemma Enterprise Co Ltd
2412 2310
2007/02/21
SA070262
GE Healthcare - Precision RX/I Fluoroscopic X-Ray System
(Model/Catalog#S1303JJ/JK/JL/JM)
GE Healthcare - Precision 500D (Model/Catalog#S0915KE,
SA070263
S0915KF)
Ortho- Clinical Diagnostics - Fetalscreen Test for D(RHO) Positive
SA070264
Fetal Red Blood Cells (Model/Catalog#780540) (Recall#33595)
Williams Medical Suppliers Plc - Comfisound (Code: D52208,
SA070265
D52209, 69.2100)
MHRA
American medical System- AMS700 Penile Prosthesis (Part no:
SA070266
72402987; Lot 475485004)
MHRA
2007/002/015/081/004
Action
Smith&Nephew - Peri-Loc Lateral- Proximal Locking Plate, Right
SA070267 (Product codes: 71800508 & 71800513) (Lots# 06CM17723 &
06CN15086)
MHRA
2007/001/016/081/012
Action
Candela - Vbeam/Aesthetica, Platiunum and Perfecta model laser
SA070268
systems
MHRA
2007/001/029/081/010
SA070269 Cardinal Health - Alaris Div -Syringe pumps (Signature Edition)
MHRA
2006/008/029/081/009
134
Action
Action
2645 8730
2007/02/21
N/A
N/A
2007/02/21
N/A
N/A
Conmed DetachaTip endoscopic Multiple use grasper and
SA070270 disposable hand held graspers and dissectors (Ratcheted and nonratcheted)
SA070271 Durex Canada - Confirm Clearly Smart Pregnancy Test
MHRA
MDA/2007/019
Health Canada
34026
SA070272 SonoSite Inc (UK Rep) - LAP/12-5MHz Laparoscopic Transducer
MHRA
2007/002/020/291/011
SA070273 Makro Medical - MAKROMED URINE TEST STRIPS - all models
MHRA
2007/001/023/081/007
2007/02/21
N/A
N/A
Type II
2007/02/21
SSL Healthcare Asia Ltd
2528 6778
2007/02/21
N/A
N/A
2007/02/22
N/A
N/A
Action
Action
SA070274
Clearview Simplify D- Dimer( Product code 505285; Kit Lot
numbers: PT030A & PT031A)
MHRA
2007/002/020/291/014
Action
2007/02/26
N/A
N/A
SA070275
Abbott - ARCHITECT FREE T3 Reagent (List # 7K63-20, 7K63-25,
7K63-30)
MHRA
2007/002/019/601/608
Action
2007/02/26
2806 4201
SA070276
Intavent Orthofix Ltd - Flexible size 2.5 Laryngeal Masks (REF
7125R and 7125DR)
MHRA
2007/002/013/081/009
Action
2007/02/27
N/A
N/A
MHRA
2007/002/019/121/006
Action
2007/02/27
N/A
N/A
Bausch & Lomb - TSV 25 Gauge High-Speed Cutter (Catalog no
SA070277 CX5825) & TSV 25 Gauge High-Speed Posterior Vitectomy Pack
(Catalog nos CX4925 & CX4925A)
135
Monthly Summary of Medical Device Safety Alerts - January 2007
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
2866 0811
N/A
N/A
N/A
N/A
SA070101
Terumo Advanced Perfusion System 1, Model 801763; Model
801764
FDA
Z-0306-2007 & Z-307-2007
Class II
2007/01/03
SA070102
Endologix Infrarenal Bifurcated Powerlink System with Visifiex
Delivery System (endovascular graft). Model No, 25-16-155BL
FDA
Z-0309-2007 & Z-310-2007
Class II
2007/01/03
SA070103
Solara Replacement Turbine, Autochuck End Cap, for dental
handpiece, part no, 064900
FDA
Z-0313-2007
Class II
2007/01/03
SA070104
801764
FDA
Z-0314-2007 & Z-0315-2007
Class II
2007/01/03
2866 0811
FDA
Z-0316-2007
Class II
2007/01/03
N/A
N/A
SA070106 Sorin Group Venous Femoral Catheter Wire Reinforced
MHRA
2006/012/012/081/008
2007/01/04
N/A
N/A
Siemens Medical Solutions Mammomat 1000 and Mammomat
SA070107
3000/Nova
MHRA
2007/001/003/081/001
2007/01/04
Siemens Ltd.
2870 7533
Posterior Acetabular Retractor-Left with Light Cord Bracket, Model
#BIO-1-1050-A, Posterior Acetabular Retrator-Right with Light Cord
SA070105
Bracket, Model #BIO-1-1050-A, packaged 1 retractor (left or right
retractor) per plastic bag
MHRA
2006/010/023/601/367
SA070109 Siemens AG Magicsas/Sienet IWM
Health Canada
33372
Action
Action
Action
Type II
Smiths Medical ASD Inc. Bivona Laryngectomy Tube, Long (Lot
SA070110
1263830)
Health Canada
33320
Type II
SA070108 GE Healthcare Technologies (Prev Datex Ohmeda) Aisys
2007/01/04
2783 1838
2007/01/08
Siemens Ltd.
2870 7533
2007/01/08
2317 0988
Kong
2738 6080
SA070111 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips
FDA
Z-0266-2007
Class I
2007/01/10
SA070112
SA070113
SA070114
SA070115
FDA
FDA
FDA
FDA
Z-0292-2007 & Z-0293-2007
Z-0308-2007
Z-0322-2007 & Z-0337-2007
Class I
Class II
Class II
Class II
2007/01/10
2007/01/10
2007/01/10
2007/01/10
2866 0811
2876 7525
2866 0811
FDA
Z-0338-2007
Class II
2007/01/10
N/A
N/A
FDA
Z-0339-2007
Class II
2007/01/10
2317 0988
Smith & Nephew Trufit CB Plug Size Codes: Red, 7mm (Part #605SA070118 001-03, Blue, 9mm (Part #605-001-05); TruFit BGS Plug Size Code
Red, 7mm (Part #600-001-03), Blue 9mm (Part#600-001-05)
FDA
Z-0440-2007 to Z-0443-2007
Class II
2007/01/10
Puritan Bennett KngithStar 330 Bi-Level Ventilator, Catalogue No.
SA070119 Y-KS330-NA. Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLYKS330-NA & DLY-KS330-SD
FDA
Z-044-2007
Class II
2007/01/10
3157 7244
Bard Composix Kugel Large Sized Patches
Philips Medical Systems HeatStart FR2+ Defibrillator,
Edwards LifeSciences-Swan-Ganz, Thermodilution Venous Infusion
SA070116 Port(VIP) Catheter with AMC Throboshield (An Antimicrobial
*Heparin Coating), Ref: 831HF75, Model 831FH75
SA070117
Smiths Medical ASD Inc. Bivona Laryngectomy Tube, ID 8.5mm,
O.D. 11mm Length 88mm, TTS 11.8mm
2645 8703
SA070120
Bayer Advia 70 Hematology Analyzer, Drew Excell 22 Hematology
Analyzer
FDA
Z-0448-2007 & Z-0449-2007
Class II
2007/01/10
2814 4829
SA070121
Abbott Laboratories, Inc. Phenobarbital-Reagent-Clinical
Chemistry, List no. 1E08-20
FDA
Z-0454-2007
Class II
2007/01/10
2806 4201
136
SA070122
Integra LifeSciences BOLD/INI-CLIP 2.2mm Drill Bit with AO
Attachment. Model/Catalog No. 159004ND
SA070123
Shenzhen Bestman Instrument Media Injectors (X-ray) contrast
medium syringe
SA070124 Corybros Ltd - CB3600
Select lots of O2Optix (lotrafilcon B) Soft Contact Lenses. The lots
affected in this recall are all lots numbers starting with 6644001 to
6721262 with expiration dates starting from 2011/09 to 2011/11,
SA070125
and lot numbers 6626127, 6636101, 6637017, 6637019, 6637103,
6640120, 6640124, 6642109, 6642119, and 6643080, all with
expiration dating of 2011/08.
SA070126 Stryker - Howmedica Hip Fracture Stem System
FDA
Z-0466-2007
Class II
2007/01/10
N/A
N/A
MHRA
2006/011/022/401/015
Action
2007/01/10
N/A
N/A
MHRA
2006/010/002/601/324
Action
2007/01/10
N/A
N/A
Health Canada
33715
Type II
2007/01/16
CIBA Vision (Hong Kong) Ltd.
2814 2121
FDA
Z-0472-2007 to Z-0476-2007
Class II
2007/01/17
STRYKER CHINA LTD
2518 6988
SA070127 SPS Blue Line Tube Clamp Adapters, Product number BL120M
FDA
Z-0445-2007
Class II
2007/01/17
N/A
N/A
Viasys V.P.I. Bird Gold pediatric ventilator, catalog no. 15653 and
SA070128
15654
FDA
Z-0480-2007 to Z-0481-2007
Class II
2007/01/17
Arjo - BHM Reacher for Portable Ceiling Lifts (Model: Part
SA070129
#700.08310-24' and Part #700.08320-36')
FDA
Z-0482-2007
Class II
2007/01/17
2508 9553
FDA
Z-0486-2007
Class II
2007/01/17
Socofar Ltd
2861 3261
Ossur - Re-Flex VSP and Low Profile Re-Flex VSP external
SA070130 prosthetic foot modules (Model no.: RFXS0002, RFXS0003,
RFLS0006 and RFL50007
SA070131 Stryker - Simplex P with Tobramycin Anitibiotic PMMA Bone
FDA
Z-0467-2007
Class II
2007/01/17
STRYKER CHINA LTD
2518 6988
FDA
Z-0486-2007 to Z-0487-2007
Class II
2007/01/17
N/A
N/A
FDA
Z-0483-2007 to Z-0484-2007
Class II
2007/01/17
2807 8517
Medtronic
International, Ltd.
N/A
N/A
2007/01/22
2919 1362
SA070135 Toshiba - Xario Main Unit (Model # SSA-660A)
Health Canada
32878 and 33122
Type II
2007/01/22
2384 0688
Toshiba - Digital Fluorography System (Model or Catalog # DFPSA070136
8000D)
Health Canada
33123
Type II
2007/01/22
2384 0688
SA070132
Varian Medical Systems GammaMed 12i and 12t radionuclide
applicator systems
Baxter Colleague Single and Triple Channel Volumetric Infusion
SA070133 Pumps (Product codes: 2M8151, 2M8151R, 2M8161, 2M8161R,
2M8153, 2M8153R, 2M8163, 2M8163R)
Medtronic - Voluntary Field Corrective Action of Reliant Stent Graft
SA070134 Balloon Catheter and Talent Coiltrac AAA Stent Graft Delivery
System with Balloon.
SA070137
Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/DC and
TSX-101A/8)
Health Canada
32870
Type II
2007/01/22
2384 0688
SA070138 Toshiba - X-Rays High Voltage Generator
Health Canada
33118
Type II
2007/01/22
2384 0688
Inverness Medical Professional Diagnostics - Clearview HCG
SA070139
Combo (Model or Catalog # 6026KCV)
Health Canada
32452
Type II
2007/01/22
Nordep Healthtech
2881 7871
SA070140
Inverness Medical Professional Diagnostics - Clearview HCG
Combo (Model or Catalog # 6026KCV)
Health Canada
32607
Type II
2007/01/22
Nordep Healthtech
2881 7871
SA070141
Philips Medical System- Allura XPER FD10 and Allura XPER
FD20/10 System, Main Unit
Health Canada
33501
Type II
2007/01/22
2876 7525
Health Canada
Health Canada
32189
33251
Type II
Type II
2007/01/22
2007/01/22
JOINHANDS TECH LTD
2738 2818
2635 3455
SA070142 Cordis Prowler Infusion Catheter
SA070143 Baylis Medical Company, Inc. - Baylis RF Cannula
Draeger Medical - Medical Air Compressor (Model or
SA070144
Catalog#8413419)
SA070145 Alsius Corp. - Cool Line Catheter Model CL-2295AE
Health Canada
33587
Type II
2007/01/22
2877 3077
Health Canada
33400
Type II
2007/01/22
N/A
N/A
137
Roche Diagnostics GMBH - Tina-Quant Gen 2 Albumin (ALBT2) R2
and Immunoglobulin G (IGGT) Assay
Health Canada
32922
Type II
2007/01/22
Limited
2485 7510
SA070147 GE Healthcare - Advantx LCN, Advantx LCLP and Innova 4100
Health Canada
33046
Type II
2007/01/22
2783 1838
I-Flow Corp. - ON-Q Painbuster, 100ml x 2ml/hr (Model or
SA070148
Catalog#PM012 )(Lot or Serial # 662449, 662742)
Health Canada
33058
Type I
2007/01/22
N/A
N/A
Health Canada
33211
Type I
2007/01/22
N/A
N/A
MHRA
2006/012/021/601/481
Action
2007/01/22
2783 1838
Health Canada
33497
Type II
2007/01/22
N/A
N/A
SA070146
SA070149
Airox Legendair Ventilator (Lot or Serial# All Airox Legendair
Ventilator LE030007, EXPECT LE020007, LE021009)
SA070150 GE Healthcare -Apex Pro/ApexPro CH Telemetry System
Interventional Technologies Europe Ltd. - 1 cm Peripheral Cutting
SA070151
Balloon
SA070152
BOC Ltd - AZ size aluminium medical oxygen cylinders fitted with a
key operated pin index valve for use in MRI units
MHRA
MDA/2007/007
2007/01/25
BOC Gases, Hong Kong Oxygen &
Acetylene Co Ltd (HKO)
2372 2288
SA070153
Beckman Coulter - Access Immunoassay System CEA (Part no
33200) (Lot no.: ALL)
MHRA
2006/004/027/121/008
Action
2007/01/25
2240 6260
MHRA
2007/001/008/081/007
Action
2007/01/25
2724 2836
Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry Systems,
SA070155 Automated Clinical Chemistry Analyzer - human serum, plasma and
urine tests
FDA
Z-0351-2007 to Z-0353-2007
Class II
2007/01/25
2814 4829
SA070154 Varian Medical - On Board Imager CBCT
SA070156 Abbott Spine TraXis Fixed Trail and TraXis Fixed Rasp
FDA
Z-0354-2007 to Z-0355-2007
Class II
2007/01/25
2806 4841
SA070157 Embeem Inc - HiZel, Trayless-sterile hydrogel wound dressing
FDA
Z-0455-2007
Class II
2007/01/25
N/A
N/A
Rymed Technologies, Inc. - RYM-5000 & RYM-5001 InVision-Plus
SA070158 Neutral Displacement and RYM-5000 InVision-Plus NEUTRAL I.V.
Connector
FDA
Z-0319-2007 to Z-0321-2007
Class II
2007/01/25
N/A
N/A
Continental Medical Labs, Inc. -Fibrin Analysis Catheter Testing
SA070159 System includes the component BD Vacutainer Luer-Lok Access
Device (Catalog#364902)
FDA
Z-0357-2007
Class II
2007/01/25
N/A
N/A
Ltd
N/A
Action
2007/01/26
2960 7128
MHRA
MDA/2007/2008
2007/01/30
N/A
N/A
MHRA
2006/007/027/401/003
Action
2007/01/30
N/A
N/A
SA070160 Boston Scientific - HTA System
SA070161
Draeger Medical - Neonatal radiant warmer: Draeger Resuscitaire
model RW82VHA-1C with variable height adjustment
Unomedical Ltd - Cord Clamps: Cutter-umbilical cord clamp clipper
SA070162 (lot#102042/118351/121457/134481/136591/142538/146675/15116
8/155746)
SA070163
Hemo Cue Ltd - HemoCue Glucose 201 and HemoCue Glucose
201RT instruments
MHRA
2007/001/015/081/014
Action
2007/01/30
2543 7442
SA070164
Siemens Diagnostics - IMMULITE 2000/2005 Chartable Report
Used with SMS
MHRA
2007/001/023/601/530
Action
2007/01/31
Siemens Ltd.
2870 7533
138
Monthly Summary of Medical Device Safety Alerts - December 2006
MDCO Ref. No.
Source of Information*
Date of Issue
(YYYY/MM/DD)
BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human CD16
SA061201
Becton Dickinson Asia Ltd.
2006/12/04
Monoclonal Antibody, Clone 3G8, Cat. No. 555403, lot # 43033
BD Pharmingen PE-Conjugated Mouse Anti-Human Fetal Hemoglobin
SA061202
2006/12/04
Monoclonal Antibody, Clone 2D12, Cat. No. 551797, lot # 38377
SA061203
SA061218
Baxter Health Flo-Gard 6200, 6201, 6300 & 6301
Depuy Int. (J&J) Preservation Uni-Compartmental Knee size 3 Fixed bearing Tibial Tray
Boston Scientific iLab Ultrasound Imaging System, Installed Models
iLab120INS and iLab240INS
Lone Star Medical Products 1100 Series Aluminum Retractor Rings,
Models #1104, 1107 and 1110
Nihon Kohden Electric Stimulator, Model number: MS-210BK, Any serial
numbers up to 02160
Computerized Medical Systems AccuSeed DS Digital Stepper, an
accessory to a prostate radiation treatment planning system, Model
Inverness Medical Professional Diagnostics NOW Legionella Urinary
Antigen Test. 22 test kit, Product Code: 852-00, Lot Number: 024448
Data Innovations Roche Modular Drive (rchmdlri) and Roche Cobas
driver (rchcob6i) analytical laboratory data interface, various software
Dentsply Friadent XiVE S plus Screw Implant D3.0/L11, D3.0/L13 and
D3.0/L15 dental implants
Cory Brothers Ltd. MPC SCT/50/6 Suctioni Tubing
Abbott Molecular Inc. RealTime CT/NG assay and RealTime CT assay
List Number 2G28 and 1L31
TomoTherapy Incorporated HI-ART System H-0000, H-0000-0001
Kavo Dental Quattrocare spray can
Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral Stent
Implantation System
Innovatek Medical Quickstick HCG Pregnancy Test Kit, Model or
Catalog # 4220-4K, Lot or Serial # 5-09076
Toshiba Medical Systems Aquilion CT Scanner, Model or Catalog #
SA061219
Philips Brilliance CT Big Bore System, Lot or Serial # 7062 and 7017
SA061204
SA061205
SA061206
SA061207
SA061208
SA061209
SA061210
SA061211
SA061212
SA061213
SA061214
SA061215
SA061216
SA061217
MHRA
2006/011/030/291/010
FSCA
2006/12/04
MHRA
2006/011/022/081/001
FSCA
2006/12/04
2006/12/06
Boston Scientific H. K. Ltd.
FDA
Z-0218-2007
Class II
FDA
Z-0221-2007
Class II
2006/12/06
FDA
Z-0222-2007
Class II
2006/12/06
FDA
Z-0223-2007 & Z-0224-2007
Class II
2006/12/06
FDA
Z-0230-2007 to Z-0232-2007 Class II
2006/12/06
SA061226
SA061227
SA061228
SA061229
SA061230
SA061231
SA061232
SA061233
SA061234
SA061235
SA061236
2575 8668
The local agent informed all affected users.
Johnson & Johnson Medical
Hong Kong
2807 8556
2960 7117
Data Innovations Asia
2398 3182
2738 2818
The local agent informed that no affected units had
been distributed in Hong Kong.
2006/12/06
2006/12/06
2006/011/030/601/437
FSCA
2006/12/06
2806 4841
MHRA
MHRA
2006/011/015/291/006
2006/012/007/081/004
FSCA
FSCA
2006/12/06
2006/12/08
Interdental Ltd.
2541 1096
MHRA
2006/012/005/601/444
FSCA
2006/12/08
Sanko Medical Systems (H.K.)
Philips Electronics Hong Kong
Ltd.
Medisource Supply (Asia) Co.
Ltd.
Ltd.
2384 0688
Health Canada
Recall # 32712
Type II
2006/12/11
Health Canada
Recall # 31601
Type II
2006/12/11
Health Canada
Recall # 32814
Type II
2006/12/11
Recall # 32787
Type II
2006/12/11
Recall # 32826
Type II
2006/12/11
Recall # 32827
Type II
2006/12/11
Recall # 32662
Type II
2006/12/11
Recall # 32817
Firm Initiated/Type III
2006/12/11
Recall # 32928
Type II
2006/12/11
Recall # 30550
Type II
Recall # 32953
Type II
2006/012/007/601/454
Z-0228-2007
Z-0244-2007
Z-0247-2007
Z-0248-2007 / Z-0249-2007
William Cook Europe Flexor Check-Flo Micropuncture Radial Artery
Access Introducer Sets with AQ Hydrophilic Coating
SA061225
MHRA
SA061240
SA061224
Action
Boston Scientific Katzen infusion wires
SA061223
2575 8668
MDA/2006/067
SA061239
SA061222
MHRA
SA061237
SA061238
SA061221
Agent Contact
Telephone No.
2006/12/06
FDA
Conmed Soft Tip Frazier, Frazier Surgical Suction Instrument and Poole
Health Canada
Suction Instrument
Health Canada
Philips Ultrasound IE33 Diagnostic Ultrasound Transducer, Identifier
Philips Medical Systems Gemini GXL 6/10/16 Slice Pet/CT System, lot
Health Canada
or serial # 882410
Health Canada
Medi-Inn Swabette, model or catalog # MIS300 and MIS401
LifeScan OneTouch Ultrasmart Blood Glucose Meter, model or catalog
LifeScan Ltd.
# 020-720 and 020-721 with serial numbers starting with TC, TD, TF or
Health Canada
Unomedical A/S Cord Clamp Clipper, Serial # M3186023572, Lot #
Toshiba Medical Systems Digital Fluorography System, Model or
Health Canada
Catalog # DFP-8000D and DFP-8000D/FPD
Bio-Rad Laboratories Diagnostics D-10 Haemoglobin Testing System Health Canada
Dual Program, model or catalog # 220-0201
Medtronic Precision Plus Transurethral Needle Ablation (TUNA) therapy
system, model 7900
MHRA
Abbott Diagnostics Architect LH Reagent
FDA
Accumetrics Inc. Verify Now P2Y12 Assay Device Kit, Part No. 85054
FDA
Teleflex Medical Neoprene Pecan Shaped Breathing Bag
Dade Behring Brand MicroScan Prompt Inoculation System-D; Catalog
FDA
#B1026-10D
FDA
Arjo Inc. Sling Rope/Connector Asembly Kits
Boston Scientific 1cm peripheral cutting balloon microsurgical dilatation
devices
MHRA
Fisher and Paykel Healthcare Ltd (NZ) Acclaim HC401 Nasal Mask
Fisher and Paykel Healthcare Ltd (NZ) All Single Use Heated Breathing
MHRA
Circuits
Arcomed Administration Set-3101-LPPJ
MHRA
Boston Scientific Hemashield vascular grafts and fabrics
SA061220
Z-0212-2007 to Z-0214-2007 Class II
Remarks
Local Agent
2006/011/023/081/004
2145 4442
2821 5480
Hong Kong
2738 6080
2006/12/11
Sanko Medical Systems (H.K.)
Ltd.
2384 0688
2006/12/11
2789 3300
2006/12/11
2919 1362
FSCA
Class II
Class II
2006/12/11
2006/12/13
2006/12/13
2806 4841
Class II
2006/12/13
Dade Behring Hong Kong Ltd
2803 0118
Class II
2006/12/13
Arjo Far East Limited
2508 9553
2006/12/13
2960 7117
FSCA
2006/12/13
2418 9698
2006/012/013/291/005
FSCA
2006/12/13
2418 9698
FSCA
2006/12/14
2006/12/15
2960 7117
2006/12/15
2960 7117
Action
2006/12/18
MDA/2006/071
2876 7525
2006/012/012/601/458
MHRA
2821 5480
139
The Government of the HKSAR
SA061241
SA061242
Lombard Medical - Bifurcated Endovascular Graft Aorfix II
Inditherm Heating Mattress
SA061243
Boston Scientific Mach 1 guide catheters
SA061244
Medtronic Rocker Reducer instruments
SA061245
Biosense Webster Europe Preface Guiding Sheath
MHRA
2006/011/023/291/013
SA061246
Guidant Ltd. Acrobat Vacuum Stabilizer System
MHRA
SA061247
SA061248
Femcare-Nikomed Ltd. Femcare Camera Sleeve
Medtronic LIFEPAK 20 Defibrillator/Monitors
Smiths Medical International CADD-Legacy PLUS and CADD-Legacy 2
Ambulatory Infusion Pumps -21-6400 & 21-6500
MHRA
SA061249
SA061250
LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips
MHRA
MHRA
FSCA
FSCA
2006/12/15
2006/12/18
2006/12/19
2960 7117
2006/12/19
2919 1362
FSCA
2006/12/18
2006/012/007/081/002
FSCA
2006/12/18
Guidant Hong Kong Ltd.
2593 2235
2006/012/018/291/025
FSCA
2006/12/19
2006/12/20
2919 1362
MHRA
2006/002/015/291/004
FSCA
2006/12/20
2317 0988
FDA
Z-0206-2007 / Z-0207-2007
Class I
2006/12/20
Hong Kong
2738 2818
Z-0148-2007
Class II
2006/12/20
AMO Asia Ltd.
2401 5861
Z-0233-2007 to Z-0242-2007 Class II
2006/12/20
2866 0811
2006/12/20
2575 8668
AMO Asia Ltd.
2401 5861
Gambro China Ltd.
2576 2688
SA061251
AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
FDA
SA061252
Terumo Cardiovascular Systems Terumo Perfusion System
BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached
Multiple Sample Adapter Sterile
FDA
SA061253
FDA
2006/012/014/081/002
2006/011/024/401/010
Z-0253-2007
Class II
SA061254
AMO PhacoFlex II Model SI40NB Intraocular Lenses
FDA
Z-0267-2007
Class II
2006/12/20
SA061255
Medline Industries Medline Premium Wet Shin Prep Tray
FDA
Z-0268-2007
Class II
2006/12/20
SA061256
Gambro Lundia AB (Monitor Division) CWP100
MHRA
2006/008/017/081/001
FSCA
2006/12/20
SA061257
Biodiagnostics Ltd. Crithidia Luciliae Slides - Catalogue no. L058 / L108
Roche Diagnostics Cobas Taqman CT test, Amplicor Chlamydia
Trachomatis Detection Kit, Amplicor Chlamydia
MHRA
2006/012/004/601/443
FSCA
2006/12/21
MHRA
2006/011/024/081/004
FSCA
2006/12/21
Limited
2485 7555
Invacare Spectra Plus Powered Wheelchair
MHRA
2004/011/004/151/010
FSCA
2006/12/21
Direct Health Ltd.
2528 1109
SA061258
SA061259
Boston Scientific Wallstent endoscopic biliary endoprosthesis with
Unistep Plus delivery system
B Braun Aesculap Metha Modular short Stem Prosthesis
BD Mini Blade
2006/12/22
2960 7117
SA061261
SA061262
MHRA
2006/011/023/081/010
FSCA
2006/12/21
2006/12/28
2277 6125
2575 8668
SA061263
FDA
Z-0261-2007 & Z-0262-2007
Class I
2006/12/27
2738 2818
SA061264
FDA
Z-0263-2007
Class I
2006/12/27
B. Braun Medical (Hong Kong)
Hong Kong
Hong Kong
2738 2818
FDA
Z-0258-2007 & Z0259-2007
Class II
2006/12/27
Ultronics Enterprise Ltd.
2764 5208
Z-0269-2007
Class II
2006/12/27
2960 7117
Z-0270-2007 to Z-0287-2007 Class II
2006/12/27
SA061260
SA061276
Medrad Invasive Blood Pressure Interface Cables (Part #3006314,
3008772 & 3010478)
Guidant Contak REnewal 3 RF, 3 RF HE, 4 RF & 4 RF HE cardiac
resynchronization therapy defibrillator
Arrow Implantable Vascular Access System - Infusion Ports with
Silicone Rubber Catheter
Maillinckrodt OptiVantage DH Power Injection System
Draeger Medical Infinity Docking Station (IDS) Delta and Kappa Patient
Monitors. Model Nos. 4715319, 5206110 and 7489375
Datex Ohmeda Compact Absorber, Disposable REF 427002100, white
to violet and REF 427002000
Terumo Advanced Perfusion System 1 Electonic Oxygen
Blender/Analyzerl Catalog No. 801188
Maquet Critical Care AB HL30 Perfusion System
Maquet Critical Care AB Jostra Heater-Cooler Unit 30 System
Elekta Desktop Pro 6.0/6.1
Bio-Rad Laboratories Diagnostics Group Liquichek Cardiac Markers
Control LT, Model 645, 645X, 646, 647, 648, 649, 649X
Guidant ACS Rotating Hemostatic Valve
SA061277
GE OEC Medical System, DBA GE Healthcare OEC 9900
SA061265
SA061266
SA061267
SA061268
SA061269
SA061270
SA061271
SA061272
SA061273
SA061274
SA061275
FDA
FDA
FDA
Z-0288-2007
Class II
2006/12/27
FDA
Z-0302-2007
Class II
2006/12/27
2877 3077
FDA
Z-0291-2007
Class II
2006/12/27
GE Medical Systems Hong Kong
Ltd.
2783 1838
FDA
Z-0294-2007
Class II
2006/12/27
2866 0811
Health Canada
Health Canada
Health Canada
Recall # 33015
Recall # 33014
Recall # 32786
Type II
Type II
Type II
2006/12/27
2006/12/27
2006/12/27
2393 9511
2393 9511
Health Canada
Recall # 33044
Type II
2006/12/27
2272 8922
Health Canada
Recall # 33048
Type II
2006/12/27
2593 2235
Health Canada
Recall # 33053
Type III
2006/12/27
Guidant Hong Kong Ltd.
Ltd.
2783 1838
SA061278
Siemens Medical Solutions Linear Accelerators
Health Canada
Recall # 33065
Type III
2006/12/27
Siemens Ltd.
2870 7533
SA061279
SA061280
SA061281
Siemens AG Lithoskop
Bausch & Lomb 20 Gauge High Speed Electric Vitrectomy Cutters
SuperDimension Bronchus System
Health Canada
MHRA
MHRA
Recall # 33214
2006/012/015/081/007
2006/012/008/081/012
Type III
FSCA
FSCA
2006/12/27
2006/12/28
2006/12/28
Siemens Ltd.
Bausch & Lomb (Hong Kong)
2870 7533
2213 3179
140
The Government of the HKSAR
Monthly Summary of Medical Device Safety Alerts - November 2006
MDCO Ref.
Source of
Reference No. by Source Alert Type by Source Date of Issue
Local Agent
Agent Contact
(YYYY/MM/DD)
No.
Information*
Telephone No.
Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe
SA060332 with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product #
FDA
Z-0051-2007
Class II Recall
2006/11/01
2574 3251
888153744
GE ApexPro FH Telemetry System, Software versions v3.8 and
SA060333
FDA
Z-0054-2007
Class II Recall
2006/11/01
2783 1838
Ltd.
earlier
Depuy PFC Oval Dome Patella, Part Number 960100, Lot:
SA060334
FDA
Z-0057-2007
Class II Recall
2006/11/01
2738 6080
2203528
Kong
Cardinal Health Cardiovascular Split Drape II, various models
SA060335
FDA
Class II Recall
2006/11/01
N/A
N/A
Z-0058-2007 to Z-0062-2007
and lot numbers
Siemens Medical Solutions Sienet Cosmos V15C, model
SA060336 number 10018969, Serial numbers 1001, 1010, 1011, 1028,
FDA
Z-0069-2007
Class II Recall
2006/11/01
Siemens Ltd.
2870 7533
and 1029Medical Solutions Syngo Imaging, Sienet Sky and
Siemens
SA060337 Sienet Magic View 300 picture archiving and communications
FDA
Z-0070-2007 to Z-0072-2007
Class II Recall
2006/11/01
Siemens Ltd.
2870 7533
systems
(1) Cook Asia (Hong Kong) Ltd.; (2)
(1) 2781 0232; (2) 2541
Cook Zilver 635 Biliary Stent, Catalog # ZIB6-80-4.0-40, lot
FDA
Z-0080-2007
Class II Recall
2006/11/01
A.R. Burkhill & Sons (Hong Kong)
SA060338
1041
1722922
Ltd.
Radiometer America Radiance Data Management System,
SA060339 Software Version 2.60, modification for the ABL800 Flex Blood
FDA
Z-0115-2007
Class II Recall
2006/11/01
N/A
N/A
Gas Analyzer, Catalog Numbers: 914-418 and 914-426
SA060340 Siemens MODULARIS Uro endourology tables
MHRA
2006/010/010/291/005
2006/11/01
Siemens Ltd.
2870 7533
Action
SA060341 Ferno Falcon Six stretcher trolleys
Boston Scientific Mach 1 Peripheral Guide Catheter, lot #
SA060342
575765
MHRA
2005/008/001/401/006
Boston Scientific H. K.
Ltd.
N/A
SA060343 Welch Allyn Propaq LT patient monitors
MHRA
2006/011/001/081/001
SA060344 Abbott CELL-DYN 22 calibrators and controls
MHRA
2006/011/003/601/388
SA060345 Ansell Micro-Touch Nitrile examination gloves
MHRA
2006/010/031/081/002
SA060346
Hardy Media HardyCHROM 0157, Catalogue Number G305,
Lot numbers 06192 and 06235
SA060347 Venoscope Neonatal Transilluminator, Model NT01
Respironics REMstar Heated humidifier, model nos. 1007861,
SA060327 R1007861, JP1007861 and 1005732, Serial no: H045582 to
H239662 (inclusive)
Action
Urgent Medical Device
Recall
Action
Action
Action
2006/11/01
N/A
N/A
2006/11/03
2960 7117
2006/11/06
N/A
N/A
2006/11/08
2806 4201
2006/11/08
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
Z-0078-2007
Class II Recall
2006/11/08
N/A
N/A
Class II Recall
2006/11/08
N/A
N/A
Respironics, Inc.
N/A
Recall
2006/11/09
2268 9229
With affected units in Hong Kong.
2006/11/09
2575 8668
2006/11/09
N/A
N/A
Action
Action
SA060349 Getinge steam sterilizers, various models
Endologix Visiflex bifurcated Delivery Catheters, 155mm, used
SA060350 for the Powerlink System (models 25-16-155BL and 28-16155BL)
MHRA
2006/009/004/081/008
FDA
N/A
Firm Press Release
2006/11/09
N/A
N/A
SA060351 Toshiba Medical Systems Aquilion and Aquilion CFX Edition
Health Canada
32674
Type II Recall
2006/11/13
2384 0688
SA060352 Toshiba Medical Systems Aquillion 16-Slice System
Health Canada
32639
Type II Recall
2006/11/13
2384 0688
SA060353 Arjo Minstrel Lift with Scale
Health Canada
32598
Type II Recall
2006/11/13
Arjo Far East Limited
2508 9553
Health Canada
32528
Type II Recall
2006/11/13
Agfa Hong Kong Ltd.
2555 9421
Health Canada
32627
Type II Recall
2006/11/13
N/A
N/A
Health Canada
32593
Type II Recall
2006/11/13
N/A
N/A
Health Canada
32498
Type II Recall
2006/11/13
Elekta Ltd.
2892 4320
Health Canada
32451
Type II Recall
2006/11/13
2877 3077
The local agents informed that no affected units had been
Z-0116-2007
2006/011/001/081/010
SA060357 Draeger Medical Narkomed 6000 Series Anesthesia Machine
FDA
MHRA
AGFA CR NX Modality Workstation, model or catalog # ES885,
versions NX 1.0.2402 and NX 1.0.2405
Implant Innovations ITHA52 Certain EP Healing Abutment, Lot
SA060355
or Serial # 560988
Calley & Currier Laminated Wooden Crutches, various models
SA060328
and catalog numbers
Elekta Instruments AB Leksell Gamma Knife C Version 1.2/4C,
SA060356
Lot or Serial # 4310 and 4336
FDA
SA060348 BD MultiVisc viscoadaptive solutions (catalog number 581745)
SA060354
Remarks
141
SA060358 Toshiba Medical Systems Opart MRI System
SA060359
SA060360
SA060361
SA060362
SA060329
SA060363
SA060364
Immucor Panocell-16, 16 x 3ml, model or catalog # 0002332,
lot or serial # 35411
Smith & Nephew Profix Hall 3/4 Fanned Sawblade, model or
catalog # 71512903
Beckman Coulter EPOCS SL Flow Cytometers with EXPO 32
ADC Software
Smiths Medical Level 1 D-60HK and DI-60HL Normothermic
I.V. Fluid Administration Sets
Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric
soft (hydrophilic) contact lenses
Enpath Medical pacemaker lead adapter and Angel Medical
Systems Lead Adaptor system
Hydrocision SpineJet XL MIS 20 and SpineJet XL MIS 30
degree Handpieces, Catalog Numbers 58662 and 58663
SA060365 DePuy Spine Bremer Halo System, various models
Ortho-Clinical Diagnostics VITROS Chemistry Products GLU
SA060366 DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per
box
Hitachi Medical Systems Echelon Magnetic Resonance Imaging
SA060367
System, Serial Number: V001
Precision Medical Easy Mate Portable Liquid Oxygen System
SA060368 (container), PM22010 Series, Model number 2201, serial
numbers P002892 through P005116
Access Point Medical Heavy Duty Rollators (rolling walker),
SA060369
Product Codes: RL12010HD and RL12011
Lumiport DermaStyle Chroma 2-blue and red light device
SA060370 indicated to be used in treating skin blemishes, portable home
therapy
SA060371 Maquet Jostra HL-20 Heart Lung Machine - guiding pins
Cook Endoscopy Fusion OMNI ERCP Catheter, Lot number
W2243511
USA Instruments 1.5T HD Head Neck Spine Array (Model
2416329, for GE 1.5T Excite MR System) and 3.0T HD Head
SA060373
Neck Spine Array (Model 2415545, for GE 3.0T Excite MR
System)
SA060330 BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129
SA060372
Health Canada
32523
Type II Recall
2006/11/13
2384 0688
Health Canada
32531
Type II Recall
2006/11/13
Uninet Technology Ltd.
2838 8423
Type II Recall
2006/11/13
2006/11/13
2240 6260
2006/11/14
2317 0988
Health Canada
32280
MHRA
2006/011/010/291/002
MHRA
2006/011/009/081/009
FDA
Z-0018-2007 to Z-0020-2007
Class II Recall
2006/11/15
Ciba Vision Hong Kong Ltd.
2814 2121
FDA
Z-0120-2007 & Z-0121-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0123-2007 & Z-0124-2007
Class II Recall
2006/11/15
N/A
N/A
Z-0130-2007 to Z-0144-2007
Class II Recall
2006/11/15
2738 6080
FDA
Z-0151-2007
Class II Recall
2006/11/15
HealthCare Diagnostics Ltd.
2563 5193
FDA
Z-0152-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0153-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0154-2007 & Z-0155-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0156-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0159-2007
Class II Recall
2006/11/15
2393 9511
FDA
Z-0160-2007
Class II Recall
2006/11/15
FDA
Z-0163-2007 & Z-0164-2007
Class II Recall
2006/11/15
N/A
N/A
Becton Dickinson and
Company (Japan)
N/A
Voluntary Recall
2006/11/15
2575 8668
The local agent confirmed having no record of importing the
affected devices into Hong Kong.
2006/11/15
2240 6260
2006/11/15
2877 3077
2006/11/15
Onwon Trading Limited
2757 7569
2006/011/014/291/014
SA060375 Draeger Medical Infant Warmer - RW82VHA-1C
MHRA
2005/005/025/401/001
SA060376 Novagen Ltd 2mm Angled Suction Tip
MHRA
2006/011/010/401/006
MHRA
2006/011/013/081/007
Medtronic
International, Ltd.
N/A
SA060379 Ferno Restraining straps/harness-Pedi-Mate 678
MHRA
2004/012/001/061/029
SA060380 Owen Mumford Unistik 3 Neonatal & Laboratory/Confort/Normal
MHRA
2006/011/013/291/002
Full Spectrum Lighting T/a S.A.D. Lightbox Company Machine
SA060381
Therapy-LPD24
MHRA
2006/010/013/601/34
SA060382 Bard Access Systems HemoGlide Catheter Kits
MHRA
2006/008/031/291/002
Medtronic SynchroMed® and IsoMed® Implantable Pain
Infusion Pumps, various models
Tyco Healthcare OptiVantage DH Contrast Media Injection
SA060383
MHRA
System
Boston Scientific System Drape (IVUS motor drive sterile plastic Boston Scientific H. K.
SA060384
cover), lot numbers M846990, M835770 and M844470
Ltd.
FDA
MHRA
SA060378
2645 8703
Kong
Beckman Coulter Access Immunoassay Systems Thyroglobulin
SA060374
Antibody
SA060377 Molnlycke Health Card Camera Drape - ProcedurePak Trays
Action
Action
2006/011/014/081/008
N/A
Action
Action
Action
Action
Important Patient Safety
Management Information
Action
Action
Action
Action
Action
Medical Device
Customer Notification
142
(1) 2781 0232; (2) 2541 The local agent informed that no affected units had been
1041
Ltd.
2006/11/16
N/A
N/A
2006/11/17
2919 1362
2006/11/17
N/A
N/A
2006/11/20
N/A
N/A
2006/11/20
N/A
N/A
2006/11/20
N/A
N/A
2006/11/20
2574 3251
2006/11/21
2960 7117
Boston Scientific Jagwire High Performance Guidewire (lot #
SA060385 8887513) and Jagwire High Performance Extendable Guidewire
Ltd.
(lot # 8887514)
N/A
Recall
2006/11/21
2960 7117
Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE
SA060331 Multi-Purpose Solutions, and COMPLETE MoisturePLUS MultiPurpose Solutions (Starter Kits)
AMO Asia Limited
N/A
Voluntary Recall
2006/11/22
AMO Asia Limited
2401 5811 and 2401
5812
MHRA
2006/009/012/291/010
Action
2006/11/21
Limited
2485 7555
FDA
Z-0165-2007 & Z-0166-2007
Class II Recall
2006/11/22
2821 5480
FDA
Z-0167-2007
Class II Recall
2006/11/22
Data Innovations Asia
2398 3182
FDA
Z-0169-2007
Class II Recall
2006/11/22
2807 8556
FDA
Z-0170-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0182-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0183-2007 & Z-0184-2007
Class II Recall
2006/11/22
2876 7525
FDA
Z-0185-2007 to Z-0188-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0189-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0190-2007
Class II Recall
2006/11/22
Zimmer PTE Ltd. (Hong Kong
branch)
2992 0968
FDA
Z-0193-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0195-2007
Class II Recall
2006/11/22
N/A
N/A
Health Canada
30937
Type II Recall
2006/11/27
N/A
N/A
Health Canada
32628
Type II Recall
2006/11/27
N/A
N/A
2006/11/27
N/A
N/A
2006/11/27
N/A
N/A
SA060386
Roche Diagnostics Acc-chek Multclix, Softclix, Softclix Plus and
CoaguChek Softclix single-patient self-testing lancing systems
SA060387
Philips Allura X-per FD10/10 and FD20/10 X-ray and
fluoroscopy systems
Data Innovations Instrument Manager Version 8:00, 8.01, 8.02,
SA060388 8.03 or 8.04 with Specimen Management and using
Results/Edit/ReleaseScreen (R/E/R)
Baxter Meridian hemodialysis instruments, product codes
SA060389
5M5576 and 5M5576R
Bemis 5 Qt. Wallmount Sharps Container, Model 150, Regular
SA060390
Size
Olsen Medical MIDAS TOUCH Electrosurgical/102 mm (4 inch)
SA060391 Blade Electrodes, Disposable, Sterile Single Use Device, Part
#30-0012 and Model #30-0002
Philips Medical Systems M3001A Multi Measurement Server
(MMS) and M1020B Pulse Oximetry Module Philips FAST Sp02
SA060392
and Pulse Oximetry Nellcor OxiMax Compatible used with the
IntelliVue or M3/M4 patient monitor M1002
Sorenson Medical ambIT Ambulatory Infusion Pump Cassettes,
SA060393 REF numbers 220139, 220140, 220266 and 220267, all serial
numbers
Eatonform Doc-U-Dose Prescription Management System, Item
SA060394
8-PKIT, Carton numbers: 16 through 39
Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Lot
SA060395 numbers: P031530, P031650, P040389, P040111, P051160,
P051161
Trionix Research Laboratory BIAD Classic 24 (24 inch
SA060396
collimator), Serial numbers B-102 through B-184
Ekos Lysus Transport Stand (infusion stand), part number
SA060397
4896-003
Balt Extrusion Flow Dependent Micro-Catheter, models MAGIC
SA060398
1.2FM, MAGIC MP and MAGIC STD
Tornier Latitude Elbow Prosthesis Radial Head, models or
SA060399
catalog # DKY056, DKY057, DKY058 and DKY059
SA060400 Rocket Medical Fetal Blood Sampling Kit
Bard Ltd. Stone Basket - 042310, 042313, 042316, 043310,
043313, 043316
Elekta Instruments AB Leksell Gamma Knife, model or catalog
SA060402
# 912800
SA060401
SA060403 Rocialle InHealth Sterile Procedure Pack - Basic Pack
SA060404
SA060405
SA060406
SA060407
SA060408
SA060409
Abbott AxSYM Matrix Cells, Product List No: 8A73-02, Lot #
37618Q100
Plus Orthopedics UC-PLUS Solution Unicondylar Knee
Systems
Exactech Optetrak B-series cemented finned tibial tray, size
2f/2t, catalog # 220-04-02, serial numbers 0886395 - 0886424
Iris Sample Processing StatSpin Express 3 Centrifuge with
RTX8 Rotor Model: M502, Serial numbers: B1562 to B1738
Dako Colorado Eridan Automated Slide Stainer and Support
Cart, REF E300 and E300SC1
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer, various serial
numbers
SA060410 Access Point Medical Canes, various models
MHRA
2006/007/005/601/166
MHRA
2006/011/024/601/421
Action
Action
Health Canada
32733
Type II Recall
2006/11/27
Elekta Ltd.
2892 4320
MHRA
2006/011/009/291/005
Action
2006/11/28
N/A
N/A
FDA
Z-0117-2007
Class II Recall
2006/11/29
2806 4201
FDA
Z-0191-2007 & Z-0192-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0196-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0198-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0199-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0201-2007
Class II Recall
2006/11/29
Hong Kong Oxygen & Acetylene
Co. Ltd.
2666 1942
FDA
Z-0202-2007 to Z-0205-2007
Class II Recall
2006/11/29
N/A
N/A
143
Click on the Press Release by AMO Asia for details:
AMO's Press Release
SA060411
Medtronic Vascular Pioneer Catheter (Crosspoint TransAccess
Catheter), Model TA-XP-001, all codes
Zimmer NexGen Complete Knee Solution Legacy Knee Tibial
Component, Catalog no. 05-5998-038-02, Lot 60472442
Zimmer Trabecular metal shoulder instrumentation proximal
provisional humeral stem, Catalog no. 00-4309-018-10, Lots:
60457716 and 60492624
Konica Minolta PrintLink III Model - ID/IV, product code no.
0770, 0771 Medical Imaging Communication Device Model IV product code 5000230 Model ID, product code 5000330
Vygon Paediatric 96Hr IV Filter 0.22M + extension line
0807.205
FDA
Z-0208-2007
Class II Recall
2006/11/29
2919 1362
2992 0968
FDA
Z-0209-2007
Class II Recall
2006/11/29
branch)
FDA
Z-0210-2007
Class II Recall
2006/11/29
branch)
2992 0968
FDA
Z-0220-2007
Class II Recall
2006/11/29
Konica Minolta Business Solutions
(HK) Ltd.
2565 8181
MHRA
2006/011/017/401/001
2006/11/29
N/A
N/A
SA060416 Smiths Medical International Monitor Patient-BCI Autocorr 3404
MHRA
2006/011/022/291/010
2006/11/29
2317 0988
SA060417 Pegasus Ltd. Altas and Paragon Bed Frames
MHRA
2006/011/003/261/001
SA060418 Bayer HealthCare ADVIA Centaur CP Immunoassay System
MHRA
2006/011/027/601/428
SA060412
SA060413
SA060414
SA060415
Action
Action
Action
Action
144
2006/11/29
N/A
N/A
2006/11/29
2814 4829
1 affected unit in Hong Kong.
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Computerized Medical Systems Software Releases 2.1.0 SA060247
Health Canada
32273
Type II Recall
2006/10/02
N/A
4.3.0, all lot numbers
Hill-Rom Patient Pendants, model or catalog # P3207A01 &
SA060248
Health Canada
32294
Type II Recall
2006/10/02
Solar Medical Ltd.
P3207A02
Radiometer Medical APS CAL 2 Solution, model or catalog #
SA060249
Health Canada
32100
Type II Recall
2006/10/02
N/A
S1730, lot or serial number QR-02
Baxter Healthcare Colleague 3 Volumetric Infusion Pump,
SA060250 models 2M8153, 2M8153R, 2M8163, 2M8163R, DNM8153 &
Health Canada
32333
Type II Recall
2006/10/02
DNM8153R
Ondine Biopharma Periowave Disinfection System Footswitch,
Health Canada
32178
Type II Recall
2006/10/02
N/A
SA060251 model or catalog # PW1002 and PW1100, lot or serial number
PW-D06-00001 to PW-D06-00400
Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H. K.
Medical Device Market
SA060252
N/A
2006/10/03
specific lots
Ltd.
Withdrawal
Huntleigh birthing beds, Models 35000 and 170000; Hoskins
SA060253
MHRA
MDA/2006/057
Action
2006/10/03
N/A
Birthcare, Models L10 and L05
Baxter Healthcare, Administration Set-Continu Flo Solution Sets
SA060254
MHRA
2006/009/020/291/016
2006/10/03
with Check Valve
Action
SA060255 B. Braun Arterial / Venous Blood Line, 7210697
MHRA
2006/009/026/291/011
2006/10/03 B. Braun Medical (Hong Kong) Ltd.
Action
Terumo Khuri Myocardial PH Monitoring System, Catalog
SA060256
FDA
Z-1517-06
Class II Recall
2006/10/04
number 7205
Kerr RempBond Clear Syringes (base and catalyst kit), a
temporary dental cement, Part Number 28637
BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder
SA060258
Number 305945 and 305950
Ogenix EpiFLO SD Clinical Users Guide (CUG), Part #01-100SA060259
1000000
International Medsurg Connection Allegiance Esmark
SA060260 Bandages, catalog numbers 24593-043A, 24593-044A, 24593063A and 24593-064A
SA060257
Agent Contact
Telephone No.
N/A
2425 0926
N/A
2807 8556
2960 7117
N/A
2807 8556
2277 6125
2866 0811
Z-1524-06
Class II Recall
2006/10/04
N/A
N/A
FDA
Z-1525-06
Class II Recall
2006/10/04
2575 8668
FDA
Z-1526-06
Class II Recall
2006/10/04
N/A
N/A
FDA
Z-1527-06 to Z-1530-06
Class II Recall
2006/10/04
N/A
N/A
SA060261 INO Therapeutics INOvent System O Ring Failures
MHRA
2006/004/003/401/004
2006/10/04
Co. Ltd.
2666 1942
SA060262 Codan Great Britain Pump volumetric Argus 708
MHRA
2006/007/012/291/010
2006/10/04
N/A
N/A
2806 4841
SA060263
SA060264
SA060265
SA060266
SA060267
Abbott Laboratories AsSYM Myoglobin Reagent Kit List
Number 7K48-20
Varian 4D Integrated Treatment Console treatment control
station for radiation therapy linear accelerators
GE Healthcare Technologies (Prev Datex Ohmeda) Monitor
Patient - N-AC
BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human
HLA-DR, DP, DQ Monoclonal Antibody, Clone TU39, Cat. No.
555556
Prorhtym Cardiac ablation system - 25mm & 30mm HIFU
ablation catherter
MHRA
2006/009/029/601/319
Varian Medical
2006-022
MHRA
2006/009/027/601/315
Becton Dickinson
Asia Ltd.
N/A
MHRA
2006/007/013/081/002
SA060268 Abbott Laboratories CELL-DYN 22 Calibrators-99120-01
MHRA
2006/010/002/901/325
SA060269 Cory Bros Ltd, Tubing suction - Ref: CST/50/6
MHRA
2006/008/015/401/002
Customer Notification
Action
Action
Action
2006/10/04
2006/10/06
2006/10/06
2006/10/09
Varian Medical Systems Pacific
Inc.
Ltd.
2783 1838
2575 8668
2006/10/10
N/A
N/A
2006/10/11
2806 4841
2006/10/11
N/A
N/A
FDA
Z-0704-06
Class II Recall
2006/10/11
Ltd.
2783 1838
FDA
Z-1301-06 to Z-1303-06
Class II Recall
2006/10/11
Ltd.
2783 1838
FDA
Z-1514-06
Class II Recall
2006/10/11
2645 8703
SA060273 GE Precision RX/I System, all units
FDA
Z-1485-06
Class II Recall
2006/10/11
Ltd.
2783 1838
Pointe Scientific Alcohol reagent sets and control standards,
SA060274
various models
FDA
Z-1543-06 to Z-1549-06
Class II Recall
2006/10/11
Evergreen Health Care Ltd.
2893 0694
145
2724 2836
GE OEC Medical Systems MiniView 6800 Digital Mobile C-arm
fluoroscopic x-ray system
GE OEC Medical Systems 9900 Elite Digital Mobile C-arm XSA060271 ray system, 9800 Fluoro C-arm X-ray system and RUS Tool
Version Software
Smith & Nephew Hip Positioning System with various System
SA060272
Components
SA060270
1 affected unit was distributed in Hong Kong.
N/A
FDA
Action
Action
Action
Correction
Action
Remarks
The local agent informed all the affected users.
GE OEC Medical Systems 4 inch Anterior Cervical Post, Part
SA060275 Number: 1006385 or 1006385-NAV, an accessory used with
the InstaTrak 3500 plus and 9800 C-Arm Navigation systems
Thoratec brand TLC-11 Portable Ventricular Assist Device
SA060276
(VAD) Driver
Stryker Navigation Systems with Dell laptop computer model
SA060277
D800
Smith & Nephew Journey Nonporous Fin-Stem Tibial Punch,
SA060278 Genesis II Nonporous Fin-Stem Tibial Punch and Genesis II
Oversized Nonporous Fin-Stem Tibial Punch
Ltd.
Class II Recall
2006/10/11
FDA
Z-0004-07
Class II Recall
2006/10/11
N/A
N/A
FDA
Z-0005-07 to Z-0008-07
Class II Recall
2006/10/11
Stryker Hong Kong
2518 6915
FDA
Z-0009-07 to Z-0011-07
Class II Recall
2006/10/11
2645 8703
SA060279 Actamed Ltd Ranger High Flow Blood/Fluid Warming Sets
MHRA
2006/004/027/601/094
Action
2006/10/12
N/A
N/A
SA060166 Jenx Ltd. Seating support systems for children
MHRA
MDA/2006/059
Immediate Action
2006/10/12
N/A
N/A
SA060280 BD Procount Kit, Part No. 340498, Lot No. 51184 and 57281
N/A
Product Field Action
Notification
2006/10/13
2575 8668
SA060237
N/A
Important Information
2006/10/13
St. Jude Medical (Hong Kong) Ltd.
2996 7650
The local agent has already informed all the concerned
hospitals and doctors.
P06-167
FDA News
2006/10/13
Kong
2735 8262
Updated on 2006/10/23. Please see SA060241 for details.
2006/010/003/081/006
Action
2006/10/16
Beijing Since Medical Scientific Co.
Ltd.
9262 1527
32353
Type II Recall
2006/10/16
2575 8668
32288
Type II Recall
2006/10/16
N/A
N/A
32120
Type II Recall
2006/10/16
Gambro China Ltd.
2576 2688
1 affected unit was distributed in Hong Kong.
32374
Type II Recall
2006/10/16
BioMerieux China Limited
2356 7033
SA060281
SA060282
SA060283
Becton Dickinson
Asia Ltd.
St. Jude APS III Model 3500/3510 and Merlin PCS Model 3650
programmers used with certain St. Jude Identity pacemakers
St. Jude Medical, Inc.
(Identity SR Model 5172, Identity DR Model 5370 and Identity
XL DR Model 5376)
LifeScan OneTouch Basic/Profile (lot # 272894A, 2619932,
2606340) and OneTouch Ultra (lot # 2691191) Blood Glucose
FDA
Test Strips
AGA Medical Corporation Delivery System Amplatzer TorqVue
MHRA
Delivery and Exchange Systems
BD Procount Progenitor Cell Enumeration, Part No. 340498, Lot
Health Canada
No. 45602
Walter Lorenz Surgical Lactosorb Suspension Screw, model or
Health Canada
catalog # 915-2335, lot or serial # 753200
SA060284 Teraklin AG Mars Treatment Kit
SA060285
SA060286
SA060287
SA060288
SA060289
SA060290
SA060291
Health Canada
Biomerieux Slidex Pneumo-Kit, model or catalog # 58821, lot or
Health Canada
serial # 50417
Michigan Instruments Thumper Mechanical CPR Device, model
Health Canada
or catalog # 1007
Randox Laboratories Fructosamine Control Level 1, lot or serial
Health Canada
# 239FR
Boston Scientific Interlock Detachable Coils For Occlusion, lot Boston Scientific H. K.
number 6628239
Ltd.
Boston Scientific Renegade 18 Microcatheter, lot number
7513978
Ltd.
Boston Scientific Stainless Steel Greenfield Vena Cava Filter, Boston Scientific H. K.
lot number 7826572
Ltd.
Advanced Bionics Linear Family Leads (product numbers SCAdvanced Bionics
2108, SC-2138, SC-2148 series)
2783 1838
Z-0001-07
SA060236
FDA
32375
Type II Recall
2006/10/16
Beijing Ji Yuan Electronic Co.
(86)10-6202-3856
32310
Type II Recall
2006/10/16
N/A
N/A
2006/10/17
2960 7117
2006/10/17
2960 7117
2006/10/17
2960 7117
2006/10/17
2960 7117
N/A
N/A
N/A
Recall
Recall
Recall
3 affected units were distributed in Hong Kong.
N/A
Important Notification
MHRA
2006/010/013/601/347
Action
2006/10/17
Elekta Ltd.
2891 2208
FDA
Z-0015-2007
Class II Recall
2006/10/18
N/A
N/A
FDA
Z-0027-2007
Class II Recall
2006/10/18
3M Hong Kong Ltd.
2806 6314
FDA
Z-0029-2007
Class II Recall
2006/10/18
N/A
N/A
FDA
Z-0030-2007
Class II Recall
2006/10/18
N/A
N/A
SA060297 AGFA CR DX-S Image Intensified Fluoroscopic X-ray system
FDA
Z-0031-2007
Class II Recall
2006/10/18
Agfa Hong Kong Ltd.
2555 9421
Haemonetics SmartSuction Harmony Powered Suction Device,
SA060298
Model number: HAR-E-115-US
FDA
Z-0035-2007
Class II Recall
2006/10/18
Haemonetics (Hong Kong) Limited
2868 9218
2006/10/19
Limited
2485 7555
SA060292 Elekta Ltd. Precise Desktop R4.2 and DesktopPro R5.0
Thoratec brand Sealed Arterial Cannula for use with the
Thoratec Ventricular Assist Device System
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use
in STERRAD 100, STERRAD 100S and STERRAD 50
SA060294
Sterilization Systems, Lot numbers 2006-12 AA through 200806 AB Medical Systems MRP-7000 and AIRIS Magnetic
Hitachi
SA060295 Resonance Imaging Systems, Software Versions: V7.0A to
V7 0J
Arrow Double-Lumen Balloon Wedge Pressure Catheter, for
SA060296 sampling blood for oxygen levels and measuring pressures in
the right heart
SA060293
SA060299 Roche Diagnostics CoaguChek PT test strips
FDA
N/A
Press Release
146
SA060239 Sunrise Medical Jay J2, Wheelchair back
SA060240
Medtronic SynchroMed EL Programmable Infusion Pumps,
Models 8627-10, 8627-18, 8627L-10, 8627L-18
SA060300 Lenox-Maclaren Bone Fragmenter, Catalog # 9150111, all lots
SA060301
SA060241
SA060302
SA060303
SA060304
SA060242
SA060305
SA060306
SA060307
SA060308
SA060309
SA060310
SA060311
Olympus Life and Material Science Europa GmbH - CRP Latex
C-Reactive Protein (OSR6199)
LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra
Blood Glucose Test Strips
GF Health Products ECAT (Extended Care Air Therapy
Systems) 2000 Safe Enclosure Bed
BD Vacutainer Push Button Blood Collection Set with Preattached Holder, Catalog numbers 367352 and 368656
Medline Industries Strider Maxi 3 and Maxi 4 Scooters, red and
blue models, all serial numbers
Eagle Parts and Products Models 624EZ and 624Mini Power
Wheel Chairs with internally threaded wheel mount motors,
Serial numbers 624EZ0010 through 624EZ0513
GE OEC 9900 Elite Fluoroscopy System with Integrated
Navigation, Catalog Numbers 887208 and 887210
GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208
and 887210
Bioplate Resorbable Bone Fixation Tack, Catalog Number 890120, Item Number SG#-45, Lot number S2964090
Excelsior Medical 0.9% Sodium Chloride Flush Syringe, 2.5 mL.
Product Code: E0100 under Hospira's label, Syrex, Lot: 22-0109D
Eatonform Doc-U-Dose Prescription Management System, Item
#8-PKIT, lots 312733, 312734, 313767 and 313768
Draeger Fabius GS Anesthesia Machine, Catalog number
8604699
Del Medical DynaRad Phantom Portable X-Ray System,
Phantom model (PH-150-CM & PH-150-G)
Medtronic Sofamor Danek Implant Hollow Reamer, 14 mm,
REF 8951405, Lot Numbers CN04J012 and CN 06A003
AGA Medical AMPLATZER PFO Occluder, Order No. 9-PFO018 and 9-PFO-025
GE ApexPro CH Telemetry System, Software version 3.8 and
earlier
MHRA
MDA/2006/060
FDA
Z-0022-0007
Medtronic
International, Ltd.
N/A
MHRA
2006/007/027/291/001
FDA
P06-174
Action
2006/10/19
N/A
N/A
Class I Recall
2006/10/20
2919 1362
2006/10/20
2919 1362
2006/10/23
2376 1805
2006/10/23
Kong
2735 8262
Voluntary Field
Corrective Action
Action
FDA News
FDA
Z-0026-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0034-2007
Class II Recall
2006/10/25
2575 8668
FDA
Z-0036-2007 & Z-00372007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0039-2007 & Z-00402007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0041-2007
Class II Recall
2006/10/25
FDA
Z-0042-2007
Class II Recall
2006/10/25
FDA
Z-0043-2007
Class II Recall
2006/10/25
Ltd.
Ltd.
Kong
2783 1838
2783 1838
2738 6080
FDA
Z-0044-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0045-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0048-2007
Class II Recall
2006/10/25
2877 3077
FDA
Z-0049-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0050-2007
Class II Recall
2006/10/25
2919 1362
FDA
Z-0052-2007 & Z-00532007
Class II Recall
2006/10/25
FDA
Z-0055-2007
Class II Recall
2006/10/25
SA060315 Omega truCATH catheters (TCH-10)
MHRA
2006/010/004/401/021
SA060316 Southern Scientific Autotilt ultrasound couches
MHRA
2006/070/019/601/356
MHRA
2006/010/020/081/015
Respironics, Inc.
N/A
Health Canada
SA060312
SA060313
SA060314
SA060317
SA060327
SA060243
SA060244
SA060318
SA060319
SA060320
SA060321
Siemens MAGNETOM Trio and MAGNETOM Trio a Tim
magnetic resonance imaging systems
Respironics REMstar Heated humidifier, model nos. 1007861,
R1007861, JP1007861 and 1005732, Serial no: H045582 to
H239662 (inclusive)
BHM Medical Kwiktrak Fix Gate, Model or Catalog # 700.11500
and 700.11505
Sunrise Medical Canada 5in Wheels Kits and Guardian
Walkers
Teleflex Medical Sher-i-Bronch Endobronchial Tube 37Fr,
Sheridan Preformed Cuffed Nasal Endo., Sheridan Preformed
Cuffed Oral Endo.5mm, Sheridan Preformed Uncuffed Oral
Endo. and Sheridan Tracheal Tube Exchanger
AMD-Ritmed Abdominal Pads, Model or Catalog # A-7059, Lot
or Serial # 2095
GE Centricity Triwin Laboratory Information System Microbiology Module, Version 7.4
Smith & Nephew Legion Offset Coupler Trials, Model or
Catalog # 71434301, 71434302, 71434304 and 71434306
Action
Action
Action
Ltd.
Ltd.
9262 1527
2783 1838
Supersedes the MDA/2006/056 (Ref: SA060163). The
manufacturer informed that no affected units had been
Update to SA060236. For enquiry, please contact the local
agent.
According to FDA, distribution of affected units was limited to
the United States only. Pending the manufacturer's
confirmation.
2006/10/25
N/A
N/A
2006/10/25
N/A
N/A
2006/10/25
Siemens Ltd.
2870 7533
Recall
2006/10/25
2268 9229
32430
Type I Recall
2006/10/30
N/A
N/A
Health Canada
32469
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32449
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32484
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32311
Type II Recall
2006/10/30
Ltd.
2783 1838
Health Canada
32286
Type II Recall
2006/10/30
2645 8703
147
SA060322
Micrus Endovascular Guidewire Insertion Device, Lot or Serial #
F22741, F22743 and F22744
Health Canada
32512
Type II Recall
2006/10/30
N/A
N/A
SA060245
LifeScan OneTouch SureStep Test Strips, Lot or serial #
2631383
Health Canada
32428
Type II Recall
2006/10/30
Kong
2735 8262
2006/10/31
N/A
N/A
2006/10/31
N/A
N/A
2006/10/31
N/A
N/A
2006/10/31
2240 6260
N/A
N/A
N/A
N/A
N/A
N/A
Alcon Hong Kong Ltd.
2161 0888
ConMed Detacha Tip Multi-Use Laparoscopic Instruments and
SA060323
Disposable Hand Held Graspers and Dissectors
MHRA
2006/010/025/081/009
SA060324 Galls Dyna Med patient transfer sheets
MHRA
2005/001/010/401/003
SA060325 Biomet modular femoral heads
MHRA
2006/010/024/181/005
MHRA
2006/010/026/111/002
SA060326
SA060246a
SA060246b
SA060246c
SA060246d
Beckman Coulter FC 500 MPL flow cytometry systems with
MXP software versions 2.0 & 2.1
北京自然美光学有限公司亮洁倍润免揉搓去蛋白护理液、生产日
期/批号06030015、规格360毫升
上海海昌隐形眼镜光学有限公司海昌隐形眼镜多功能护理液、生
产日期/批号20051027、规格500毫升
广州保视宁光学产品有限公司保视宁去蛋白软性接触镜护理液、
生产日期/批号2005/09/18、规格360毫升
Alcon Opti-Free Express Contact Lens Care Solution (爱尔康杀
菌全护理液), lot number #63188F and manufacturing date
Beijing Health
Inspection Website
N/A
Action
Action
Action
Action
Public Annoucement
148
2006/10/31
Extension of the recall case # SA060238. The local agent
informed that no affected units had been distributed in Hong
Kong.
The State Food and Drug Administration (SFDA) of the PRC
informed that, among the four brands, only the Alcon brand is
sold in Hong Kong. Alcon Hong Kong Ltd. informed that the
affected lot of its product was not distributed in Hong Kong.
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Gantry Direct Drive systems in Varian High Energy Clinac linear
Varian Medical
SA060167
N/A
2006/09/01
Inc.
accelerators
Correction
SA060168 Zimmer-M/DN, Trilogy, HGP II and Herbert Bone Screws
MHRA
2006/007/013/081/005
2006/09/01
Action
branch)
Codman EDS III Drainage System, model or catalog # 82-1731,
SA060169
Health Canada
32097
Type II Recall
2006/09/04
lot or serial # CGHBGC and CGHBGD
Kong
Smith & Nephew Hewson Suture Retrievers Item 7111-1579, lot
SA060170
Health Canada
32117
Type II Recall
2006/09/04
or serial # 05HSM0014
Mentor Clear Advantage With Aloe MECs, model or catalog #
SA060171
Health Canada
32095
Type II Recall
2006/09/04
N/A
26-06100, 26-06200, 26-06300, 26-06400 & 26-06500
Biomerieux Vitek 2 Compact 30 System, Vitek 2 Compact 60
SA060172
Health Canada
31891
Type II Recall
2006/09/04
System and Vitek 2 System
SA060173 Kueschall Airlite Manual Wheelchair, K Series 2005
SA060174 Boston Scientific PT2 Guide Wire
SA060175 Baxter Healthcare Cryote Freezing Container
SA060176
SA060177
SA060178
SA060179
SA060180
SA060181
Dideco Electa and Compact Advanced Autotransfusion Wash
Sets
Dade Behring Limited Dimension clinical chemistry system
Tacrolimus (TACR) Flex reagent cartridge (DF107) Lots:
FM6334, FD6344 and FA6351
Radiometer America Transcutaneous Monitor for pO2 and
pCO2, Model # TCM4
BioGenex brand Hepatitis B Virus Core Antigen Antibody and
Surface Antigen Antibody
Diagnostica Stago Staclot LA 20 tests, Catalog #0594, LA
Assay, Hexagonal Phase Phospholipid Neutralization Assay
Radiometer America safePICO Samplers, self-filling arterial
blood samplers
SA060182 Delphi IVantage Volumetric Ambulatory Infusion Pump/System
BD Unopette System Tests for Erythrocyte Fragility Test Kit,
catalog # 365830
Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry
SA060184 Systems, Automated Clinical Chemistry Analyzer - human
serum, plasma and urine tests
Pointe Scientific AutoHDL Cholesterol Reagent Sets, various
SA060185
models
Bayer Healthcare RapidLab 1200 Systems, models 1245 and
SA060186
1265 - blood gases, electrolyte and blood pH test systems
SA060183
Health Canada
32191
Ltd.
N/A
MHRA
2006/008/031/081/004
MHRA
2006/008/029/291/003
2356 7033
2006/09/04
Direct Health Ltd.
2528 1109
2006/09/05
2960 7117
2006/09/05
2807 8556
2006/09/05
N/A
N/A
2006/09/06
2803 0118
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1438-06 & Z-1439-06
Class II Recall
2006/09/06
Science International Corporation
2543 7442
FDA
Z-1441-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1443-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1445-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1446-06
Class II Recall
2006/09/06
2575 8668
FDA
Z-1448-06 to Z-1450-06
Class II Recall
2006/09/06
2814 4829
FDA
Z-1454-06 to Z-1459-06
Class II Recall
2006/09/06
2893 0694
FDA
Z-1464-06 & Z-1465-06
Class II Recall
2006/09/06
2814 4829
2006/006/014/601/150
2006/008/015/121/001
Codman CSF External Drainage System III, 82-1731(EDS III
SA060189 without ventricular Catheter), Lot Nos.: CGHBGF, CGGCT5,
CGGCT8, CGGCT9
MHRA
2006/008/021/081/006
Ltd.
N/A
MHRA
2006/008/010/401/007
MHRA
2006/008/024/081/004
SA060193 Sorin Group S5 Heart Lung Machine
MHRA
2006/008/003/401/007
SA060194 Intavent Orthofix Laryngeal mask airway
MHRA
2006/009/004/291/003
N/A
Z-1437-06
MHRA
Roche Diagnostics Elecsys Folate II assay on the Elecsys 2010
system
2645 8703
FDA
MHRA
SA060192
2738 6080
2006/009/004/291/014
Action
Action
Action
Recall
Action
Action
Action
Action
149
Remarks
2992 0968
MHRA
SA060188 Siemens Medical Solutions Siregraph CF
SA060191 Penlon Sigma Delta Sevoflurane Vaporizer
Recall
Action
Action
2724 2836
Action
SA060187 ELLA Esophageal Stent - Boubella-E, Boubella, Flexella
SA060190 Lumenis DuoTome SideLite 550 Micron Delivery System
Type II Recall
Agent Contact
Telephone No.
3 affected units were distributed in Hong Kong.
2006/09/06
N/A
N/A
2006/09/06
Siemens Ltd.
2870 7533
2 affected units in Hong Kong.
2006/09/07
Kong
2738 6080
2006/09/08
2960 7117
2006/09/08
N/A
N/A
2006/09/08
Limited
2485 7555
2006/09/08
N/A
N/A
2006/09/08
N/A
N/A
Respironics NICO model 7300 Cardiopulmonary Management
Celki Medical
System - serial numbers beginning with 138Company
Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H. K.
SA060196
lot/batch number 6040734
Ltd.
SA060197 Boston Scientific NAMIC Fluid Injection Line, batch/lot 2011867
Ltd.
Radiometer America D826 Accessory kit for single tcpO2
SA060198 Electrodes for use with the TCM400 Transcutaneous Monitor
FDA
(Cutaneous Oxygen Monitor) Part Number: 904-308
Zimmer VERSYS, MAYO and ZMR Hip Prosthesis Systems
SA060199
FDA
Femoral Stem and Body, various sizes
SA060195
N/A
N/A
N/A
Important Medical Device
Recall Notification
Recall
Recall
2006/09/09
2268 9258
2006/09/12
2960 7117
2006/09/12
2960 7117
N/A
N/A
Z-1436-06
Class II Recall
2006/09/13
Z-1467-06 to Z-1480-06
Class II Recall
2006/09/13
MHRA
2006/007/017/291/008
Action
2006/09/14
Health Canada
32208
Type I Recall
2006/09/18
Stryker Hong Kong
Health Canada
32272
Type I Recall
2006/09/18
Co. Ltd.
2666 1942
Health Canada
32198
Type II Recall
2006/09/18
2877 3077
Health Canada
32241
Type II Recall
2006/09/18
2807 8556
Health Canada
32257
Type II Recall
2006/09/18
N/A
N/A
SA060204 AGFA IMPAX 5.2 System, model or catalog # IMPAX MA3000
Health Canada
32134
Type II Recall
2006/09/18
Agfa Hong Kong Ltd.
2873 9336
GE OEC Medical Systems OEC Mini 6800 C-ARM, various lot
or serial numbers
Health Canada
32268
Type II Recall
2006/09/18
MHRA
MDA/2006/054
Immediate Action
2006/09/18
FDA
Z-1461-06 to Z-1463-06
Class II Recall
2006/09/20
2575 8668
FDA
Z-1487-06
Class II Recall
2006/09/20
2876 7525
FDA
Z-1496-06 & Z-1497-06
Class II Recall
2006/09/20
N/A
SA060200 AGA Medical Amplatzer VSD Occluder
SA060159
SA060160
SA060201
SA060202
SA060203
SA060205
Stryker Biotech Calstrux, model or catalog # 400-05CN, 40010CN and 400-15CN
Datex-Ohmeda Aisys Carestation, model or catalog # 10119000-000
Draeger Medical Infant Care Isolette C2000 Incubators, model
or catalog # C2HS
Baxter Healthcare Continu-Flo Sets With Check Valve, various
models or catalog numbers
AMG Medical IV Pole, model or catalog number 775-855P and
775-860
SA060161 Lifescan OneTouch Ultra 2 Blood Glucose Meters
BD Vacutainer Blood Collection Assembly with BD Blunt Plastic
Cannula, Vacutainer Luer Adapter and Direct Draw Adapters
Philips Medical Systems IntelliVue MultiMeasurement Server
SA060207 (MMS)/Multimeasurement Server, physiological patient
monitoring system. Model: M3001A
Skytron General Purpose Surgical Table, Models 6600 and
SA060208
6600B (battery model)
SA060206
branch)
Ltd.
Ltd.
Kong
SA060209 Greiner bio-one Vacuette Tube, Item # 454332, lot # B050609
FDA
Z-1498-06
Class II Recall
2006/09/20
Mekim Ltd.
SA060210 Xiros Plc Neoligaments 6mm and 8mm Staple Impactors
FDA
Z-1500-06 & Z-1501-06
Class II Recall
2006/09/20
N/A
2992 0968
9262 1527
2518 6915
2738 2818
MHRA
2006/009/019/181/008
2006/09/20
N/A
FDA
Z-1503-06
Class II Recall
2006/09/22
(1) Solar-Med Ltd; (2) Goodman
Medical Supplies Ltd.
Smith and Nephew Genesis II Non-porous fin Stem Tibial
SA060212 Punches, Codes 711440480, 71440482, 71440484 and
71440486
MHRA
2006/009/015/131/001
Action
2006/09/22
2645 8703
SA060213 Huntleigh birthing beds, Models 35000 and 170000
MHRA
2005/007/018/291/018
2006/09/22
N/A
N/A
SA060214 Hoskins Lifecare birthing beds- Models L05 an dL10
MHRA
2005/007/018/291/018
2006/09/22
N/A
N/A
SA060215 Smith and Nephew TC100 2.7mm Cortical Bone Screws
MHRA
2006/009/020/291/027
2006/09/22
2645 8703
MHRA
2006/009/022/291/010
2006/09/25
Kong
2738 2818
2006/09/26
2960 7117
2006/09/26
N/A
N/A
2783 1838
2575 8668
SA060218 Eschmann Equipment Ltd. Narrow Split Plate Connector
GE Precision 500D Radiographic and Fluoroscopic Imaging
SA060219
System, all serial numbers
BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 and
SA060220
240953
Ltd.
N/A
MHRA
2006/009/011/601/207
FDA
Z-1304-06
Class II Recall
2006/09/27
Ltd.
FDA
Z-1505-06
Class II Recall
2006/09/27
150
2774 8339
N/A
N/A
(1) 2425 0926; (2) 2332 15 affected units in Hong Kong. Rectification programme
4455
completed.
SA060211 Hill-Rom Affinity Three Birthing Bed, Model P3700
Biosense Webster Europe RefStart Catheter with QwikPatch
External Reference Patch
Boston Scientific Flexima all purpose drainage catheters, lot
SA060217
number 8955327
The local agent will inform all the future users about the
concerned issue.
N/A
SA060162 Ansell Ltd. Microtouch Ultra PF Examination gloves
SA060216
2783 1838
Action
Action
Action
Action
Action
Recall
Action
2 affected units in Hong Kong. Rectification programme has
been completed.
SA060221 Conmed System 2500 and 5000 Electrosurgical Units
FDA
Z-1507-06 & Z-1508-06
Class II Recall
2006/09/27
N/A
N/A
Invacare Solara 2G, Spree GT and Spree XT (SPRXT) manual
SA060222
wheelchairs
FDA
Z-1509-06 to Z-1511-06
Class II Recall
2006/09/27
Direct Health Ltd.
2528 1109
SA060223 Stryker Power-Pro Powered Ambulance Cot, Model 6500
FDA
Z-1513-06
Class II Recall
2006/09/27
Stryker Hong Kong
2518 6915
Z-1521-06
Class II Recall
2006/09/27
N/A
N/A
2006/09/27
2240 6260
2006/09/27
Ltd.
2783 1838
2006/09/27
2317 0988
2006/09/28
2960 7117
2006/09/28
2575 8668
2006/09/28
2806 4841
SA060224
SA060225
SA060226
SA060227
SA060228
SA060229
SA060230
SA060231
Kerr Optibond Solo Plus Self-Etch Adhesive System, Part
FDA
Number 31966
Beckman Coulter LH700 series Hematology Analyzers 2B3 2B4
MHRA
and 2B5 Software
GE Healthcare Technologies Gas absorbers Compact Absorber
MHRA
427002000
Smiths Medical Chest Drain - Portex Chest Drainage System
MHRA
with Adjustable Straw - 2000ml
Boston Scientific Vaxcel Implantable Chest Ports with PASV
Valve Technology, specific lots
Ltd.
BD Tube, 14mL 17x100mm PS W/SN CAP 25/PAC, lot #
Becton Dickinson
6152968 and BD Procount (IVD), lot # 340398
Asia Ltd.
Abbott Laboratories FSH calibrator and AsSY Master calibrator
MHRA
batches
Abbott Laboratories CELL-DYN Sapphire List Number 08H00MHRA
01
SA060163 Sunrise Medical Jay J2, Wheelchair back
CryoCath Arctic Circler Curvilinear Cardiac Cryoablation
SA060164 Catheters, catalog nos. 2AC20, 2AC22, 2AC24, 2AC26 and
2AC30
AMO COMPLETE Amino Moist Multi-Purpose Solution, 360mL
SA060165
x 2, lot numbers ZB02542, ZB02563, ZB02567 and ZB02575
Coloplast Drainage bag - 5062 - Conveen Urine Bag, 1500ml,
SA060232
90cm tube
MHRA
CryoCath
Technologies, Inc.
Advanced Medical
Optics, Inc.
2006/009/022/291/004
2006/009/005/601/267
2006/009/025/291/001
N/A
N/A
2006/009/027/601/314
2006/008/025/601/253
MDA/2006/056
N/A
N/A
MHRA
2006/009/019/181/006
SA060233 Micrus Endovascular Watusi Guide Wire System
MHRA
2006/009/019/181/004
Hill-Rom Dynamis LI140, I148, LI150; Gerialit LI114, LI1245,
SA060234
LI146, LI163
MHRA
2006/009/004/291/006
SA060235 Sendal S.A/Arcomedical Infusion Ltd, Volumed 310PK2J
MHRA
2006/009/025/401/010
LifeScan Inc.
N/A
LifeScan Inc. SureStep Pro (part #010-797, lot #2634187008)
SA060238 and OneTouch SureStep (part #020-052, lot #2627353) Blood
Glucose Test Strips
Action
Action
Action
Recall
Worldwide Medical
Device Recall
Action
Action
2006/09/28
2806 4841
Action
2006/09/28
N/A
N/A
Market Withdrawal
2006/09/28
Pacific Medical (HK) Ltd.
2343 8009
2006/09/28
AMO Asia Limited
2401 5861
2006/09/29
N/A
N/A
2006/09/29
N/A
N/A
2006/09/29
N/A
N/A
2006/09/29
N/A
N/A
2006/09/29
Kong
2735 8262
Voluntary Limited Market
Recall
Action
Action
Action
Action
Press Release
151
Superseded by MDA/2006/060.
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
SA060070 Biotronik - Stratos LV-T Pacemaker
MHRA
2006/007/027/291/016
2006/08/01
N/A
Action
Dade Behring N Rheumatology Standard SL for RF, N/T
SA060071
MHRA
2006/006/026/131/002
2006/08/01
Rheumatology Control SL/1 and SL/2 for RF on BN System
Action
Becton Dickinson Vacutainer Direct Draw adaptor product code
SA060072
MHRA
MDA/2006/043
Action
2006/08/02
364896 and Vacutainer Luer adaptor product code 367300
SA060073 AFOS Ltd. Endoscope storage facility (ESF)
SA060074
SA060075
SCC Soft Computer SoftPath ASXII Software Releases 2.3.0
and 4.3.7
SCC Soft Computer SoftPath ASCII Software, Releases 1.2,
2.1, and 2.3
Brainlab ExacTrac Robotics for installation on the Varian Exact
Couch, a component of the Novalis Shaped Beam Surgery
System
St. Francis Medical Technologies brand X STOP® Interspinous
Process Decompression (IPD) System
Radiometer America Waste tubing, Model # 842-326 (pump
tube for waste) and Model # 842-327 (pump tube for solution)
Agent Contact
Telephone No.
N/A
2803 0118
2575 8668
MHRA
MDA/2006/044
Action
2006/08/02
N/A
N/A
FDA
Z-1243-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1252-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1255-06
Class II Recall
2006/08/02
Brainlab Ltd. (Hong Kong)
2417 1881
FDA
Z-1258-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1260-06
Class II Recall
2006/08/02
N/A
N/A
SA060079 Radiometer America Dri-Tex BG-OX Cartridge, Model # D7120
FDA
Z-1261-06
Class II Recall
2006/08/02
N/A
N/A
Radiometer America Radiance Data Management System
SA060080 Software Version 2.42 (Stand-alone software package) for the
Radiance STAT Analyzer Management System
FDA
Z-1262-06
Class II Recall
2006/08/02
N/A
N/A
Z-1263-06 to Z-1265-06
Class II Recall
2006/08/02
N/A
N/A
Z-1266-06 & Z-1267-06
Class II Recall
2006/08/02
2866 0811
SA060076
SA060077
SA060078
SA060081 Microcuff Pediatric and Adult Endotracheal Tubes, various sizes
FDA
Terumo Advanced Perfusion System 4 inch diameter Roller
SA060082 Pump (model 801040) and 1 Large Roller Pump (model
FDA
801041)
Varian Medical Systems Gamma Win software, part number
SA060083
FDA
GM11019110, versions up to and including 1.62
Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
SA060084
FDA
various sizes
LifeCell Repliform Tissue Regeneration Matrix, catalog
SA060085
numbers 820241, 820245 and 820246
Ltd.
Z-1268-06 to Z-1270-06
Class II Recall
2006/08/02
Z-1271-06 to Z-1285-06
Class II Recall
2006/08/02
N/A
SA060086 Corin Ltd. Standard Neck Modular Head 28mm
MHRA
2006/007/031/601/190
the Binding Site, Freelite human kappa free kit & human
SA060087
lambda free kit assays used on Hitachi & BNII instruments
MHRA
2006/007/003/291/017
SA060088 Abbott Laboratories Cystic Fibrosis V3 Genotyping Assay
MHRA
2006/008/001/601/092
SA060089 Technovent Optical Conformer Impression Conformer
SA060090
SA060091
SA060092
SA060093
SA060094
SA060065
SA060066
Integra Neurosciences Ultrasonic surgical Aspirator System,
model or catalog # 1529161 and 1529165
Tomotherapy Incorporated HI-ART System, Lot or Serial #
10009, 10037 and 10014
Medrad Neurovascular Array Coils, model or catalog #
M64NVA
GE Healthcare Innova 2100IQ, lot or serial # 469545BU6 and
479238BU8
Sunrise Medical CCG Joerns Ultracare Model 770 AC Powered
beds, model or catalog # U770, U770-GNDAL and U770AL
BHM Medical Reacher for Transportable Ceiling Lift, Model or
Catalog # 700.08310 and 700.08320
Nellcor Puritan Bennett Satin-Slip Intubating Stylet, Model or
Catalog # 85863, Lots beginning with 05 and 06
2724 2836
2992 0968
2006/08/03
2960 7117
2006/08/03
N/A
N/A
2006/08/03
Bio-Gene Technology Ltd.
2646 6101
2006/08/03
2806 4841
MHRA
2006/007/031/081/009
2006/08/04
N/A
N/A
Health Canada
30936
Type II Recall
2006/08/07
N/A
N/A
Health Canada
31533
Type II Recall
2006/08/07
N/A
N/A
Health Canada
31863
Type II Recall
2006/08/07
Ultronics Enterprise Ltd.
2764 5208
2783 1838
N/A
The manufacturer informed all the affected users.
Health Canada
31920
Type II Recall
2006/08/07
Ltd.
Health Canada
31981
Type II Recall
2006/08/07
N/A
Health Canada
31344
Type I Recall
2006/08/07
N/A
N/A
Health Canada
31892
Type I Recall
2006/08/07
3157 7244
2006/08/07
Limited
2485 7555
2006/08/07
2317 0988
SA060095 Roche Diagnostics GGT/IFCC Granulate Reagent
MHRA
2006/007/013/291/005
SA060096 Smiths Medical International-Custom Epidural Pack
MHRA
2006/007/031/081/001
Recall
Action
Action
Action
Action
Inc.
branch)
Remarks
Action
Action
152
Action
Action
Action
SA060097 Smiths Medical Catheter, central venous
MHRA
2006/007/027/291/010
Baxter Healthcare Blood cell separator Amicus Apheresis Kit
SA060098
(Lot A06C21046, A06D10088, A06D10237, A06D25060)
MHRA
2006/007/013/291/004 03a
SA060099 Medtronic Midas Rex Classic GS and Legend dissecting tools
MHRA
2006/008/002/291/003
SA060100 Sedana Medical AnaConDa Anaesthetic conserving device
MHRA
MDA/2006/045
Action
FDA
Z-1305-06
FDA
Z-1315-06
SA060101
SA060102
SA060103
SA060104
SA060105
SA060106
Kensey Nash TriActiv ProGuard Embolic Protection System,
part number 61000-01
Applied Biotech Medplus ER Drug Screen Test, Model #
5800KAB
Radiometer Medical Aps Capilliary blood sample tube caps
contained in safe clinitube kits
CryoCath Arctic Circler curvilinear cardiac cryoablation
catheters, catalog no. 2AC30 and lot nos. 50103, 50312,
50327, 50418, 00035, 00169, 00486
Therakos Therakos UVARXTS small bowl procedural kit
(Catalog No. XT125). Lot nos. U706, U707, U708, U709, U710,
U711 U712
DeSoutter Medical, Sagittal Blade-Opposed Tooth
SA060107 Days Healthcare Strider Maxi 3, Maxi 4 & Maxi 4 Plus
Coloplast A/S, Simpla Al Silicone Indwelling Catheters Code:
SA060108
367516 Male Ch16 Lot 696770
SA060109 Respironics Esprit Ventilator Power Supply
SA060110
SA060111
SA060112
SA060113
Gambro Renal Prismaflex Continuous Renal Relacement
System, Model 6023014700
Boston Scientific vanSonnenberg Sump Catheter, lot/batch
number 8606405
Richard Wolf Single Use Tem Tubing Sets, Type 4170.801 Batch 060232
Abbott brand FreeStyle and FreeStyle Flash Blood Glucose
Meters
SA060114 MediSurg Fugo Blade Incising Tip Assembly
SA060115
SA060116
SA060117
SA060118
SA060119
Tekia TEKLENS II (TEKIA label) and Polylens A60 (Polytech
label) Model 614 intraocular lens
ArthroCare OPUS Speedstitch Suture Cartridge with
Magnumwire, Catalog number OM-6006
Radiometer America Blood Gas and Co-Ox Electrolyte &
Metabolyte Analyzer, ABL-700 and ABL-800 Series
Radiometer America Capillary (end) caps, accessory for use
with blood gas analyzers included in Radiometer's CLINITUBES
kits, Model # 904-439 and 904-453
Pointe Scientific Liquid Glucose HEX(R1), HEX(R2), HEX and
HEXO Reagents and Reagent Sets
SA060120 Zimmer sterile bone screws, various models and sizes
SA060121 Edwards Lifesciences Aquarius Heamofiltration machine
SA060122 Medicina Infant Feeding Tubes
SA060067
Roche Diagnostics Accu-chek Advantage for Accudata GTS,
Accu-Soft & Accu-Chek Advantage Blood Glucose Meters
SA060068 Gambro Prismaflex Continuous Renal Replacement System
Bio-Rad Laboratories Genetic System HIV-2 EIA, Model or
Catalog # 32536, lot or serial # 032AY1 & 139AY1
Beckman Coulter FP1000 Cell Preparation System, model or
SA060124
catalog # 624922
SA060123
2006/08/07
2317 0988
2006/08/07
2807 8556
2006/08/09
2919 1362
2006/08/09
N/A
N/A
Class II Recall
2006/08/09
N/A
N/A
Class II Recall
2006/08/09
N/A
N/A
2006/08/09
N/A
N/A
2006/08/10
Pacific Medical (HK) Co. Ltd.
2755 6948
2006/08/10
N/A
N/A
2006/08/10
N/A
N/A
2006/08/11
N/A
N/A
2006/007/010/291/001
Action
CryoCath
Technologies Ltd.
N/A
Action
MHRA
2006/008/002/601/194
MHRA
2006/008/004/081/002
MHRA
2006/003/001/261/001
MHRA
MHRA
2006/007/012/291/005
Celki Medical
Company
N/A
MHRA
2006/007/031/081/014
Ltd.
N/A
Action
Action
Action
Action
Urgent Field Action
Notification
Action
Recall
Action
2006/08/11
N/A
N/A
2006/08/14
2268 9228
2006/08/14
Gambro China Ltd.
2576 2688
2006/08/16
2960 7117
MHRA
2006/008/015/081/011
2006/08/16
N/A
N/A
FDA
Z-1306-06 & Z-1307-06
Class II Recall
2006/08/16
2806 4210
FDA
Z-1224-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1311-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1312-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1317-06 & Z-1318-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1321-06 & Z-1322-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1326-06 to Z-1333-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1335-06 to Z-1351-06
Class II Recall
2006/08/16
branch)
2992 0968
2006/08/17
N/A
N/A
MHRA
2005/005/006/401/010
MHRA
2006/007/010/291/007
Health Canada
31495
Action
Action
Type I Recall
2006/08/18
N/A
N/A
2006/08/21
Limited
2485 7510
Health Canada
31616
Type I Recall
2006/08/21
Gambro China Ltd.
2576 2688
Health Canada
32029
Type I Recall
2006/08/21
2789 3300
Health Canada
31805
Type II Recall
2006/08/21
2240 6260
153
For further details, please see the website notice:
http://www.mdco.gov.hk/english/recalls/recalls_20060828.htm
l
SA060125
Baxter Healthcare Arena SPP and SPX Hemodialysis Delivery
Systems, Hemodialysis Machine 1550, Machine 1550 Single
Needle Hemodialysis and System 1000 Dialysate Delivery
System, all serial numbers
Health Canada
32017
Type II Recall
2006/08/21
2807 8556
SA060126 Osmetech OPTI CCA Blood Gas & Electrolyte Analyz
Health Canada
32028
Type II Recall
2006/08/21
N/A
N/A
SA060127 Smiths Medical Hotline L-10 Gas Vent
Health Canada
32033
Type II Recall
2006/08/21
2317 0988
Health Canada
31890
Type II Recall
2006/08/21
2645 8703
Health Canada
32037
Type II Recall
2006/08/21
N/A
N/A
Health Canada
32040
Type II Recall
2006/08/21
Siemens Ltd.
2870 7533
Health Canada
32043
Type II Recall
2006/08/21
Siemens Ltd.
2870 7533
Health Canada
32048
Type II Recall
2006/08/21
N/A
N/A
SA060128
SA060129
SA060130
SA060131
SA060132
Smith & Nephew Electroblade Resector 4.5, 4.5 Elite/FR and
Trivex Resector Kit
Edwards Lifesciences Vascushunt Silicone Balloon Shunt,
model or catalog # T3103AS, lot or serial # 58220388
Siemens Arcadis Orbic and Arcadis Varic, model or catalog #
8081080 and 8080017
Siemens Lithoskop, model or catalog # 8355088, lot or serial #
1019
Nomos (North American Scientific) Corvus Planning System
6.0/6.1
Fujinon Mobile Endoscopy Cart, lot or serial # 125769, 125770,
125774, 125767 and 125772
Health Canada
31389
Type II Recall
2006/08/21
Goodman Medical Supplies Ltd.
2332 4455
SA060134 Maquet Critical Care HL30 Perfusion System
Health Canada
31875
Type II Recall
2006/08/21
2393 9511
SA060135 Gambro Prismaflex Modele 6023014700, all serial numbers
Health Canada
32059
Type II Recall
2006/08/21
Gambro China Ltd.
2576 2688
Health Canada
32092
Type II Recall
2006/08/21
Siemens Ltd.
2870 7533
2006/08/21
2240 6260
2006/08/21
2814 4829
SA060133
Siemens Medical Solutions Oncology Care Systems ZXT
SA060136
Treatment Table, model or catalog # 9820952 and 05844621
Beckman Coulter Unicel DxI 800 Access Immunoassay System
SA060137
Wash Buffer
SA060138 Bayer Healthcare ADVIA Centaur CP Immunoassay Analyser
Cordis Neurovascular Pre-shaped Prowler and pre-shaped
SA060139
PROWLER SELECT infusion catheters
Roche Diagnostics Accu-chek Comfort Curve, Advantage,
SA060140
Sensor Comfort and Inform Blood Glucose Meter Test Strips
Orthopaedic implants manufactured by Proconcept SA France:
CIFEC cervical cages; LIFEC lumbar cagesl ALIFEC lumbar
SA060141
cages; SRE/SEO spinal screw systems; CANALETTO carpal
tunnel protection implants
SA060142 Maquet Critical Care AB Heart Lung Machines HL20 and HL30
SA060143
SA060144
SA060145
SA060146
SA060147
SA060148
SA060149
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit,
Catalog No. 1931601
Radiometer America Blood Gas and Co-Ox2 Electrolyte &
Metabolyte Analyzers, ABL-700 and ABL-800 Series
Pointe Scientific Alkaline Phosphatase reagents, buffers and
substrates, various models
Varian Medical Systems GammaMed software programs for the
GammaMed models 12i and 12it radionuclide applicator
systems
Siemens LANTIS XLINK (Impac MultiAccess Sequencer) on
Varian accelerators with the MLC3PI interface
Baxter Intermate and Infusor Large volume (LV) infusion pumps
- all models
Cardinal Health Alaris SE Pump (formerly Signature Edition
Infusion Pump), all models
SA060150 Chiltern Invadex ceiling track patient hoists with turntables
SA060151 B Braun Aesculap NC 464T and NC468T Acetabular cups
INO Therapeutics (Datex Ohmeda) INOvent Nitric Oxide
Delivery System, Model Number 1605-9000-000
Zimmer Trabecular Metal Reverse Shoulder System
SA060153
Glenosphere and Base Plate
BioCare Systems LumiWave 1X4 Infrared Therapy Device,
SA060154
Catalog # LW1X4
SA060152
MHRA
2006/008/016/081/005
MHRA
2006/008/015/121/002
Action
Action
Action
MHRA
2006/008/016/081/012
FDA
Z-1377-06 to Z-1384-06
Class II Recall
2006/08/22
MHRA
MDA/2006/046
Immediate Action
2006/08/22
N/A
N/A
MHRA
2006/008/022/081/011
Action
2006/08/23
2393 9511
FDA
Z-1385-06
Class II Recall
2006/08/23
Limited
2485 7555
FDA
Z-1386-06 & Z-1387-06
Class II Recall
2006/08/23
N/A
N/A
FDA
Z-1388-06 to Z-1397-06
Class II Recall
2006/08/23
2893 0694
FDA
Z-1398-06 & Z-1399-06
Class II Recall
2006/08/23
Inc.
2724 2836
FDA
Z-1401-06
Class II Recall
2006/08/23
Siemens Ltd.
2870 7533
MHRA
MDA/2006/048
Action
2006/08/24
2807 8556
FDA
N/A
Press Release
2006/08/28
The Vita Company Ltd.
2548 7483
MHRA
MDA/2006/050
Action
2006/08/29
N/A
N/A
MHRA
2006/008/021/291/006
Action
2006/08/30
2277 6125
FDA
Z-1410-06
Class II Recall
2006/08/30
FDA
Z-1416-06 to Z-1418-06
Class II Recall
2006/08/30
FDA
Z-1419-06
Class II Recall
2006/08/30
154
2006/08/21
Kong
Limited
Co. Ltd.
branch)
N/A
2738 2818
2485 7510
2666 1942
2992 0968
N/A
A & E Industries Guardian Walker and Guardian 5 inch Walker
Wheel Kits, various models
Cobe Optima XP Hollow Fiber, CML Duo Flat Sheet and
SA060156 Optimin Hollow Fiber Sealed System Membrane
Oxygenators/Reservoirs, various models
MicroVision Medical MicroScan Lens Disposable Plastic Cap
SA060157
used with MicroScan Video Microscope
SA060155
SA060069 Medtronic LIFEPAK 20 Defibrillator/Monitors
SA060158 Abbott Laboratories Xsystems CA 15-3 controls
FDA
Z-1420-06 & Z-1421-06
Class II Recall
2006/08/30
N/A
N/A
FDA
Z-1422-06 to Z-1429-06
Class II Recall
2006/08/30
N/A
N/A
FDA
Z-1435-06
Class II Recall
2006/08/30
N/A
N/A
Medtronic
International, Ltd.
N/A
2006/08/31
2919 1362
5 affected units in Hong Kong. Rectification completed.
MHRA
2006/008/023/291/007
2006/08/31
2806 4841
Correction
Action
155
MDCO Ref.
Source of
Local Agent
(YYYY/MM/DD)
No.
Information*
Boston Scientific
SA060001 Boston Scientific Expo and Impulse Angiographic Catheter
N/A
2006/07/03
Boston Scientific Hong Kong Ltd.
Hong Kong Ltd.
Recall
SA060002 Adept-Med brand Glassman Viscera Retainer FISH
Suros Surgical ATEC Breast Biopsy and Excision System
Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09
Biomerieux OBSERVA R02 (version R02.00.17) computers
SA060004 using PSC 6000 or HHP Barcode Scanners connected to
BacT/ALERT 3D
SA060003
SA060005 Leica M520 Surgical Microscope
B. Braun 9F (O/S) Locking Tearway Introducers, non-sterile,
Catalog number 614008
St. Jude Medical CPS Slitter, Valve Bypass Tool (VBT), Direct
SA060007
SL, Aim and Implant Kit, various models
Roche Calcium Reagent Kit for use on the Cobas MIRA
SA060008
Chemistry System
SA060006
SA060009 Welch Allyn PIC 50 external defibrillator/monitor
SA060010 Boston Scientific Urovac bladder evacuator
SA060011
Boston Scientific Carotid WALLSTENT endoprothesis with
Monorail delivery system
SA060012 Cook Malleable Tip Filiform, model or catalog # 110245
Cook Duette Multi Band Mucosectomy Kit, model or catalog #
DT-6
Beckman Coulter UniCel DxC 600, 600i and 800 Synchron
SA060014 Clinical Systems, model or catalog # A20463, A27331 and
A29764
Coopersurgical 60cc Handy-Vak Locking Syringe, model or
SA060015
catalog # MX 500
Bio-Rad Laboratories Diagnostics Group Liquichek Pediatric
SA060016
Control, model or catalog # 353X, 354 and 355
SA060013
SA060017 Plus Orthopedics Femoral Clamp TKR (slim)
SA060018
SA060019
SA060020
SA060021
SA060022
SA060023
SA060024
SA060025
Gyrus ACMI PKS PlasmaSEAL Open Forceps, model 2103PK
and 917015PK
MDS Nordion Theratron 780C, 780E, 1000, 1000E, Phoenix,
Elite 80 and Elite 100 Cobalt Radiotherapies
Terang Nusa Sterile Triumph LT Latex Powder-Free Surgeons
Gloves, lot number T502504322
ArthroCare OPUS Smartstitch Suture Cartridge (catalog
number OM-8071) and Smartstitch Magnum Wire Suture
Cartridge (catalog number OM-8075)
Sorenson Medical ambIT Ambulatory Infusion Therapy
Intermittent Pump, catalog number 220245
Southmedic Vapofils with Stainless Steel Block Ends, Item
Numbers V0507F (Isoflurane) and V0507S (Sevofluane)
Respironics NeoPAP Neonatal CPAP/Humidification System
(Ventilator, Continuous), model number 1025310
Spacelabs Medical 1400 MHz Telemetry System,. Model
91341-09
SA060026 Siemens 3D-I/III Ceiling Stand, Diagnostic x-ray tube mount
SA060027
Cardinal Health Extension Set Model G304020M and
G400200B
SA060028 Hand pendants of Varian C-Series Clinac linear accelerators
Agent Contact
Telephone No.
2960 7117
Remarks
FDA
Z-1156-06
Class II Recall
2006/07/05
Solar Medical Ltd.
2425 0926
FDA
Z-1160-06
Class II Recall
2006/07/05
N/A
N/A
FDA
Z-1161-06
Class II Recall
2006/07/05
2356 7033
FDA
Z-1162-06
Class II Recall
2006/07/05
Leica Microsystems Ltd. (Hong
Kong)
2564 6699
FDA
Z-1163-06
Class II Recall
2006/07/05
2277 6125
FDA
Z-1164-06 to Z-1168-06
Class II Recall
2006/07/05
St. Jude Medical (Hong Kong) Ltd.
2996 7601
FDA
Z-1176-06
Class II Recall
2006/07/05
Limited
2485 7555
FDA
Z-1195-06
Class I Recall
2006/07/07
N/A
N/A
2006/07/07
2960 7117
2006/07/08
2960 7117
Boston Scientific
Hong Kong Ltd.
Boston Scientific
Hong Kong Ltd.
N/A
N/A
Recall
Recall
(1) 2781 0232; (2) 2541
1041
Ltd.
(1) 2781 0232; (2) 2541
1041
Ltd.
Health Canada
31746
Type II Recall
2006/07/10
Health Canada
31750
Type II Recall
2006/07/10
Health Canada
31742
Type II Recall
2006/07/10
2240 6260
Health Canada
30621
Type II Recall
2006/07/10
N/A
N/A
Health Canada
31622
Type II Recall
2006/07/10
2789 3300
MHRA
2006/006/022/291/010
Action
2006/07/10
N/A
N/A
FDA
Z-1175-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1178-06 to Z-1184-06
Class II Recall
2006/07/12
MDS Nordion (Hong Kong)
2827 8666
FDA
Z-1185-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1186-06 & Z-1187-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1188-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1189-06 & Z-1190-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1191-06
Class II Recall
2006/07/12
2268 9228
FDA
Z-1202-06
Class II Recall
2006/07/12
Suburfarm Investment & Trading
Co. Ltd.
2780 9421
FDA
Z-1205-06
Class II Recall
2006/07/12
Siemens Medical Solutions Ltd.
2870 7533
MHRA
2006/007/010/291/024
Action
2006/07/12
N/A
N/A
FDA
Z-1206-06
Class II Recall
2006/07/12
Inc.
2724 2836
156
35 units of the affected models previously supplied in Hong
Kong.
The local agent has informed all affected users. No product
recall was necessary.
SA060029
Disetronic D-TRONplus power packs used in D-TRONplus
insulin pumps
SA060030 Rocket Sekdubger Chest Drainage Set
FDA
MHRA
N/A
2006/007/003/291/024
Firm Press Release
Action
Recall
Action
Action
Action
Action
2006/07/13
Limited
2485 7597
2006/07/13
N/A
N/A
2006/07/14
2960 7117
2006/07/14
N/A
N/A
2006/07/14
N/A
N/A
2006/07/14
N/A
N/A
Boston Scientific
Hong Kong Ltd.
N/A
SA060032 Bio Stat Gentamicin Calibrator
MHRA
2006/006/016/401/017
SA060033 Joint Replacement Instrumentation Ltd. Brill Bit
MHRA
2006/007/003/291/014
MHRA
2006/007/013/081/004
MHRA
2006/007/013/291/004
2006/07/17
2807 8556
FDA
Z-1196-06
Class II Recall
2006/07/19
Ltd.
2783 1838
FDA
Z-1207-06 to Z-1211-06
Class II Recall
2006/07/19
N/A
N/A
FDA
Z-1212-06
Class II Recall
2006/07/19
N/A
N/A
FDA
Z-1219-06 to Z-1221-06
Class II Recall
2006/07/19
N/A
N/A
FDA
Z-1222-06
Class II Recall
2006/07/19
N/A
N/A
Class II Recall
2006/07/19
N/A
N/A
2006/07/19
N/A
N/A
SA060031 EMS Swiss LithoClast Ultra ultrasound handpiece kit
SA060034
Wako Chemical Lp(a) Calibrator (Code No. 417-41491) Lot
52F5
SA060035 Baxter Healthcare Blood cell separator Amicus Apheresis Kit
SA060036
SA060037
SA060038
SA060039
SA060040
SA060041
GE Healthcare S/5 Anesthesia Delivery Unit Fresh Gas Control
(A-FGC1) Unit
Sammons Preston Rolyan ValueLine and Midland Mat
Platforms, various models
Vanguard Medical Concepts Reprocessed Ethicon Bladeless
Trocars, model 35NLT, 35NST, 35OL
Kensey Nash TriActiv System Procedure Kit and Balloon
Inflation Syringe
International Biophysics Corporation (IBC) Suction Handle
(Sterile), part # 1990S
International Biophysics Corporation (IBC) FloProbe (Nonsterile), part # 3080N
SA060042 Bard 8F Bard Channel Steerable Shealth
SA060043 Medtronic Model 7428 Kinetra Implantable Neurostimulator
Medtronic Model 8731 intrathecal catheters and model 8598
intrathecal catheter distal revision kits
Cardinal Health (formerly known as ALARIS) IVAC P4000
SA060045
Syringe pump
SA060044
FDA
Z-1223-06
MHRA
2006/007/017/601/173
Medtronic
International, Ltd.
N/A
FDA
N/A
Action
Voluntary Field
Corrective Action
Urgent: Worldwide
Medical Device Recall
2006/07/19
2919 1355
2006/07/21
2919 1362
31 affected units in Hong Kong. Rectification completed.
MHRA
MDA/2006/042
Action
2006/07/24
N/A
N/A
SA060046 CIBA Vision Clerz 15ml, lot or serial # 48329
Health Canada
28894
Type II Recall
2006/07/24
Novartis Pharmaceuticals (HK) Ltd.
2881 4235
SA060047 Oxoid Imipenem 10ug Discs
Health Canada
31477
Type II Recall
2006/07/24
South East Chemicals &
Instruments Ltd.
2802 6333
106 units distributed in Hong Kong.
Health Canada
31861
Type II Recall
2006/07/24
2866 0811
Health Canada
Terumo Cardiovascular Systems Advanced Perfusion System
1-Centrifugal and 1-Roller Pump
Bellco Formula, Formula 2000, Formula 2000 Domus, Formula
SA060049
2000 Plus and Formula 2000 Plus Domus Hemodialysis
SA060048
31353
Type II Recall
2006/07/24
N/A
N/A
Boston Scientific
Hong Kong Ltd.
N/A
Recall
2006/07/25
2960 7117
Teleflex Medical Green Spec Fiberoptic Laryngoscope Handle SA060051
- Stubby/Short, catalog number 004413300
FDA
Z-1225-06
Class II Recall
2006/07/26
N/A
N/A
SA060052 Smith & Nephew TriVex Resector Kits, various models
FDA
Z-1226-06 to Z-1229-06
Class II Recall
2006/07/26
2645 8703
SA060053 Smith & Nephew Dyonics Electroblade 4.5, various models
FDA
Z-1230-06 to Z-1233-06
Class II Recall
2006/07/26
2645 8703
SA060054 3M Nexcare First Aid High Performance Gauze Pad
FDA
Z-1234-06
Class II Recall
2006/07/26
3M Hong Kong Ltd.
2806 6314
SA060055 Gore Tag Thoracic Endoprosthesis Systems
FDA
Z-1236-06 & Z-1237-06
Class II Recall
2006/07/26
W.L. Gore & Associates (Hong
Kong) Limited
2622 9622
Aksys PHD Personal Hemodialysis System for daily home
SA060056
hemodialysis, Model 1M101
FDA
Z-1239-06
Class II Recall
2006/07/26
N/A
N/A
SA060057 Cordis INFINITI 6 French Diagnostic Catheter
FDA
Z-1240-06
Class II Recall
2006/07/26
Johnson & Johnson (Medical)
Hong Kong Ltd.
2738 6080
Class II Recall
2006/07/26
Instrumentation Laboratory Ltd.
2792 7773
2006/07/26
2806 4201
2006/07/26
Olympus Hong Kong Ltd.
2376 1805
2
SA060050 Boston Scientific Cutting Balloon Ultra Monorail Device
Instrumentation Laboratory HemosIL and Hemoliance
RecombiPlasTin, Prothrombin Time Test
Abbott Laboratories Murex HTLV I + II, List Number: 8E22-02,
SA060059
Lot Number: J156610 and J156710
Olympus Life and Material Science Europa GmbH SA060060
Immunoglobulin M, OSR6146
SA060058
FDA
Z-1246-06 & Z-1247-06
MHRA
2006/006/029/291/002
MHRA
2006/005/015/291/003
Action
Action
157
Cordis SV-5 and SV-8 Peripheral Steerable Guidewires Catalog
503-558, 503-558X, 503-658, 503-658X (41 specific lots only)
Baxa Ltd. Reusable enteral feeding dispenser 50ml for
SA060062
attachement to female oral ports
Potasium electrode for Roche Hitachi 917 Modular Analytics,
SA060063
Lot number L33 and L99 and all M lots
Beckman Coulter Cytomics FC 500 Flow Cytometers System
SA060064
with CXP Software versions: 2.0 and 2.1
SA060061
MHRA
2006/007/026/081/004
MHRA
2006/007/025/291/014
MHRA
2006/007/021/081/003
MHRA
2006/007/028/291/004
Action
Action
Action
Action
158
Kong
2738 6080
2006/07/27
N/A
N/A
2006/07/31
Limited
2485 7597
2006/07/31
2240 6260
2006/07/27

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