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

Transcription

Major Safety Alerts in December 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 December 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
Local Agent
Agent
Contact
Telephone
2009/12/02
BD
2575 8668
2009/12/03
Philips Electronic Hong Kong Ltd
2821 5364
Class II
2009/12/04
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
Class II
2009/12/04
N.A.
N.A.
2810 7533
Source of
Information*
Reference No. by
Source
BD
N.A.
Firm Initiated
Field Action
Philips
N.A.
Firm Initiated
Field Action
Bausch & Lomb ReNu Multi-Purpose Solution (Lot# GA8028)
FDA
Z-0159-2010
ConMed Electrosurgery
FDA
Z-0165-2010
Description of Product
BD CD45 APC-H7, Cat. No 641408
Philips SureSigns Patient Monitors, Vital Signs Monitors and Vital Signs Viewe
Alert Type by Date of Issue
Source
(YYYY/MM/DD)
Siemens Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM
FDA
Z-0174-2010
Class II
2009/12/04
Siemens Healthcare Diagnostic
Limited
Baxter System 1000 family of Hemodialysis Instruments with 4.B.09, 4.B.1.1 an
FDA
Z-0179-2010
Class II
2009/12/04
Baxter Healthcare Ltd
2807 8516
Boston Scientific Guidant LATITUDE communicator (Model: 6481)
FDA
Z-0180-2010
Class II
2009/12/04
Boston Scientific Hong Kong Ltd
2960 7136
Stryker 2.1mm Cross-Cut Fissure Bur (Ref: 2296-101-621)
FDA
Z-0263-2010
Class II
2009/12/04
Stryker China Ltd
2518 6915
Cyberonics VNS Therapy Demipulse and Demipulse Duo (Models 103 and 104
MHRA
2009/011/025/291/008
FSCA
2009/12/04
N.A.
N.A.
Corin Uniglide unicondylar knee, femoral component (Part no. 514-0400, Lot no
MHRA
2009/011/030/081/004
FSCA
2009/12/04
N.A.
N.A.
Trinity Biotech Trinicheck Control Level 3 (Product code: T4103)
MHRA
2009/011/030/081/007
FSCA
2009/12/04
N.A.
N.A.
ThermoFisher Scientific Oxoid Ready Poured Plate, F.A.A. + Nalidixic acid + Tw
MHRA
2009/011/027/601/001
FSCA
2009/12/04
N.A.
N.A.
Fresenius Kabi Agilia Volumat Administration Sets VLON90
MHRA
2009/011/025/291/010
FSCA
2009/12/04
Fresenius Kabi Hong Kong Ltd.
2116 2683
2996 7688
St Jude Medical Epicor Ultrawand LP
MHRA
2009/011/012/081/010
FSCA
2009/12/04
St. Jude Medical (Hong Kong)
Ltd.
Nipro Europe Pureflux Dialyser (PF-210L)
MHRA
2009/005/007/061/011
FSCA
2009/12/04
N.A.
N.A.
WFR-Aquaplast/Q-Fix Systems kVue Couchtop
MHRA
2009/010/030/401/006
FSCA
2009/12/04
N.A.
N.A.
FDA
N.A.
Safety Notice
2009/12/07
Swedish Trading Co. Ltd.
2953 5192
MHRA
2009/012/002/081/007
FSCA
2009/12/08
Medtronic International Ltd.
2919 1362
2783 1838
STERIS System Processor (SS1)
Medtronic Legend AF01 Footed Attachment
GE Medical Systems Dynamic MRI imaging using CADstream with "pure" softw Health Canada
50777
Type II
2009/12/08
GE Medical Systems Hong Kong
Ltd.
Getinge Steam Sterilizer 422HC, 433HC, 522HC, 533HC, 633HC, 733HC, 833
Health Canada
50976
Type II
2009/12/08
N.A.
N.A.
Elekta Instruments Leksell gamma Knife Perfexion 715000
Health Canada
51437
Type II
2009/12/08
Elekta Limited, HK
2891 2208
Derma Sciences Dupaque X-Ray Detectable Sponges
Health Canada
51464
Type II
2009/12/08
N.A.
N.A.
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
51706
Type I
2009/12/08
Uninet Technology LTD
2838 8423
ConMed Linvatec Advantage, 2-Button Turbo Handpiece D9924
Health Canada
51507
Type II
2009/12/08
Anaheim Medical Products
N.A.
Elekta Instruments Leksell gamma Knife Perfexion 715000
Health Canada
51522
Type II
2009/12/08
Elekta Limited, HK
2891 2208
Stryker Endoscopy SDC HD Capture Recorder / SDC HD Capture Device
240-050-888 / 240-050-890
Health Canada
51583
Type II
2009/12/08
Stryker China Ltd
2518 6915
Zimmer Dental Advent 4.5mmd Platform Tapered Abutment AVACT
Health Canada
51588
Type II
2009/12/08
mmer PTE Ltd. (Hong Kong branc
2992 0968
Sysmex Reagents RET-Search II RED-700A
Health Canada
51623
Type II
2009/12/08
N.A.
N.A.
Baxter Healthcare Buretrol IV Solution Adm. Sets Clearlink 2C8864
Health Canada
51663
Type II
2009/12/08
2807 8516
Stryker Communications Vertical Surgical Table 0788-100-000, 0788-100-001,
Health Canada
51664
Type II
2009/12/08
Stryker China Ltd
2518 6915
Smith & Nephew BHR Streamline Cup Introducers 90128285
Health Canada
51665
Type II
2009/12/08
Smiths & Nephew Ltd
9651 5523
Medxl Intravenous Infusion Accessory IVMED20 / IVMED60
Health Canada
51696
Type II
2009/12/08
N.A.
N.A.
Nonin Medical Model 7600 - Oximeter Pod
Health Canada
51731
Type II
2009/12/08
Celki Medical Company
2332 3366
Stryker Instrumentsb CBC II Blood Conservation Kit 225-414-000
Health Canada
51764
Type II
2009/12/08
Stryker China Ltd
2518 6915
2783 1838
51766
Type II
2009/12/08
Ltd.
N.A.
Firm Initiated
Field Action
2009/12/08
2960 7136
BD
N.A.
Firm Initiated
Field Action
2009/12/08
BD
2575 8668
Celki Medical
Company
N.A.
Firm Initiated
Field Action
2009/12/08
2268 9201
Tepnel Diagnostics Elucigene CF30 (Lot: CF030B19838)
MHRA
2009/008/014/601/001
FSCA
2009/12/09
N.A.
N.A.
Immucor Anti-Co(b) (Item number 0008307, Lot number 6081004300)
MHRA
2009/012/001/081/003
FSCA
2009/12/10
2838 8423
2738 6027
GE Healthcare Signa HDE 1.5T MRI System - Magnet M3335SE
Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs
BD BD Sterile BBL Trypticase Soy Agar with Lecithin and Polysorbate 80,
299896, 221961 & 292480
SeQual Eclipse Oxygen System Model 1000 (Distributed bet Jun06 & Jan 08)
Health Canada
Boston Scientific
Biosense Webster (a JNJ company) Carto 3 System
MHRA
2009/011/030/081/018
FSCA
2009/12/10
Johnson & Johnson Medical
(HK)
Quotient Diagnostics Quo-Test A1c reagents, catalogue reference 0031, lot 01
MHRA
2009/011/030/081/026
FSCA
2009/12/10
N.A.
N.A.
FDA
Z-0286-2010 to Z0287-2010
Class II
2009/12/11
2821 5480
Stryker Taper V40 Femoral Head (Cat. no. 6260-5-326) & LFIT V40 Femoral H
FDA
Z-0390-2010 to Z0391-2010
Class II
2009/12/11
Stryker China Ltd
2518 6915
Merit Medical Systems Convenience Trays
FDA
Z-0413-2010
Class II
2009/12/11
King Health Limited
2481 3787
Stryker Thor Anterior Plating System Non Sterile Thor Standard Screws
FDA
Z-0423-2010 to Z0454-2010
Class II
2009/12/11
Stryker China Ltd
2518 6915
Cargille Laboratories Modified Kingsbury-Clark Albumin Standards (Catalog nu
FDA
Z-0479-2010
Class II
2009/12/11
N.A.
N.A.
2009/12/11
(HK)
2738 6027
Philips Respiratory Gating System (Catalog #NPTA540)
Animas (JNJ) ezManager Max Diabetes Management System version 2.0.9.
FDA
Z-0481-2010
Class II
Altomed Aspiration Handpieces Style Curved: Style 45, Style 60 And Style 90 T
MHRA
2009/012/003/081/005
FSCA
2009/12/11
N.A.
N.A.
MHRA
2009/012/003/081/004
FSCA
2009/12/11
Olympus Hong Kong and China
Ltd
2170 5678
Varian Medical
Systems Pacific
Inc
CP-01117
Firm Initiated
Field Action
2009/12/11
Varian Medical Systems Pacific
Inc.
2722 8122
B&H Surgical Instrument Makers Single use bayonet bipolar/monopolar forceps
MHRA
2009/012/002/081/002
FSCA
2009/12/15
N.A.
N.A.
NeoVista Vidion Reusable Delivery Module (Cat. No. ASY-1419-EN)
MHRA
2009/012/003/081/003
FSCA
2009/12/16
N.A.
N.A.
Aesculap AG & Co. KG (a divison of B. Braun) Orthopilot Active Transmitter Hi
MHRA
2009/011/030/081/022
FSCA
2009/12/16
B. Braun Medical (Hong Kong)
Ltd.
2529 2009
Biomet Vanguard lock-on femoral impactor (32-486206)
MHRA
2009/012/007/601/001
FSCA
2009/12/18
N.A.
N.A.
Trinity Biotech Trinicheck Control Level 1; Trinicheck Control Level 2 (T4101 an
MHRA
2009/012/009/081/008
FSCA
2009/12/18
N.A.
N.A.
Gebrüder Martin Genos MC/MT MINI Internal Distractor
MHRA
2009/012/010/081/003
FSCA
2009/12/18
N.A.
N.A.
Bakare Kleerside Adjustable Nursing Bed
MHRA
2009/010/021/081/006
FSCA
2009/12/18
N.A.
N.A.
BD Difco Decarboxylase Base Moeller 289020
BD
N.A.
Firm Initiated
Field Action
2009/12/21
BD
2575 8668
Coloplast Titan OTR Inflatable Penile Prosthesis, 18cm scrotal Bioflex cylinder
FDA
Z-0171-2010
Class II
2009/12/21
Coloplast (HK) LTD
3628 7427
Alphatec Spine NOVEL SPINAL SPACER SYSTEM
FDA
Z-0190-2010
Class II
2009/12/21
Milverton Ltd.
2367 8123
Organogenesis Apligraf (draftskin) packaging
FDA
Z-0181-2010
Class II
2009/12/21
N.A.
N.A.
Zimmer Gender Solutions Natural-Knee Flex System
FDA
Z-0199-2010 to Z0258-2010
Class II
2009/12/21
2992 0968
Philips GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL (Ca
FDA
Z-0260-2010 to Z0261-2010
Class II
2009/12/21
2821 5480
Synthes Norian CRS Rotary Mixer Cement 10cc (Cat. 614.10.01S)
FDA
Z-0269-2010
Class II
2009/12/21
Synthes (Hong Kong) Ltd
2724 2032
Biomet K-Wire/Trocar Point (REF 35-351534)
FDA
Z-0367-2010
Class II
2009/12/21
N.A.
N.A.
Biosense Webster (a JNJ company) NaviStar RMT Diagnostic/Ablation Steerab
FDA
Z-0368-2010 to Z0369-2010
Class II
2009/12/21
(HK)
2738 6027
Smith & Nephew Oxinium Femoral Head (REF 71343603)
FDA
Z-0389-2010
Class II
2009/12/21
Smiths & Nephew Ltd
9651 5523
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style
FDA
Z-0419-2010
Class II
2009/12/21
2821 5480
Tornier LMP-50 (Lesser Metatarsal Phalangeal Implant)
FDA
Z-0455-2010
Class II
2009/12/21
N.A.
N.A.
Nutech Bath Safe Adjustable Shower Seat, Adjustable Transfer Bench, Showe
FDA
Z-0459-2010 to Z0465-2010
Class II
2009/12/21
N.A.
N.A.
Pentron TempSpan Dual-Cure Temporary Crown and Bridge Material, Part num
FDA
Z-0482-2010
Class II
2009/12/21
N.A.
N.A.
Olympus Keymed CelonLab POWER (Ref. WB991029, 991.029)
Varian Clinac C-series and Novalis Tx
Alphatec Spine Zodiac Polyaxial Spinal Fixation System, Part Number: 62665-5
FDA
Z-0491-2010
Class II
2009/12/21
N.A.
N.A.
Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, REF 904842P
FDA
Z-1091-2010
Class II
2009/12/21
N.A.
N.A.
Alphatec Spine ILLICO Posterior Thoracolumbar Access Retractor, Part Numbe
FDA
Z-0498-2010
Class II
2009/12/21
N.A.
N.A.
MHRA
2009/012/014/081/003
FSCA
2009/12/21
2992 0968
BD
N.A.
Firm Initiated
Field Action
2009/12/21
BD
2575 8668
N.A.
Firm Initiated
Field Action
2009/12/21
Maquet Hong Kong Ltd.
2393 9511
2783 1838
Zimmer Nexgen MIS procedures TM tibial tray size 8, Part No. 005954-057-02
BD BACTEC Blood Culture media, 442192 442260 442265 442193 442206
Maquet Hong
Kong Ltd.
Intervascular Vascular Prothesis IGK1608, IGK2010
2009/012/014/081/024
FSCA
2009/12/22
Ltd.
N.A.
Firm Initiated
Field Action
2009/12/22
2960 7136
New Deal Hintegra Talar Cutting Guides, Left Cutting Guide, Right Cutting Guid Health Canada
51435
Type II
2009/12/23
N.A.
N.A.
Bio-Rad MRSA Select Reference 63747 Coffret 20 Plaque
51525
Type II
2009/12/23
Bio-Rad Pacific Ltd.
2789 3300
2802 6333
GE Healthcare OEC IT3000, IT2500 (EnTrak), IT2500 Plus (EnTrak Plus), IT35
Boston Scientific Guider Softip Guide Catheter
MHRA
Boston Scientific
Hong Kong Ltd
Health Canada
Remel Rapid Eric Electronic Compendium RE8323600
Health Canada
51669
Type I
2009/12/23
Hong Kong South East
Chemicals & Instruments Ltd
Berlin Heart Excor System-Connecting Set for Cannula
Health Canada
51703
Type I
2009/12/23
N.A.
N.A.
Getinge Washer Disinfectors 9027, 9100, 9120, 9125, 9218
Health Canada
51707
Type II
2009/12/23
N.A.
N.A.
Imaging Sciences International i-CAT 3D Dental Imaging System
Health Canada
51709
Type II
2009/12/23
N.A.
N.A.
Vascular Solutions Pronto-Short Extraction Catheter
Health Canada
51819
Type II
2009/12/23
N.A.
N.A.
Roche Molecular Systems Amplicor STD Specimen & Transport Kit
Health Canada
51858
Type II
2009/12/23 Roche Diagnostics (Hong Kong) Ltd 2485 7510
Toshiba Medical Systems Diagnositc Ultrasound Transducers / Probe PVT-681
Health Canada
51870
Type II
2009/12/23
Sanko Medical Systems (HK)
LTD
2384 0688
Becton Dickinson Canada BD 30ml Luer-Lok Syringes 309650
Health Canada
51921
Type II
2009/12/23
BD
2575 8668
Imaging Sciences International i-CAT 3D Dental Imaging System
Health Canada
51944
Type II
2009/12/23
N.A.
N.A.
Oxoid Brain Heart Infusion CM0225
MHRA
2009/012/015/601/001
FSCA
2009/12/24
N.A.
N.A.
ThermoFisher Scientific Oxoid Bottled Media, Brain Heart Infusion Broth BO036
MHRA
2009/012/010/601/003
FSCA
2009/12/24
N.A.
N.A.
Biomet 19mm diameter Oxford Revision Stems (Ref# 650-0735, 650-0736, 650
MHRA
2009/012/016/081/009
FSCA
2009/12/24
N.A.
N.A.
Stryker Ankle Arthrodesis Nail (Cat. no. 18181030S, 18181130S, 18181230S,
MHRA
2009/012/015/081/027
FSCA
2009/12/24
Stryker China Ltd
2518 6915
Megadyne Medical Products E-Z CLEAN Non Stick Cautery Tip (Lot no. 91469
FDA
Z-0486-2010
Class III
2009/12/28
N.A.
N.A.
Stryker Super SecurFit HA Hip Stem (Cat. no. J6051-0425, J0651-0525, J6051
FDA
Z-0556-2010 to Z0557-2010
Class II
2009/12/28
Stryker China Ltd
2518 6915
Zimmer Spine Abbott Spine Sequoia dorsal height & revision tool (REF 3367-1
FDA
Z-0554-2010
Class II
2009/12/28
2992 0968
Merit Medical Systems Connecting Tube (K10-04129, K10-04131), Monarch (IN
FDA
Z-0510-2010 to Z0524-2010
Class II
2009/12/28
King Health Limited
2481 3787
Alphatec Spine Solanas Titanium Pedicle Screw (Part No. 63035-12, 63035-14
FDA
Z-0502-2010 to Z0503-2010
Class II
2009/12/28
Milverton Ltd.
2367 8123
Zimmer Gender Solutions Nexgen Complete Knee Solution (REF 00-5764-013
FDA
Z-0501-2010
Class II
2009/12/28
2992 0968
FDA
Z-0466-2010 to Z0477-2010
Class II
2009/12/28
Stryker China Ltd
2518 6915
FDA
Z-0375-2010 to Z0388-2010
Class II
2009/12/28
2992 0968
FDA
N.A.
Press
Release
2009/12/29
N.A.
N.A.
MHRA
2009/012/017/081/003
FSCA
2009/12/30
Limited
2810 7533
2009/12/30
Roche Diagnostics (Hong Kong)
Ltd
2481 3387
2810 7533
Stryker Scorpio Femoral Components (70-3007R, 70-4107R, 71-3003L, 71-300
Zimmer Natural Nail System (REF 00-2490-001-00, 00-2490-001-05, 00-2490Encompass Group Thermoflect Product Line
Siemens Glucose Biosensor (Lot no. 2809)
Roche Diagnostics Accu-Chek Inform II (Mat. No. 05060303001, 05060311001
MHRA
2009/012/016/081/031
FSCA
Siemens Dimension IBCT Flex reagent cartridge DF84
MHRA
2009/012/022/081/014
FSCA
2009/12/30
Limited
Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System (product n
MHRA
2009/012/018/601/003
FSCA
2009/12/30
Beckman Coulter Hong Kong Ltd
2240 6150
N.A.
Firm Initiated
Field Action
2009/12/30
Varian Medical Systems Pacific
Inc.
2724 2836
Varian Medical
Varian Eclipse Client versions 7.3 (build 7.3.10), 8.0 (builds 7.5x), 8.1 (builds 8 Systems Pacific
Inc
Major Safety Alerts in November 2009 (This page is subject to further review)
Source of
Information*
Reference No. by
Source
Alert Type by
Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
Terumo Sarns Disposable Centrifugal Pump (Model# 164275)
Health Canada
51040
Type II
3-Nov-09
TERUMO CHINA (H.K.)
LTD.
2866 0811
Sorin Revolution Centrifugal Blood Pump (Model no. 50300700)
Health Canada
51015
Type II
3-Nov-09
N.A.
N.A.
Stryker Neptune 2 Ultra Rover (Model 0702-001-00)
Health Canada
51120
Type II
3-Nov-09
Stryker China Ltd
2518 6915
GE Giraffe & Panda T-Piece Resuscitation System (Model # M1091316,
M1091335, M1091365)
Health Canada
51025
Type II
3-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
Health Canada
51053
Type II
3-Nov-09
Maquet Hong Kong LTD.
2393 9511
2960 7136
Maquet Connection Bracket 1180.36AO
Boston Scientific Imager II Urology Torque Catheters
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated Field
Action
3-Nov-09
Boston Scientific Hong
Kong Ltd
Medtronic Titan Anchor (Model 3550-39)
Medtronic
International Ltd.
N.A.
Action
3-Nov-09
Medtronic International,
Ltd.
2919 1362
MHRA
N.A.
MDA
6-Nov-09
N.A.
N.A.
Boston Scientific IMAGERT II Angiographic Catheter (Peripheral
Intervention)
Boston Scientific
Hong Kong Ltd
N.A.
Action
9-Nov-09
Kong Ltd
2960 7136
Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor
FDA
Z-2030-2009
Class I
9-Nov-09
Ltd.
2919 1362
Covidien Pedi-Cap CO2 Detector
FDA
Z-2047-2009
Class I
9-Nov-09
Covidien
3157 7220
Penumbra Neuron 5F Select Catheter
FDA
Z-2049-2009
Class I
9-Nov-09
Synapse Therapeutics
Limited
9106 1836
Roche/Hitachi Preciset TDM I (Cat. no. 03375790 190); Roche/Hitachi
Preciset TDM II (Cat. no. 03375781 190)
FDA
Z-2000-2009 to Z2001-2009
Class II
9-Nov-09
Roche Diagnostics (Hong
Kong) Ltd
2485 7510
BD Diagnostics GeneOhm (BDDG) (Cat no. 441242; 441244)
FDA
Z-2000-2009 to Z2001-2009
Class II
9-Nov-09
BD
2575 8668
Accuracy CyberKnife Treatment Delivery System
FDA
Z-1810-2009
Class II
9-Nov-09
Accuray Asia Ltd
2247 8628
Oak Tree International EASYMax N self-Monitoring Blood Glucose
System (Recall# Z-1937-2009)
FDA
Z-1937-2009
Class II
9-Nov-09
N.A.
N.A.
Teleflex Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Hudson RICA
Sheridan, ET Tube, Sher-I-Bronch LS & Sher-I-Bronch RS, Sher-IBronch Accessory Pack
FDA
Z-1940-2009 to Z1944-2009
Class II
9-Nov-09
N.A.
N.A.
BD Q-Syte Luer Access Split-Septum (Cat no. 385100) and Q-Syte
Extension Set (Cat. No. 385102)
BD
N.A.
Action
9-Nov-09
BD
2575 8668
AMO Asia Limited
N.A.
Action
9-Nov-09
AMO Asia Limited
2401 5711
URIT Medical Electronic Uritest 13G urine test strips
AMO Vitrax II Opthalmic Viscosurgical Device (Sodium Hyaluronate 3%)
Beckman Coulter PK7300 automated pre-transfusion analyser and consum
MHRA
2009/011/002/081/01
6
FSCA
9-Nov-09
Beckman Coulter Hong
Kong Ltd
2240 6150
Joerns Healthcare OXFORD Mobile Hoists, Ceiling Hoists and Bathing Pr
MHRA
2009/007/022/401/00
3
FSCA
9-Nov-09
N.A.
N.A.
Smith & Nephew Trigen internal hex screw, model 71642220
MHRA
2009/011/002/601/00
2
FSCA
9-Nov-09
Smith & Nephew LTD
2648 7700
Swann-Morton Blade shape no. 27
MHRA
2009/010/021/601/00
2
FSCA
9-Nov-09
N.A.
N.A.
Health Canada
50934
Type II
9-Nov-09
N.A.
N.A.
Orthofab Triporteur Star 4 and Quadriporteur Star 4
Medical Device Control Office
Department of Health
The Government of HKSAR
Smith & Nephew Endo Femoral Aimers
Health Canada
50942
Type I
9-Nov-09
Smith & Nephew LTD
9651 5523
Diasorin Gammacoat Plasma Renin Activity 123I RIA Kit
Health Canada
51278
Type II
9-Nov-09
N.A.
N.A.
Olsen Medical Midas Touch Needle Electrode
Health Canada
51204
Type II
9-Nov-09
N.A.
N.A.
Draeger Medical
Hong Kong Ltd
N.A.
Action
10-Nov-09
Draeger Medical Hong
Kong Ltd
2877 3077
MHRA
MDA/2009/072
MDA
10-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
BD
N.A.
Action
10-Nov-09
BD
2575 8668
AMO Asia Limited
N.A.
Action
11-Nov-09
AMO Asia Limited
2401 5711
Siemens Mammomat Inspiration [system: 10140000; biopsy Unit: 105013
MHRA
2009/010/020/081/01
0
FSCA
11-Nov-09
Siemens Healthcare
Diagnostic Limited
2810 7533
Medical Devices Group XiO, releases 4.3.0 to 4.50.00
MHRA
2009/010/023/601/00
7
FSCA
11-Nov-09
N.A.
N.A.
Cardiac Science Powerheart AED G3, Cardio Vive, Responder
MHRA
2009/010/026/081/00
4
FSCA
11-Nov-09
N.A.
N.A.
FDA
N.A.
Class I
12-Nov-09
N.A.
N.A.
Bausch & Lomb
(Hong Kong ) Ltd
N.A.
Action
12-Nov-09
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
MHRA
MDA/2009/074
MDA
13-Nov-09
Maquet Hong Kong Ltd.
2393 9511
Whatman Body Fluid Collection Paper 903
FDA
Z-1871-2009
Class II
13-Nov-09
N.A.
N.A.
Abiomed AB5000 Portable Driver (Catalog number: 0025-0000)
FDA
Z-1914-2009
Class II
13-Nov-09
N.A.
N.A.
Remington Medical Chiba Needle Marked Model: CNM-2308
FDA
Z-1935-2009
Class II
13-Nov-09
N.A.
N.A.
Verathon BladderScan BVI 9400
FDA
Z-1939-2009
Class II
13-Nov-09
N.A.
N.A.
Abbott AxSYM Cancer Assay Disk Version 5.0
FDA
Z-2222-2009
Class II
13-Nov-09
Abbott Laboratories LTD.
2593 2211
Biomet 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, Osseoti
FDA
Z-2227-2009
Class II
13-Nov-09
Ositek (HK), Inc. Ltd
3157 1757
Leonhard Lang SKINTACT Electrodes for Defibrillation, S&W Electrodes
for Defibrillation
FDA
Z-2233-2009 to Z2234-2009
Class II
13-Nov-09
N.A.
N.A.
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT
100-48 and LT 60-24
FDA
Z-2249-2009 to Z2250-2009
Class II
13-Nov-09
B. Braun Medical Hong
Kong
25292009
Abbott Martel Printer Accessory to i-STAT Portable Clinical Analyzer,
rechargeable battery pack (Cat. No. 06723-91, 06F21-35)
FDA
Z-2328-2009
Class II
13-Nov-09
2593 2211
ConMed Linvatec PowerPro, PowerProMax and Mpower handpieces
FDA
Z-1950-2009 to Z1952-2009
Class I
13-Nov-09
N.A.
N.A.
ConMed Linvatec MC5057 Universal Cable
FDA
Z-2007-2009
Class I
13-Nov-09
N.A.
N.A.
Dragermedical Omega or Omega S package which may include
SC7000/SC8000/SC9000XL, Kappa, Delta/Delta XL (Delta Family) and
Infinity Explorer, in combination with the Trident NMT and / or PiCCO
SmartPod
GE Healthcare Tec 6 Plus Desflurane vaporiser
BD Hettich Centrifuge for PREPStain System (SAP# 490664, 490663)
AMO Tecnis 1-Piece Intraocular Lens (Model# ZCB00)
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter (Model
No. EC1001 and EC65)
Bausch & Lomb Boston Conditioning Solution Original
Maquet Servo 300 and 900 ventilators (SV300 and SV900)
Synthes Ti Synex II Vertebral Body Replacement (VBR)
FDA
N.A.
Class I
13-Nov-09
Synthes (Hong Kong) Ltd.
2724 2032
MHRA
2009/011/006/081/00
3
FSCA
16-Nov-09
Stryker China Ltd.
2518 6915
Joerns Healthcare OXFORD Battery Charger for Mermaid & Historic
Oxford Hoists
MHRA
2008/001/024/401/00
5
FSCA
16-Nov-09
N.A.
N.A.
Invacare User manual of Rea Azalea wheelchair range
MHRA
2008/011/020/061/00
8
FSCA
16-Nov-09
Direct Health LTD
N.A.
FDA
N.A.
Press Release
16-Nov-09
N.A.
N.A.
Joerns Healthcare OXFORD slings, all types
MHRA
2008/011/006/401/01
3
FSCA
17-Nov-09
N.A.
N.A.
Beckman Coulter UniCel DxI system software, versions 4.2 or 4.2.1
(used on UniCel DxI 800 and 600 Access immunoassay systems and
UniCel DxC 880i, 860i, 680i and 660i SYNCHRON Access clinical
systems)
MHRA
2009/011/002/601/00
3
FSCA
17-Nov-09
Beckman Coulter Hong
Kong Ltd
2240 6150
Smiths Medical
2183502-11/16/09003-R
Action
17-Nov-09
Goodman Medical
Supplies Ltd
2332 4455
Press Release
18-Nov-09
N.A.
N.A.
2783 1838
Stryker Navigation PC SPC-1
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices
Smiths Medical Medfusion Syringe Pumps (Models: 3010A, 3500)
FDA
N.A.
GE Healthcare Voluson E6 and Voluson E8 Diagnostic Ultrasound
Systems using software versions 9.0.0, 9.0.1, and 9.0.2
Cardiovascular Systems ViperSheath Sheath Introducer
MHRA
2009/011/005/601/00
1
FSCA
19-Nov-09
GE Medical Systems
Hong Kong Ltd.
Lindare Medical Kryptonite Bone Cement (Product code: KRYP-Z-10,
KRYP-X-10, KRYP-Z-03, KRYP-X-03)
MHRA
2009/010/023/081/00
4
FSCA
19-Nov-09
N.A.
N.A.
Thermo Fisher Scientific Oxoid ready-poured plate, Mueller Hinton agar,
4mm depth (PO0152A)
MHRA
2009/011/004/601/00
2
FSCA
19-Nov-09
N.A.
N.A.
Stryker Flat foot resorbable implant
MHRA
2009/011/002/081/00
7
FSCA
19-Nov-09
Stryker China Ltd
2518 6915
Elmdown C01A KyphX HV-R Bone Cement, C01B KyphX HV-R Bone
Cement with Mixer
MHRA
2009/011/011/081/00
2
FSCA
19-Nov-09
Medtronic International
Ltd.
2919 1362
MHRA
2009/001/007/401/01
3
FSCA
19-Nov-09
Direct Health LTD
N.A.
FDA
Z-1706-2009 to Z1709-2009
Class II
19-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
2529 2009
Invacare Meteor Scooter
GE Vascular Drape, Drape, Disposable Pack
B. Braun Celsite Access Port Model ST305P
FDA
Z-1961-2009
Class II
19-Nov-09
B. Braun Medical Hong
Kong
Theken Spine iLink Bone Void Filler (Model Number: 50-05-0010)
FDA
Z-1965-2009
Class II
19-Nov-09
N.A.
N.A.
FDA
Z-1994-2009 to Z1995-2009
Class II
19-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
FDA
Z-1998-2009
Class II
19-Nov-09
N.A.
N.A.
FDA
Z-2002-2009 to Z2004-2009
Class II
19-Nov-09
Kong) Ltd
2485 7510
2770 6877
GE Healthcare Datex-Ohmeda S/5 Critical Care Monitor and S/5
Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & LICUO5A software
Lumitex Ultra-Thin LightMat Surgical Illuminator (Model Number:
UA2550)
Roche Coaguchek XS System (04837975001), Coaguchek XS PST Kit
(04837738001), Coaguchek XS Plus Care Kit (05021537001)
Vbm Medizintechnik Vertriebs Gmbh Transtracheal (Jet Ventilation)
Catheter ACU 1060.1
FDA
Z-2010-2009
Class II
19-Nov-09
Foxwood Medical
Supplies
HACH SteriChek Residual Peroxide Reagent Strips
FDA
Z-2016-2009
Class II
19-Nov-09
EuroTech (Far East) Ltd.
281 40 311
MHRA
2009/011/006/081/02
0
FSCA
19-Nov-09
Siemens Healthcare
Diagnostic Limited
2810 7533
ev3 Protégé EverFlex Biliary Stent System (Model no. PRP35-06-100080, Lot 7821736)
MHRA
2009/011/013/081/00
2
FSCA
20-Nov-09
Sinomed Company Ltd.
2887 7640
Siemens Syngo Imaging XS VA60 and VA70 in combination with "JPEG
Compression" license
MHRA
2009/009/022/081/01
7
FSCA
20-Nov-09
Siemens Healthcare
Diagnostic Limited
2810 7533
ZOLL R Series defibrillators
MHRA
2009/009/014/291/00
4
FSCA
20-Nov-09
Suburfarm Investment &
Trading Co.
2780 9421
Siemens AXIOM Artis MP, AXIOM Artis dMP and AXIOM Artis Zee
Multipurpose
Roche Diagnostics Elecsys Thyroglobulin
MHRA
2009/011/010/081/00
5
FSCA
20-Nov-09
Kong) Ltd
2485 7510
Abbott SCC Bar Code Scanner used with m2000rt, m2000sp and m24sp i
MHRA
2009/011/015/601/00
1
FSCA
23-Nov-09
2593 2211
Thoratec HeartMate II and HeartMate XVE LVAS, 12-volt sealed lead
acid battery clips (Model no. 1237)
MHRA
2009/011/012/081/00
3
FSCA
23-Nov-09
N.A.
N.A.
GE Healthcare Innova 2121IQ and 3131IQ
MHRA
2009/011/013/081/01
7
FSCA
23-Nov-09
GE Medical Systems
Hong Kong Ltd.
2783 1838
Mediplus Low Mix Dual Infusion Set with Gravity IV Valve (product code:
6604)
MHRA
2009/011/012/601/00
6
FSCA
23-Nov-09
N.A.
N.A.
Medtronic
International Ltd.
N.A.
Action
23-Nov-09
Ltd./Pacific Medical (HK)
Ltd
2919 1362/ 2343
8009
Zimmer Sesamoid Plasty Workstation Power Cord (part number
200.304)
MHRA
2009/011/010/081/00
9
FSCA
24-Nov-09
Zimmer PTE Ltd. (Hong
Kong branch)
2992 0968
Respironics V60 Ventilator (Part No. 1053614)
MHRA
2009/010/023/081/00
2
FSCA
25-Nov-09
2268 9201
BD
N.A.
Action
25-Nov-09
BD
2575 8668
FSCA
26-Nov-09
N.A.
N.A.
FSCA
26-Nov-09
N.A.
N.A.
Medtronic CryoCath Arctic Front System
BD BBL Prepared Sterile Pack Plates Trypticase Soy Agar, Sterile Pack,
221236 (Lot No. 9266717)
Newdeal Panta support device (Cat. No. 519110)
MHRA
Thermo Fisher Scientific Oxoid ready-poured plate, DCA (Hynes),
PO0126A
MHRA
2009/011/023/081/00
4
2009/011/019/601/00
5
Cordis CROSSOVER Sheath Introducer (Cat. No. 403545S, 403585S,
403645S, 403685S, 403745S, 403785S)
FDA
Z-0087-2010
Class I
26-Nov-09
Johnson & Johnson
Medical (HK)
2738 6027
Ortho Development Pivot BiPolar Head (Part no. 133-2846, 133-2847,
133-2848, 133-2851, 133-2852)
FDA
Z-0086-2010
Class II
26-Nov-09
N.A.
N.A.
GF Health Products John Bunn 1392 Series Jackson Tracheostomy
Stainless Steel Tube
FDA
Z-0139-2009
Class II
26-Nov-09
N.A.
N.A.
Cardinal Health Craig Calibrated Cannula (Cat. No. OS5000-005)
FDA
Z-0141-2010
Class II
26-Nov-09
N.A.
N.A.
FDA
Z-0148-2010 to Z0149-2010
Class II
26-Nov-09
Stryker China Ltd
2518 6915
Health Canada
51375
Class II
26-Nov-09
N.A.
N.A.
2783 1838
Stryker Stair-PRO Stair Chair (Model 6251 and 6252)
Wallace OY Trinest Microplate Incubator and Shaker (Model : 12960050)
Health Canada
48250
Type II
26-Nov-09
GE Medical Systems
Hong Kong Ltd.
Bausch & Lomb
(Hong Kong ) Ltd
N.A.
Action
26-Nov-09
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
Hospira Limited
N.A.
Action
26-Nov-09
Hospira Limited
2898 2886
Immucor Galileo Echo (Cat. no. 0087000)
MHRA
2009/011/023/081/02
6
FSCA
27-Nov-09
2838 8423
Sybron Dental Specialities Elements Gutta Percha and Elements
RealSeal cartridge kits (Part no. 972-1002, 972-1003, 972-2001, 9722002)
MHRA
2009/011/017/081/01
4
FSCA
30-Nov-09
N.A.
N.A.
GE Apexpro Telemetry System - Clinical Info
Bausch & Lomb SoFlex SE Silicone Posterior Chamber Intraocular Lens
(Model L161SE, Lot 4916928 (23.5D))
Hospira IV Administration Sets with Borla clamp
Monthly Summary of Medical Device Safety Alerts - October 2009
Date of Issue
Source of
Alert Type by
Local Agent
Agent Contact Telephone No
(YYYY/MM/D
Reference No. by Source
Information*
Source
D)
Sorin Revolution sterile ventricular pump
2009/009/025/081/014
02-Oct-09
N.A.
N.A.
MHRA
FSCA
Maquet Hong
2393 9511
MAQUET Hanaulux 2004, 2005, 3004, 3005 & Blue 130 and ALM XTEN
MHRA
2009/009/014/291/024
FSCA
02-Oct-09
Kong LTD.
Siemens
Siemens Axiom Artis – US Terason 2000 with Terason 2000 SW version
2009/008/025/081/023
02-Oct-09
2810 7533
MHRA
FSCA
Healthcare
3.1.9 or earlier
Diagnostic
Olympus Hong
2170 5678
ALOKA (Olympus) ultrasound system SSD-ALPHA10
2009/009/015/291/004
02-Oct-09
MHRA
FSCA
Kong and China
Ltd
Direct Health
Invacare Duo Range Wheelchairs
2007/002/005/081/015
02-Oct-09
2528 1109
MHRA
FSCA
LTD
GE Medical
2783 1838
GE Centricity Laboratory, software version 3.3AImp
2009/006/001/291/012
02-Oct-09
Systems Hong
MHRA
FSCA
Kong Ltd.
ArthroCare ArthroWand Saber 30 with Integrated Cable (Cat No. AC4330Z-1900-2009
05-Oct-09
N.A.
N.A.
FDA
Class II
01)
GE Medical
GE Healthcare Signa Ovation 0.35T and Signa Openspeed 0.7T MR
Z-1722-2009 to Z-1723-2009
2783 1838
05-Oct-09
Systems Hong
FDA
Class II
Systems
Kong Ltd.
Hill-Rom Clinitron Cll Air Fluidized Therapy Units and Clinitron Up-Lift Ai
FDA
Z-1902-2009 to Z-1903-2009
Class II
05-Oct-09
N.A.
N.A.
Fluidized Therapy Units
Perkin Elmer Specimen Gate Laboratory (Product Code: 5002-0180,
Z-1905-2009
05-Oct-09
N.A.
N.A.
software version 1.2 and 1.3) and Specimen Gate Lab - MSMS Data Suite
FDA
Class II
(Product code 5002-03 10)
Allied Healthcare Products Empty M9, Empty D, Empty Jumbo D aluminum
oxygen cylinders and First Responder Kit containing a 240-liter aluminum
FDA
Z-2031-2009 to Z-2038-2009
Class II
05-Oct-09
N.A.
N.A.
oxygen cylinder
Hitachi EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners and
FDA
Z-2054-2009 to Z-2055-2009
Class II
05-Oct-09
N.A.
N.A.
EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners
Unomedical Manual Pulmonary Resuscitators
N.A.
Press Release
2009/10/06
N.A.
N.A.
FDA
Stryker Triathlon AR 4:1 Cutting Blocks - Size 1-8 (Cat. no. 6541-0-701 Z-1916-2009 to Z-191708-Oct-09 Stryker China Ltd
2518 6915
6541-0-708) and Triathlon MIS 4:1 Cutting Blocks - Size 1-8 (Cat no.: 6541FDA
Class II
2009
5-701 - 6541-5-708)
AGFA Hong
2555 9421
AGFA NX 2008 Central Monitoring System (CMS) (Product Code: E2FB6)
FDA
Z-1889-2009
Class II
08-Oct-09
Kong Limited
Teleflex Sheridan Preformed Cuffed Tracheal Tube Nasal 6.5 (CAT. NO. 5FDA
Z-1890-2009 to Z-1891-2009
Class II
08-Oct-09
N.A.
N.A.
22313) and Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0 (Cat no. 5Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with
Sanko Medical
FDA
Z-0005-2009
Class II
08-Oct-09
238400688
version 3.40 or higher software
Systems (HK)
Angiodynamics SmartPort CT Port Access System (Cat no. CT80STPD)
Z-1898-2009
08-Oct-09
N.A.
N.A.
FDA
Class II
GE Medical
GE Healthcare Centricity CARDDAS V3.1: 2D Echo Form
2009/009/028/081/009
08-Oct-09
2783 1838
FDA
FSCA
Systems Hong
Kong Ltd.
Cochlear (HK)
Firm Initiated
Cochlear (HK)
Cochlear Non-Magnetic Plug, Z50100, Implant Magnet Z50101
N.A.
08-Oct-09
2530 5773
Ltd
Field Action
Ltd
Boston
Boston Scientific
Firm Initiated
2960 7136
N.A.
09-Oct-09
Boston Scientific Guider Softip Guide Catheter
Scientific Hong
Field Action
Hong Kong Ltd
Johnson and
Johnson and
Johnson and Johnson (Ortho Clinical Diagnostics) enGen Laboratory
Firm Initiated
Johnson (Ortho
Johnson (Ortho
Automation System / TCAutomation Products (Software version 2.8.2 and
N.A.
09-Oct-09
2737 6162
Field Action
Clinical
Clinical
below)
Diagnostics)
Diagnostics)
Newdeal BBOP Lock Plantar Basal Plates
2009/010/005/081/006
12-Oct-09
N.A.
N.A.
MHRA
FSCA
10
Medtronic BRYAN Cervical Disc System 6470114, 6470115, 6470116,
6470117, 6470118
Angiotech (Medical Device Technologies, Inc.) Various pouches
Richardson Healthcare SwabX X-ray Detectable Gauze Swabs
Unomedical Manual Pulmonary Resuscitators
Merck Serono pH Indicator Strips
Astra Tech Medena Tapered Tip (Product Ref. No. 68104)
Natus neoBLUE mini LED Phototherapy System
Haemonetics MCS+9000 Devices (Hardware Safety System update)
Huntleigh Healthcare Dopplex Centrale DC11 patient monitor central unit
Arcoma ArcoTable NT (Product Ref. 0055)
Bard Magnum Disposable Biopsy Core Needle 16 gauge (Catalog numbers:
MN1610, MN1613, MN1616 and MN1620)
Sybaritic NannoLight MP50 (Model No.: 304207-MP, 404207, 404207-MP,
404207-B, 404208-B, 404208-MP)
Bard Peripheral Plastic Radiolucent Coaxial (VC10118P, VC10140P) and
MR Coaxial (VC10140MR, VC10118MR)
Apheresis Technologies PlasmaPro Plasma Pump (Model PP-05) (Owner
Manual Modifications)
Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp
(5C4482) and Minicap Extended Life PD Transfer Set Extra Short (4") with
Stryker Vertier Surgical Table (Part no 0788100000, 0788100001,
0788100000S and 0788100001S)
MHRA
2009/009/018/081/014
FSCA
12-Oct-09
MHRA
MHRA
FDA
MHRA
MHRA
MHRA
Haemonetics
(Hong Kong)
Limited
MHRA
MHRA
Bard Pacific
Health Care
Co. Ltd
2009/009/011/291/002
2009/009/029/081/014
N.A.
2009/006/024/291/003
2009/010/002/081/003
2009/009/029/081/017
FSCA
FSCA
Press Release
FSCA
FSCA
FSCA
12-Oct-09
12-Oct-09
13-Oct-09
13-Oct-09
13-Oct-09
14-Oct-09
N.A.
Firm Initiated
Field Action
14-Oct-09
2008/012/019/401/005
2009/009/028/081/020
FSCA
FSCA
15-Oct-09
15-Oct-09
Medtronic
International, Ltd.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Haemonetics
(Hong Kong)
Limited
N.A.
N.A.
N.A.
Firm Initiated
Field Action
15-Oct-09
Conmed Limited
2854 4413
FDA
Z-1444-2009
Class II
16-Oct-09
N.A.
N.A.
FDA
Z-1879-2009 to Z-1882-2009
Class II
16-Oct-09
N.A.
N.A.
FDA
Z-1897-2009
Class II
16-Oct-09
N.A.
N.A.
2807 8516
2919 1300
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2116 3166
N.A.
N.A.
FDA
Z-1893-2009 to Z-1894-2009
Class II
16-Oct-09
Baxter
Healthcare Ltd
FDA
Z-1899-2009
Class II
16-Oct-09
Stryker China Ltd
2518 6915
2807 8516
MHRA
2009/010/008/081/016
FSCA
16-Oct-09
Baxter
Healthcare Ltd
MHRA
2009/009/014/291/021
FSCA
16-Oct-09
Stryker China Ltd
2518 6915
Health Canada
50850
Type II
19-Oct-09
N.A.
Heath Canada
50793
Type II
19-Oct-09
Health Canada
49927
Type II
19-Oct-09
2783 1838
MHRA
2009/010/012/081/001
FSCA
19-Oct-09
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter
ESTECH COBRA® Adhere XL Surgical System, Magnetic Introducer,
Introducer and Introducer Set
MHRA
2009/010/012/081/002
FSCA
19-Oct-09
N.A.
Siemens
Healthcare
Diagnostic
GE Medical
Systems Hong
Kong Ltd.
Johnson &
Johnson Medical
(HK)
N.A.
MHRA
2009/007/006/081/014
FSCA
19-Oct-09
N.A.
N.A.
Zimmer Durom Acetabular Cup
MHRA
2009/009/022/081/016
FSCA
19-Oct-09
Roche Diagnostics ONLINE TDM Gentamicin Assay, used with cobas c 501
and Modular Analytics <P> analysers
MHRA
2009/010/001/081/007
FSCA
19-Oct-09
Roche Diagnostics cobas b 221 MSS cassette (Product ref. 03261085184)
MHRA
2009/009/015/291/021
FSCA
19-Oct-09
N.A.
Firm Initiated
Field Action
20-Oct-09
Baxter Healthcare Tisseel and Duploject Spray Sets
Stryker Surgical protocols for hip implants: Cutting Edge Calcar Planer and
Accolade TMZF
Fisher and Paykel Healthcare Heater Wire Adaptors (Model# 900MR800)
Siemens Acuson S2000 (Model no. 10041461)
GE AW Volumeshare (Model no S30321ZK) and AW Volumeshare2 (Model
no. 5183859-3, 5183859-4, 5183859-5)
Ethicon (JNJ) Gynecare Morcellex Tissue Morcellator (product code:
MX0100, MX0100R)
Baxter COLLEAGUE Triple Channel Mono, CX and CXE Volumetric infusion
Baxter
Pumps (Product Codes: 2M8153, 2M8153K, 2M8163)
Healthcare Ltd
11
Zimmer PTE Ltd.
(Hong Kong
branch)
Roche
Diagnostics
(Hong Kong) Ltd
Roche
Diagnostics
(Hong Kong) Ltd
Baxter
Healthcare Ltd
2810 7533
2738 6027
N.A.
2992 0968
2485 7510
2486 7510
2807 8516
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Varian Medical
Systems Pacific
Inc.
Viking Group HK
Ltd
Philips Electronic
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
20-Oct-09
N.A.
Firm Initiated
Field Action
20-Oct-09
N.A.
Firm Initiated
Field Action
22-Oct-09
MHRA
2009/006/003/291/015
FSCA
22-Oct-09
Philips Avalon Fetal Monitors, Models FM20, FM30, FM40 and FM50
MHRA
2009/010/015/081/013
FSCA
23-Oct-09
Wallach Surgical Devices LL100 CO2 Cryosurgical System and accessories
MHRA
2009/010/002/081/008
FSCA
23-Oct-09
GE Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT 02
FDA
Z-1558-2009
Class II
27-Oct-09
GE CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1,
MP100 Hardware)
FDA
Z-1600-2009
Class II
27-Oct-09
Cardinal Health Pyxis Anesthesia System 3500
Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile
(Cat no. 48906075)
FDA
Z-1883-2009
Class II
27-Oct-09
GE Medical
Systems Hong
Kong Ltd.
GE Medical
Systems Hong
Kong Ltd.
N.A.
FDA
Z-1886-2009
Class II
27-Oct-09
Stryker China Ltd
2518 6915
Abbott FreeStyle Lite Blood Gluose Test Strips (Part no 70822-02)
FDA
Z-1936-2009
Class II
27-Oct-09
Abbott Diabetes
Care
2806 4204
FDA
Z-1948-2009
Class II
27-Oct-09
N.A.
N.A.
FDA
Z-1997-2009
Class II
27-Oct-09
N.A.
N.A.
FDA
Z-2017-2009 to Z-2021-2009
Class II
27-Oct-09
N.A.
N.A.
FDA
Z-2079-2009 to Z-2108-2009
Class II
27-Oct-09
N.A.
N.A.
FDA
Z-2232-2009
Class II
27-Oct-09
N.A.
N.A.
FDA
Z-2236-2009 to Z-2237-2009
Class II
27-Oct-09
FDA
Z-2238-2009
Class II
27-Oct-09
GE Innova 2000, Innova 3100/3100IQ, Innova 4100/4100IQ
FDA
Z-2240-2009 to Z-2242-2009
Class II
27-Oct-09
BrainLab Radiotherapy Treatment Planning Software (Cat no 20610, 20620,
20630)
N.A.
Beckman Coulter
Hong Kong Ltd
GE Medical
Systems Hong
Kong Ltd.
FDA
Z-2251-2009
Class II
27-Oct-09
Varian VARiS Vision version 6.2, 6.1 and 6.0
Varian Clinac, Trilogy and Novalis Tx
Varian Various products (Stereotactic Radiosurgery Treatments)
AAT (GB) Ltd C-max U/2
BARD Simpulse SOLO System with Soft Splash Shield Tip (Product Code:
0067590)
IMTEC MDI Hybrid Implant O-Ball abutment (Product Code: MII-0B13, MIIOB15)
BARD Button Device Continuous Feeding Tube (REF: 000256, 000292,
000282, 000283, 000284)
Integra Life Sciences Nerve Block Tray, Single Shot Epidural Tray, Hand
Drill-Sterile, Universal Block Tray, Block Tray, Biopsy Tray, Tuohy Needle,
Custom Procedure Tray
Oridion Medical Capnostream20 capnograph pulse oximeter monitor and
monitor with printer
Action Products Bol-X-II (item no 32052 and 32102)
Beckman Coulter SYNCHRON Systems Salicylate (SALY) Reagent (Part no
378194)
Abbott Flexiflo Quantum Enteral Pump (Model # 50596, 50598 and 59322)
Wright Medical ADVANCE Canal Filling Stem Extension (Item No.
KSP10140, KSP12140)
Orthofix ISKD Intramedullary Skeletal Kinetic Distractor
Stryker Reflex Hybrid Screw Extractor (Cat. No. 48511905B, 48511905D)
Oxoid Antimicrobial Susceptibility Testing Discs Moxifloxacin 5ug (code
CT1633B)
Vairan 4D Integrated Treatment Console
BD Vactainer Urine Kit (364954, 364956, 364957, 364988)
FDA
Z-2252-2009
Class II
27-Oct-09
BrainLAB Ltd
Abbott
Laboratories
Starry Medical
Technology, Ltd
2722 8122
2722 8122
2722 8122
2395 6339
2783 1838
2783 1838
N.A.
N.A.
2240 6150
2783 1838
2417 1881
2961 4503
MHRA
2009/010/014/081/008
FSCA
27-Oct-09
MHRA
MHRA
MHRA
Varian Medical
Systems Pacific
Inc.
2009/010/014/081/017
2009/010/013/081/008
2009/010/016/601/003
FSCA
FSCA
FSCA
27-Oct-09
28-Oct-09
28-Oct-09
Stryker China Ltd
2518 6915
N.A.
Firm Initiated
Field Action
28-Oct-09
2722 8122
BD
N.A.
Firm Initiated
Field Action
Varian Medical
Systems Pacific
Inc.
28-Oct-09
BD
2575 8668
12
GE Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software
FDA
Z-2316-2009
Class II
29-Oct-09
Posey Key Lock Belt, Fifth Point Restraint, Connecting Strap/Belt, Locking
Twice-As Tough Cuffs, Locking Twice-As Tough Ambulatory Belt, Swedish
FDA
Z-2254-2009 to Z-2275-2009
Class II
29-Oct-09
Siemens EasyLink Informatics System included with the Dimension Vista
System (Part No. 1000046623)
FDA
Z-1991-2009
Class II
29-Oct-09
Qualitest Pharmaceuticals Accusure Insulin Syringes
Ergolet Luna track lift spreader bar
ThermoFisher Brain Heart Infusion Broth, EB0366E, lot number 1090463
FDA
MHRA
MHRA
N.A.
2009/009/029/081/024
2009/010/020/601/002
Press Release
FSCA
FSCA
29-Oct-09
29-Oct-09
29-Oct-09
Medtronic MiniMed Paradigm Veo Insulin Pumps MMT-554 and MMT-754
MHRA
2009/009/030/291/008
FSCA
29-Oct-09
Horiba ABX Pentra 400
MHRA
2009/010/021/081/016
FSCA
29-Oct-09
13
GE Medical
Systems Hong
Kong Ltd.
2783 1838
N.A.
N.A.
Siemens
Healthcare
Diagnostic
Limited
N.A.
Medtronic
International, Ltd.
2810 7533
N.A.
2919 1300
Monthly Summary of Medical Device Safety Alerts - September 2009
Source of
Reference No. by
Date of Issue
Agent Contact
Local Agent
Alert Type by Source
(YYYY/MM/DD)
Information*
Source
Telephone No
GE Healthcare Innova 2000, 3100 and 4100
MHRA
2009/008/026/291/006
FSCA
03-Sep-09
cal Systems Hong K
2783 1838
Medi-Plinth Equipment GY02E GP Gynae Examination Couch
MHRA
2009/008/026/291/019
FSCA
03-Sep-09
N.A.
N.A.
Smiths Medical Omnifuse GB/EN with Lockable Cover (product code:
0157-0001)
MHRA
2009/008/024/291/008
FSCA
03-Sep-09
N.A.
N.A.
AMO Asia Limited
N.A.
Firm Initiated Field Action
03-Sep-09
AMO Asia Limited
2401 5711
MHRA
2009/008/024/081/013
FCSA
04-Sep-09
Philips Health
Care (Great China)
2821 5226
MHRA
2009/008/026/291/007
FSCA
04-Sep-09
Stryker China Ltd
2518 6915
AMO (Abbott Medical Optics, Inc.) WaveScan Offline Programming
Module (OPM) Software, Version 3.67
Philips Healthcare HeartStart MRx M3536A
Stryker Transport Stretcher 737, Stryker SM104 M-Series Stretcher
1007, Stryker Trauma Stretcher 1027, Stryker Eye Surgery Stretcher
1079
GE Healthcare Innova 2100IQ, 2121IQ, 3100IQ, 3131IQ and 4100IQ
with GE Fluoro UPS 20KVA
GE Medical
Systems Hong
Kong Ltd.
Celki Medical
Company
MHRA
2009/008/026/291/012
FSCA
04-Sep-09
2783 1838
Philips Respironics Esprit Ventilator System, Model no V1000 (Product
no 1001456)
FDA
Z-1813-2009
Class II
04-Sep-09
Hospira Phoenix Infusion System with MedNet Software
FDA
Z-1815-2009
Class II
04-Sep-09
Hospira Limited
2898 2886
Stryker Reflex Hybrid Level Anterior Cervical Plate, Reflex Hybrid
variable self-drilling screw and Reflex Hybrid Variable Self-Tapping
Screw
FDA
Z-1958-2009 to Z-1960-2009
Class II
04-Sep-09
Stryker China Ltd
2518 6915
Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management
Protection system)
2268 9201
FDA
Z-1934-2009
Class II
04-Sep-09
N.A.
N.A.
Teleflex Medical Sheri-I-Bronch Endobronchial Tube Kit and Sher-ISWIV Double Swivel Tracheal Tube
Health Canada
50274
Type I
07-Sep-09
N.A.
N.A.
Teleflex Medical Surgical Scissors
Health Canada
49787
Type II
07-Sep-09
N.A.
N.A.
Stryker Pain Pimp Catheters, Infusion Sets and Pain Pump2 Kits
Health Canada
49458
Type II
07-Sep-09
Stryker China Ltd
2518 6915
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
238400688
Toshiba Aquillion One (Model # TSX-301A/2)
Health Canada
50342
Type II
07-Sep-09
Sanko Medical
Systems (HK) LTD
Zimmer Versys Hip System Femoral Head (Model # 801802802)
Health Canada
50277
Type II
07-Sep-09
PTE Ltd. (Hong Kong
2992 0968
Bio-Rad Pacific
Ltd.
N.A.
Bio-Rad Laboratories Anti-Cardiolipin IGM Test Kit (Model# 425-2020)
Health Canada
50175
Type II
07-Sep-09
Diagnostic Systems Laboratories (DSL) Active Cortisol Enzyme
Immunoassay Kit (Model# DSL-10-2000)
Health Canada
50075
Type II
07-Sep-09
Technidata TDWorkstation Working With Sebia Hyris (Model# TD-WST01)
Health Canada
50203
Type II
07-Sep-09
N.A.
N.A.
Accuray CyberKnife Robotic Radiosurgery System (Model#28000)
Health Canada
50252
Type II
07-Sep-09
Accuray Asia Ltd
2247 8628
Invacare Action 3 Comfort
MHRA
2009/001/020/301/002
FSCA
07-Sep-09
Direct Health LTD
N.A.
Invacare Birdie, Birdie Compact, Birdie Plus and Birdie Electrical Mobile
Hoists
MHRA
2009/008/017/261/004
FSCA
07-Sep-09
Direct Health LTD
N.A.
14
man Coulter Hong Ko
2240 6150
MHRA
2009/008/020/081/001
FSCA
07-Sep-09
N.A.
N.A.
Karma Mobility Karma 20" Self Propel Wheelchair
IMTEC (a 3M company) ILUMAVision software, version 2.1.0
MHRA
2009/004/023/401/007
FSCA
08-Sep-09
N.A.
N.A.
Siemens Immulite 2000 Androstenedione (L2KAO) kit, Immulite 2500
Androstenedione (L5KAO) kit
MHRA
2009/008/028/081/007
FSCA
07-Sep-09
Healthcare Diagnost
2810 7533
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.
Medtronic
International Ltd.
2919 1362
Medtronic Enterra Therapy System
Trinity Biotech Multichannel Discrete Analyzer (MDA) II coiled axis tubing
(Product Number BX34138-901, BX45612568)
MHRA
2009/008/025/081/001
FSCA
07-Sep-09
MHRA
2009/007/006/081/015
FSCA
07-Sep-09
N.A.
N.A.
2919 1362
Medrronic
International Ltd
N.A.
08-Sep-09
Medrronic
International Ltd
FDA
N.A.
Press Release
10-Sep-09
Anaheim Medical
2527 9929
MHRA
2009/008/028/081/002
FSCA
10-Sep-09
N.A.
N.A.
BD
N.A.
10-Sep-09
BD
2803 5320
Draeger Stabilet Infant Warming System (Model # 200, 300, 1250, 1500,
200/3000, 2000, 2200/3200, 3000 and 3200)
FDA
Z-1955-2009
Class I
10-Sep-09
N.A.
N.A.
Luv N' Care Gel Filled Teethers - Nuby, Cottontails and Playskool
FDA
Z-1878-2009
Class I
10-Sep-09
N.A.
N.A.
Dreager Heater Elements for Resuscitaire Infant Radiant Warmers
(Model # RW82, RW82 VHA, WBR82 and WMRW82)
FDA
Z-1693-2009
Class II
10-Sep-09
N.A.
N.A.
International Technidyne (ITC) Hemochron Jr. ACT-LR Assay (JACTLR) (Recall#: Z-1732-2009)
FDA
Z-1732-2009
Class II
10-Sep-09
N.A.
N.A.
Amvex Integrated Flowmeter
FDA
Z-1724-2009
Class II
10-Sep-09
N.A.
N.A.
MHRA
2009/008/028/081/009
FSCA
17-Sep-09
N.A.
N.A.
Medtronic Concerto CRT-D and Virtuoso ICD
Conmed PRO5 and PRO6 series handpieces and MC5057 Universal
cable
Biomet Kent Hip Twist Drills (Item No. 31-401478 & 31-401479)
BD Difco Trypsin 250 (Cat No: 215240 & 215250)
CardioChek PTS panels CHOL+HDL+GLU, panel test strips
Siemens Immulite 1000 / 2000 / 2500 hsCRP (high sensitivity CRP)
MHRA
2009/009/009/291/005
FSCA
17-Sep-09
Siemens Immulite 1000 Total T4, LKT4 kit
MHRA
2009/009/003/291/009
FSCA
17-Sep-09
Baxter System 1000 with 4.B.0.9, 4.B.1.1 and 4.B.1.3 software
MHRA
2009/009/007/291/017
FSCA
17-Sep-09
Siemens
Healthcare
Diagnostic Limited
Siemens
Healthcare
Diagnostic Limited
GE Healthcare Seno Advantage 1.x, 2.0 & 2.1
MHRA
2009/009/004/291/015
FSCA
17-Sep-09
GE Medical
Systems Hong
Kong Ltd
IMPAC Medical Systems (Elekta) SEQUENCER for MOSAIQ
MHRA
2009/009/001/291/012
FSCA
17-Sep-09
N.A.
Maquet Harness Safety System for transport of CS300 Intra-Aortic
Balloon Pump
MHRA
2009/009/001/291/021
FSCA
17-Sep-09
GE Healthcare Image Diagnost MammoWorkstation
MHRA
2009/009/004/291/016
FSCA
17-Sep-09
GE Healthcare Uni-Circuit Kit, Adult, Disposable
FDA
Z-1870-2009
Class II
18-Sep-09
Stryker 100ml Autofuser PainPump
FDA
Z-1823-2009 to Z-1868-2009
Class II
Bard Access System Gauderer Genie II, Ponsky, Bard, FASTRAC
FDA
Z-2179-2009 to Z-2207-2009
Class II
15
2810 7533
2810 7533
2807 8516
2783 1838
N.A.
Maquet Hong
Kong LTD.
GE Medical
Systems Hong
Kong Ltd.
GE Medical
Systems Hong
Kong Ltd.
2783 1838
18-Sep-09
Stryker China Ltd
2518 6915
18-Sep-09
N.A.
N.A.
2393 9511
2783 1838
Smith & Nephew Orthopaedics PIP Fixation Hinge Kit (Ref 101638)
FDA
Z-2027-2009
Class II
18-Sep-09
American Optisurgical Horizon Phacoemulsification System (Model HZN2030)
FDA
Z-1808-2009
Class II
18-Sep-09
Smith & Nephew
LTD
9651 5523
N.A.
N.A.
Olympus Hong
Kong and China
Ltd
Boston Scientific
Hong Kong Ltd
Gyrus Acmi (Olympus) PKS SEAL Open Forceps, product codes
3103PK, 3104PK, 3105PK, 915000PK, 915005PK & 915010PK
MHRA
2009/008/019/601/002
FSCA
18-Sep-09
Boston Scientific LATITUDE communicator (model: 6468, 6476)
MHRA
2009/009/009/291/009
FSCA
18-Sep-09
Beckman Coulter SYNCHRON Systems Phenobarbital (PHE) Reagent
MHRA
2009/009/001/601/001
FSCA
18-Sep-09
man Coulter Hong Ko
2240 6150
Ventana Medical Systems (Roche) PATHWAY HER-2/neu (4B5) Rabbit
Monoclonal Primary Antibody
MHRA
2009/009/010/291/005
FSCA
18-Sep-09
Diagnostics (Hong Ko
2485 7510
2170 5678
2960 7136
MHRA
2009/009/007/291/015
FSCA
18-Sep-09
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
18-Sep-09
Boston Scientific
Hong Kong Ltd
2960 7136
Picis Anesthesia Manager (Model# 4220), PACU Manager (Model #
4245) and Critical Care Manager
Health Canada
50507
Type II
21-Sep-09
N.A.
N.A.
Beckman Coulter Synchron CX Immuno-Protein Calibrator (Model#
442840)
Health Canada
50657
Type II
21-Sep-09
man Coulter Hong Ko
2240 6150
21-Sep-09
Carl Zeiss Far East
Co. Ltd
2332 0402
3628 7427
Fenwal AMICUS Separator
Boston Scientific Swiss LithoClast Pneumatic Probes
Carl Zeiss Meditec Stratus OCT Tomographer Vers. 6.0 Software
(Model# Stratus OCT, Software Version 6.0.0)
Health Canada
50625
Type II
Coloplast InterDry Ag (Model# 7910, lot# 1789435)
Health Canada
50228
Type II
21-Sep-09
Coloplast (HK)
LTD
Hurricane Medical Hydrodissector Cannulas (Model# 4027, lot# 90402)
Health Canada
50440
Type II
21-Sep-09
N.A.
N.A.
Philips Medical HeartStart MRx, Defibrillator/Monitor (Model# M3535A,
M3536A)
Health Canada
50623
Type II
21-Sep-09
Philips Health
Care (Great China)
2821 5226
Immucor Galileo 500ul Syringes (Model# 64999, 65050)
Health Canada
50526
Type II
21-Sep-09
GE Healthcare Datex Ohmeda Carestations Interface
Health Canada
47422
Type II
21-Sep-09
Health Canada
50601
Type II
21-Sep-09
Boston Scientific Cobra Electrosurgical System (Model# M00448100,
M00448110, M0048400)
Philips Gyroscan Intera ACS 1.5 Tesla MR System and Intera 1.5 T MR
Systems-Coils
Uninet Technology
LTD
GE Medical
Systems Hong
Kong Ltd
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great China)
2838 8423
2783 1838
2960 7136
Health Canada
50623
Type II
21-Sep-09
Implant Direct Screwplant Implants, Screwplant Healing Collars, Legacy
Healing Collars, Screwindirect implants, Screwplus implants, Screwdirect
implants, replant implants and replus implants
Health Canada
50598
Type II
21-Sep-09
N.A.
N.A.
Biomimed Aquesure Disposable Filters (Lot# 042709, 042309, 042209)
Health Canada
50420
Type II
21-Sep-09
N.A.
N.A.
Cook Sydney IVF Culture Oil (Model# K-SICO-200)
Health Canada
47702
Type II
21-Sep-09
N.A.
N.A.
Immucor Capture-R Ready Screen (4) (Model# 0066802, 0066812, lot#
K226)
Health Canada
50618
Type II
21-Sep-09
N.A.
N.A.
The Anspach Effort Emax 2 Plus System - Foot Pedal (Model# EPLUSFP, Lot# SN C08301701901)
Health Canada
50456
Type II
21-Sep-09
N.A.
N.A.
MHRA
2009/009/014/291/019
FSCA
21-Sep-09
Healthcare (HKSAR
3157 7220
BrainLAB Ltd
N.A.
22-Sep-09
BrainLAB Ltd
2417 1881
Boston Scientific
Hong Kong Ltd
N.A.
23-Sep-09
Boston Scientific
Hong Kong Ltd
2960 7136
Tyco CT9000ADV
BrainLAB Navigation Software Knee (version 2.1.1 and all previous
versions) and/or BrainLAB Planning Software knee (all versions) in
combination with Zimmer INNEX Implants
Boston Scientific Liberte Bare-Metal Coronary Stents
16
2821 5226
ConMed Livatec PowerPro, PowerProMax and Mpower I handpieces
MHRA
2009/008/024/081/010
FSCA
23-Sep-09
N.A.
N.A.
ConMed Linvatec Universal Cable (3.6 metres / 12 feet)
MHRA
2009/008/024/081/009
FSCA
23-Sep-09
N.A.
N.A.
GE Healthcare Proteus XR/a, Revolution XR/d, and Definium 8000
systems with Fixed Table Models # 2259988, 2259988-2, 2351505 and
5131070
MHRA
2009/009/014/291/022
FSCA
23-Sep-09
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
N.A.
23-Sep-09
Boston Scientific
Hong Kong Ltd
2960 7136
Wright Medical CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH.
(Ref 38AM-3604, 38AM-3635)
FDA
Z-1715-2009 to Z-1716-2009
Class II
24-Sep-09
N.A.
N.A.
Med Tec Foot Lok Cushion (Part no. MTAFS01)
N.A.
Varian Medical
Systems Pacific
Inc
N.A.
2724 2836
N.A.
N.A.
Boston Scientific CircuCool Fluid Circulation Pump
FDA
Z-1721-2009
Class II
24-Sep-09
Varian VARiS LINK
MHRA
2009/009/011/291/003
FSCA
24-Sep-09
Mölnlycke ProcedurePak (Lap Chole Pack)
MHRA
2009/009/015/291/010
FSCA
24-Sep-09
MHRA
2009/009/015/291/003
FSCA
24-Sep-09
Arcoma OrbixTop, ArcoSphere
Zimmer Magna -FX Cannulated Screw Fixation
Penumbra Neuron Delivery Catheter 070
BD Probetec ET CT/GC Endocervical Speciment Collection and Dry
Transport System-Pink (Cat no. 440476)
Zimmer PTE Ltd
(Hong Kong
branch)
Synapse
Therapeutics
Limited
BD
Zimmer PTE Ltd.
(Hong Kong
branch)
Synapse
Therapeutics
Limited
N.A.
N.A.
N.A.
24-Sep-09
N.A.
24-Sep-09
N.A.
24-Sep-09
BD
2575 8668
Draeger Medical
Hong Kong Ltd
28773077
N.A.
N.A.
Draeger Medical Sola 500, Sola 500 Mobil, Sola 700 and Stella
MHRA
2009/006/017/291/019
FSCA
25-Sep-09
Mölnlycke ProcedurePak (Lap Chole Pack)
MHRA
2009/009/021/081/012
FSCA
25-Sep-09
Science
International
Corporation
Philips Electronic
Hong Kong Ltd
Uninet Technology
LTD
Sigma-Aldrich
China Inc.
2992 0968
9106 1836
MHRA
2009/008/007/081/016
FSCA
29-Sep-09
Philips Electronic
Hong Kong Ltd
N.A.
29-Sep-09
Immucor Echo Blood Grouping Analyser
MHRA
2009/009/022/081/019
FSCA
30-Sep-09
Sigma-Aldrich Histopaque 1077-1 reagent
MHRA
2009/009/021/081/010
FSCA
30-Sep-09
Trinity Biotech MDA Auto Dimer (Product code: T3103)
MHRA
2009/009/023/081/015
FSCA
30-Sep-09
N.A.
N.A.
BD
N.A.
30-Sep-09
BD
2575 8668
Boston Scientific
Hong Kong Ltd
N.A.
30-Sep-09
Boston Scientific
Hong Kong Ltd
2960 7136
Phadia Varelisa U1RNP Antibodies, 17096
Philips HeartStart FR2 M3860A/M3861A, M3840A/M3841A
BD BBL Lactophenol Cotton Blue Stain Droppers (Cat no 26118)
Boston Scientific Equalizer Occlusion Balloon Catheter
17
2543 7442
2821 5364
2838 8423
N.A.
Monthly Summary of Medical Device Safety Alerts - August 2009
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Boston Scientific Guidant Contak Renewal 3 CRT-D, 3HE CRT-D, 4CRT-D,
4HE CRT-D, 4AVT CRT-D, 4AVT HE CRT-D and Vitality DS VR
FDA
Z-1620-2009 to Z-1621-2009
Class II
2009/08/03
Philips TumorLoc software application (software versions: 23.1.1, 20.7.13 and
20.8.15) and TumorLoc Software Application for the EBW
FDA
Z-1578-2009 to Z-1580-2009
Class II
2009/08/03
Stryker Triathlon Revision Instruments (1,2,7,8 TGC Upper Tray and 3-6 TGC
Upper Tray)
FDA
Z-1618-2009 to Z-1619-2009
Class II
2009/08/03
Stryker China Ltd
2518 6915
Stryker Amico E-Cylinder Canister Holder (Catalog/Product Number: 0682-001111 & 0682-000-449)
FDA
Z-1569-2009
Class II
2009/08/03
Stryker China Ltd
2518 6915
Sybaritic DERMALIFE Spa jet 2G System, Feng Shui 2G, Oceana 2G System,
Takara
FDA
Z-1602-2009 to Z-1605-2009
Class II
2009/08/03
N.A.
N.A.
N.A.
Local Agent
Agent Contact Telephone No
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great
China)
2960 7136
2821 5480
Steris ACS2000 Ambulatory Surgical Table (Model # MTS110003)
FDA
Z-1597-2009
Class II
2009/08/03
Swedish Trading
Co., Ltd
XoranConnect Software version 4.1.0.6
FDA
Z-1577-2009
Class II
2009/08/03
N.A.
N.A.
Stryker PainPump Catheters packaged with PainPump2 (Product code:
0525050000 & 0525158000)
MHRA
2009/003/018/401/006
FSCA
2009/08/03
Stryker China Ltd
2518 6915
B. Braun AV-Set Dialog (R) GB, AV-Set Dialog Standard (R), AV-Set Dialog (R)
Fr & AV-Set Dialog (R) Fr Modified
MHRA
2009/007/021/081/010
FSCA
2009/08/03
B. Braun Medical
Hong Kong
N.A.
Barrington Healthcare (supplied by Hill-Rom) Thermo contour mattress for
hospital beds
MHRA
MDA/2009/051
MDA
2009/08/04
N.A.
N.A.
Siemens Diagnostic Ultrasound System Acuson S2000 (software VA10A,
VA10B, VA10C, VA15 & VA15A)
MHRA
2009/007/008/291/002
FSCA
2009/08/04
Healthcare Diagnos
2810 7533
Unomedical Careline Easi-MT Urine Bag (Product code: 47-60 LBH)
MHRA
2009/005/019/401/007
FSCA
2009/08/04
N.A.
N.A.
Invacare REA Assist wheelchairs
MHRA
2009/001/020/401/015
FSCA
2009/08/04
N.A.
N.A.
Days Healthcare 338 Escape Lite Manual Wheelchair (Model No. 338S/SN)
MHRA
2009/005/005/061/005
FSCA
2009/08/04
N.A.
N.A.
N.A.
Action
2009/08/04
BD
3575 8668
BD Beaver Optimum Blade, 15 Straight
BD
Newdeal Large Qwix Measurer (Ref./Cat. no. 119150)
MHRA
2009/007/029/081/006
FSCA
2009/08/05
N.A.
N.A.
Minerva Dental Silverfil
MHRA
2009/004/029/061/012
FSCA
2009/08/05
N.A.
N.A.
Roche Diagnostics Lightcycler Capillaries (100μL, M-Grade, ID/Cat No.
03612066001)
MHRA
2009/007/009/081/002
FSCA
2009/08/05
iagnostics (Hong Ko
2485 7510
ThermoFisher PO0794A Brilliance U.T.I. Medium
MHRA
2009/007/024/601/001
FSCA
2009/08/05
N.A.
N.A.
Siemens Immulite 2000 & 2500 AlaTOP Allergy Screen (Cat.No. L2KAT2 &
L5KAT2 resp.)
MHRA
2009/007/021/081/002
FSCA
2009/08/05
Healthcare Diagnos
2810 7533
Beckman Coulter Tube Assembly #142, V2, V12 Wash
MHRA
2009/007/030/601/003
FSCA
2009/08/05
an Coulter Hong Ko
2240 6150
FDA
N.A.
Press Release
2009/08/05
N.A.
N.A.
2009/08/06
GE Medical
Systems Hong
Kong Ltd.
2783 1838
Cardinal Health Alaris System
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
18
Class II
Abbott StarClose Vascular Closure System (Part no 14677-01)
FDA
Z-1657-2009
Class II
2009/08/06
Philips IntelliVue Clinical Information Portfolio Software Version D.0
FDA
Z-1654-2009
Class II
2009/08/06
Hitachi CXR4 Computed Tomography (CT) Scanners(version 1.51 or less) and
Hitachii ECLOS Computed Tomography (CT) Scanners (Software version 2.11
or less)
FDA
Z-1651-2009 to Z-1652-2009
Class II
2009/08/06
Siemens Somatom Definition Model AS/AS+ (Model no. 8098027)
FDA
Z-1675-2009
Class II
2009/08/06
FDA
Z-1650-2009
Class II
2009/08/06
FDA
Siemens Syngo Imaging Version V31 Picture Archiving and Communication
System (Model no 10014063)
Blackstone Medical (Orthofix Spinal Implants) ICON Modular Pedicle Screw
System (P/N's 54-90 II, 54-9020, 549030)
Abbott
Laboratories LTD.
Philips Health
Care (Great
N.A.
Siemens
Healthcare
Siemens
Healthcare
2593 2211
2821 5480
N.A.
2810 7533
2810 7533
Z-1655-2009
Class II
2009/08/06
N.A.
N.A.
Kong Ltd
N.A.
Action
2009/08/06
Boston Scientific
Hong Kong Ltd
2960 7136
Dynex Technologies DS2 automated microplate processing system
MHRA
MDA/2009/052
MDA
2009/08/06
N.A.
N.A.
GE AdvantageSim MD versions 7.4 through 7.6 inclusive
MHRA
2009/004/016/061/001
FSCA
2009/08/06
cal Systems Hong K
2783 1838
Penumbra Separator for Neuron Intracranial Access System PSS032 and
PSS041
MHRA
2009/007/031/081/003
FSCA
2009/08/06
N.A.
N.A.
Accuray Cyberknife Robotic Radiosurgery System (Systems SN#128 and
higher with 2005 Edition Robot Controller)
MHRA
2009/007/028/081/004
FSCA
2009/08/06
Accuray Asia Ltd
2247 8628
Kong Ltd
N.A.
Action
2009/08/07
Varian Clinac IX Radio Therapy Delivery System (Model / Catalog# 2100C,
21EXS, CLINAC IX H27, CLINAC IX H29)
Health Canada
50003
Type II
2009/08/10
Beckman Coulter Synchron Rheumatoid Factor (RF) Reagent (Model/Catalog #
475136)
Health Canada
49912
Type II
2009/08/10
an Coulter Hong Ko
2240 6150
Stryker (Howmedical Osteonics) Cancellous Bone Screws and Gap Plate Screw
Health Canada
49712
Type II
2009/08/10
Stryker China Ltd
2518 6915
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
Health Canada
49713
Type II
2009/08/10
Stryker China Ltd
2518 6915
Philips PCR AC-500/PCR AC-5000 Basic System (model/catalog# MCR1511)
Health Canada
46769
Type II
2009/08/10
Health Care (Great
2821 5480
Philips Brilliance 40/64 Slice CT System (Model no 4550 110 02031) & Gemini
TF PET/CT System (Model# 4550 110 09021)
Health Canada
46654
Type II
2009/08/10
Health Care (Great
2821 5480
GE AW Volumeshare -CT Perfusion 4 (Model # 5189396)
Health Canada
48164
Type II
2009/08/10
cal Systems Hong K
2783 1838
GE CIC Pro Clinical Information Centre
Health Canada
46547
Type II
2009/08/10
cal Systems Hong K
2783 1838
Cardinal Health Bypass TGH Kit and Valve TGH Kit
Health Canada
49952
Type II
2009/08/10
N.A.
N.A.
Medrad Stellant CT Dual Injector Systems P3T (Model/Catalog # 3007301,
3010432, 3014849)
Health Canada
49618
Type II
2009/08/10
N.A.
N.A.
Health Canada
49896
Type II
2009/08/10
N.A.
N.A.
Health Canada
48476
Type II
2009/08/10
N.A.
N.A.
Boston Scientific HTA Procedure Set
Boston Scientific Neurovascular Spinnaker Elite Flow Directed Microcatheter
Trinity Biotech Trinclot APTT HS (Product Code: T1204, Lot no R324001)
Arrow (Teleflex Medical) Central Venous Catheterization Set (Model # CS12123-E, CS-15123-E) and Central Venous Catheter (Model # MC-12123, MC15123)
19
Boston Scientific
Hong Kong Ltd
Varian Medical
Systems Pacific
Inc
2960 7136
2724 2836
Posey Soft Belt With Crotch Strap (Model# 4125C) and Breezeline Pelvi Holder
(Model#4411)
Health Canada
49840
Type II
2009/08/10
N.A.
N.A.
Kuschall K-Junior Manual Wheelchair (Model # K-Junior, Lot# 806135534)
Health Canada
49293
Type II
2009/08/10
N.A.
N.A.
Breg Kodiak Power Supply (Lot # 3508, 3908, 4308, 4808)
Health Canada
49511
Type II
2009/08/10
Type II
2009/08/10
Immucor Fetal Bleed Screening Test (Model # 7892, Lot # 17411)
Health Canada
49726
Smith & Nephew LTD
N.A.
Boston Scientific Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Boston Scientific Hong
Catheter, Expo Angiographic (Diagnostic) Catheter
Kong Ltd
N.A.
Smith & Nephew Disposable Blade
Action
Action
2009/08/10
2009/08/10
N.A.
Uninet
Technology LTD
Smith & Nephew
LTD
Boston Scientific
Hong Kong Ltd
N.A.
2838 8423
9651 5523
2960 7136
Aesculap Targon PFT Depth Stop KH535R for Drill KH536R
MHRA
2009/008/004/081/015
FSCA
2009/08/10
N.A.
N.A.
Disc Motion Technologies InLign ARC (TrueDyne PDS) (part no. TDF-0044-20)
MHRA
2009/007/021/291/008
FSCA
2009/08/10
N.A.
N.A.
Uninet
Technology LTD
2838 8423
Immucor Gamma Benelux Gamma ELU-KIT II Buffering Solution
MHRA
2009/007/030/081/002
FSCA
2009/08/10
Wyeth ReFacto AF
MHRA
2009/006/002/081/001
FSCA
2009/08/10
N.A.
N.A.
2593 2211
Abbott ARCHITECT i2000 & i2000SR Analyser (List numbers 8C89, 1G17 &
3M74)
Teleflex Medical Multifit Nebulizer and Multifit Nebulizer with BOC Adapter
(Cat.No.922800 & 922820)
MHRA
2009/007/030/601/004
FSCA
2009/08/10
Abbott
Laboratories LTD.
MHRA
2009/008/003/291/016
FSCA
2009/08/11
N.A.
N.A.
GE Ventri
MHRA
2009/008/011/291/005
FSCA
2009/08/13
2783 1838
Toshiba Multi-plane transoesophageal transducer, model PET-511BTM
MHRA
2008/012/003/291/010
FSCA
2009/08/13
238400688
Stryker Accolade TMZF Hip Stem
FDA
Z-1354-2009 to Z-1684-2009
Class II
2009/08/14
cal Systems Hong K
Sanko Medical
Systems (HK)
LTD
Stryker China Ltd
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
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
PTE Ltd. (Hong Kong
2992 0968
Medtronic INTREPID Spinal System and Coverplate
FDA
Z-1796-2009 to Z-1802-2009
Class II
2009/08/14
Steris Cmax 110v Surgical Table Hand Control
FDA
Z-1599-2009
Class II
2009/08/14
Raytec Yan X-Ray Detectable Gauze
Medronic
International Ltd
Swedish Trading
Co., Ltd
Winner Medical
(Hong Kong) Ltd
2518 6915
2919 1300
N.A.
HA
N.A.
N.A.
2009/08/14
Roche Diagnostics cobas e 411
MHRA
2009/008/005/081/010
FSCA
2009/08/17
iagnostics (Hong Ko
2485 7510
Stryker MIS Diamond Burs
MHRA
2009/008/010/291/001
FSCA
2009/08/17
Stryker China Ltd
2518 6915
ConMed Linvatec UltraPower Diamond Wheel Burs
MHRA
2009/008/011/291/001
FSCA
2009/08/17
ConMed Limited
N.A.
Linet Eleganza 3 and Latera bedframes
MHRA
2009/007/020/601/004
FSCA
2009/08/17
N.A.
N.A.
Fresenius Kabi Ambix activ Set ambulatory (refs. E4302 & 2892095) and Ambix
activ Set stationary (refs. E4529 & 2892098)
MHRA
2009/008/007/601/002
FSCA
2009/08/17
N.A.
N.A.
Zimmer Various targeting components for the Zimmer Natural Nail
MHRA
2009/008/007/081/015
FSCA
2009/08/17
PTE Ltd. (Hong Kong
2992 0968
2009/08/17
B. Braun Medical
Hong Kong
N.A.
Aesculap NN340 Columbus RP Gliding Surface T4/4+ 10mm (lot 51405551)
NN222 Columbus DD Tibial Insert SZ 2/2+ 14mm (lot 51400343)
MHRA
2009/008/006/081/004
20
FSCA
3170 7000
Stryker Scorpio femoral components (Cat.No. 70-3007R, 80-4405L, 80-4407R)
Medtronic LIFEPAK 15 Defibrillator/Monitor
Invacare REA Azalea base
2009/007/029/081/004
FSCA
2009/08/17
Stryker China Ltd
2518 6915
Medtronic
International Ltd.
N.A.
Action
2009/08/17
Medtronic
International Ltd.
2919 1362
MHRA
MHRA
2009/001/007/401/001
FSCA
2009/08/19
Direct Health LTD
N.A.
Hospira AC Power Cords
FDA
N.A.
Press Release
2009/08/20
Hospira Limited
2898 2886
Stryker Trident Hemispherical Acetabular Shell (Part no 508-11-72J)
FDA
Z-1685-2009
Class II
2009/08/20
Stryker China Ltd
2518 6915
Boston Scientific
Hong Kong Ltd
Arjo Huntleigh
(Hong Kong) Ltd.
Johnson &
Johnson Medical
(HK)
Siemens
Healthcare
Diagnostic Limited
Boston Scientific EndoVive Safety PEG Kit and Standard PEG Kit
FDA
Z-1625-2009 to Z-1632-2009
Class II
2009/08/20
Arjo Huntleigh Passive Clip Slings and Flite Clip Slings
FDA
Z-1636-2009 to Z-1637-2009
Class II
2009/08/20
2960 7136
Johnson & Johnson Spine Expedium SFX Cross Connector System Torque
Driver Shaft (REF: 2894-10-300)
FDA
Z-1670-2009
Class II
2009/08/20
Siemens Symbia S Series SPECT System (Part 8717741) and Symbia T Series
SPECT-CT System (Part 10275010)
FDA
Z-1676-2009 to Z-1677-2009
Class II
2009/08/20
Zimmer ITST Intertorchanteric/Subtrochanteric fixation tapered reamer (REF
2258-50-00)
FDA
Z-1701-2009 to Z-1702-2009
Class II
2009/08/20
PTE Ltd. (Hong Kong
2992 0968
Smith & Nephew IMHS CP, 3.2mm, Tip Threaded Guide Pin (Ref 71687000)
FDA
Z-1704-2009
Class II
2009/08/20
Smith & Nephew
LTD
9651 5523
Stat Super-Fine Pen Needles and Allison Medical Sure Comfort Pen Needles
with Silicon Tip
FDA
Z-1596-2009
Class II
2009/08/20
N.A.
N.A.
Arrow Large-Bore Central Venous Catheters
FDA
Z-1671-2009 to Z-1672-2009
Class II
2009/08/20
N.A.
N.A.
TomoTherapy Hi-Art system
MHRA
2009/008/013/081/025
FSCA
2009/08/20
N.A.
N.A.
Teleflex Medical Sher-I-Swiv, Sher-I-Bronch
MHRA
2009/008/013/081/024
FSCA
2009/08/20
N.A.
N.A.
AMO (Abbott Medical Optics, Inc.) WaveScan WaveFront System Offline
Programming Module, international version
MHRA
2009/008/012/291/010
FSCA
2009/08/20
N.A.
N.A.
ConMed Linvatec Lightwave Suction Ablator
MHRA
2009/008/010/291/012
FSCA
2009/08/20
N.A.
Gyrus Acmi (Olympus) PlasmaKinetic SuperSect / PK SuperSect Instrument
MHRA
2009/007/013/601/001
FSCA
2009/08/20
2170 5678
Maquet Servo 300 ventilator (SV300)
MHRA
MDA/2009/056
MDA
2009/08/20
ConMed Ltd
Olympus Hong
Kong and China
Ltd
N.A.
Pride Riser Recliner
MHRA
2008/006/024/401/014
FSCA
2009/08/21
N.A.
N.A.
ConMed Linvatec Arthro-Knife Sheathed Knife
MHRA
2009/008/012/291/012
FSCA
2009/08/21
N.A.
N.A.
Spacelabs Healthcare ECG cable with integrated leadwires (PNs: 700-0008-22,
700-0008-23, 700-0008-24, and 700-0008-25)
MHRA
2009/008/004/291/002
FSCA
2009/08/21
N.A.
N.A.
2783 1838
2508 1416
2738 6027
2810 7533
N.A.
MHRA
2009/008/011/601/003
FSCA
2009/08/21
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)
GE Medical
Systems Hong
Kong Ltd
BrainLAB Ltd
N.A.
Action
2009/08/21
BrainLAB Ltd
2417 1881
GE Instatrak 3500 System (Model # 1006236-001)
Health Canada
49926
Type II
2009/08/24
cal Systems Hong K
2783 1838
GE N-DISVENT-02
21
GE Compax 40E Table (Model # 2208203, 2225864, 2225881)
Health Canada
49649
Type II
2009/08/24
cal Systems Hong K
2783 1838
GE Innova 4100 IQ - Main Unit (Model # 2335129) & Innova 2000
Cardiovascular System (Model no S1872LC)
Health Canada
50099
Type II
2009/08/24
cal Systems Hong K
2783 1838
GE Innova 4100 IQ - Main Unit (Model # 2335129) & Innova 2000
Cardiovascular System (Model no S1872LC)
Health Canada
49983
Type II
2009/08/24
cal Systems Hong K
2783 1838
GE Reusable Metal Needle Guides & Bushings
Health Canada
48986
Type I
2009/08/24
cal Systems Hong K
2783 1838
Stryker (Howmedica Osteonics) Delta Ceramic Ball Heads (Model # 18-3200)
Health Canada
50100
Type II
2009/08/24
Stryker China Ltd
2518 6915
Smith & Nephew 4.0mm Direct Measuring Gauge (Model # 71117083)
Health Canada
49969
Type II
2009/08/24
Siemens Easylink Informatics System (Model# 100034941)
Health Canada
49974
Type II
2009/08/24
Welch Allyn Vital-Signs Monitor
Health Canada
49917
Type II
2009/08/24
Vascular Solutions Twin-Pass Access Catheter (Model# 5200)
Health Canada
49872
Type I
Philips Respironics M Series Humidifier
Celki Medical
Company
Tyco (Nellcor, Puritan Bennett) PediCap End-Tidal CO2 Detectors
Action
Action
N.A.
Smith & Nephew
LTD
Siemens
Healthcare
2648 7700
2810 7533
N.A.
N.A.
2009/08/24
N.A.
N.A.
2009/08/24
Celki Medical
Company
2268 9201
o Healthcare (HKSAR) L
N.A.
2009/08/24
Healthcare (HKSAR
3157 7220
Gebrüder MARTIN Acrobat 2000 Spring Arm
MHRA
2009/008/017/081/011
FSCA
2009/08/24
N.A.
N.A.
Cellestis QuantiFERON-TB Gold TB-Antigen Tubes
MHRA
2009/008/017/081/021
FSCA
2009/08/24
N.A.
N.A.
One Lambda HLA B27 FITC Conjugated Monoclonal Antibody
MHRA
2009/008/014/081/012
FSCA
2009/08/24
N.A.
N.A.
Trinity Biotech Auto D Dimer Kit (Product Number CRS126B)
MHRA
2009/008/017/081/026
FSCA
2009/08/24
N.A.
N.A.
FSCA
2009/08/24
Arjo Huntleigh
(Hong Kong) Ltd.
2508 1416
Arjo Maxi Move Scoop Stretcher (model # KRA2210-20)
MHRA
Össur Hiptric Frame (Item # 980121, 980122, 980123)
MHRA
2009/007/029/401/003
FSCA
2009/08/24
N.A.
N.A.
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.
Action
2009/08/25
BD
2575 8668
Medtronic
International Ltd.
N.A.
Action
2009/08/25
Medtronic
International Ltd.
2919 1362
Ortho-Clinical Diagnostics Veridex LLC CellSearch Circulating Tumor Cell (CTC)
Kit (product code 7900001)
MHRA
2009/008/019/081/011
FSCA
2009/08/26
N.A.
N.A.
Roche ACCU-Chek Softclix Lancing Device, Active Meter Kit, Voicemate Meter,
Aviva Meter Kit, Compact Plus Meter Kit and Coaguchex XS Systems for
Patient Self-testing
FDA
Z-1590-2009 to Z-1595-2009
Class II
2009/08/27
Roche
Diagnostics (Hong
Kong) Ltd
2485 7510
SJM (St. Jude Medical) Peel Away Introducer (REF 405116, 405153)
FDA
Z-1713-2009 to Z-1714-2009
Class II
2009/08/27
GE Drapes and Sterile Covers
FDA
Z-1730-2009
Class II
2009/08/27
2783 1838
Siemens Dimension Cardiac Tropnin I Flex Reagent cartridge (CTNI)
FDA
Z-1731-2009
Class II
2009/08/27
N.A.
GE Medical
Systems Hong
Siemens
Healthcare
X Spine Systems Capless Li Pedicle Screw System
FDA
Z-1694-2009
Class II
2009/08/27
BD CLAY ADAMS Dynac III Centrifuge 120V (Cat/Model no.: 420104)
Medtronic LIFEPAK CR Plus Defibrillator
2009/007/022/291/009
22
N.A.
N.A.
2810 7533
N.A.
Source Production & Equipment M-19 (Iridium 192): Brachytherapy source
Suarez Foot Choice Therapeutic Foot Massager (Model no YS-322)
Johnson & Johnson STERRAD CYCLESURE and CYCLESURE 24 Biological
Indicator(s)
Medtronic Sutureless Connector (SC) Intrathecal Catheters Cot Compatible with
IsoMed Constant - Flow Infusion Pumps
FDA
Z-1717-2009
Class II
2009/08/27
N.A.
N.A.
FDA
Johnson & Johnson
Medical (HK)
Z-1697-2009
Class II
Action
2009/08/27
N.A.
Johnson &
Johnson Medical
(HK)
Medtronic
International Ltd.
N.A.
Medtronic
International Ltd.
N.A.
Action
N.A.
2009/08/27
2009/08/28
2738 6027
2919 1362
Smith Medical Portex Tracheal Tube and Portex Paediatric Tracheal Tube
MHRA
2009/008/013/081/007
FSCA
2009/08/28
N.A.
N.A.
Biomerica EZ PSA and Fortel PSA (Part number 1081)
MHRA
2009/008/024/081/014
FSCA
2009/08/28
N.A.
N.A.
Boston Scientific Renegade Fiber Braided Microcatheters and Renegade Hi-Flo Boston Scientific Hong
Microcatheter
Kong Ltd
Boston Scientific Renegade Fiber Braided Microcatheters, Renegade Hi-Flo
Microcatheter and Renegade Hi-Flo Microcatheter Kits
Kong Ltd
Boston Scientific Contour SE Microspheres
Kong Ltd
Action
Action
N.A.
N.A.
Action
N.A.
23
2009/08/31
2009/08/31
2009/08/31
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
2960 7136
2960 7136
2960 7136
Monthly Summary of Medical Device Safety Alerts - July 2009
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada,
C
d
Source of
Date of Issue
Reference No. by Source Alert Type by Source
Local Agent
(YYYY/MM/DD)
Information*
Siemens E.CAM Patient Handling System (PHS) Field of View (FOV)
Siemens Healthcare
FDA
Z-1505-2009
Class II
2009/07/02
indicator bars (Part no 43 66 618 and 43 81 088)
Diagnostic Limited
Arrow Embolectomy Catheters
Z-1471-2009 to Z-1473-2009
Class II
2009/07/02
Cemma Enterprise Co., Ltd
FDA
Inverness Medical BioSrar Strep A OIA MAX (Product Code 90003)
Z-1506-2009
Class II
2009/07/02
N.A.
FDA
Edwards LifeSciences BM25
2009/006/018/081/010
FSCA
2009/07/02
N.A.
MHRA
GE Medical Systems Hong
GE CT Perfusion 4
MHRA
2009/003/019/061/005
FSCA
2009/07/02
Kong Ltd.
Cardinal Health Alaris GP volumetric pump and Alaris GP Guardrails
MHRA
2009/006/017/291/018
FSCA
2009/07/02
Cardinal Health
volumetric pump
Bausch & Lomb (Hong Kong
Bausch & Lomb
N.A.
2009/07/02
Bausch & Lomb Boston Conditioning Solution Original Formula
(Hong Kong ) Ltd
Action
) Ltd
Agfa NX software
2009/006/029/081/013
FSCA
2009/07/06
AGFA Hong Kong Limited
MHRA
Edwards Lifesciences Fogarty Occlusion Catheter
2009/006/026/081/006
FSCA
2009/07/06
N.A.
MHRA
GE Signa Excite 1.5T MR systems
MHRA
2009/006/024/291/013
FSCA
2009/07/06
Kong Ltd.
Solutions Health Care
Likoscale Adaptor
2009/006/022/301/001
FSCA
2009/07/06
MHRA
Products
Karomed COMM-METAL Supreme Profiling Bed
2009/001/028/301/003
FSCA
2009/07/06
N.A.
MHRA
Sidhil Bradshaw Bariatric Bed
2009/006/016/261/001
FSCA
2009/07/06
N.A.
MHRA
Wescott Medical Sae-Flo
2009/004/014/401/004
FSCA
2009/07/06
N.A.
MHRA
Philips Health Care (Great
Philips Dental Application v4.0.0 to v4.0.1.9999 on the Extended
MHRA
2009/006/010/291/008
FSCA
2009/07/06
Brilliance Workspace
China)
Medtronic
Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump
Firm Initiated Field Actio
2009/07/06
N.A.
International Ltd.
Battery Performance
Philips Intellivue MP70 Patient Monitor System (Model # M8007A)
Health Canada
48839
Type II
2009/07/07
China)
Philips Mulitdiagnost Eleva-Flat Detector and Allura XPER FD10/10-Main
Health Canada
48595
Type II
2009/07/07
Unit
China)
Philips Achieve 3.0T MRI System-Main Unit and Achieva 1.5T MRI
Health Canada
49149
Type II
2009/07/07
China)
System-Main Unit
Philips Brilliance 6/10/16 Slice CT-SERTWR Dent
Health Canada
49151
Type II
2009/07/07
China)
Zimmer ZMR Hip System-Stems
Health Canada
48913
Type II
2009/07/07
Kong branch)
Zimmer Alumina Ceramic Femoral Head
Health Canada
48988
Type II
2009/07/07
Kong branch)
Zimmer 2.7mm Cortical Screw Self-Tapping
Health Canada
48914
Type II
2009/07/07
Kong branch)
Smith & Nephew Disposable Endoscopic Surgery Blades
48408
Type II
2009/07/07
Smith & Nephew LTD
Health Canada
GE Muse Cardiology Information System
Health Canada
46833
Type II
2009/07/07
Kong Ltd.
GE Carescape V100
Health Canada
46236
Type II
2009/07/07
Kong Ltd.
Varian Medical Systems
Varian Aria Radiation Oncology
Health Canada
49074
Type II
2009/07/07
Pacific Inc.
Getinge Washer Disinfectors with transformer
48035
Type II
2009/07/07
N.A.
Health Canada
Data Innovations Instrument Manager
48997
Type II
2009/07/07
N.A.
Health Canada
Picis OR Manager, Preop Manager, Anesthesia Manager, PACU
Health Canada
48937
Type II
2009/07/07
N.A.
Manager, Critical Care Manager
Boston Scientific
Boston Scientific Hong Kong
N.A.
2009/07/08
Boston Scientific Flexima Biliary Catheter System
Ltd
Hong Kong Ltd
Action
24
Agent Contact
Telephone No
2810 7533
2412 2310
N.A.
N.A.
2783 1838
N.A.
2213 3371
2555 9421
N.A.
2783 1838
2688 2933
N.A.
N.A.
N.A.
2821 5480
2919 1362
2821 5480
2821 5480
2821 5480
2821 5480
2992 0968
2992 0968
2992 0968
2992 0968
2783 1838
2783 1838
2724 2836
N.A.
N.A.
N.A.
2960 7136
Respironics BiPAP Focus Noninvasive Ventilator System
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate
(Model no. 6420-00-002, 6420-01-002, 6420-00-200, 6420-01-200)
FDA
Z-1606-2009
Class I
2009/07/09
FDA
Z-1482-2009 to Z-1485-2009
Class II
2009/07/09
Kong branch)
Kong branch)
Kong branch)
China)
Kong Ltd.
2268 9258
2992 0968
2992 0968
Zimmer Steinmann Pins (Model no. 00-0187-03-69)
FDA
Z-1481-2009
Class II
2009/07/09
Zimmer Gender Solutions Natural Knee Flex System (Product No. 005410-017-01)
FDA
Z-1477-2009
Class II
2009/07/09
Philips Brilliance iCT software v2.5.0 (Model 728306)
FDA
Z-1582-2009
Class II
2009/07/09
GE Centricity PACS Software
FDA
Z-1549-2009
Class II
2009/07/09
FDA
Z-1474-2009 to Z-1476-2009
Class II
2009/07/09
Kong Ltd.
2783 1838
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System;
Innova 3100/3100IQ Cardiovascular Imaging System and Innova
4100/4100IQ Cardiovascular Imaging System
Stryker Xia Dual Anterior Staple (Catalog no. 03820115)
Biomet OSS FINN Proximal Femoral Trial, OSS Letson Proximal Femoral
Trial, OSS Elliptical Proximal Femoral Tra
Bard StartLock Intravenous (IV) Catheter Stabilization Kit (Catalog no
IVK0124)
Arrow various devices
Ascension Normed TX8 Driver (Catalog no 503004268)
Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling Tube
Mount (DCTM)
BD 60ml Lurt-Lok Syringes (Recorder Number 309653; Lot No.:
819101A)
Boston Scientific Flexima and Percuflex drainage catheter family (pigtail
style, peripheral interventions), Percuflex and percutaneous model
drainage catheter family (urology)
Medtronic Model 8551 Synchromed Refill Kits w/ reversed UBD and Mfg
Dates
Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT-397,
MMT-398 and MMT-399
Boston Scientific LeVeen Needle Electrodes - 5.0cm
Zimmer Intertrochanteric / Subtrochanteric Fixation Tapered Reamer 002258-050-00
Smith & Nephew Disposable Impactor Cap 74120152 for use with BHR
Acetabular Cups
Aidapt VB539 Solo Deluxe Shower Seat and VB535 Solo Deluxe Shower
Seat with Pads
Unipath Clearview hCG Pregnancy Test 506788
2992 0968
2821 5480
2783 1838
FDA
Z-1525-2009
Class II
2009/07/09
Stryker China Ltd
2518 6915
FDA
Z-1526-2009 to Z-1531-2009
Class II
2009/07/09
N.A.
N.A.
FDA
FDA
FDA
Z-1539-2009
Z-1489-2009 to Z-1503-2009
Z-1524-2009
Class II
Class II
Class II
2009/07/09
2009/07/09
2009/07/09
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
FDA
Z-1247-2009
Class II
2009/07/09
N.A.
N.A.
BD
N.A.
Action
2009/07/09
BD
2575 8668
MHRA
MDA/2009/043
MDA
2009/07/10
Ltd
2960 7136
2009/07/10
2919 1362
2919 1362
Medtronic
International Ltd.
Medtronic
International Ltd.
Boston Scientific
Hong Kong Ltd
Action
Action
Action
N.A.
N.A.
N.A.
2009/07/10
2009/07/10
MHRA
2009/006/008/291/011
FSCA
2009/07/13
MHRA
2009/006/019/601/002
FSCA
2009/07/13
Ltd
Kong branch)
Smith & Nephew LTD
2960 7136
2992 0968
2648 7700
MHRA
2009/006/029/261/001
FSCA
2009/07/13
N.A.
N.A.
MHRA
2009/005/011/291/018
FSCA
2009/07/13
N.A.
Zimmer Dynesys Top Loading Spacer Cutter
MHRA
2009/006/018/291/006
FSCA
2009/07/13
Microm (a part of ThermoFisher Scientific) STP 420D Tissue Processor
Biodiagnostics MPO QuickCard
Nopac Healthcare Chelmer 200
MHRA
MHRA
MHRA
2009/006/023/291/002
2009/006/023/601/001
2009/006/002/301/001
FSCA
FSCA
FSCA
2009/07/13
2009/07/13
2009/07/14
Siemens Stratus CS Acute Care Troponin I CalPak.
FDA
Z-1246-2009
Class II
2009/07/20
Genicon Suction irrigation device (Cat no. 700-005-010, 700-010-005)
Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling Tube
Mount (DTCM)
RSW International First Steps medicine feeder
FDA
Z-1406-2009 to Z-1407-2009
Class II
2009/07/20
N.A.
Kong branch)
N.A.
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
N.A.
FDA
Z-1247-2009
Class II
2009/07/20
N.A.
N.A.
MHRA
MDA/2009/045
MDA
2009/07/21
N.A.
N.A.
2992 0968
N.A.
N.A.
N.A.
2810 7533
N.A.
Vital Signs Broselow / Hinkle Pediatric Emergency System Intraosseus
Modules
MHRA
2009/007/006/081/012
FSCA
2009/07/21
N.A.
N.A.
Aqua Joy Premier Plus and Junior Plus bathlifts
MHRA
2008/005/007/401/005
FSCA
2009/07/21
N.A.
N.A.
25
Zimmer Nexgen Rotating Hinge Knee-Femoral Component and Nexgen
Rotating Hinge Knee-Tibial Component
Baxter Isolex 300 and 300I Magnetic Cell Separator
Abbott Stat G3+ Cartridges (Model no.: 06F03-01 and 06F03-02; Lot:
P08321C)
Brainlab M3 Micro-MLC for Varian with MLC (Model: 41600-3, 41600-5,
41600-6)
Litecure LCT-1000 Therapy Laser
Nobel Biocare Impression Coping Closed Tray Regular Platform 05x9mm
(Lot 687218)
Hill-Rom Flexicair (Model I3000, M4000)
Wallac Delfia Xpress PAPP-A Kit (Model no. 6003-0020)
Gyrus Acmi (Olympus) Sur-Catch No Tip Nitinol Stone Basket (Model no.
5711222)
Vygon Neonatal / Paediatric 96 hour I.V. Filter 0807.204
Penumbra Neuron Delivery Catheter 053
Elekta Desktop Pro
Bemis Quick Fit 3000cc Suction Liner
Medos Medizintechnik Hilite Oxygenators (models 7000, 7000LT, 2800,
2400LT, 1000 & 800LT)
Siemens Stratus CS Acute Care Troponin I CalPak
Medtronic One Source Pack, One Source Pack Magellan and Ideal
MAXPAC Total System
GE Centricity PACS RA 1000 Workstation software (for diagnostic image
analysis)
Philips TumorLoc Software for the Brilliance Big Bore (BB) and the CT
Extended Brilliance Workstation (EBW) (Model # 4550 116 02431)
Johnson & Johnson Sterrad 50 Sterilizer (Product Code 10050)
Sybaritic Hydration Station with Pedestal (Part # E30003-01 and E3000301D)
Gendex VixWin Platinum Imaging Software, versions 1.0, 1.1 and 1.2
Radiometer Waste bottles Part No/Article no. a) 905-590/D512 and b)
905-802/D513
Biomet 3i ACT3020 Twist Drills
One Lambda Flow Class I and Flow Class II Positive Control Serum
Oxoid Oxidase Identification Sticks BR0064A
Intuitive Surgical Da Vinci S Surgical System
Boston Scientific Prolieve Thermodilatation System Kit
Stryker E-Cylinder Canister Holder (Model# 0682-000-449, 0682-001111)
Stryker Dall Miles Trochanter Cable Grip System (Model # 6704-0-210;
Serial # 29233201)
Stryker S3 Med/Surg Bed Fowler (Model# 302S3-000-000) and Secure II
Med/Surg Bed Fowler (Model# 3002-000-000)
Stryker Trident Acetabular Surgical Protocol
Smith & Nephew Genesis II Femorals (Model # 71420026, Lot #
08HM17084)
Smith & Nephew Exogen Bone Healing System (Model # 71034101)
Smith & Nephew BHR Acetabular Cups (Model#74120152)
2009/07/22
Kong branch)
2807 8516
2009/07/22
2593 2211
2417 1881
Health Canada
49105
Type II
2009/07/22
Health Canada
48344
Type II
Health Canada
48497
Type II
Health Canada
47235
Type II
2009/07/22
BrainLAB Ltd
Health Canada
49192
Type II
2009/07/22
N.A.
N.A.
Health Canada
48621
Type II
2009/07/22
Nobel Biocare Asia Ltd
2845 1266
Health Canada
Health Canada
49146
48607
Type II
Type II
2009/07/22
2009/07/22
N.A.
N.A.
Health Canada
49030
Type II
2009/07/22
MHRA
MHRA
MHRA
MHRA
2009/007/010/601/002
2009/007/010/081/010
2009/003/010/291/010
2009/006/019/601/003
FSCA
FSCA
FSCA
FSCA
2009/07/22
2009/07/22
2009/07/22
2009/07/22
N.A.
N.A.
Olympus Hong Kong and
China Ltd
N.A.
N.A.
N.A.
N.A.
MHRA
2009/006/025/081/008
FSCA
2009/07/22
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
2810 7533
Medtronic Internation Ltd
2919 1362
FDA
Z-1555-2009
Class II
2009/07/23
FDA
Z-1550-2009 to Z-1552-2009
Class II
2009/07/23
FDA
Z-1543-2009
Class II
2009/07/23
FDA
Z-1542-2009
Class II
2009/07/23
FDA
Z-1570-2009
Class II
2009/07/23
FDA
FDA
Z-1245-2009
Z-1548-2009
Class II
Class II
2009/07/23
2009/07/23
Kong Ltd.
China)
Johnson & Johnson Hong
Kong Ltd
N.A.
N.A.
2170 5678
N.A.
N.A.
N.A.
N.A.
2783 1838
2821 5480
2738 6027
N.A.
N.A.
FDA
Z-1554-2009
Class II
2009/07/23
N.A.
N.A.
MHRA
MHRA
MHRA
MHRA
Boston Scientific
Hong Kong Ltd
Health Canada
2009/007/017/081/002
2009/007/003/081/001
2009/007/006/601/008
2009/007/006/081/011
FSCA
FSCA
FSCA
FSCA
2009/07/23
2009/07/24
2009/07/24
2009/07/24
N.A.
N.A.
N.A.
N.A.
N.A.
Firm Initiated Field Actio
2009/07/24
49172
Type II
2009/07/27
Ositek (Hong Kong) Inc. Ltd
N.A.
N.A.
N.A.
Ltd
Stryker China Ltd
2518 6915
Health Canada
49278
Type II
2009/07/27
Stryker China Ltd
2518 6915
2960 7136
Health Canada
49199
Type II
2009/07/27
Stryker China Ltd
2518 6915
Health Canada
Health Canada
Health Canada
Health Canada
49269
49201
49177
49557
Type II
Type II
Type II
Type II
2009/07/27
2009/07/27
2009/07/27
2009/07/27
Stryker China Ltd
Smith & Nephew LTD
Smith & Nephew LTD
Smith & Nephew LTD
Sanko Medical Systems
(HK) LTD
Kong branch)
Kong) Ltd
2518 6915
2648 7700
2648 7700
2648 7700
Toshiba Digical Radiography Imaging System (Model# TFD-3000A1/WV)
Health Canada
49202
Type II
2009/07/27
Zimmer Coonrad/Morrey Total Elbow System (Model # 32-8105-038-00;
Lot# 61249897, 61249899)
Health Canada
49362
Type II
2009/07/27
Roche Amplilink Software v 3.1.1, v 3.1.2, v3.2, v3.2.1, v3.2.2
Health Canada
48878
Type II
2009/07/27
2992 0968
26
238400688
2992 0968
2485 7510
Cardiac Science Quinton QStress TM55 Stress Treadmill (Serial #
11040079567, 11040079568)
Advanced Bionics Removable Magnet Hires 90K (Model# CI 1400-01,
CI-1400-01, CI-1400-02H)
Trinity Biotech Mumps IgM 1 Plate (Trinity Elisa Kit Model# 2325960)
Medtronic Integrated Power Console System (Ref# 1898001 & EC300)
Innogenetics INNO-LIA HCV Score (product code: 80538)
Innogenetics Innotest hPLAP (product code: 80326)
Philips BrightView Gamma Camera
Cyberonics VNS Therapy Programming Software, used with VNS
Therapy Pulse and Pulse Duo Generators
Mountway CU-3000 Smart Charger (for use with Neptune and Aquila)
Össur Icelock Expulsion Valve 551
Stryker Various titanium bone screws and modular join prostheses
Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D 5.1.
Applied Medical Resources 15x100mm Kii Optical Access System, nonthreaded
Remploy Access heavy duty manual wheelchair
Boston Scientific RF Ablation System Foot Switch used with EPT-1000
Cardiac Ablation Systems (Cat#840)
Abbott Clinical Chemistry Total Bilirubin (List number: 6L45-20 & 6L45-40)
Health Canada
49032
Health Canada
49409
Vastec Medical
Limited
Medtronic
International Ltd.
MHRA
MHRA
MHRA
Type II
2009/07/27
N.A.
N.A.
Type II
2009/07/27
N.A.
N.A.
2009/07/27
Vastec Medical Limited
2897 1912
2009/07/27
2919 1362
2009/007/017/081/005
2009/007/017/081/001
Action
Action
FSCA
FSCA
2009/07/27
2009/07/27
N.A.
N.A.
2009/007/020/291/020
FSCA
2009/07/27
N.A.
N.A.
China)
N.A.
N.A.
2821 5480
MHRA
2009/007/021/081/008
FSCA
2009/07/27
N.A.
N.A.
MHRA
MHRA
MHRA
MHRA
2009/007/021/301/001
2009/006/025/081/007
2009/007/008/081/004
MDA/2009/048
FSCA
FSCA
FSCA
MDA
2009/07/27
2009/07/27
2009/07/27
2009/07/29
N.A.
N.A.
Stryker China Ltd
N.A.
N.A.
2518 6915
2555 9421
MHRA
2009/006/015/291/028
FSCA
2009/07/29
N.A.
N.A.
MHRA
Boston Scientific
Hong Kong Ltd
MHRA
2009/004/029/401/010
2009/07/29
2009/07/30
Roche Diagnostics CoaguChek XS, CoaguChek XS Plus
MHRA
2009/007/016/081/002
FSCA
2009/07/31
DePuy LCS Duofix Femoral Component
Trulife RM512700 extra long double adjustable soft handle elbow
crutches
Roche Diagnostics Factor V Leiden Kit
MHRA
2009/007/024/081/003
FSCA
2009/07/31
MHRA
2009/007/007/401/005
FSCA
2009/07/31
MHRA
2009/007/015/081/009
FSCA
2009/07/31
Maxter Cathéters Oral / enteral feeding syringe
MHRA
2009/001/016/401/004
FSCA
2009/07/31
N.A.
Ltd
Kong) Ltd
(HK)
N.A.
Kong) Ltd
N.A.
N.A.
2009/007/010/601/001
FSCA
Action
FSCA
N.A.
27
2009/07/29
2960 7136
2593 2211
2485 7510
2738 6027
N.A.
2485 7510
N.A.
Monthly Summary of Medical Device Safety Alerts - June 2009
Source of
Reference No. by
Alert Type by
Date of Issue
Agent Contact
Local Agent
(YYYY/MM/DD)
Information*
Source
Source
Telephone No
Hologic Discovery and Explorer X-ray Bone Densitometer Systems
2009/004/029/061/013
FSCA
2009/06/01
N.A.
N.A.
MHRA
CME McKinley T34 Syringe Driver
2009/004/028/291/009
FSCA
2009/06/01
N.A.
N.A.
MHRA
GE Medical
GE Signa Ovation systems with CTL Array, XL Body Flex and Open Body Coils
FSCA
2009/06/01
2783 1838
MHRA
Systems Hong
2009/003/012/061/013
Kong Ltd.
ThermoFisher Scientific Salmonella Chromogenic medium PO0958A
2009/005/008/601/004
FSCA
2009/06/01
N.A.
N.A.
MHRA
DePuy PFC Sigma Cruciate Retaining Non-Porous Size 5 Left Femoral
MHRA
2009/005/014/081/001
FSCA
2009/06/01
N.A.
N.A.
Component
KeyMed, Olympus, Aloka WM-NP1 (Workstation)
2009/005/007/061/003
FSCA
2009/06/01
N.A.
N.A.
MHRA
Stryker Triathlon TS Knee System Offset Adapter Trial
2009/005/013/081/011
FSCA
2009/06/01
Stryker China Ltd
2518 6915
MHRA
Teleflex Medical (Athlone) Arrow 12 French Triple-Lumen 20cm & 16cm LargeMHRA
2009/005/014/081/003
FSCA
2009/06/01
N.A.
N.A.
Bore Central Venous Catheters
Moria Evolution 3E
2009/003/023/401/006
FSCA
2009/06/01
N.A.
N.A.
MHRA
Welch Allyn Vital Signs Monitor VSM 300
2008/012/005/601/002
FSCA
2009/06/01
N.A.
N.A.
MHRA
Aerocrine NIOX and NIOX Flex, 03-1000 resp 03-1000-F
2009/005/014/051/012
FSCA
2009/06/01
N.A.
N.A.
MHRA
Siemens
Siemens Medical Acuson X300 System with Swiftlink Connector DL260
MHRA
2009/005/014/081/012
FSCA
2009/06/01
2810 7533
Healthcare
Medical Devices Group Computer treatment planning
2009/005/017/601/002
FSCA
2009/06/01
N.A.
N.A.
MHRA
Smith & Nephew Legion Pressfit Stems 71424053 & 71424043
2009/004/016/051/009
FSCA
2009/06/01
N.A.
N.A.
MHRA
Stryker Mantis Rod Inserter Shaft
2009/005/006/061/001
FSCA
2009/06/01
N.A.
N.A.
MHRA
ThermoFisher PB0378A
2009/005/006/601/001
FSCA
2009/06/01
N.A.
N.A.
MHRA
ThermoFisher PO1110A
FSCA
2009/06/01
N.A.
N.A.
MHRA
2009/005/006/601/002
Roche Diagnostics Elecsys Folate III
FSCA
2009/06/01
2009/004/029/061/008
Diagnostics (Hong Ko
2485 7510
MHRA
Merit Medical Systems Prelude Short Sheath Introducer
2009/004/024/051/002
FSCA
2009/06/01
King Health Limited
2481 3787
MHRA
CalMed Op-Flex Poole (Handle Set) contained within Procedure Packs
2009/005/014/291/013
FSCA
2009/06/01
N.A.
N.A.
MHRA
Siemens
Siemens Medical ACUSON Sequoia, auxiliary CW transducer
MHRA
2009/005/014/081/013
FSCA
2009/06/01
2810 7533
Healthcare
Park World
Medmont E300 Corneal Topographer, DV2000 Digital Imaging Software and
2880 9689
Health Canada
45746
Type II
2009/06/02
Development Ltd
M700 Automated Perimeter
Ethicon (JNJ) Endopath Endoscopic Linear Cutters (Model # LONG45A;
Health Canada
47966
Type II
2009/06/02
N.A.
N.A.
ATB45, ATW45; NAW45)
CMS Focal Software CD
48015
Type II
2009/06/02
N.A.
N.A.
Health Canada
Uninet Technology
Immucor Gallileo Echo Blood Analyzer (Model 87000)
Health Canada
47888
Type II
2009/06/02
2838 8423
LTD
FisherDiagnostics Infinity Glucose Hexokinase Reagent (Catalog # TR15498)
47989
Type II
2009/06/02
N.A.
N.A.
Health Canada
Premier Dental Integra CEM (Model# 3001410)
48059
Type II
2009/06/02
N.A.
N.A.
Health Canada
Otto Bock Asia
Leckey Four-point Pelvic Harness (Model no 122-719)
Health Canada
47922
Type II
2009/06/02
2598 9772
Pacific Limited
Sunrise Mobility Quickie LXI Manual Wheelchair (Model# LXI-034741, LXIHealth Canada
47380
Type II
2009/06/02
N.A.
N.A.
034609, LXI-034740, LXI-034500)
Beckman Coulter Synchron Systems Ammonia (AMM) Reagent
2240 6150
47835
Type II
2009/06/02 man Coulter Hong Ko
Health Canada
(Model#439770)
47987
Type II
2009/06/02
N.A.
N.A.
Sonomed Vumax Ophthalmic Ultrasound Scanner (Model#SHFS35-S)
Health Canada
Boston Scientific
2960 7136
Boston Scientific Contak Renewal 4 CRT-D and Vitality 2 Acid
Health Canada
47031
Type II
2009/06/02
Hong Kong Ltd
MEDEX SBI Injector
2009/003/010/601/001
FSCA
2009/06/03
N.A.
N.A.
MHRA
Promotal SAS Quest and Duolys exam couches and Ambéo, 3181 and 3185
2009/005/011/291/012
FSCA
2009/06/03
N.A.
N.A.
MHRA
chairs
GE Healthcare Definium 5000 digital X-ray systems
2009/005/007/051/002
FSCA
2009/06/03
N.A.
N.A.
MHRA
Siemens
Siemens Medical Symbia S and Symbia T
MHRA
2009/003/016/291/004
FSCA
2009/06/03
2810 7533
Healthcare
Marflow AG - Medical Equipment Grabit 3 prong grasping forcep
2009/002/027/401/005
FSCA
2009/06/03
N.A.
N.A.
MHRA
28
Corin Uniglide Unicondylar Knee - femoral component
MHRA
Varian Medical
Systems Pacific Inc.
2009/004/023/061/002
FSCA
Action
2009/06/03
Depuy (JNJ) Knee Replacement Implant
MHRA
MDA/2009/037
MDA
2009/06/04
Arjo Maxilift
Beckman Coulter AutoMate Sample Processing Systems
MHRA
2009/004/016/261/001
FSCA
2009/06/05
MHRA
2009/005/014/601/001
2009/06/05
BD Syringe 10ml Luer-Lok
BD
N.A.
FSCA
Action
GE Healthcare ApexPro Telemetry System
FDA
Z-1227-2009
Class II
2009/06/08
Alcon 25 GA Total Plus Pak and Vitrectomy 25 GA Custom Pak
FDA
Z-1412-2009 to Z1413-2009
Class II
2009/06/08
Kimberly-Clark Synthetic Powder Free Vinyl Exam Gloves (Size: S, M and L)
(Cat. No. 55031, 55032, 55033)
FDA
Z-1414-2009
Class II
2009/06/08
Abbott ARCHITECT Reaction Vessel (List no 7C15-01)
FDA
Z-1398-2009
Class II
2009/06/08
FDA
Z-1398-2009
Class II
2009/06/08
Varian Clinacs with C Series version 7.x and the SRS Motion Disable Option
N.A.
2009/06/03
2009/06/05
Abbott Cell-Dyn Ruby Hematology Analyzer with System Softare Version
2.0ML (List no. 08H67-01)
Siemens Medical Immulite 2000 and Immulite 2500 digital Fluidics PC Board
(Part no. 450116-0002)
MEDRAD Sterile Disposable Syringe Kit (Catalog. no DSK 130-Q)
FDA
Z-1399-2009
Class II
2009/06/08
FDA
Z-1228-2009
Class II
2009/06/08
Synthes Spine Square Nut MR Safe (Catalog no. 03.311.060)
FDA
Z-1324-2009
Class II
2009/06/08
Class II
2009/06/08
Synthes Spine InSitu Bender Cutter Kit Wide Sterile (Cat. No. 530.521S) and
InSitu Bender Cutter Kit Narrow Sterile (Cat. No. 530.522S)
Zimmer TM-400 Broach Handle
AGA Medical Amplatzer Cardiac Plug
Zimmer TransFx External Fixation System drill bit, quick connect
MHRA
MHRA
MHRA
Z-1248-2009 to Z1249-2009
Z-1267-2009 to Z1307-2009
2009/005/011/291/010
2009/002/018/291/006
2009/005/007/061/017
Ortho-Clinical Diagnostics Veridex LLC CellTracks AutoPrep System
MHRA
MHRA
Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire
Biomet Microfixation Arthrosimplicity and OnPoint Scope kits, Becton Dickinson
syringe component
Siemens Medical Immulite 2000 / Immulite 2500 Chemiluminescent Substrate
Module
Trinity Biotech TriniCAL Reference Plasma and TriniCHECK Control Levels 1,
2&3
Beckman Coulter UniCel DxC 880i, 860i, 680i & 660i Synchron Access Clinical
Systems
Invacare Harrier Plus, HD & XHD
FDA
FDA
2508 9553
2240 6150
2575 8668
2783 1838
2568 0636
2334 3361
2593 2211
2593 2211
2810 7533
65-6752 5318
2724 2032
2724 2032
2009/06/08
N.A.
N.A.
2009/06/08
2009/06/08
2009/06/08
2992 0968
N.A.
2992 0968
2009/005/012/081/014
FSCA
2009/06/08
PTE Ltd. (Hong Kong
N.A.
PTE Ltd. (Hong Kong
Ortho Clinical
Diagnostics
2009/004/002/601/001
FSCA
2009/06/08
N.A.
N.A.
Siemens
Healthcare
N.A.
MHRA
2009/005/027/081/003
FSCA
2009/06/08
MHRA
2009/005/027/291/008
FSCA
2009/06/08
MHRA
2009/005/021/601/001
FSCA
2009/06/09
man Coulter Hong Ko
N.A.
Philips Health Care
(Great China)
N.A.
Gambro Hong
Kong Ltd
N.A.
GE Medical
Systems Hong
Kong Ltd.
N.A.
N.A.
N.A.
2007/005/024/061/002
FSCA
2009/06/09
2009/005/028/051/005
FSCA
2009/06/09
MHRA
Gambro Hong Kong
Ltd
MHRA
2009/005/029/081/003
FSCA
Action
2009/005/028/051/010
FSCA
2009/06/09
N.A.
2009/06/10
GE Healthcare Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ & 3131IQ
MHRA
2009/006/002/081/006
FSCA
2009/06/11
Tosoh Bioscience Hemoglobin F&A2 control set
Trinity Biotech TriniCLOT aPPT HS
EBI Titanium Cannulated Screws and Bone Screws
MHRA
MHRA
MHRA
2009/005/014/051/010
2009/005/022/081/001
2009/004/024/601/004
FSCA
FSCA
FSCA
2009/06/11
2009/06/11
2009/06/11
GE Medical
Systems Hong
Kong Ltd.
Alcon Hong Kong
Ltd
Kimberly-Clark
(Hong Kong)
Abbott
Laboratories LTD.
Abbott
Laboratories LTD.
Siemens
Healthcare
Medrad Asia
Pte Ltd
Synthes (Hong
Kong) Ltd
Synthes (Hong
Kong) Ltd
2738 6027
FSCA
FSCA
FSCA
MHRA
Mölnlycke Phaco Pack Shepton Mallet JAV 17177
Gambro AK200 S equipped with UFD and AK 200 ULTRA S in combination
with BiCart Select
Allergan Medical FloWatch-PAB
BD
N.A.
2724 2836
Class II
MHRA
Philips Synergy Flex-M / Shoulder Coil
N.A.
Varian Medical
Systems Pacific
Johnson &
Johnson Medical
ArjoHuntleigh
(Hong Kong) Ltd
man Coulter Hong Ko
29
2009/06/11
2737 5504
2810 7533
N.A.
2240 6150
N.A.
2821 5480
N.A.
2839 9710
N.A.
2783 1838
N.A.
N.A.
N.A.
Philips MD Allura FD
Varian Eclipse Treatment planning System, version 8.6 and earlier (Product
Code: H48)
Stryker Gamma3 Plus Obese Targeting System, Gamma3S Trochanteric Nail
170 and Gamma 3
Stryker Surgical Table Headrest (Catalog/Part # 0788-300-012)
Terumo Advanced Perfusion System 1 Central Control Monitor (Catalog no
802100)
Biomet Dual Offset Broach Handle, Clamping Style, Left (REF 31-555403) and
Right (REF 31-555404)
Spectranetics SLS II Lasr Sheath Kit, 14F (REF 500-012)
Varian CLINAC Software Versions 6.X and 7.X (Remote Auto Motions)
Zimmer Nexgan LPS and Nexgen LPS-Flex Femoral Components
Roche PSM with Validation Module (Model# 03009696001, 03265439001)
MHRA
Varian Medical
FDA
FDA
FDA
FDA
FDA
Varian Medical
Health Canada
Health Canada
2009/006/003/291/017
FSCA
2009/06/12
N.A.
Action
2009/06/12
Class II
2009/06/15
Stryker China Ltd
2518 6915
2009/06/15
2518 6915
Z-1224-2009
Class II
2009/06/15
Stryker China Ltd
TERUMO CHINA
(H.K.) LTD.
Z-1352-2009 to Z1353-2009
Z-1264-2009
2866 0811
Class II
2009/06/15
N.A.
N.A.
2009/06/15
47890
Type II
2009/06/15
N.A.
Varian Medical
Systems Pacific
PTE Ltd. (Hong Kong
Roche Diagnostics
(Hong Kong) Ltd
Abbott
Laboratories LTD.
Stryker China Ltd
Siemens
Healthcare
N.A.
48206
Class II
Action
Type II
N.A.
2009/06/15
2009/06/15
Health Canada
48245
Type II
2009/06/15
Health Canada
48207
Type II
2009/06/15
Siemens Acuson S2000 VA10 (Model / Catalog# 10041461)
Health Canada
48077
Type II
2009/06/15
Cook Zenith Renu AAA Converter, Zenith Renu AAA Main Body and Zenith
AAA Main Body Bifurcated Stent
Medline Penrose Drain
Ansell Healthcare Derma Prene Ultra Surgical Glove (Model/Catalog # 851365
/ 851470)
Motion Concepts Tilt/Elevating Seating System and Tilt/Elevate/Recline Seating
System
Walter Lorenz Surgical (Biomet Microfixation) Dean Scissors (Model: 09-0142)
Health Canada
46283
Type II
Health Canada
47701
Type II
Viewsonic VGM 19" Monitor
Health Canada
48079
Type II
2009/06/15
ThermoFisher PO0171A brilliant green agar
Heliosphere Bag Intragastric Balloon
2722 8122
Class II
Abbott i-STAT 1 Analyzer System-Instrument (Model/Catalog # 06F16-10)
Abbott POWERSAIL Coronary Dilatation Catheter
2821 5480
Z-1349-2009 to Z1351-2009
Z-1418-2009
Stryker Austin Moore Stems - Curved 43mm (Model/Catalog# 6939-0-430)
Roche Accu-chek Performa
Philips Health Care
(Great China)
Varian Medical
Systems Pacific
2722 8122
2992 0968
2485 7510
2593 2211
2518 6915
2810 7533
Health Canada
47349
Type II
2009/06/15
N.A.
N.A.
Health Canada
48072
Type II
2009/06/15
N.A.
N.A.
Health Canada
48229
Type II
2009/06/15
N.A.
N.A.
2009/06/15
N.A.
N.A.
2009/06/15
N.A.
ViewSonic Hong
Kong
Roche Diagnostics
(Hong Kong) Ltd
Abbott
Laboratories LTD.
N.A.
N.A.
GE Medical
Systems Hong
Kong Ltd.
N.A.
Ortho Clinical
Diagnostics
Philips Health Care
(Great China)
Synthes (Hong
Kong) Ltd
Roche Diagnostics
(Hong Kong) Ltd
Abbott Laboratories
LTD.
MHRA
MHRA
Action
N.A.
Action
2009/006/004/601/002
FSCA
MDA/2009/040
MDA
2009/06/17
2009/06/19
N.A.
2009/06/16
2009/06/16
N.A.
3690 1398
2481 3387
2593 2211
N.A.
N.A.
GE Healthcare Ge Signa Hdx 3T MR Systems, Ge Signa Hdxt 3T MR Systems
MHRA
2009/006/008/291/012
FSCA
2009/06/19
Edwards Lifesciences Introflex Tuohy-Borst Valve Introducer
Ortho-Clinical Diagnostics VITROS 3600 immunodiagnostic system, VITROS
5600 integradeted system
MHRA
2009/005/028/051/012
FSCA
2009/06/19
MHRA
2009/006/002/051/003
FSCA
2009/06/22
Philips CareVue Chart Release C.O. (Part Number 862246)
FDA
Z-1436-2009
Class II
2009/06/22
Synthes Zero-P StarDrive Screwdriver Shaft, T8 (Catalog# 03.617.902)
FDA
Z-1348-2009
Class II
2009/06/22
FDA
Z-1435-2009
Class II
2009/06/22
N.A.
N.A.
FDA
Z-1244-2009
Class II
2009/06/22
N.A.
N.A.
2009/06/22
BD
2575 8668
2009/06/22
Cemma Enterprise
Co., Ltd
2412 2310
Innovative Neurotronics WalkAide Stimulator System Control Module (Part No.
20-0100)
TEVA Medical Device TEVADAPTOR Closed Drug Reconstitution and Transfer
System (Model no. MG412110)
BD Beaver Arthro-Lok Pointed Tip 4mm Blade (Cat no. 376780)
Arrow International Pediatric Two-Limen Central Venous Catheterization Set
with Blue FlexTip Catheter (Cat no. CS-14502)
BD
Cemma Enterprise
Co., Ltd
Action
Action
N.A.
N.A.
30
2783 1838
N.A.
N.A.
2821 5480
2724 2032
Select Healthcare Locomotor lifting slings for adults and children
Philips Avalon Fetal Monitor
Boston Scientific Resolution Clip
Philips Respironics MicroElite Nebulizer Compressors (Medel Product No.
91709 to 91716, Respironics Product No. 1053626, 1053677 to 1053683)
MDA/2009/041
MDA
MHRA
2009/006/010/291/016
FSCA
MHRA
N.A.
Kong Ltd
Action
2009/06/23
2009/06/23
2009/06/22
MHRA
2009/005/013/081/008
FSCA
2009/06/24
Terumo Advanced Perfusion System 1 (Catalog no 802100)
Health Canada
46444
Type II
2009/06/25
Bard Vacora Vacuum Biopsy System (Model# VC10118P) and Vacora
Vacuum Biopsy System-Cannula (Model# VC10118MR)
Health Canada
47925
Type II
2009/06/25
GE Healthcare AW Volumeshare2 - Software Options (Model# B79011MA)
Health Canada
45984
Type II
2009/06/25
Stryker Vertier Table Headrest Attachment (Model # 0788-300-012)
ACIST Angiographic System - Manifold Kit (Model # BT2000)
CMS XIO Radiation Treatment Planning System
R&D Systems Quantikine IVD Human B2-Microglobulin (Lot # 260980)
MedovationsInsufflation Tubing With Filter (Model no SU1101)
Medical Devices Group Computer treatment planning release 4.34.00 through
4 40 00
Siemens Artiste digital linear accelerators with syngo RT Therapist version 4.1
connected to LANTIS
Siemens Artiste digital linear accelerator with syngo RT Therapist Version 4.1
build 67 and build 122
PENTAX Suction Valve (Types, Of-B136, Of-B140, Of-B163, Of-B179 in
endoscopy)
Siemens Mavig Portegra 2
Health Canada
Health Canada
Health Canada
Health Canada
Health Canada
MHRA
48498
48480
48447
48674
48488
2009/006/011/601/001
Type II
Type II
Type II
Type II
Type II
FSCA
2009/06/25
2009/06/25
2009/06/25
2009/06/25
2009/06/25
2009/06/25
MHRA
2009/006/008/291/014
FSCA
2009/06/25
MHRA
2009/006/008/291/013
FSCA
2009/06/25
MHRA
2009/005/020/291/005
Z-1437-2009 to Z1443-2009
Z-1419-2009 to Z1420-2009
FSCA
2009/06/25
Class II
2009/06/26
Class II
2009/06/26
Class II
2009/06/26
Advanced Sterilization Products (JNJ) STERRAD 50 Sterilization System
(Product Code 10050) and STERRAD NX Sterilization System (Prodoct Code
Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler
(REF J-ES-090500-BL)
Bard E LUMINEXX Biliary Stent
GE Signa Ovation 0.35T, GE Signa Openspeed 0.7T
Terumo pre-connected haemoconcentrator with drainage bag (adult or
paediatric)
FDA
FDA
FDA
MHRA
MHRA
FDA
Siemens Advia Centaur Hepatitis B Core Total (HBcT) Assay
MHRA
Ormesa New Bug
MHRA
Ethicon (JNJ) Endoloop Ligature Pds II Suture
MHRA
DxS Therascreen: EGFR29 Mutation Kit
MHRA
ThermoFisher Scientific PO0287A Yersinia Agar (CIN Med)
MHRA
Possum HC603C IR Mains Switch
Maquet Servo 300 ventilator (SV300)
MHRA
MHRA
Z-1416-2009
Z-1453-2009 to Z1469-2009
2009/006/002/081/003
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
Philips Health Care
(Great China)
TERUMO CHINA
(H.K.) LTD.
N.A.
GE Medical
Systems Hong
Kong Ltd.
Stryker China Ltd
N.A.
N.A.
N.A.
N.A.
N.A.
Siemens
Healthcare
Siemens
Healthcare
N.A.
Siemens
Healthcare
Johnson &
Johnson Hong
AR Burkill & Sons
(HK) Ltd
N.A.
N.A.
2960 7136
2821 5480
2866 0811
N.A.
2783 1838
2518 6915
N.A.
N.A.
N.A.
N.A.
N.A.
2810 7533
2810 7533
N.A.
2810 7533
2738 6027
2541 1041
Class II
2009/06/26
N.A.
N.A.
FSCA
2009/06/26
2783 1838
2009/006/009/081/006
FSCA
2009/06/26
2009/006/011/291/002
2008-011-013-301001
2009/006/012/291/005
FSCA
2009/06/26
FSCA
2009/06/26
FSCA
2009/06/29
FSCA
2009/06/29
ical Systems Hong K
TERUMO CHINA
(H.K.) LTD.
Siemens
Healthcare
N.A.
Johnson &
Johnson Medical
N.A.
FSCA
2009/06/29
N.A.
N.A.
FSCA
MDA
2009/06/29
2009/06/30
N.A.
N.A.
N.A.
N.A.
2009/005/028/051/014
2009/006/017/601/003
,
2009/004/023/301/001
MDA/2009/042
31
2866 0811
2810 7533
N.A.
2738 6027
N.A.
Monthly Summary of Medical Device Safety Alerts - May 2009
Date of Issue
Reference No. by
Agent Contact Telephone
Source of Information*
Local Agent
(YYYY/MM/DD)
Source
No
Roche ACCU-CHEK Spirit Insulin Pump
N.A.
Press Release
04-May-09
gnostics (Hong
2485 7510
FDA
Accuray Synchrony Respiratory Tracking System
2009/004/017/061/012
FSCA
04-May-09
Accuray Asia Ltd
2247 8628
MHRA
Sunrise Medical Breezy 100 and Breezy 300
2008/006/025/261/001
FSCA
04-May-09
N.A.
N.A.
MHRA
Elekta XVI (Synergy® kV Detector)
2009/003/011/061/002
FSCA
04-May-09
N.A.
N.A.
MHRA
Great Bear cubCATH Intermittent Catheter AVP10
2009/003/025/061/007
FSCA
04-May-09
N.A.
N.A.
MHRA
Maquet MEDAP BORA UP 2080 Universal suction pump
2009/003/025/061/017
FSCA
04-May-09
quet Hong Kong
2393 9511
MHRA
Nucletron Oncentra Prostate CT/MR option
2009/004/022/291/006
FSCA
04-May-09
N.A.
N.A.
MHRA
Medtronic
2919 1362
Medtronic Sprinter OTW Product (TPL 970)
Medtronic International Ltd
N.A.
05-May-09
International
Action
Ltd.
Stryker China
Stryker PainPump2
FDA
-1182-2009 to Z-1194-200
Class II
07-May-09
2518 6915
Ltd
Cardinal
Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module (Model 8120)
Z-1237-2009
Class II
07-May-09
N.A.
FDA
Health
Siemens
Healthcare
Siemens Syngo Imaging (Model# 10 014 063)
FDA
Z-1235-2009
Class II
07-May-09
2810 7533
Diagnostic
Limited
Tri-State Centurion Products
-1319-2009 to Z-1322-200
Class II
07-May-09
N.A.
N.A.
FDA
Starry Medical
2961 4503
Wright Medical Screwdriver for 3.5mm Screws (DARCO System, REF: DC4261)
Z-1208-2009
Class II
07-May-09
FDA
Technology,
Ltd
Hill-Rom TotalCare Bed (Model P1900)
Z-1317-2009
Class II
07-May-09
N.A.
N.A.
FDA
Medtronic
2919 1362
Medtronic Model 37085 Restore 1x4 DBS Extension Kit
N.A.
07-May-09
International
Action
Ltd.
Smith &
Smith & Nephew Blades
Smiths & Nephew Ltd
N.A.
07-May-09
9651 5523
Nephew LTD
Action
Invacare XLT Self Propelling Wheelchair with rear wheels set back - anti tipper
2008/011/010/061/017
FSCA
08-May-09
N.A.
N.A.
MHRA
Biosite
2855 6883
Biosite Triage Cardiac Panel
FDA
Z-1391-2009
Class I
11-May-09
Incorporated
Boston
2960 7136
Boston Scientific Safety and Standard Push PEG Kits
N.A.
11-May-09
Scientific
Kong Ltd
Action
Hong Kong
Boston
2960 7136
Boston Scientific Neuroform3 Microdelivery Stent System
N.A.
11-May-09
Scientific
Kong Ltd
Action
Hong Kong
Smith &
11-May-09
2648 7700
Smith & Nephew Reflection Microstable Acetabular Liner (REF 71740250)
Smiths & Nephew Ltd
Z-1004-2009
Nephew Ltd
Action
BD Insuline Syringe (Cat no. 328420)
BD
N.A.
13-May-09
BD
2575 8668
Molift Smart
2009/001/020/301/001
FSCA
13-May-09
N.A.
N.A.
MHRA
ThermoFisher TPHA Test Kit.
2009/004/028/061/014
FSCA
13-May-09
N.A.
N.A.
MHRA
Johnson &
Johnson & Johnson
Cordis Cypher Select Sirolimus Eluting Coronary Stents (Hub Crack)
2738 6027
N.A.
13-May-09
Johnson
Medical (HK)
Action
Medical (HK)
Siemens
Healthcare
2810 7533
Siemens Mammomat Novation DR (Model No. 06646900)
FDA
Z-1233-2009
Class II
14-May-09
Diagnostic
Limited
GE Medical
GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6, 5.0.7, 5.0.8 and 4.1
Z-1232-2009
Class II
14-May-09
2783 1838
FDA
Systems
Hong Kong
32
Nova Biomedical Stat Profile Critical Care Xpress (CCX and CXX+), CCX Creatinine Membrane
Kit for CCX analyzer (Catalog # 35238)
FDA
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
Pacific Inc.
N.A.
Health Canada
47695
Bard Truguide Coazial Biopsy Needle (Model: C4140A, C1810B, C1813B, C1816B, C1820B,
C2013B, C2016B, C2020B)
Stryker Restoration Modular Cone Bodies (Model: 6276-1-121, 6276-1-125, 6276-1-219, 6276-1325)
Z-1328-2009
Class II
14-May-09
N.A.
N.A.
Action
15-May-09
Varian
Medical
Systems
2724 2836
Type II
14-May-09
N.A.
N.A.
Stryker China
Ltd
Boston
Scientific
Hong Kong
N.A.
N.A.
N.A.
Beckman
Coulter Hong
Kong Ltd
N.A.
N.A.
N.A.
Beckman
Coulter Hong
Kong Ltd
Health Canada
47576
Type II
14-May-09
Boston Scientific Percutaneous combination stent (Model: 410-111, 112, 126, 202-207, 304-305)
Health Canada
47581
Type II
14-May-09
UNOMEDICAL Paradigm Silhouette Infusion Set (Model: MMT-377600, 378600, 381600,
382600)
Norwex Silvercare Toothbrush (Model: 22963)
Spacelabs Medical Medical Flat Panel Power Supply (Model: 010-1619-00, 010-1655-00)
Health Canada
Health Canada
Health Canada
47734
47238
47582
Type II
Type II
Type II
15-May-09
15-May-09
15-May-09
Beckman Coulter Flow-set Fluorospheres (Model: 6607007)
Health Canada
47347
Type II
15-May-09
Biomet Orthopedics C2A Ringloc Acetabular System - 28 mm (Model: 12-115112)
Biomet Microfixation Byrd Screw 2.0x6mm Self Drilling (Model: 01-0267)
Bard Max-Core Disposable Bipsy Instr. (Model: MC1810, MC1816, MC1820)
Health Canada
Health Canada
Health Canada
47389
46721
47251
Type II
Type II
Type II
15-May-09
15-May-09
15-May-09
Beckman Coulter Access Systems Total BHCG Reagent Kit (Model: 33500)
Health Canada
47348
Type II
15-May-09
Health Canada
46908
Type II
15-May-09
N.A.
N.A.
Health Canada
47632
Type II
15-May-09
N.A.
N.A.
Health Canada
Health Canada
47393
47714
Type II
Type II
15-May-09
15-May-09
N.A.
N.A.
Philips Holter
Health Canada
47704
Type II
15-May-09
B. Braun IV set with Universal Spike, 2 Ultrasite (Model: 352079/CSP152VSL), Primary IV Set
with 3 Ultrasite (Model: 352049, 375100)
Health Canada
47750
Type II
15-May-09
BMH Medical Combi Sling (626002), Sling Deluxe Child (626002C), Sling Mesh Deluxe Child
(626002C-M), Sling Deluxe Oversize (626003), Sling
Health Canada
47789
Type II
15-May-09
Cardiac Pacemakers Cognis CRT-D HE (N106), Cognis CRT-D (N107), Teligen ICD (VR-HE
DF1)(E110), Teligen ICD (DR-HE IS-1)(E110)
Health Canada
47936
Type II
15-May-09
MHRA
MDA/2009/032
MDA
18-May-09
N.A.
Action
19-May-09
Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)
FDA
Z-1411-2009
Class I
19-May-09
BD 20ml Luer-Lok Syringe (Recorder Number 309661)
Roche MagNA Pure LC Workstation
BD
FDA
N.A.
Z-1255-2009
Class II
19-May-09
21-May-09
N.A.
N.A.
Philips Health
Care (Great
China)
B. Braun
Medical Hong
Kong
Arjo Huntleigh
(Hong Kong)
Ltd.
Boston
Scientific
Hong Kong
N.A.
Medtronic
International
Ltd.
Celki Medical
Company
BD
gnostics (Hong
Arrow International A) Percutaneous Sheet, B) Central Venous Catheterization Set/Kit, C)
Temporary Pacing Catheter, D) Two-lumen Central Catheterization Kit, E) Percutaneous Sheath
Introducers Sets, F) Stopcocks, G) Arterial Access Products, H) Thrombolic Device Rotator Drive
Unit, I) Tretorola Percutaneous Thombolic Device, J) Percutaneous Sheath Introducer, K) Super
Arrow-Flex Percut Sheath Intro, L) Stopcock with Luer Lock, M) Stopcock Manifold, N) MultiLumen 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)
Ace Surgical Supply 5/0 Polyglycolic Acid Absorbable Suture (Model: 34630)
Wallac OYT Neogram Amino Acids Mass Spec Kit
ALL Models Bioprosthetic Heart valves
Medtronic Kappa 600/700/900 Series and Sigma 100/200/300 Series Pacemakers
33
2518 6915
2960 7136
N.A.
N.A.
N.A.
2240 6150
N.A.
N.A.
N.A.
2240 6150
2821 5480
2277 6125
2508 1416
2960 7136
N.A.
2919 1362
2268 9258
2575 8668
2485 7510
FDA
Z-1397-2009
Class II
21-May-09
Varian Acuity (Auto-fit MLC feature)
Pacific Inc.
N.A.
Action
21-May-09
Varian Acuity (Changes to Asymmetric and Symmetric Field Axis Properties During Verification
Simulation
Pacific Inc.
N.A.
Action
22-May-09
Kong Ltd
N.A.
Action
22-May-09
Radiometer Medical ABL800 Flex analyser
ThermoFisher Scientific Columbia Blood Agar PB0122A
Trinity Biotech TriniCLOT aPTT S
Biomet Orthopedics Offset tibial tray adaptor 5.0mm
Unisurge OP-Flex Poole (handle set) contained within Procedure Packs
Integra LifeScience Licox Oxygen Catheter Micro-Probes (models CC1 and CC1.2)
MHRA
MHRA
MHRA
MHRA
MHRA
MHRA
2009/004/021/061/004
2009/004/023/601/001
2009/004/028/061/018
2009/003/005/601/002
2009/003/020/061/016
2009/004/024/051/001
FSCA
FSCA
FSCA
FSCA
FSCA
FSCA
25-May-09
25-May-09
25-May-09
25-May-09
25-May-09
25-May-09
Oxoid (Ely) ProSpecT Adenovirus R240096
MHRA
2009/004/023/601/003
FSCA
25-May-09
Siemens Dimension Enzymatic Creatinine Flex Reagent Cartridge
MHRA
2009/004/027/291/022
FSCA
25-May-09
Biomet Microfixation Lactosorb Pectus Stabiliser
Trinity Biotech Captia Measles IgM ELISA test kit
Stanmore Implants METS Modular Tumour System
KeyMed, Olympus, Aloka Endoscope - MU-1
Edwards Lifesciences Aquarius systems GEF08200, GEF09500, GEF09600, GEF09700
Roche cobas 6000 analyzer series (including cobas c 501 and cobas e601 modules) Middleware
Solutions instrument Manager Standard and Middleware Solutions instrument Manager Server
MHRA
MHRA
MHRA
MHRA
MHRA
2009/004/015/601/003
2009/004/017/061/009
2009/004/009/061/008
2008/012/023/601/003
2009/004/006/291/009
FSCA
FSCA
FSCA
FSCA
FSCA
25-May-09
25-May-09
25-May-09
25-May-09
25-May-09
GE Medical
Systems
Hong Kong
Varian
Medical
Systems
Varian
Medical
Systems
Boston
Scientific
Hong Kong
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Hong Kong
South East
Chemicals &
Instruments
Siemens
Healthcare
Diagnostic
Limited
N.A.
N.A.
N.A.
N.A.
N.A.
FDA
-1393-2009 to Z-1394-200
Class II
29-May-09
gnostics (Hong
GE Centricity TriWin Laboratory Information System
Boston Scientifc FORTE GUIDE WIRE
GE Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System
FDA
Z-1195-2009
Class II
29-May-09
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0 (model no 270-2000)
FDA
Z-1395-2009
Class II
29-May-09
Remel Staphaurex Plus Kit (Catalog. no. R30950102 and R30950201)
FDA
Z-1400-2009
Class II
29-May-09
29-May-09
29-May-09
BD Insyte Autoguard IV Catheter (Cat. No. 381812; Lot no. 8171780)
BD
N.A.
Smiths & Nephew Ltd
N.A.
Cardinal Health Esteem Blue with Neu-Thera Polyisoprene Surgeon Gloves
MHRA
2009/005/007/051/005
Action
FSCA
Wright Medical Darco Cannulated Hex Driver
MHRA
2009/003/003/291/016
FSCA
29-May-09
Rocialle InHealth Procedure Packs containing Suction Catheter
MHRA
2009/005/013/291/002
FSCA
29-May-09
Smith & Nephew DYONICS 25 tubeset kits (Cat no. 7211005; 7211006)
34
29-May-09
GE Medical
Systems
Hong Kong
Bio-Rad
Pacific Ltd.
Hong Kong
South East
Chemicals &
Instruments
BD
Smith &
Nephew LTD
N.A.
Starry Medical
Technology,
Ltd
N.A.
2783 1838
2724 2836
2724 2836
2960 7136
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2802 6333
2810 7533
N.A.
N.A.
N.A.
N.A.
N.A.
2485 7510
2783 1838
N.A.
2802 6333
2575 8668
2648 7700
N.A.
2961 4503
N.A.
Monthly Summary of Medical Device Safety Alerts - April 2009
Source of
Date of Issue
Alert Type by
(YYYY/MM/DD)
Information*
Source
Local Agent
Agent Contact Telephone
No
Tri-State Centurion Products
FDA
N.A.
Class I
2009/04/02
N.A.
N.A.
Roche COBAS c 11 Analyzer with ISE Module option, GMMI No. 04777433001
FDA
Z-1009-2009
Class II
2009/04/02
Diagnostics (Hong Kon
2485 7510
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM V 4.0, MODEL NO 270-2600
FDA
Z-1041-2009
Class II
2009/04/02
N.A.
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300 and 5400-300
FDA
Z-1052-2009
Class II
2009/04/02
Stryker China Ltd
2518 6915
Class II
2009/04/02
Leica Microsystems
Ltd
2564 6699
Class II
2009/04/02
N.A.
N.A.
2009/04/02
Medtronic
International Ltd.
2919 1362
2009/04/03
3M
2806 6349
2783 1838
Lecia QCA and iQCA software
DiaSorin LIASON ® Chemiluminescence Analyzer Model #15970 Colorimeter, Photometer,
Spectrophotometer for clinical use
Medtronic Physio-Control Bisphasic LIFEPAK® 12 Defibrillator/monitor
3M No Sting Barrier Film (Model 3346E)
FDA
Z-1040-2009
FDA
Z-1042-2009
Medtronic
International Ltd
N.A.
3M
N.A.
Action
Action
GE Healthcare ViewPoint Image Archiving and Reporting System
MHRA
2009/001/007/401/004
FSCA
2009/04/06
GE Medical Systems
Hong Kong Ltd.
Gas Control Equipment Sabre Therapy Probe Regulator
MHRA
2009/003/024/291/011
FSCA
2009/04/06
N.A.
N.A.
CODAN Burette Sets
MHRA
2009/003/023/291/013
FSCA
2009/04/06
N.A.
N.A.
Roche Ambulatory insulin infusion pump. Accu-Chek Spirit
MHRA
MDA/2009/024
MDA
2009/04/07
2485 7510
Biomet Biolox Delta Ceramic Heads 28mm, +5mm (T1 taper)
MHRA
2009/003/017/061/004
FSCA
2009/04/07
N.A.
N.A.
ThermoFisher Columbia blood agar - PB0122A
MHRA
2009/003/024/601/003
FSCA
2009/04/07
N.A.
N.A.
GE Healthcare S/5 iCentral and iCentral Client (L-NET05 and L-NETC05)
FDA
Z-1039-2009
Class II
2009/04/14
GE Medical Systems
Hong Kong Ltd.
2783 1838
Stryker Electric Stretcher with the Quick Drop CPR option (Model 1050 and Model 1550)
FDA
Z-1230-2009 to Z-1231-2009
Class II
2009/04/14
Stryker China Ltd
2518 6915
Stelkast Dual Taper Wedge Pressed Fit Femoral Component
FDA
Z-1073-2009
Class II
2009/04/14
N.A.
N.A.
Zues Scientific Sm ELISA Test System (Product no.: 2Z2831G and 43270CE)
FDA
Z-1089-2009
Class II
2009/04/14
N.A.
N.A.
Trumpf Medical ILED Surgical Light (Model no ILED3, ILED5 and ILED5K)
FDA
Z-1122-2009
Class II
2009/04/14
MPF China (Hong Kong
2880 9808
FDA
Z-1020-2009
Class II
2009/04/14
N.A.
N.A.
N.A.
Action
2009/04/14
Johnson & Johnson
Medical (HK)
2738 6027
Theragenics Spacers of varying lengths
Johnson and Johnson Ethicon Endo-Surgery Device - Ets-FLEX45
Tepnel Quick-Type for LIFEMATCH Update CD
Teleflex Medical (Arrow) 30, 40 and 50 cc Intra-Aortic Ballloon
Johnson & Johnson
Medical (HK)
MHRA
2009/003/026/601/014
FSCA
2009/04/15
N.A.
N.A.
FDA
Z-1210-2009 to Z-1222-2009
Class I
2009/04/16
N.A.
N.A.
35
Cardinal Health (Viasys Healthcare) Sonora Transcranial Doppler (TCD) System (Model Sonara,
Part no 982A0469 and 982A0470)
FDA
Z-0998-2009 to Z-0999-2009
Class II
2009/04/16
Biomet Offset Tibial Tray Adaptor, 5.0 MM, Sterile, REF 141491
FDA
Z-1061-2009
Class II
Cardinal Health
N.A.
2009/04/16
N.A.
N.A.
2593 2211
2485 7510
Abbott CELL-Dyn Ruby Hematology Analyzer (List no 08H67-01)
FDA
Z-1064-2009
Class II
2009/04/16
Abbott Laboratories
LTD.
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
Boston Scientific Convoy Advanced Delivery Sheath Kit and Soft Tip Sheath Multipurpose
Introducing Sheath Kit
FDA
Z-1071-2009 to Z-1072-2009
Class II
2009/04/16
GE Healthcare Infinia Hawkeye and Hawkeye 4
FDA
Z-1094-2009 to Z-1095-2009
Class II
2009/04/16
GE Healthcare Infinia, Hawkeye for Infinia and Infinia Hawkeye 4
FDA
Z-1119-2009 to Z-1121-2009
Class II
2009/04/16
Cardinal Health ReadyMed Elastomeric Ambulatory Pump
FDA
Z-1170-2009
Class II
2009/04/16
Cardinal Health
N.A.
Medtronic Physio Control Internal Sterilizable Paddles and Handles without discharge control for
use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors
FDA
Z-1171-2009
Class II
2009/04/16
Medtronic
International Ltd.
2919 1362
Bard Dual Port Wizard Low Profile Replacement Gastrostomy Device
FDA
Z-1096-2009 to Z-1117-2009
Class II
2009/04/16
N.A.
N.A.
Integra Bilayer Matrix Wound Dressing, 8" x 10" (20cm x 25cm); Non-pyrogenic
FDA
Z-1174-2009
Class II
2009/04/16
N.A.
N.A.
diaDexus PLAC Test Reagent Kit (Catalog no 90110)
FDA
Z-1204-2009
Class II
2009/04/16
N.A.
N.A.
Teleflex Medical Pilling Coronary Scissors (Cataolg no 352164-352169 & 352178)
FDA
Z-1175-2009 to Z-1181-2009
Class II
2009/04/16
N.A.
N.A.
Boston Scientific
Hong Kong Ltd
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
Siemens HM Reaction Vessels (RXV1A)
MHRA
2008/012/002/061/010
FSCA
2009/04/16
i-sens Caresens II BGM
Others
N.A.
N.A.
2009/04/17
Siemens Healthcare
Diagnostic Limited
BioScan Ltd
Sybron Pitt Easy Implant
MHRA
2008/012/002/061/010
FSCA
2009/04/20
N.A.
2960 7136
2783 1838
2783 1838
2810 7533
3589 6670
N.A.
James Leckey EAS Floor Mat
MHRA
2009/003/016/301/002
FSCA
2009/04/22
N.A.
N.A.
Homecraft Rolyan Frimley folding stool model AA1550
MHRA
2009/001/030/401/010
FSCA
2009/04/22
N.A.
N.A.
FDA
Z-1251-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
Stryker Modular Replacement System (MRS) Cemented Stems
Stryker AxSOS T8 Screwdriver and AxSOS Torque Limiting Screwdriver
FDA
Z-1062-2009 to Z-1063-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
Stryker Trio Small Offset Connector Non Sterile (Catalog no 48902015)
FDA
Z-0986-2009
Class II
2009/04/23
Stryker China Ltd
2518 6915
GE Healthcare Infinia, Infinia Hawkeye and Infinia Hawkeye 4
FDA
Z-1001-2009 to Z-1003-2009
Class II
2009/04/23
GE Medical Systems
Hong Kong Ltd.
2783 1838
Abbott AxSYM HBsAg Reagent Pack, AxSYM CMV IgG Regent Pack, AxSYM CORE 2.0
Reagent Pack, AxSYM Folate Reagent Pack, AxSYM Myoglobin Reagent Pack and AxSYM
Troponin-I ADV Reagent Pack
FDA
Z-1046-2009 to Z-1051-2009
Class II
2009/04/23
Abbott Laboratories
LTD.
2593 2211
Maquet ALM Prismatic Surgical Light 9551 DF and ALM Prismatic Surgical Light 54004 SF
FDA
Z-1153-2009 to Z-1154-2009
Class II
2009/04/23
Maquet Hong Kong
LTD.
2393 9511
Cardiovascular System DiamondBack 360, CSI ViperWire Orbital Atherectomy Guide Wire (REF:
GW14335FRM)
FDA
Z-1250-2009
Class II
2009/04/23
N.A.
N.A.
MHRA
2009/003/030/061/008
FSCA
2009/04/23
N.A.
N.A.
St.Jude Medical EP-4 Stimulator 2 and 4 channels and EP WorkMate containing the EP4
stimulator
36
Philips HeartStart XL M4735A Defibrillator/Monitor
Philips Health Care
(Great China)
Philips HeartStart MRx/MRxE M3535A/M3536A/M3536J Defibrillator/Monitor
Philips Health Care
(Great China)
N.A.
Action
N.A.
Action
2009/04/23
Philips Health Care
(Great China)
2821 5226
2009/04/23
Philips Health Care
(Great China)
2821 5226
ThermoFisher BO0332D Ringers Solution 1/4 Strength lot 1067747
MHRA
2009/001/029/601/001
FSCA
2009/04/29
N.A.
N.A.
Stryker Restoration Modular Cone Bodies
MHRA
2009/003/025/291/008
FSCA
2009/04/29
Stryker China Ltd
2518 6915
FDA
Z-1069-2009
Class II
2009/04/30
Abbott Laboratories
LTD.
2593 2211
Abbott Hematology Reagent Syringe (List no 08H49-02)
Berchtold Operon Electrical Operating Room Table
FDA
Z-1123-2009
Class II
2009/04/30
N.A.
N.A.
Pointe Scientific Liquid Auto HDL CHolesterol Reagent Set
FDA
Z-1200-2009 to Z-1201-2009
Class II
2009/04/30
N.A.
N.A.
DiaDexus PLAC Test Calibrator Kit (Catalog No. 90108 and 10-0108)
FDA
Z-1205-2009
Class II
2009/04/30
N.A.
N.A.
37
Monthly Summary of Medical Device Safety Alerts - March 2009
Date of
Agent Contact
Source of
Reference No. by
Alert Type by
Local Agent
Issue
Telephone No
Information*
Source
Source
(YYYY/MM/D
Draeger Medical Oxylog 3000 Ventilator (2M86955)
Health Canada
44596
Type II
2009/03/03
Oxoid Limited Oxoid Fraser Broth Base (CM0895B)
Health Canada
45182
Type II
2009/03/03
N.A.
2009/03/03
N.A.
South East Chemicals &
Instruments Ltd
N.A.
Biomet Modular Microplasty Cup Inserter
Health Canada
43310
Type II
Miltex Stainless Steel Surgical Blades
Health Canada
46242
Type II
2009/03/03
N.A.
N.A.
Ohio Willow Wood Duralite Pyramid Receiver Proximal Adapter (FND-136102)
Health Canada
44165
Type II
2009/03/03
N.A.
N.A.
GE Diamond Mammography X-Ray Equipment (81000)
Health Canada
44731
Type II
2009/03/03
GE Datrex-Ohmeda Network and Icentral (M1113714, M1113715)
Health Canada
44822
Type II
2009/03/03
Health Canada
44184
Type II
2009/03/03
Health Canada
45981
Type II
2009/03/03
Stryker (Howmedica Osteonics) Securefit Hip Stem - 132 degree, Securefit Hip
Stem - 127 degree, Solar Shoulder - Humeral Component, Ostenoics Omnifit
Hip Stem
Stryker (Howmedica Osteonics) Osteonics Omnifit M-HA Hip Stem, Accolade
TMZF Press Fit Stem 132 Degree, Accolade TMZF Press Fit Stem 127
Degree
GE OEC Mobile Elite C-Arms Gen. Platform, OEC Mobile Elite - Arms Cooling
Siemens Immulite 2000 system-analyzer class III & II, Immulite 2000 Instrument Class IV
Health Canada
44335
Type II
2009/03/03
Health Canada
46193
Type II
2009/03/03
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
Draeger Evita 4, Evita 2 Dura, Evita XL
Health Canada
42978
Type II
DORC international MembraneBlue© 0.5ml syringe
Kong Ltd.
Kong Ltd.
N.A.
N.A.
2783 1838
2783 1838
Stryker China Ltd
2518 6915
Stryker China Ltd
2518 6915
Kong Ltd.
Limited
2783 1838
2810 7533
2009/03/03
China)
2821 5480
2009/03/03
N.A.
N.A.
MHRA
MDA/2009/017
MDA
2009/03/04
Philips Diagnostic Ultrasound System (Model HD3 and HDI4000)
FDA
522-2009 to Z-0523-2
Class II
2009/03/05
Medtronic Surgical Membrane Oxygenator
FDA
Z-0975-2009
Class II
Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Enegry Suction Probe
(Model no 279-351-200)
FDA
Z-0972-2009
Abbott ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge)
(List no: 07L02-01)
FDA
Abbott Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator (List
No. 1E69-03)
N.A.
N.A.
2009/03/05
China)
2919 1362
Class II
2009/03/05
Stryker China Ltd
2518 6915
Z-0951-2009
Class II
2009/03/05
2593 2211
FDA
Z-0950-2009
Class II
2009/03/05
2593 2211
Terumo Advanced Perfusion System 1
FDA
909-2009 to Z-0910-2
Class II
2009/03/05
TERUMO CHINA (H.K.) LTD.
2866 0811
Excelsior Medical Sterile Field Saline Flush (Product codes: E0100 20, 100 92240 and 100 92-30)
FDA
Z-0973-2009
Class II
2009/03/05
N.A.
N.A.
Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophillic
Coating (REF USH-526-R, GPN REF G49966)
FDA
Z-0980-2009
Class II
2009/03/05
N.A.
N.A.
Welch Allyn
N.A.
2009/03/05
N.A.
N.A.
Medtronic
International Ltd
N.A.
2009/03/10
2919 1362
Welch Allyn AED 10 and former MRL Jumpstart Automated External
Defibrillators
Medtronic Physio-Control Lifepak 20 defibrillator/monitor - Keypad
Action
Action
38
2821 5480
Sunrise Medical Quickie Groove battery powered wheelchairs
MHRA
MDA/2009/018
MDA
2009/03/10
N.A.
N.A.
CMS Software 4.3.1 through 4.40.00
MHRA
2009/002/015/601/001
FSCA
2009/03/10
N.A.
N.A.
Cardiac Science Powerheart and First Save AED
FDA
916-2009 to Z-0922-2
Class II
2009/03/12
N.A.
N.A.
InteliFUSE Drill Bit (REF: DB.150.JL and DB.200.JL)
FDA
032-2009 to Z-1033-2
Class II
2009/03/12
N.A.
N.A.
(HK)
2738 6027
Johnson and Johnson (Animas) Meter Remote for OneTouch Ping Glucose
Management System
FDA
Z-0955-2009
Class II
2009/03/12
Zimmer Orthosoft Navitrack, OS Unicodylar Knee 1.0- Universal
FDA
Z-0985-2009
Class II
2009/03/12 mmer PTE Ltd. (Hong Kong branc
2992 0968
Stryker Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS
Femoral Components (Catalog no 5532-G-713 & 5532-G-813)
FDA
Z-1013-2009
Class II
2009/03/12
Stryker China Ltd
2518 6915
Medtronic VARI-STIM III Nerve Locator/Stimulator
FDA
Z-0947-2009
Class II
2009/03/12
2919 1362
Hospira Symbiq One-Channel (List no 16026-04) and Two-Channel (list no
16027-04) Infusion System
FDA
Z-0944-2009
Class II
2009/03/12
Hospira Limited
2898 2886
GE Healthcare Innova Biplane 3131
MHRA
2008/006/013/601/413
FSCA
Zimmer NCB cancellous screw 4.5mmx 48mm Self tapping
MHRA
2009/002/020/291/022
FSCA
2009/03/13
Kong Ltd
VYGON PROTECT-A-SPIRAL – 300CM
MHRA
2009/002/026/601/003
FSCA
2009/03/13
N.A.
IPSOGEN JAK2 MutaScreen Kit
MHRA
2009/002/010/291/016
FSCA
2009/03/16
Philips Multi Diagnost Eleva FD - Leaking X-Ray Tube Grid
MHRA
2008/011/020/061/028
FSCA
2009/03/16
N.A.
China)
Boston Scientific
Hong Kong Ltd
N.A.
BD
N.A.
Boston Scientific Wiseguide Guide Catheter
BD Falcon 100 x 20 mm Tissue Culture - Treated Dish (BD Cat no 353003)
Action
Action
2783 1838
2992 0968
N.A.
N.A.
2821 5226
2009/03/16 Boston Scientific Hong Kong Ltd
2960 7136
2009/03/17
2575 8668
BD
MHRA
2008/011/006/301/002
FSCA
2009/03/18
N.A.
N.A.
Stryker Triathlon Primary
Health Canada
46302
Type II
2009/03/18
Stryker China Ltd
2518 6915
Stryker Triathlon Primary Cemented Baseplate (5520-B-400)
Health Canada
46208
Type II
2009/03/18
Stryker China Ltd
2518 6915
Smith & Nephew Tandem Unipolar 46 mm Femoral Heads (126646)
Health Canada
46556
Type II
2009/03/18
Smith & Nephew LTD
N.A.
2992 0968
Unihoist University Bath Hoist and University Bath Hoist Transporter
Zimmer Minimally Invasive Solutions Technology Offset RASP Handles
Health Canada
46270
Type II
2009/03/18
Zimmer PTE Ltd. (Hong Kong
branch)
Technidata Logiciel TDHIsto/CytoSoftware
Health Canada
44729
Type II
2009/03/18
N.A.
N.A.
Computerized Medical Systems Focal Software CD
Health Canada
46521
Type II
2009/03/18
N.A.
N.A.
Bard Fantrac "Paul" Gastric Access Port Kit (Model 5729)
Health Canada
45860
Type II
2009/03/18
N.A.
N.A.
Genzyme Diagnostics Enzymatic Creatinine Assay
Health Canada
46641
Type II
2009/03/18
N.A.
N.A.
Nipro Blood Tubing Set for Hemodialysis (A230TR/V810TR)
Health Canada
45627
Type II
2009/03/18
N.A.
N.A.
Armstrong Medical Amsorb Plus Prefilled Bubble-Can Universal WTOV
Health Canada
46652
Type II
2009/03/18
N.A.
N.A.
Cardinal Health Sterile Pacemaker and Defibrillator Pack (SAN30PAXXX),
Sterile Shoulder Pack (SOP30ASXXX)
Health Canada
46636
Type II
2009/03/18
Cardinal Health
N.A.
PDSII Monofilament suture, Coated Vicryl Absorable Suture, PDS II Suture,
Monocryl Plus Antibacterial Suture, Coated Vicryl Plus Antibacterial Ethicon
Suture
Health Canada
46404
Type II
2009/03/18
(HK)
2738 6027
39
Baxter Healthcare Colleague Volumetric Infusion Pump, Colleague 3
Volumetric Infusion Pump, Colleague Guardian Enhanced CXE Pump,
Colleague Guardian Enhanced 3CXE Pump, French Colleague CXE
Volumetric Pump, French Colleague 3 CXE Volumetric Pump
Health Canada
Biomet Sports Medicine 9-10mm Ezloc Femoral Fixation Device (904781)
Health Canada
44280
Type II
2009/03/18
FDA
092-2009 to Z-1093-2
Class II
2009/03/19
45280
Type II
2009/03/18
N.A.
2807 8516
N.A.
Medtronic PROSTIVA RE Model 8929 Hand Piece
FDA
Z-1060-2009
Class II
2009/03/19
Kong Ltd.
Medtronic TSRH 3DX Implant Set and TSRH Spinal System
FDA
014-2009 to Z-1017-2
Class II
2009/03/19
2919 1362
Stryker Cordless Driver 3 Handpiece, Rotary Handpiece, Reciprocating Saw,
Sternum Saw, Sagittal Saw and Precision Oscillating Tip Saw
FDA
021-2009 to Z-1030-2
Class II
2009/03/19
Stryker China Ltd
2518 6915
Zimmer Most Hinged Tibia Baseplate Spacer (REF 5020-06-001)
FDA
Z-0996-2009
Class II
Integra Mosail Putty and Dermal Regeneration Template-TS
FDA
034-2009 to Z-1035-2
Class II
2009/03/19
N.A.
N.A.
Pointe Scientific Glucose Oxidase Reagent
FDA
Z-1091-2009
Class II
2009/03/19
N.A.
N.A.
MHRA
2009/003/006/051/003
FSCA
2009/03/19
Hong Kong South East
Chemicals & Instruments Ltd
2802 6333
2009/03/19
ConMed Limited
N.A.
2009/03/19
China)
2821 5226
GE Innova 3100/3100IQ and Innova 4100 /4100IQ
Remel Wellcolex colour salmonella Kits, R30858301 (50 tests)/R30858302
ConMed Fortis II
Philips GXR RF Systems with DI (EasyDiagnost Eleva)
ConMed Limited
N.A.
Philips Health Care
(Great China)
CORONA
MEDICAL
N.A.
2919 1362
2992 0968
2009/03/20
N.A.
N.A.
MHRA
2009/002/013/601/003
FSCA
2009/03/23
Kong Ltd.
2783 1838
Medtronic
International Ltd
N.A.
Action
2009/03/23
2919 1362
Maquet Servo ventilators 300 and 300A
MHRA
MDA/2009/020
MDA
2009/03/25
Maquet Hong Kong Ltd
2393 9511
Smiths Medical Near empty flag kits product code 0131-0122 and halfnut,
leadscrew and flag kits product code 0131-0236 for 3000 series graseby
syringe pumps
MHRA
2009/002/020/291/012
FSCA
2009/03/25OODMAN MEDICAL SUPPLIES LT
GE Datex-Ohmeda Aisys and GE Datex-Ohmeda Avance Anesthesia
Machines
MHRA
2009/002/017/601/001
FSCA
2009/03/25
Draeger Medical Patient monitor bracket
MHRA
2009/003/010/051/014
FSCA
2009/03/25 Draeger Medical Hong Kong Ltd.
MHRA
2009/001/007/401/004
CORONA MEDICAL Patient Beds (Side Rails)
GE AS/3 Anaesthesia Delivery Unit, S/5 Anaesthesia Delivery Unit, and ADU
Carestation
Medtronic Sprint Fidelis Lead
Aidapt VR231 Lenham adjustable height commode
N.A.
Action
Action
Action
2783 1838
Kong Ltd.
2332 4455
2783 1838
2877-3077
FSCA
2009/03/25
N.A.
N.A.
Abbott Laboratories
LTD.
N.A.
Action
2009/03/25
2593 2211
BD PrepStain System (Model no.: 799-14000-00)
FDA
Z-1090-2009
Class II
2009/03/26
BD
2575 8668
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
(HK)
2738 6027
Rochester Medical Magic3 (Intermittent Catheter) and HydroSil (Intermittent
Catheter)
FDA
074-2009 to Z-1087-2
Class II
2009/03/26
N.A.
N.A.
Biosite Triage Drugs of Abuse Panel (Model No 95000)
FDA
Z-1088-2009
Class II
2009/03/26
Biosite Incorporated
2855 6883
N.A.
Action
2009/03/26
BD
2575 8668
Abbott Xience V Everilimus Eluting Coronary Stent System, 2.5 x 28mm
BD Insyte Autoguard Shielded IV Catheter
BD
40
Boston Scientific Flexima and Percuflex Drainage Catheter Family (Pigtail
Style)
GE Mobile Care Server L-WEB05 and iCentral L-NET05
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap
Shunt Ventricular Catheter, BioGlide
Novo Nordisk NovofineR Needles 31G, 0.25 mm x 6 mm lot number 08J02S
AstraZeneca Nebuchamber
ZOLL AED Plus Defibrillator
Boston Scientific
Hong Kong Ltd
N.A.
Action
2009/03/27 Boston Scientific Hong Kong Ltd
2960 7136
MHRA
2008/009/018/601/004
FSCA
2009/03/27
Kong Ltd.
FDA
N.A.
Class I
2009/03/30
2919 1362
MHRA
MDA/2009/021
MDA
2009/03/30
N.A.
N.A.
2009/03/30
Astrazeneca Hong Kong Ltd
2491 5206
2009/03/31
Suburfarm Investment &
Trading Co.
2780 9421
Astrazeneca Hong
Kong Ltd
Health Canada
N.A.
N.A.
Action
Urgent Safety
Information
41
2783 1838
Monthly Summary of Medical Device Safety Alerts - February 2009
Source of
Reference No. by
Alert Type by
Date of Issue
Agent Contact
Local Agent
(YYYY/MM/DD)
Information*
Source
Source
Telephone No
Medtronic
Medtronic
Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor
N.A.
2009/02/02
2919 1350
International Ltd
Action
International Ltd.
Beckman Coulter UniCel DxC 880i Synchron Access Clinical Systems
MHRA
2009/001/023/601/001
FSCA
2009/02/02
an Coulter Hong Ko
Xcelens IDEA 613XC
MHRA
2009/001/026/291/003
FSCA
2009/02/02
N.A.
N.A.
Stryker GAMMA3 Trochanteric Nail 180 Operative Technique
MHRA
2009/001/008/291/002
FSCA
2009/02/02
Stryker China Ltd
2518 6915
Activate Patron Bohemia TOM Cross Country Chassis
MHRA
2008/009/016/401/009
FSCA
2009/02/02
N.A.
N.A.
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.
ThermoFisher BO0471D, 0.1% Peptone Water + 0.85% Salt
MHRA
2009/001/026/601/005
FSCA
2009/02/02
N.A.
N.A.
ThermoFisher EB0348D, Maximum Recovery Diluent
MHRA
2009/001/026/601/006
FSCA
2009/02/02
N.A.
N.A.
MHRA
Johnson &
Johnson Medical
(HK)
BD
2009/001/028/601/002
FSCA
2009/02/02
GE Centricity PACS RA1000 Workstation
FDA
Z-0836-2009
Action
Action
Class II
iCAD 3TP TheraMap Software and 3TP PrecisionPoint Software
FDA
0653-2009 to Z-0654-20
Class II
2009/02/05
Smith & Nephew
LTD
Johnson &
Johnson Medical
(HK)
BD
GE Medical
Systems Hong
N.A.
Virtus Expressaire, Disposable Tourniquet Cuff (Cuff type A70107010,
A70107011)
FDA
0907-2009 to Z-0908-20
Class II
2009/02/05
N.A.
N.A.
Fresenius Medical CombiSet True Flow Series, Hemodialysis Blood Tubing
FDA
0859-2009 to Z-0860-20
Class II
2009/02/05
Medical Care Asia
2802 2900
Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only
(Catalog no.: R6357A, R6397A)
FDA
Z-0854-2009
Class II
2009/02/05
N.A.
N.A.
Coloplast EasiCath intermittent urinary catheters
MHRA
MDA/2009/007
MDA
2009/02/05
N.A.
N.A.
Teleflex Medical Ligating clips
MHRA
MDA/2009/008
MDA
2009/02/09
N.A.
N.A.
MHRA
2009/001/026/291/007
FSCA
Smiths & Nephew
N.A.
Ltd
Action
2008/011/010/061/024
FSCA
MHRA
2009/02/09
N.A.
9651 5523
2009/02/10
N.A.
Smiths &
Nephew Ltd
N.A.
2009/001/030/291/008
2009/02/10
BD
886-2722-5660
TE Ltd. (Hong Kon
Johnson &
Johnson Medical
N.A.
2992 0968
Smith & Nephew BHR BRIDGING CUP, 66MM PRODUCT CODE 74120366
Johnson and Johnson DePuy Vac-Mix plus pre-packed with Endurance Bone
Cement
BD FACS Sample Prep Assistant (SPA or SPA II)
Johnson and Johnson (DePuy) DNP Anatomic Fracture Repair System
Smith & Nephew Compass PIP Hinge
Doddmed Metrax Primedic HeartSave AED, HeartSave AED-M
BD Vacutainer Plastic Sodium Heparin Blood Collection Tube with Green BD
Hemogard Closure, 13 x 75 mm, 4 ml.
MHRA
N.A.
N.A.
FSCA
2009/02/03
2009/02/03
2009/02/05
2009/02/09
Zimmer Coonrad/Morrey Total Elbow System Surgical Technique
MHRA
2009/002/005/291/017
FSCA
2009/02/10
Johnson and Johnson STERRAD 50 Sterilization System
MHRA
2009/001/030/291/010
FSCA
2009/02/10
ThermoFisher BO0348N Maximum Recovery Diluent
MHRA
2009/001/029/601/002
FSCA
2009/02/10
N.A.
Action
Medtronic LIFEPAK 20 Defibrillator / Monitor
Medtronic
International Ltd
2009/02/11
Medtronic O-Arm Intraoperative Imaging System (Catalog no.: BI-700-0027)
FDA
Z-0624-2009
Class II
2009/02/12
FDA
0670-2009 to Z-0674-20
Class II
2009/02/12
42
Medtronic
International Ltd.
Medtronic
International Ltd.
TERUMO CHINA
(H K ) LTD
2240 6150
N.A.
2738 6027
886-2722-5660
2783 1838
N.A.
N.A.
2738 6027
N.A.
2919 1362
2919 1362
2866 0811
Stryker Restoration Modular Conical Distal Stem, Titanium Alloy (Catalog no 62767-017 (17mm); 6276-7-014 (14mm))
FDA
Z-0884-2009
Class II
2009/02/12
Stryker China Ltd
2518 6915
Stryker various modular components
FDA
0888-2009 to Z-0902-20
Class II
2009/02/12
Stryker China Ltd
2518 6915
Biomet MicrofixationLactosorb System (REF: 915-1006); Lactosorb, Office Fixation
Kit (REF: 915-1000); MF Set (REF: 01-6871); Office System (REF: 01-6851)
FDA
0864-2009 to Z-0867-20
Class II
2009/02/12
N.A.
N.A.
Activate Hi-Lo Powered Wheelchair
MHRA
2008/010/001/061/003
FSCA
2009/02/12
N.A.
N.A.
Invacare Flamingo Hoist
MHRA
2009/001/022/301/001
FSCA
2009/02/12
N.A.
N.A.
Mecall UNISTAT L floor stand
Vitech Scientific Starrsed Compact Interrliner
MHRA
MHRA
2008/012/030/401/007
2008/007/023/401/007
2009/02/12
2009/02/12
N.A.
N.A.
N.A.
N.A.
BrainLAB Ltd
N.A.
FSCA
FSCA
Action
2009/02/12
BrainLAB Ltd
2417 1881
Type II
2009/02/13
Millipore Hong
Kong
2803 9249
2807 8516
BrainLAB Radiolucent Spine Reference Clamp
Millipore Corporation Bioscience Simulfluor Flu A/B Immunofluor Assay
(Model:3121, 5250)
Health Canada
45681
Baxter Healthcare Rear Case Assembly For Auto Syringe (Model: 1M8560R)
Health Canada
43803
Type II
2009/02/13
Baxter
Healthcare Ltd
Problem Solving Concepts Prosolv Cardiovascular Image and Information
Management
Health Canada
46106
Type II
2009/02/13
N.A.
N.A.
Encore Medical Modular Femoral Neck
Health Canada
44847
Type II
2009/02/13
N.A.
N.A.
Tremblay Harrison Minute Lab PSA Semi-Quantitative Test (Model: PSD-A1, PSSA1)
Health Canada
46147
Type II
2009/02/13
N.A.
N.A.
Imaging Sciences International Gendex GXCB-500 Cone Beam 3-D Imaging
(Model: 45997)
Health Canada
45997
Type II
2009/02/13
N.A.
N.A.
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
45821
Type II
2009/02/13
2838 8423
Medtronic Durepair Dura Regeneration Matrix
Health Canada
45672
Type II
2009/02/13
Uninet
Technology
MedtronicLTD
Bio-Rad Laboratories Bioplex 2200 Detector Calibration Packs
Health Canada
45218
Type II
2009/02/13
Bio-Rad Laboratories Liquicheck Cardiac Markers Control LT - Trilevel (145), Level
1(146), Level 2 (147), Level 3 (148), Trilevel Minipak (145x)
Health Canada
45219
Type II
2009/02/13
ThermoFisher BO0351G, Tryptone soya broth, lot number 1066679
MHRA
2009/001/026/601/003
FSCA
2009/02/13
N.A.
TRB Chemedica Visiol Syringe 20mg/ml
MHRA
2008/012/023/291/008
FSCA
2009/02/13
N.A.
N.A.
BD Insyte Autogard I.V Catheter
MHRA
2009/001/030/291/009
FSCA
2009/02/16
BD
886-2722-5660
Elekta Precise Treatment Table
MHRA
2009/002/011/291/007
FSCA
2009/02/16
N.A.
BioMerieux Bacteriology culture medium. Chocolate agar + PolyViteX VCAT3 agar
MHRA
MDA/2009/011
MDA
2009/02/17
2356 7033
Mast Laboratories V Factor Catridges
MHRA
2009/002/009/601/001
FSCA
2009/02/18
N.A.
Biomerieux
China Ltd. (HK
office)
N.A.
STAAR Surgical Aquaflow collagen glaucoma drainage device
MHRA
2008/011/024/291/008
FSCA
2009/02/18
N.A.
N.A.
Spacelabs Healthcare Blease 700/900 Ventilator
MHRA
2009/002/005/291/006
FSCA
2009/02/18
N.A.
N.A.
Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit
FDA
Z-0863-2009
Class II
2009/02/19
N.A.
N.A.
Stryker PainPump (Prodcut no.: 0500-166-025, 0500-166-050, 0500-200-000;
REF: 500-166-25; 500-166-50, 500-200
FDA
0923-2009 to Z-0925-20
Class II
2009/02/19
Stryker China Ltd
2518 6915
Stryker PainPump 2 Blockaid (REF 575-100)
FDA
Z-0926-2009
Class II
2009/02/19
Stryker China Ltd
2518 6915
Stryker AVS AL Spacer Trial Inserter; Non Sterile (Catalog no 48329800)
FDA
Z-0936-2009
Class II
2009/02/19
Stryker China Ltd
2518 6915
43
International Ltd
Bio-Rad Pacific
Ltd
Bio-Rad Pacific
Ltd.
2919 1362
N.A.
N.A.
N.A.
N.A.
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis)
FDA
Z-0928-2009
Class II
2009/02/19
Siemens Artiste MV Digital Linear Accelerator System equipped with 160 MCL
Accessory Holder
FDA
Z-0949-2009
Class II
2009/02/19
AGFA IMPAX Cardiovascular Polling Procedure version 1.00.09
FDA
Z-0945-2009
Class II
2009/02/19
GE Medical
Systems Hong
Siemens
Healthcare
Diagnostic
FA Hong Kong Lim
Posey Connecting Straps and Belts/Locking Cuffs
FDA
Z-0934-2009
Class II
2009/02/19
N.A.
N.A.
Advanced Bionics HR90K Platinum Series Headpiece; Platinum Series Headpiece
; S-Series Long Range Headpiece, S- Series Short Range Headpiece
FDA
0956-2009 to Z-0959-20
Class II
2009/02/19
N.A.
N.A.
Synthes Nfix II System, N-Hance System, TI N-Hance Rod, Nflex Stabilization
System
FDA
0963-2009 to Z-0968-20
Class II
2009/02/19
Synthes (Hong
Kong) Ltd
2724 2032
Teleflex Medical CC IAB Catheters/Volume Connectors
MHRA
2009/002/010/291/018
FSCA
2009/02/20
Maquet Heartstring II Proximal Seal System
MHRA
2009/002/013/051/002
FSCA
2009/02/23
Blatchford Endolite 30mm Pyramid Adapt
MHRA
2008/009/008/401/012
FSCA
2009/02/23
Siemens Sireskop SX and AXIOM Sireskop SD
MHRA
2009/002/013/051/003
FSCA
2009/02/23
Tyco Shiley 3.0 Cuffless Paediatric Tracheostomy
MHRA
2009/001/023/291/001
FSCA
2009/02/24
Johnson and Johnson (DePuy) Total knee replacement implant femoral
components – PFC SIGMA
MHRA
MDA/2009/016
MDA
2009/02/25
Edwards Lifesciences Swan-Ganz Thermodilution Catheters
MHRA
2009/002/018/291/008
FSCA
2009/02/25
Abbott RealTime HIV-1 Assay
MHRA
2009/002/019/291/015
FSCA
2009/02/25
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.
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
Medical Systems Pa
2724 2836
Boston Scientific Atlantis PV Peripheral Imaging Catheter (Model no H749364560)
FDA
Z-0837-2009
Class II
2009/02/26
N.A.
Maquet Hong
Kong LTD
Siemens
Healthcare
Healthcare (HKSAR
Johnson &
Johnson Medical
(HK)
N.A.
Abbott
Laboratories
Boston Scientific
Hong Kong Ltd
Philips Health
Care (Great
Siemens
Healthcare
Diagnostic
Siemens
Healthcare
Diagnostic
2783 1838
2810 7533
2555 9421
N.A.
2393 9511
2810 7533
3157 7220
2738 6027
N.A.
2593 2211
2960 7136
2821 5480
Philips M8000-64100 Table Mount
FDA
Z-0817-2009
Class II
2009/02/26
Siemens Drive Belt for Radiation Therapy Simulation Systems SIMVIEW 3000 and
SIMVIEW NT with CT option or IDI
FDA
Z-0646-2009
Class II
2009/02/26
Siemens MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo
Panels and MicroScan Synergies Plus Negative Panels
FDA
0540-2009 to Z-0541-20
Class II
2009/02/26
Zoll Monitor portion of the LifeVest device (Model no. WCD3000 and WCD3100)
FDA
Z-0883-2009
Class II
2009/02/26
N.A.
N.A.
Ossur 3" Titanium Skull Pin, 3" Ceramic Tip Pin,2 1/4" Ceramic Tip Pin
FDA
0594-2009 to Z-0596-20
Class II
2009/02/26
N.A.
N.A.
Mako Surgical Femoral Array (Model no 0150ARR00001) and Tibial Array (Model
no 0150ARR00002)
FDA
Z-0915-2009
Class II
2009/02/26
N.A.
N.A.
Baxter System 1000 and Arena Haemodialysis instruments
MHRA
2009/002/010/291/017
FSCA
2009/02/27
axter Healthcare L
2807 8516
Edwards Lifesciences Fem-FlexII Paediatric Catheter
MHRA
2009/002/018/291/010
FSCA
2009/02/27
GE Giraffe Warmer & Panda iRes
MHRA
2009/001/021/601/001
FSCA
2009/02/27
Bio-Rad Laboratories Variant II Sytem with CDM 3.5 software, 3.6T System
Health Canada
46347
Type I
2009/02/27
Boston Scientific Precision Spinal Cord stimulation system
Health Canada
44523
Type II
2009/02/27
N.A.
GE Medical
Systems Hong
Bio-Rad Pacific
Ltd.
Boston Scientific
Hong Kong Ltd
44
2810 7533
2810 7533
N.A.
2783 1838
N.A.
2960 7136
Bard Access Ponsky Non-Ballon Gastrostomy tube
Health Canada
42263
Type II
2009/02/27
Fresenius Medical Patient On Line
Health Canada
41821
Type II
2009/02/27
45
N.A.
Fresenius
Medical Care
N.A.
2802 2900
Monthly Summary of Medical Device Safety Alerts - January 2009
Source of
Alert Type by Date of Issue
Agent Contact
Local Agent
(YYYY/MM/DD)
Information*
Source
Telephone No
TERUMO CHINA
2866 0811
Z-0445-2009 to Z-0446-2009
Class II
2009/01/02
Terumo Advanced Perfusion System 1 (Model 801763 and 801764)
FDA
(H.K.) LTD.
CTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel Harvesting
Boston Scientific
FDA
Z-0476-2009
Class II
2009/01/02
2960 7136
System with VASOVIEW Flexible Endoscopic Tools
Hong Kong Ltd
FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66-FA-SF)
Z-0486-2009
Class II
2009/01/02
N.A.
N.A.
FDA
Gold Pacific
Smiths Medical Wallace Oocyte Recovery Needles, Oocyte Recovery sets
2544 2602
FDA
Z-0593-2009
Class II
2009/01/02
(Product no. ONS1633LL-750 and ONS1733LL-750)
Enterprises
Siemens
SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)
FDA
Z-0524-2009
Class II
2009/01/02
2810 7533
Healthcare
Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025)
Z-0480-2009
Class II
2009/01/02
N.A.
N.A.
FDA
Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001)
Z-0500-2009
Class II
2009/01/02
N.A.
N.A.
FDA
Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation Chair
MHRA
2008/011/028/061/020
FSCA
2009/01/07
Stryker China Ltd
2518 6915
Model 6253
Johnson &
Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II
MHRA
2008/012/009/061/007
FSCA
2009/01/07
2738 6027
Johnson Medical
ArthroCare Saber 30 with Integrated Cable Wand
2008/012/009/061/003
FSCA
2009/01/08
N.A.
N.A.
MHRA
EV3 Marathon Flow Directed Micro Catheter Catalog Number 105-5055
2008/012/009/061/015
FSCA
2009/01/08
N.A.
N.A.
MHRA
GE Medical
GE Centricity Ultra Laboratory System Software
Z-0472-2009
Class II
2009/01/08
2783 1838
FDA
Systems Hong
Kong Ltd.
Siemens
Z-0543-2009 to Z-0545-2009
Class II
2009/01/08
2810 7533
Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace
FDA
Healthcare
Alphatec Spine Novel PEEK VBR XS
Z-0507-2009 to Z-0508-2009
Class II
2009/01/08
N.A.
N.A.
FDA
Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K
Z-0604-2009
Class II
2009/01/08
N.A.
N.A.
FDA
Stryker Leibinger New Generation/Universal Mandibular System
Z-0610-2009
Class II
2009/01/08
Stryker China Ltd
2518 6915
FDA
Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator
Z-0617-2009
Class II
2009/01/08
N.A.
N.A.
FDA
CovaTec Flexi-Seal Fecal Management System Advanced Odor Control Kit.
Z-0618-2008
Class II
2009/01/08
N.A.
N.A.
FDA
Rx only
Z-0644-2009 to Z-0645-2009
Class II
2009/01/08
N.A.
N.A.
Edwards Lifesciences EndoClamp aortic catheter
FDA
Hyphen BioMed Biophen Heparin 6 (various lots)
2008/012/003/061/001
FSCA
2009/01/09
N.A.
N.A.
MHRA
Siemens
Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay
MHRA
2008/012/023/051/001
FSCA
2009/01/09
2810 7533
Healthcare
Arcomedical Infusion Syramed SP6000 Syringe Pumps
2008/011/005/601/004
FSCA
2009/01/09
N.A.
N.A.
MHRA
Boston
Firm Initiated
Boston Scientific
Scientific
N.A.
2009/01/13
2960 7136
Boston Scientific Safety and Standard Push PEG Kits
Field Action
Hong Kong Ltd
Hong Kong
Ltd
Zimmer NexGen® Complete Knee Solution Provisional Articular Surface
2008/012/016/061/007
FSCA
2009/01/14 PTE Ltd. (Hong Kong
2992 0968
MHRA
ThermoFisher BO0366G Brain heart infusion, lot number 1070312
2008/012/015/601/005
FSCA
2009/01/14
N.A.
N.A.
MHRA
GE Medical
GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP Fluoroscopic
Z-0341-2009 to Z-0342-2009
Class II
2009/01/14
2783 1838
FDA
Systems Hong
x-Ray System
Kong Ltd.
Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and RL-01
Z-0439-2009 to Z-0440-2009
Class II
2009/01/14
N.A.
N.A.
FDA
Innovative Implant Sinu-Lift System (Model SLS-1)
Z-0505-2009
Class II
2009/01/14
N.A.
N.A.
FDA
Biomet Compress Instrument Anchor Plug Holders
Z-0517-2009 to Z-0521-2009
Class II
2009/01/14
N.A.
N.A.
FDA
Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared and Pro
Z-0600-2009 to Z-0603-2009
Class II
2009/01/14
N.A.
N.A.
FDA
2000
Z-0542-2009
Class II
2009/01/14 Diagnostics (Hong Ko
2485 7510
Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no 04522320190)
FDA
GE Medical
GE Solar 8000M System
Z-0285-2009
Class II
2009/01/14
2783 1838
Systems Hong
FDA
Kong Ltd.
46
Siemens CT syngo Dual Energy Viewer (Model 10094833)
FDA
Z-0647-2009
Class II
2009/01/14
Hitachi CXR4 Computed Tomography Scanner
ACIST CVi Angiographic Injection System (Model: CVi Toshiba interface
Cable)
Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX)
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate (Ref
6420-01-230)
Frontier Medical Repose Mattress and Cushion
FDA
FDA
FDA
Z-0608-2009
Z-0643-2009
Z-0607-2009
Class II
Class II
Class II
2009/01/14
2009/01/14
2009/01/14
Boston Scientific Stonetome Single-Use Stone Removal Device
Stryker Intouch Bed Model 2130 with positionpro (model: 2130-000-000),
Intouch Bed Model 2140 with Positionpro (model: 2140-000-000)
Biomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office Fixation
Kit, C) 1.5/IMF Small Office Set
Siemens
Healthcare
N.A.
N.A.
N.A.
2009/01/14 PTE Ltd. (Hong Kong
2810 7533
N.A.
N.A.
N.A.
FDA
Z-0871-2009
Class II
MHRA
Boston
Scientific
Hong Kong
Ltd
2008/009/015/301/001
FSCA
2009/01/15
N.A.
N.A.
N.A.
Firm Initiated
Field Action
2009/01/15
Boston Scientific
Hong Kong Ltd
2960 7136
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.
Toshiba Aquilion One (TSX-310A/2)
Health Canada
44879
Type II
2009/01/15
Invacare Careguard Mattress
Health Canada
45093
Type II
2009/01/15
Medtronic DLP Pericardial / Intracardiac Sump
Health Canada
45468
Type II
2009/01/15
Philips Easydiagnost Eleva
Health Canada
45433
Type II
2009/01/15
Convatec Flexi-Seal FMS Advanced Odor Control
Health Canada
45051
Type II
2009/01/15
KCI Kinair IV
Health Canada
45500
Type II
2009/01/15
Maquet Maquet Foot Paddle
Health Canada
44983
Type II
2009/01/15
Philips Multi Diagnostic Eleva-Flat Detector-IM
Health Canada
44908
Type II
2009/01/15
Stryker Patient Registration Mask (Box of 5)
Coloplast Philips Bougle
Health Canada
Health Canada
45115
45314
Type II
Type II
2009/01/15
2009/01/15
Roche Diagnostics Process System Manager
Health Canada
44820
Type II
2009/01/15
Smith & Nephew Reflection Hip PE Inlay (7174-0250)
Health Canada
45263
Type II
2009/01/15
Synthes (Canada) Synfix LR, Low Profile U-Joint Driver
Health Canada
45120
Type II
2009/01/15
KCI Therapulse ATP
Health Canada
44999
Type II
2009/01/15
Biomerieux Vitek 2 GN Card
Health Canada
44650
Type II
2009/01/15
Abbott Voyager RX Coronary Dilation Catheter (1011759-08, 1011759-12)
Health Canada
44757
Type II
2009/01/15
44817
Type II
2009/01/15
45310
Type II
2009/01/15
Sanko Medical
Systems (HK) LTD
Direct Health LTD
Medtronic
International, Ltd.
Philips Health
Care (Great
Bristol-Myers
Squibb (HK) LTD.
N.A.
Maquet Hong
Kong LTD.
Philips Health
Care (Great
Stryker China Ltd
Coloplast (HK)
LTD
Roche Diagnostics
(Hong Kong) Ltd
Smith & Nephew
LTD
Synthes
International Ltd.
N.A.
Biomerieux China
Ltd. (HK office)
Abbott
Laboratories LTD.
Philips Health
Care (Great
China)
Philips Health
Care (Great
China)
2992 0968
238400688
N.A.
2919 1300
2821 5480
2510 6146
N.A.
2393 9511
2821 5480
2518 6915
3628 7427
2485 7510
2648 7700
N.A.
N.A.
2356 7033
2593 2211
Philips A) Allura XER FD10/10, B) Allura XPER FD20/10 System, C) Integris
H5000C Cardiology Imaging System (722016), D) Integris Allura (722043*),
Health Canada
E) Allura XPER FD10, F) Allura XPER FD20 System
Philips A) Allura XPER FD20/10 System, B) Integris H5000C Cardiology
Imaging System (722016), C) Integris Allura (722043*), D) Allura XPER FD10, Health Canada
E) Allura XPER FD20 System
Stryker A)Intouch Critical Care Bed Model 2130 (2130-000-000), B) Intouch
Health Canada
critical Care Bed Model 2140 (2140-000-000)
St Jude Medical Epicor LP Connecting Cable
MHRA
45351
Type II
2009/01/15
Stryker China Ltd
2518 6915
2008/012/010/061/001
FSCA
2009/01/20
BioMerieux Vironostika HIV Uni-Form II Ag/Ab
MHRA
2008/011/019/061/001
FSCA
2009/01/20
2356 7033
Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units)
MHRA
2008/010/002/401/007
FSCA
2009/01/20
N.A.
Biomerieux China
Ltd. (HK office)
N.A.
47
2821 5480
2821 5480
N.A.
N.A.
Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay
MHRA
2008/012/001/061/004
FSCA
2009/01/20
Biomet Sterile 1/3 Tubular Plates (85 mm x 7 Holes)
ThermoFisher BO0351E, Tryptone soya broth, lot number 1045903
Ortho Solutions FPS Locking Screws (14mm/18ms)
ThermoFisher TPHA Test Kit
MHRA
MHRA
MHRA
MHRA
2008/012/002/291/002
2008/012/015/601/004
2008/010/017/401/001
2008/012/022/051/001
FSCA
FSCA
FSCA
FSCA
2009/01/20
2009/01/20
2009/01/20
2009/01/20
Siemens
Healthcare
man Medical Supplie
N.A.
N.A.
N.A.
Biomerieux China
Ltd. (HK office)
hpro Technology Co
Abbott
Laboratories LTD.
man Medical Supplie
N.A.
N.A.
N.A.
Hong Kong and Chin
Siemens
Healthcare
N.A.
h & Lomb (Hong Kon
Maquet Hong
Kong LTD.
Philips Health
Care (Great
dtronic International,
2810 7533
2332 4455
N.A.
N.A.
N.A.
2356 7033
BioMerieux Chocolate PolyViteX VCAT3 agar
MHRA
2008/012/001/601/001
FSCA
2009/01/21
Diagnostica Stago STA - Cuvettes
MHRA
2008/012/030/291/017
FSCA
2009/01/21
Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H49-02
MHRA
2008/012/022/601/003
FSCA
2009/01/21
Smiths Medical BCI 9200 Advisor Vital Signs Monitor
CMS Software 4.3.1 through 4.40.00
Sorin Mini Bypass Bag
Days Healthcare Walking frame
Olympus PK7300 blood grouping system
MHRA
MHRA
MHRA
MHRA
MHRA
2008/012/030/061/006
2008/012/012/601/004
2008/012/031/061/002
2008/010/007/401/016
2008/012/023/051/002
FSCA
FSCA
FSCA
FSCA
FSCA
2009/01/21
2009/01/21
2009/01/21
2009/01/21
2009/01/21
Siemens Sentinel Apolipoprotein B
MHRA
2009/001/005/061/005
FSCA
2009/01/21
Otto Bock Blizzard Active Wheelchair
Bausch & Lomb Akreos Advanced Optics Aspheric Lens
MHRA
MHRA
2008/012/029/301/002
2008/012/019/291/002
FSCA
FSCA
2009/01/21
2009/01/21
Maquet SERVO 300A Automode
MHRA
2008/012/016/061/001
FSCA
2009/01/21
Philips Pulmonary Toolkit
MHRA
2008/012/029/291/001
FSCA
2009/01/22
Medtronic MicroTargetingTM Drive System and Accessories
Baxter System 1000 Series of Hemodialysis Instruments with 4.D.0.3 or
4.D.0.4 Software
Kivi Uniloc wheelchair docking system AKE 04
Varian Medical Systems Eclipse 8.5 (build 8.2.2X) systems with distributed
Calculation Framework (DCF) 8.2.22 (Model no H48)
MHRA
2008/012/030/291/011
FSCA
2009/01/22
MHRA
2009/001/013/291/003
FSCA
2009/01/22 Baxter Healthcare Lt
MHRA
2009/001/012/301/001
FSCA
2009/01/22
FDA
N.A.
Class II
2009/01/22 Medical Systems Pa
GE Centricity Enterprise Web 3.0 software
FDA
Z-0870-2009
Class II
2009/01/22
2783 1838
Stryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630-G-108)
and Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no: 5630-G-122)
GE Medical
Systems Hong
Kong Ltd.
FDA
Z-0869-2009
Class II
2009/01/22
Stryker China Ltd
2518 6915
Siemens Ariste MV Digital Linear Accelerator
FDA
Z-0857-2009
Class II
2009/01/22
Dade Behring (a Siemens Company) Dimension EXL Clinical Chemistry
System
FDA
Z-0581-2009
Class II
2009/01/22
Abbott Clinical Chemistry Bilirubin Calibrator
FDA
Z-0580-2009
Class II
2009/01/22
Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE Cup
FDA
Z-0532-2009 to Z-0539-2009
Class II
2009/01/22
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
N.A.
Siemens
Healthcare
Siemens
Healthcare
Abbott
Laboratories LTD.
Johnson &
Johnson Medical
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
2807 8516
N.A.
2724 2836
2810 7533
2810 7533
2593 2211
2738 6027
FDA
Z-0129-2009
Class II
2009/01/22
an Coulter Hong Ko
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
2008/010/024/401/007
FSCA
2009/01/23
N.A.
N.A.
48
Roche Hitachi 917 Modular Analytics
MHRA
2008/011/026/291/009
FSCA
2009/01/29
ThermoFisher Lactose peptone water with Durham's tube - BO0435B
Joint Replacement Instrumentation BiPolar Head
A2U Nano supportive seating system
Advanced Healthcare Technology Babypod II, Evo2 and Evo3
MHRA
MHRA
MHRA
MHRA
2009/001/012/601/001
2009/001/008/061/005
2008/012/023/401/006
2008/012/012/401/010
FSCA
FSCA
FSCA
FSCA
2009/01/29
2009/01/29
2009/01/29
2009/01/29
Siemens Somatom Definition AS
MHRA
2008/012/012/291/003
FSCA
2009/01/29
Siemens syngo Workflow MLR
MHRA
2008/012/022/051/003
FSCA
2009/01/29
Stryker Pneumo Sure XL High Flow Insufflator
Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M.
tuberculosis Complex, ACCUPROBE M. avium Complex
Croma-Pharma Quatrix Acrylic Intraocular lenses with a preloaded injector
ThermoFisher Oxoid Staphytect Plus Dry Spot Kit
Invacare Action® 2000 Manual Wheelchair
MHRA
2009/001/016/291/004
FSCA
2009/01/29
GE Medical
Systems Hong
Kong Ltd.
N.A.
Stryker China Ltd
Roche Diagnostics
(Hong Kong) Ltd
N.A.
N.A.
N.A.
N.A.
Siemens
Healthcare
Siemens
Healthcare
Stryker China Ltd
MHRA
2009/001/014/601/004
FSCA
2009/01/29
N.A.
N.A.
MHRA
MHRA
MHRA
2009/001/012/291/017
2008/010/017/061/003
2008/010/020/401/012
FSCA
FSCA
FSCA
2009/01/29
2009/01/29
2009/01/29
N.A.
N.A.
N.A.
MHRA
2009/001/021/291/004
FSCA
2009/01/29
N.A.
N.A.
N.A.
Philips Health
Care (Great
Coloplast (HK)
LTD
Bausch & Lomb
(Hong Kong ) Ltd
2821 5480
2009/01/30
Stryker China Ltd
2518 6915
GE OEC 7600 and OEC 7700
MHRA
2009/001/009/061/002
FSCA
2009/01/29
Elekta Leksell GainmaPlan / Leksell SurgiPlan
Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade
MHRA
MHRA
2008/012/017/061/006
2009/001/007/061/008
FSCA
FSCA
2009/01/29
2009/01/29
Philips PCR Eleva
Coloplast Philips Catheter, 1Eye, Female Metric Thread (Catalogue no.
AG55)
Bausch & Lomb High Speed Vitrectomy cutter product (CX4804)
Coloplast
(HK) Ltd
Bausch &
Lomb
N.A.
N.A.
Firm Initiated
Field Action
Firm Initiated
Field Action
2009/01/30
2009/01/30
2783 1838
N.A.
2518 6915
2485 7510
N.A.
N.A.
N.A.
N.A.
2810 7533
2810 7533
2518 6915
3628 7428
2213 3371
Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing (Model
no 0350600006)
Stryker Vision 3 Flat Panel Shroud (Part#0682-000-414, 0682-000-415 and
0682-000-416)
Stryker Dri-Lok Disposable Cannula
FDA
Z-0625-2009
Class II
2009/01/30
Stryker China Ltd
2518 6915
FDA
Z-0868-2009
Class II
2009/01/30
2518 6915
Z-0597-2009
Class II
2009/01/30
Stryker China Ltd
Philips Health
Care (Great
Philips Health
Care (Great
Accuray Asia Ltd
GE Medical
Systems Hong
Kong Ltd.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
Maquet Hong
Kong LTD.
Stryker China Ltd
Arjo Huntleigh
(Hong Kong) Ltd.
Roche Diagnostics
(Hong Kong) Ltd
FDA
Z-0652-2009
Class II
Philips Vertical drive brake on patient supports
FDA
Philips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System
(software)
Accuray CyberKnife Robotic Radiosurgery System
FDA
Z-0001-2009
Class II
2009/01/30
FDA
Z-0629-2009
Class II
2009/01/30
GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ
FDA
Z-0473-2009 to Z-0475-2009
Class II
2009/01/30
Z-0615-2009 to Z-0616-2009
FDA
Z-0626-2009
FDA
Z-0598-2009
FDA
Z-0513-2009 to Z-0516-2009
FDA
Z-0506-2009
FDA
45563
Health Canada
45100
Health Canada
Class II
Class II
Class II
Class II
Class II
Type II
Type II
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
2009/01/30
Cardinal Health Esmark Elastic Bandage
INGfertility Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant
Alimed Gait Belt (Transfer Aid) (Model 72108, 72109)
Quantimetrix QuanTscopics Urine Microscopics Contro
Hill- Rom 70 Semi-Electric Bed (Model HS-968)
Ansell Healthcare Products Conform XT - Gloves (Model: 69318)
Ossur HF ReSolve Open Back Halo Ring
Maquet Reservoirs (BEQ-VHK 2001)
Health Canada
45565
Type II
2009/01/30
Styker Dri-Lok Disposable Cannulas
Health Canada
45616
Type II
2009/01/30
BHM Medical Ergolift, Ergolift-2
Health Canada
45626
Type I
2009/01/30
Roche Diagnostics Process System Manager (Model: 3009696001)
Health Canada
45358
Type I
2009/01/30
49
2821 5480
2821 5480
2247 8628
2783 1838
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.
2393 9511
2518 6915
2508 1416
2485 7510
Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K)
Harvest Technologies Autologous Platelet Concentrate System (Model: APC201)
Philips A) Multidiagnost Eleva - Image Intensifier (70832), B) Multidiagnost
Eleva - Flat Detector (70834), C) Omnidiagnost Eleva (Model: 708027)
White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ Zirconia
Disc
MC Healthcare Products QP2508 Hand Pendant (Model: HB43-U010-00/01
Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500-415)
Health Canada
41402
Type II
2009/01/30
Health Canada
45706
Type II
2009/01/30
Health Canada
45311
Type II
2009/01/30
Health Canada
Health Canada
Health Canada
44705
45786
45802
Type II
Type II
Type II
2009/01/30
2009/01/30
2009/01/30
50
Baxter Healthcare
Ltd
N.A.
Philips Health
Care (Great
N.A.
N.A.
N.A.
2807 8516
N.A.
2821 5480
N.A.
N.A.
N.A.
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
Zimmer PTE Ltd. (Hong Kong branch)
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
Siemens Healthcare Diagnostic Limited
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
N/A
05-Dec-08
2960 7136
SN081210
Boston Scientific RF Ablation System Foot Switch
Boston Scientific
Hong Kong Ltd
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
Johnson & Johnson Medical (HK)
2738 6027
SN081213
Medtronic EnTrust® Implantable Cardioverter Defibrillators
MHRA
2008/011/021/061/005
FSCA
08-Dec-08
Medtronic International, Ltd.
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
N/A
10-Dec-08
Varian Medical Systems Pacific Inc.
2722 8123
SN081215
Varian Linear accelerators other than Clinac
Varian Medical
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
GE Medical Systems Hong Kong Ltd.
2783 1888
MHRA
2008/011/028/061/015
FSCA
15-Dec-08
2807 8555
FDA
Z-0343-2009
Class I
15-Dec-08
AMO Asia Limited
2480 3330
SN081217
SN081218
Baxter COLLEAGUE Triple Channel Mono, and CXE Volumetric
Infusion Pumps 2M8153K and 2M9163
AMO Healon D Ophthalmic Viscosurgical Device (Lot No.
UD30654)
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
51
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
Health Canada
44867
Type II
17-Dec-08
N/A
N/A
SN081235
SN081236
SN081237
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
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
52
SN081250
Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades
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
SN081257
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
N/A
Class I
22-Dec-08
N/A
N/A
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
Bard Pacific Health
Care Co Ltd
Medtronic
International Ltd
FDA
Z-0412-2009 to Z-0413-2009
Class II
30-Dec-08
Arjo Huntleigh (Hong Kong) Ltd
2508 9553
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
53
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
Tyco Healthcare (HKSAR) LTD
3157 7220
SN081113
Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation
FDA
Z-0184-2009 to Z-0187-2009
Class II
2008/11/07
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 18060125)
FDA
Z-0191-2009
Class II
2008/11/07
Stryker China Ltd
2518 6988
SN081122
Stryker Ray TFC Device with End Caps
FDA
Z-0151-2009
Class II
2008/11/07
Stryker China Ltd
2518 6988
54
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
Roche Diagnostics (Hong Kong) Ltd
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
55
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
Goodman Medical Supplies Ltd
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
56
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
57
SN0811100
B Braun Diacap Ultra Dialysis Fluid and Online Filter, 7107366 and
7107365
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
SN0811101 Stryker V40 ORTHINOX femoral head 28/-4 mm & 28/0 mm
SN0811102 Johnson & Johnson Sterrad 100S Sterilizers
SN0811103
Baxter COLLEAGUE Triple Channel Mono CX and CXE Volumetric
Infusion Pumps (Product Codes: 2M8153K)
Boston Scientific NAMIC Custom Angiographic Kit
SN0811108
(REF/Catalog#60190254)
SN0811109
Sunquest Laboratory System (Software version: Sunquest
Laboratory v5.4.2, v6.1, v6.2 and v6.3)
FDA
Z-0214-2009
Class II
2008/11/21
N/A
N/A
SN0811110
Gabauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin
Refrigerant (Aerosol Can) (P/N 0386-0020-20)
FDA
Z-0218-2009
Class II
2008/11/21
N/A
N/A
SN0811111 Smith & Nephew SOFTSILK 1.5 SCREW, 8mm x 20mm
MHRA
2008/011/014/061/008
FSCA
2008/11/21
N/A
N/A
SN0811112 Codman, A J&J Archimedes implantable infusion pump
MHRA
2008/004/021/061/008
FSCA
2008/11/21
2738 6027
Comis Orthopaedics MIHR Modular Femoral Head Sleeve Size 0,
SN0811113
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# M800064100)
MHRA
2008/011/019/061/021
FSCA
2008/11/24
2821 5480
MHRA
2008/011/018/601/002
FSCA
2008/11/24
2783 1838
Health Canada
44383
Type II
2008/11/24
N/A
N/A
SN0811114
SN0811115 GE Giraffe OmniBed (Cleaning & Care Guidelines)
SN0811116 Phadia Varelisa U1RNP Antibodies Kit (model 17096)
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
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
SN0811125 Terumo Advanced Perfusion System 1 (Model 801040 and 801041)
SN0811126
Abbott CELL-DYN Sapphire Hematology Analyzer (List no 08H0001, 08H00-03)
FDA
Z-2388-2008
Class II
2008/11/28
2907 5911
FDA
Z-0309-2009 to Z-0310-2009
Class II
2008/11/28
2866 0811
FDA
Z-0306-2009
Class II
2008/11/28
2593 2211
58
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
59
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
SN081017
Naviscan PEM Flex Solo II PET Scanner
FDA
Z-2229-2008
Class II
02-Oct-08
N/A
N/A
2645 8703
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
60
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
Draeger Medical Hong Kong Ltd.
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
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
SN081043
SN081044
ev3" 55442-2920, sterile EO, single Use, Visi-Pro BalloonExpandable Peripheral
Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS)
Model 802
FDA
Z-1692-2008
Class II
13-Oct-08
COVIDEN
3157 7220
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
61
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
FDA
Z-2350-2008
Class II
13-Oct-08
N/A
N/A
SN081058
SN081059
SN081060
SCC Soft Computer SoftPath GUI Release Software Versions 3.17
and 4.1
Kyphon KyphX Osteo Introducer System with blunt tip introducer
stylet
Steris Small Renaissance Eagle 3000
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
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
2645 8703
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
N/A
Action
15-Oct-08
2960 7136
SN081075
Boston Scientific Atlantis PV 15 MHz Imaging Catheter
Boston Scientific
Hong Kong Ltd
62
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
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)
N/A
SN081090
Abbott Flexiflo Quantum Pump Set (List # 50604)
FDA
Z-2305-2008
Class II
16-Oct-08
2806 4021
SN081091
FDA
Z-2212-2008
Class II
16-Oct-08
2810 7533
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
GE Datex-Ohmeda Engstrom Carestation
SN081097
SN081092
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
FDA
Z-1829-2008
Class II
16-Oct-08
2783 1838
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
63
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
MHRA
2008/010/007/601/002
FSCA
23-Oct-08
N/A
N/A
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
2008/010/010/061/004
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
SN0810127
SN0810128
SN0810129
SN0810130
Lomax Mobility Kid Active folding manual wheelchair with swing
away footrests
Boston Scientific TruPath Biopsy Device and easy Core Biopsy
Device
Boston Scientfic easyCore Biopsy System (Endoscopy)
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
N/A
N/A
64
Action
Action
SN0810131
Steris Quick Connect component (p/n 201048)
FDA
Z-2462-2008
Class II
27-Oct-08
Swedish Trading Co., Ltd
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
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
FDA
Z-2405-2008
Class II
27-Oct-08
2240 6150
SN0810142
Beckman Coulter Synchron Acetaminophen (ACTM) Reagent (Part
No. 472169)
Cardinal Health NicoletOne 5.30.2 Software
FDA
Z-2459-2008
Class II
27-Oct-08
Cardinal Health
SN0810143
Boston Scientific easy Core Biopsy Device (Peripheral Interventions)
Boston Scientific
Hong Kong Ltd
N/A
Action
27-Oct-08
2960 7136
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
SN0810141
N/A
SN0810145
GE Healthcare Giraffe and Panda Warmers
MHRA
2008/010/014/601/001
FSCA
27-Oct-08
2783 1838
SN0810146
Medtronic OptiVol CareAlert and CareLink Transmissions Issue
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
MHRA
2008/010/010/061/012
FSCA
28-Oct-08
N/A
N/A
SN0810147
Invacare Typhoon 1 & 2 Power Wheelchairs
SN0810148
Thoratec HeartMate II LVAS
SN0810149
Helena Laboratories Manual D-dimer 5250
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
65
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
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
66
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
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
FSCA
Action
Action
2008/09/02
N/A
N/A
2008/09/03
Boston Scientific HK Limited
2960 7136
2008/09/03
2907 5911
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
67
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
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
SN080924
Bostson Scientific Smash Balloon Dilatation Catheter
SN080925
SN080926
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
2008/09/12
Solar-med Limited
2425 0926
N/A
Goodwin Health Care
Ltd
N/A
Solar-med Limited
N/A
Action
Action
SN080947
Invivo Lithium Polymer Wireless Module Batteries
SN080948
Teleflex Weck Clips products : Hemolok clips, Horizon Clips and
Hemoclip
SN080949
Vital Signs Light Wand Orotracheal Lighted Stylet
MHRA
2008/008/028/061/002
FSCA
2008/09/16
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
68
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
2008/09/16
2575 8668
2008/09/16
2738 6027
2008/09/17
2960 7136
2008/09/18
2783 1838
SN080956
SN080957
BD FACSAria Sorters running BD FACSDiva Software, version 3.0
or later
Johnson and Johnson ASP Automatic Endoscope Reprocessor
(AER)
SN080958
Boston Scientific iLabR Ultrasound Imaging Systems
SN080959
GE Healthcare Responder 2000 Defibrillator
BD Asia Ltd (Hong
Kong)
Johnson & Johnson
Medical Hong Kong
Boston Scientific
Hong Kong Ltd
MHRA
N/A
N/A
N/A
2008/008/013/061/012
Action
Action
Action
FSCA
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
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
69
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
Z-1819-2008 to Z-1820-2008
Class II
2008/09/19
N/A
N/A
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
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
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
FDA
Z-1827-2008
Class II
2008/09/22
N/A
N/A
SN080990
Merit Medical Systems Fluid Administration Set, Custom Kit
FDA
Z-1800-2008 to Z-1807-2008
Class II
2008/09/22
N/A
N/A
SN080991
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
FDA
Z-1790-2008 to Z-1799-2008
Class II
2008/09/22
N/A
N/A
SN080992
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
SN080996
SN081001
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
SN081002
70
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
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
SN081023
Greiner Bio-One Vacuette, Plastic Cannula HOLDEX (Ref 450216)
FDA
Z-2134-2008
Class II
2008/09/26
Mekim Ltd
2774 8300
FDA
Z-2205-2008 to Z-2208-2008
Class II
2008/09/26
N/A
N/A
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)
Health Canada
43308
Type II
2008/09/29
2821 5480
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
71
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
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
SN081042
Coloplast Folysil Xtra Silicone Indwelling Catheters
MHRA
2008/008/028/401/010
FSCA
2008/09/29
Coloplast (Hong Kong) Ltd
N/A
SN081043
Utah Intran Plus IUPC trays
MHRA
2008/009/016/051/001
FSCA
2008/09/30
N/A
N/A
SN081044
Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120
MHRA
2008/006/005/291/004
FSCA
2008/09/30
Siemens Ltd
2810 7533
SN081045
Draeger Sub-Acute Care Ventilator Carina
MHRA
2008/007/003/401/011
FSCA
2008/09/30
N/A
N/A
SN081046
BD Visitec High Viscosity Injector
MHRA
2008/009/022/061/010
FSCA
2008/09/30
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
N/A
SN081052
EBI Trauma Fixation Systems
FDA
Z-2012-2008
Class II
2008/09/30
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
72
Source of
Information*
MHRA
MDA/2008/059
MDA
Date of Issue
(YYYY/MM/DD)
2008/08/01
SN080802
Levitronix CentriMag Systems
MHRA
2008/002/026/401/001
FSCA
2008/08/01
N/A
N/A
SN080803
Stryker Scorpio Series 7000 Tibial Impactor/Extractor
MHRA
2008/007/007/061/017
FSCA
2008/08/01
Stryker China Ltd
2518 6915
SN080804
ThermoFisher Scientific BO0348V Maximum recovery diluent
MHRA
2008/007/018/601/501
FSCA
2008/08/01
N/A
N/A
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
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
SN080819
Johnson and Johnson Depu Delta XTEND
MHRA
2008/007/023/061/004
FSCA
2008/08/11
Johnson & Johnson Medical Hong
Kong
SN080820
Baxter COLLEAGUE Triple Channel Mono and CXE Volumetric
Infusion Pumps
MHRA
2008/007/022/051/006
FSCA
2008/08/13
N/A
N/A
SN080821
Stille Sonesta 6210 fluoroscopy procedure table
MHRA
MDA/2008/063
MDA
2008/08/13
N/A
N/A
SN080822
ThermoFisher EB0212E Cooked meat medium
MHRA
2008/007/021/601/503
FSCA
2008/08/13
N/A
N/A
SN080823
Regulatory Insight Rolling Walkers (Rollators)
Health Canada
42905
Type II
2008/08/13
N/A
N/A
SN080824
Maquet Servo-I (Model 640870800 E407E)
Health Canada
43009
Type II
2008/08/13
2393 9511
73
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
Beckman Coulter Cytomics FC 500 Flow Cytometry System with
Data Innovations Instrument Manager (Part no 626553 and
6605628)
FDA
Z-1529-2008
Class II
2008/08/14
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
2783 1838
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
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
74
SN080852
Roche Diagnostics modular analytics
SN080853
Edwards Lifescience Accusol 35 Harmofialysis solutions for Acute
Renal Therapy
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
SN080854
Chiron PROCLEIX (Assay Reagent)
Press
SN080855
ArthroCare Topaz XL ArthroWand
MHRA
N/A
N/A
2008/08/21
Chiron Limited
2161 3104
2008/008/001/061/001
FSCA
2008/08/21
N/A
SN080856
MedtronicLIFEPAK CR Plus and LIFEPAK Express Defibrillator
MHRA
N/A
2008/008/004/051/010
FSCA
2008/08/21
2919 1300
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
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
SN080859
Varian Medical Systems On-Board Imager, versions 1.0.15 and
1.2.05 Imaging Accessory to Medical Linear Accelerator
FDA
Z-1442-2008
Class II
2008/08/21
2722 8123
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
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
SN080860
SN080861
SN080862
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
Tyco Healthcare (HKSAR) LTD
2574 3251
SN080881
Philips Allura XPER FD10, Allura XPER FD 20 system, Allura XPER
FD 20/10 System, Integris Allura, Integris H5000F Cardiology
Imaging System
Health Canada
43276
Type II
2008/08/27
2876 7525
75
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
SN080898
Medline Bariatric Wheelchair
FDA
Z-1770-2008 to Z-1772-2008
Class II
2008/08/28
N/A
N/A
SN080899
FDA
Z-1773-2008
Class II
2008/08/28
N/A
N/A
FDA
Z-2140-2008
Class II
2008/08/28
N/A
N/A
SN080901
EKOS EndoWave Infusion System
Acumed Osteo-Clage Cable System Package Assembly (01-0001S)
StatSampler 200 uL, Li Heparin (Ref: SS2H)
FDA
Z-2234-2008
Class II
2008/08/28
N/A
N/A
SN080902
Philips HeartStart MRx Monitor/Defibrillator
MHRA
2008/008/018/061/026
FSCA
2008/08/28
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
SN080900
76
Source of
Information*
MHRA
MDA/2008/044
MDA
Date of Issue
(YYYY/MM/DD)
2008/07/02
N/A
Agent Contact
Telephone No
N/A
SN080702
Abbott Diagnostics ARCHITECT c8000 System
MHRA
2008/006/002/601/380
FSCA
2008/07/02
2806 4021
SN080703
Anspach Sterile Single-use Cuting Burrs
MHRA
2008/006/011/291/004
FSCA
2008/07/02
N/A
N/A
SN080704
Arrow International Cannon catheter , Cannon catheter II and Edge
catheter
MHRA
2008/006/018/061/010
FSCA
2008/07/02
N/A
N/A
SN080705
TerumoTubing packs for extracorporeal circulation of blood
MHRA
2008/005/021/401/005
FSCA
2008/07/02
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
MDCO Ref.
No.
SN080701 Invacare Action³ manual wheelchair
Local Agent
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
SN080719
Boston Scientific Lumenis/Slimline Fiber Strippers
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/07/03
2960 7136
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
77
SN080728
TherapostureTheracare Beds supplied with Mesh Linked Padded
Rails
Medtronic SynchroMed® II Implantable Infusion Pump
SN080729
Liko AB Universal SlingBar
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
SN080730
Invacare Harrier Heavy Duty (HD) battery powered wheelchair
MHRA
MDA/2008/050
MDA
2008/07/08
N/A
N/A
SN080731
Quest 88 Kaye Posture Control Walkers
MHRA
2007/011/015/401/003
FSCA
2008/07/08
N/A
N/A
Steris Quick Connect (Model QXCXXXX)
Health Canada
38366
Type II
2008/07/10
N/A
Health Canada
39224
Type II
2008/07/10
Cardinal Health
N/A
Health Canada
39313
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080732
SN080734
Cardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal Pack,
C) Sterile Cardiovascular Universal
Siemens Oncor Expression (Model 7360717, 8139839)
SN080735
Siemens AG Somatom Definition (Model 7741445)
Health Canada
39782
Type II
2008/07/10
Siemens Ltd.
2810 7533
SN080736
GE Healthcare Precision RX/I Remote Imaging System (Model
5117828)
Health Canada
40889
Type II
2008/07/10
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
78
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
SN080767
Boston Scientific Platinum PlusT Cononary Guidwire
MHRA
2008/007/001/061/022
FSCA
2008/07/14
Boston Scientific HK Ltd
SN080768
Dade Behring StratusR CS Acute Care? Troponin I TestPaks
MHRA
2008/007/002/061/014
FSCA
2008/07/16
Siemens Ltd.
2810 7533
SN080769
Abbott ARCHITECT Total β-HCG calibrator
MHRA
2008/006/015/601/416
FSCA
2008/07/16
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
79
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
2919 1300
SN080805
Sunrise Medical Manual and Powered Wheelchairs
MHRA
2007/003/006/401/005
FSCA
2008/07/28
N/A
N/A
SN080806
Abbott ARCHITECT AFP assay
MHRA
2008/007/011/601/482
FSCA
2008/07/28
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
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
SN080812
Aidservice Medi-Tec Classic hoist
Troponin I Rapid Test and Myoglobin/CK-MB/Troponin I Combo
Test
Fresenius Injectomat 50ml syringe
MHRA
2008/007/015/061/014
FSCA
2008/07/31
N/A
N/A
SN080813
Philips Axis and Irix Gamma Cameras
MHRA
2008/007/014/061/004
FSCA
2008/07/31
2821 5480
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
Beckman Coulter Cytomics FC 500 Flow Cytometry System with
CXP Software version 2.1 and 2.2
FDA
Z-2016-2008 to Z-2033-2008
Class II
2008/07/31
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,
2008/07/31
2821 5480
SN080811
Health Canada
42936
80
Type II
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)
SN080825
SN080826
SN080827
Health Canada
42406
Type II
2008/07/31
Gambro Hong Kong Ltd
2839 7010
Health Canada
42939
Type II
2008/07/31
Stryker China Ltd
2518 6915
Health Canada
42974
Type II
2008/07/31
2783 1838
Health Canada
42906
Type II
2008/07/31
2839 7010
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
81
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
Source of
Information*
Bausch and Lomb
Boston Scientific
Hong Kong Ltd
MHRA
MHRA
MHRA
Affaps
N/A
Date of Issue
(YYYY/MM/DD)
Firm Initiated Field Action 2008/06/02
Baush and Lomb
Agent Contact
Telephone No
2213 3371
N/A
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
Local Agent
SN080603
SN080604
SN080605
SN080606
Hitachi Hi-Vision Ultrasound System
Siemens ADVIA Centaur CP
Thermogenesis Vapor Bypass Assembly (110v/220v)
Varian TPS Eclipse
SN080607
MHRA
2008/005/009/121/006
FSCA
2008/06/04
Stryker China Ltd
2518 6988
Health Canada
42116
Type II
2008/06/05
2806 4021
SN080609
Stryker Kinemax Plus Revision TS Tibial Insert
Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E6903)
AGA Medical Amplatzer PFO Occluder
Health Canada
41996
Type II
2008/06/05
AGA Medical Corporation (Asia Pacific)
N/A
SN080610
Arrow Balloon Temporary Pacing Catheter Kit
Health Canada
41991
Type II
2008/06/05
N/A
N/A
SN080611
BHM Ergiscake Scake abd Swivel Bar
Health Canada
41995
Type II
2008/06/05
Arjo Far East Ltd
2508 9553
Health Canada
41858
Type II
2008/06/05
2789 3300
SN080608
SN080612
SN080613
Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and
minipak
Bio-Rad Varient B-Thalassemia Short Program
Health Canada
42066
Type II
2008/06/05
2789 3300
SN080614
Cardinal Health Sterile Mammoplasty Pack, Sterile Total Knee Pack
and Othopedie-Fusion Posterieure
Health Canada
42115
Type II
2008/06/05
Cardinal Health
N/A
SN080615
Cook Hilal Embolization Coils
Health Canada
42174
Type II
2008/06/05
2781 0232
SN080616
Hill-Rom 100 Low Beds
Health Canada
41708
Type II
2008/06/05
N/A
N/A
SN080617
Imaging Sciences I-CAT 17-19, 3D Dental Imaging System (Model
1-10-1-0) and I-Cat 3D Imaging System- Main Unit (Model 91400000-0000)
Health Canada
42021
Type I
2008/06/05
N/A
N/A
SN080618
Johnson and Johnson Depuy Lupine BR Anchor With Orthocord
Health Canada
42075
Type II
2008/06/05
Health Canada
42071
Type II
2008/06/05
Health Canada
40792
Type II
2008/06/05
2919 1300
N/A
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
Kong
Kong
2738 2818
2738 2818
SN080621
Nova Biomedical Statstrip Glucose Hospital Meter
Health Canada
42078
Type II
2008/06/05
N/A
SN080622
Oxoid Haemophilus Selective Agar
Health Canada
42190
Type II
2008/06/05
N/A
N/A
SN080623
Philips Brilliance CT 16 Power Slice
Health Canada
40156
Type II
2008/06/05
Philips Electronics Hong Kong Ltd.
2876 7525
SN080624
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
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
82
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
SN080653
GE Healthcare Centricity PASCS Software versions: 3.0.0X, 3.0.1X,
3.0.2.X AND 3.0.3X
MHRA
2008/006/003/291/010
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080654
GE Healthcare DST-XL Carmera
MHRA
2008/005/030/061/024
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080655
GE Healthcare Innova 2100IO, 3100/3100IQ and 4100/4100IQ
Cardiovascular X-ray System
MHRA
2008/005/030/061/034
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080656
GE Healthcare OEC 9900, 9800 and 8800 series
MHRA
2008/005/030/061/025
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080657
GE Healthcare Pressure Sensitive Device (PSD)
MHRA
2008/003/025/061/015
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080658
GE Healthcare S/5 iCentral versions L-NET03, L-NETC03, LNET05, L-NETC05
MHRA
2008/005/002/601/317
FSCA
2008/06/17
GE Healthcare
2609 9233
MHRA
2008/005/028/061/019
FSCA
2008/06/17
MHRA
2008/005/009/121/011
FSCA
2008/06/17
MHRA
2008/006/003/291/004
FSCA
2008/06/17
N/A
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
83
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
N/A
2008/06/23
2960 7136
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
Kimal Safety Fistula Needle
SN080682
SN080666
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
MHRA
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
MHRA
2008/006/011/601/402
FSCA
2008/06/23
N/A
N/A
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
SN080692
Boston Scientific implantables devices, ICD and CRT-D
N/A
2008/06/26
2960 7136
SN080693
Computerized Medical Systems XIO Radiation Treatment Planning
System
Health Canada
42336
Type II
2008/06/27
N/A
N/A
SN080694
Philips Isite Ipacs (Model ISITE ENTERPRISE V.3.5, ISITE
RADIOLOGY V.3.5, IVAULT V.3.5)
Health Canada
42273
Type II
2008/06/27
2821 5480
SN080679
SN080687
Coloplast (Hong
Kong) Ltd
Boston Scientific
Hong Kong Ltd
84
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
85
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
SN080507 Phonak Rubber Dome BTE hearing instruments
MHRA
2007/011/020/061/002
FSCA
2008/05/07
N/A
N/A
Edwards Lifesciences Aquarius Regular Haemofiltration Machine
SN080508
with software version 4.01.11
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
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)
2519 9182
SN080521 National Biological Houva III
Health Canada
41407
Type II
2008/05/08
N/A
N/A
SN080505 Bausch & Lomb XP MicroKeratome motors
SN080506
SN080509
Accuray CyberKnife Robotic Radiosurgery System MultiPlan
Treatment Planning Sofetware (Catalog No 022986)
Stryker Advanced Cement Mixer (ACM) Bowl and Base (REF 306554)
86
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)
SN080533
Zimmer Hemovac, HAS, Sergivac, Infection Control and MiniHemovac 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
SN080536
Smiths Medical BCI Mini-Torr Plus NIBP Monitor with SpO2 & Builtin Printer, 6004
MHRA
2008/004/015/061/013
FSCA
2008/05/14
Goodwin Health Care Holdings Ltd
2408 8838
SN080537
P3 Medical Robertshaw Endobronchial tubes (PVC, Disposable)
MHRA
2007/012/022/601/001
FSCA
2008/05/14
Ultra Care Company Ltd
N/A
SN080538 Fisher & Paykel Healthcare Patient Warmers
MHRA
2008/004/022/061/020
FSCA
2008/05/14
N/A
N/A
SN080539 Gambro Spectra Optia Apheresis System
MHRA
2008/004/023/061/013
FSCA
2008/05/14
Gambro China Ltd
2839 9710
SN080540 Thoratec HeartMate II LVAS
Fisher Healthcare Sure-Vue Serum/Urine hCD-STAT (Catalog no.
SN080541 FHC-A202, Product Codes: FHC-A202-KFI3O and FHC-A202KFI5O)
SN080542 Medefil Heparin I.V. Flush Syringe
MHRA
2008/004/023/291/003
FSCA
2008/05/14
N/A
N/A
FDA
Z-1118-2008
Class II
2008/05/15
N/A
N/A
FDA
Z-1543-2008 to Z-1545-2008
Class II
2008/05/15
N/A
N/A
SN080543 Siemens ADVIA Centaur HAV IgM
FDA
Z-1119-2008
Class II
2008/05/15
Siemens Ltd.
2810 7533
SN080544 Philips Healthcare iSite PACS image management system
FDA
Z-1141-2008
Class II
2008/05/15
2332 4455
SN080545 Tyco Healthcare Monoject Prefill
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
SN080546
Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation
Device
SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Action
Action
N/A
N/A
87
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
MHRA
2008/004/023/061/009
FSCA
2008/05/22
2277 6611
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
SN080567 B Braun Dialog+ Machines with DF Option
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
N/A
Company
Company
Company
SN080570 Masimo Rainbow Rad-57 Pluse CO-Oximeter
MHRA
MDA/2008/033
MDA
2008/05/22
SN080571 Dade Behring Stratus CS Cardiac Troponin I Calpak (CCTNI-CR)
MHRA
2008/004/030/601/310
FSCA
2008/05/23
MHRA
2008/004/029/061/003
FSCA
2008/05/23
MHRA
2008/004/017/601/273
FSCA
2008/05/23
SN080572
Dade Behring N Latex CDT Kit (OPCS03) and N Latex CDT (kit)
(OPCS05)
SN080573 Dade Behring Dimension Clinical Chemistry System
88
N/A
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
SN080578 Draeger Medical Oxylog 3000
Health Canada
41844
Type II
2008/05/23
2877 3077
Johnson & Johnson
Medical Hong Kong
N/A
Action
2008/05/23
Kong
2738 6000
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/05/26
2960 7136
SN080579 Johnson and Johnson STERRAD Sterilization Systems Oil Mist
SN080580 Boston Scientific RotaWire Guidewire
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
MHRA
2007/009/012/301/002
FSCA
2008/05/29
N/A
N/A
SN080583 Pointe Scientific Liquid ALT (SGPT) reagent set
SN080584 Park House Healthcare VERSAtec Back
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
89
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
SN080417 Medivance Instruments Velopex Extra X
MHRA
2008/001/003/061/013
FSCA
2008/04/11
N/A
N/A
Thermogenesis Disposable Processing Set for the AXP System 8SN080418
5101
MHRA
2008/003/012/061/002
FSCA
2008/04/11
N/A
N/A
SN080419 Elekta Stereotactic Body Frame CT and MRI indicators
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
SN080420
Abbott OPTIUM-H Blood Glucose Test Strips (Lot no. 53929/ Part
No. 80111-01)
90
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
FDA
Z-0916-2008
Class II
2008/04/17
L&S Dental Supplies Limited
2815 8115
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
SN080434
Ormco Grengloo (Unidose Tips), Bracket adhesive and tooth
conditioner (Part Number 740-0322)
SN080435 Nonin Model 2500 PalmSAT handheld pluse Oximeter
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)
91
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
Health Canada
41330
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
SN080450 Trinity Biotech MDA Auto Dimer (Product Code T3103)
MHRA
2008/004/003/061/016
FSCA
2008/04/23
N/A
N/A
SN080451 ITC AVOXimeter 1000 / AVOXimeter 1000E
MHRA
2008/002/021/061/018
FSCA
2008/04/23
N/A
N/A
SN080452 MEDNET TOPS OUS Fusion System
MHRA
2008/001/025/291/005
FSCA
2008/04/23
N/A
N/A
MHRA
2008/002/029/601/140
FSCA
2008/04/23
N/A
N/A
MHRA
MDA/2008/028
MDA
2008/04/23
N/A
N/A
GE Medical Systems
Hong Kong Ltd.
N/A
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
SN080453
Medfor S400 and S227 Femoral Head Storage Pot, Labelled,
double wrapped
SN080454 Merlin Medical Disposable pen torch (Model no. W2137)
SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes)
92
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
2485 7510
SN080306
Roche Accutrend GC
Health Canada
39757
Type II
2008/03/03
Limited
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
93
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
94
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
95
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
96
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
SA080205
VNUS 7F ClosureFAST Catheter (Order# CF7-7-60 and CIF7-7100)
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
SA080213
Superior Oxy Serve II Oxygen Conserving Regulator (Model #
MCRB-870-6)
SA080214 Toshiba Aquilion 32, 64, Super 4 and Toshiba 256-Slice Scanner
SA080215
Philips Brilliance Big Bore CT Scanners using software v2.2.1
through v2.2.5
MHRA
2008/001/024/291/004
FSCA
04-Feb-08
2876 7525
SA080216
Abbott AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0
(List # 3D54-08)
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
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
97
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
FDA
Z-0527-2008 to Z-0528-2008
Class II
11-Feb-08
2807 8555
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
FDA
Z-0699-2008
Class II
18-Feb-08
N/A
N/A
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
Fresenius Medical Care Asia-Pacific
Ltd.
2802 2900
SA080222 Respironics Esprit ventilators
SA080224
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
SA080226
Philips Gemini 16 and 64-slice PET/CT Systems, Gemini GXL 6, 10
and 16 slice PET/CT Systems
Arkray Assure 3 Blood Glucose Test Strips (PRODUCT NO
SA080235
555050)
SA080236
Biomet Ringloc Instrumentation Impactor Plate (Ref/Part # 31400620 - 31-400623, 31-400626, 31-400628)
Fresenius Medical Care Optiflux 180NR Advanced Fresenius
SA080239
Polysulfone (Catalog no. 0500318E)
FDA
Z-0738-2008
Class II
18-Feb-08
SA080240 Cook THSCF-35-260-3-AUS2
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
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
98
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2)
A.R. Burkhill & Sons (Hong Kong) Ltd.
2541 1041
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
FDA
Z-0718-2008
Class II
22-Feb-08
2724 2836
Varian VARiS 1.4g; Linear Accelerator with RTP Exchange v6.2,
SA080250
v6.6 and v8.0 (Models : ALL)
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
2485 7510
SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX
MHRA
2008/002/006/291/001
FSCA
22-Feb-08
Limited
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
Chattem Icy Hot Heat Therapy Air Activated Heat adhesive heating
patch - (i) Back; (ii) Arm, Neck, and Leg
FDA
N/A
Press Release
26-Feb-08
N/A
N/A
Philips Easy Diagnost Eleva family, Easy Diagnost Classic family
SA080259
and Diagnost 76 plus family
MHRA
2008/002/012/061/008
FSCA
27-Feb-08
2876 7525
SA080260 Medtronic Internal Defrillation Handles and Electrodes
MHRA
2008/002/015/061/001
FSCA
27-Feb-08
886-22183-6130
Baxa Corporation EM4200 Exacta-Mix Compounder Operating
SA080261
Software V1.05, 1.06 & 1.06.1
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
FDA
N/A
Press Release
29-Feb-08
2807 8555
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
SA080258
SA080262 Bausch and Lomb Stellaris Vision Enhancement System
Baxter Heparin Sodium Injection multi-dose, single dose vials and
SA080263
HEP-LOCK heparine flush products (lots: ALL)
SA080264
Siemens Primus Linear Accelerator System and Mevatron Linear
Accelerator Systems
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)
99
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
2008/002/006/061/001
FSCA
29-Feb-08
Stryker China Ltd
2518 6988
SA080271
Nova EZ CHEM Creatinine Meter, Control Solution and Linearity
Solution
SA080274
Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No
1320-0231)
MHRA
SA080275
Philips Digital Diagnost family, Bucky Diagnost family, Easy
Diagnost family, Thoravision
MHRA
2008/002/019/061/020
FSCA
29-Feb-08
2876 7525
MHRA
2007/010/031/061/010
FSCA
29-Feb-08
Kong
2738 2818
SA080276 Depuy polyethylene knee bearings
100
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
SA080119
Fresenius Medical Care multiFiltrate acute dialysis system
MHRA
2007/012/017/051/003
FSCA
2008/01/09
Fresenius Medical Care Asia Pacific
Ltd.
N/A
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
SA080120
SA080121
SA080122
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)
101
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
102
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
SA080161
St. Jude Medical Epic, Atlas and Convert Family of ICDs
St. Jude Medical
N/A
Action
2008/01/18
St. Jude Medical
N/A
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
ev3 IntraStent Unmounted Balloon Expandable Stents
2008/001/017/291/013
FSCA
2008/01/24
N/A
N/A
Medtronic
International Ltd
N/A
Action
2008/01/24
2891 4456
MHRA
2008/001/011/291/003
FSCA
2008/01/28
Conmed Limited
2854 4413
SA080172
Chattanooga Electrotherapy Devices (Intelect and Vectra Series)
MHRA
2007/012/020/061/019
FSCA
2008/01/28
N/A
N/A
SA080173
Lombard Medical Aorfix Stent Grafts
MHRA
2008/001/017/291/011
FSCA
2008/01/28
N/A
N/A
SA080174
Dixons Tudor Edwards Double Rib
MHRA
2008/001/017/601/001
FSCA
2008/01/28
N/A
N/A
SA080175
Cyberonics VNS Therapy Lead Model 302
MHRA
2008/001/002/061/002
FSCA
2008/01/28
GM Medical
N/A
SA080176
BD FACS Sample Prep Assistant II instruments
MHRA
2007/010/002/061/013
FSCA
2008/01/28
BD
2575 8668
103
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
104
FSCA
Monthly Summary of Medical Device Safety Alerts -December 2007
MDCO Ref.
No.
SA071201
Medtronic Bravo pH capsule with delivery system (Proudct
Numbers 9012B1011 and 9012B1001)
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
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
105
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
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
SA071235
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
106
SA071252
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
SA071253
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)
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
SA071270
Terumo Artifical vascular graft - Triplex
SA071271
Bayer Contour TS blood glucose test strips
SA071272
Toshiba Aquilion 32 and Aquilion 64
Health Canada
39250
Type II
2007/12/31
2384 0688
SA071273
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
Health Canada
39286
Type II
2007/12/31
2814 0481
SA071274
SA071275
Instrumentation Laboratory HemosIL RecombiPlasTin and
Hemoliance RecombiPlasTin
Beckman Coulter Cytomics FC 500 Flow Cytometer and Cytomics
FC 500 MPL
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
107
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
108
Month
*Note: FDA
F d Ref.
d
MDCO
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA071101
Smith & Nephew, Birmingham Hip Resurfacing Acetabular Cup
FDA
Z-0017-2008 to Z-0033-2008
Class II
2007/11/01
Smith & Nephew Ltd.
2648 7700
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
BD Microkeratome K3000 and K4000 (Cat No. 378660)
FDA
Z-0062-2008
Class II
2007/11/01
BD
2575 8668
SA071105
Steris QFC1728 and QFC1729 Quick Connects
Stryker Trident PSL HA Cluster Acetabular Shell and HA solid back
acetabular shell
FDA
Z-0101-2008
Class II
2007/11/01
FDA
Z-0072-2008 to Z-0073-2008
Class II
2007/11/01
Stryker China Ltd
2518 6988
N/A
SA071106
SA071107
Integra Flat Foot Implant KALIX II (Ref141 0xx)
MHRA
2007/008/010/061/008
FSCA
2007/11/02
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
109
SA071126
Remel Wellcogen N Meningitidis B/E Coli K
Health Canada
37147
Type II
2007/11/12
Wenline Company
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
2521 2439
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
MHRA
2007/006/005/401/014
FSCA
2007/11/20
N/A
N/A
SA071142
APC Medical Bedside Temporary Cardiac Pacemaker (Model
4170)
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
2007/009/027/601/003
FSCA
2007/11/22
N/A
N/A
Boston Scientific LeVeen SuperSlim Needle Electrodes
Ltd
N/A
Action
2007/11/26
2960 7128
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
SA071141
SA071145
SA071146
SA071147
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)
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
110
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
SA071162
Hill-Rom Versacare Hospital Beds (model P3200 and P3201)
SA071163
GE OEC Insta Trak 3500 Plus with the Cranial Application
FDA
Z-0183-2007
Class II
2007/11/27
2783 1838
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
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
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
111
MDCO Ref.
No.
SA071001
Boston Scientific Advanced Bionics Electrode Insertion Tool for
HiRes 90KR with HiFocus HelixR Electrode
Source of
Information*
Ltd
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
N/A
Action
2007/10/02
2960 7128
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)
Otto Bock Asia Pacific Limited
2598 9772
2007/10/10
2960 7128
SA071029
Boston Scientific Advanced Bionics PrecisionR Implantable Pulse
Generator -UPNM365SC11100
FSCA
Action
Action
2007/10/08
Boston Scientific Transend EX Standard 0.014" Guidewire
MHRA
Ltd
Ltd
2007/004/010/301/001
SA071028
2007/10/10
2960 7128
SA071021
N/A
N/A
112
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
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
SA071035
SA071036
SA071037
SA071038
SA071039
Invacare REA Wheelchair Pelvic Belt
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
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
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
2007/010/004/291/001
FSCA
2007/10/15
2807 8555
SA071044
Medtronic Sprint Fidelis Defibrillation Leads
Medtronic
International, Ltd.
N/A
Action
2007/10/15
2919 1362
SA071045
Toshiba Nemio and Nemio XG Ultrasound systems
MHRA
2007/009/026/061/007
FSCA
2007/10/16
2384 0688
SA071040
SA071041
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
Otto Bock Asia Pacific Limited
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
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
SA071051
SA071052
SA071055
Cyberonics VNS Therapy Software, Model 250
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
2007/009/027/061/010
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
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
113
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
Abbott ARCHITECT cSystems
Medtronic Nexframe Stereotactic System
MHRA
MHRA
2007/009/014/601/003
2007/010/011/061/005
FSCA
FSCA
2007/10/23
2007/10/23
2806 4021
2919 1362
Gelita Medical Gelitacel Oxidized Cellulose Haemostat Gauze
MHRA
2007/010/015/291/003
FSCA
2007/10/23
N/A
N/A
FDA
Z-0044-2008 to Z-0046-2008
Class II
2007/10/25
BD
2575 8668
SA071070
SA071071
SA071072
SA071073
SA071074
SA071075
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
Siemens Clinitest hCG Cassette
MHRA
2007/010/018/061/010
FSCA
2007/10/25
Siemens Ltd.
2810 7533
SA071079
Smiths Medical EMS Ventilator circuits (Product code W196-002)
MHRA
MDA/2007/080
MDA
2007/10/25
N/A
SA071076
114
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
Health Canada
36419
Type II
2007/09/14
N/A
N/A
Health Canada
36844
Type II
2007/09/14
N/A
N/A
Health Canada
36800
Type II
2007/09/14
N/A
N/A
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
SA070915 Conmed Linvatec Ultrapower Burr and Ultrapower Burr Diamond
SA070916 PreMD PREVU* Point of Care Skin Sterol Test
SA070917
Source of
Information*
Ltd
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
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
115
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
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
SA070928 Elekta Synergy Linear accelerator XVI
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
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
Depuy Engage Modular Revision Hip Implant Component
B. Bruan Medical Normal Saline Flush Syringes (Lot no "SFR")
Stericom STE 4021 Proctoscope
SA070944
SA070945
SA070946
2007/007/025/061/016
FSCA
2007/09/17
FDA
N/A
Press Release
2007/09/18
2277 6162
MHRA
2007/007/030/061/008
FSCA
2007/09/18
N/A
N/A
Limited
Smiths & Nephew Healthcare (Hong
Kong)
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
SA070941 Universal Hospital Supplies Sterile suction connecting tubing (ref
no. UN30026FFM)
SA070942
Eschmann Electrosurgery bipolar unit (model TDB 60)
SA070943
MHRA
Kong
Welch Allyn AED20 Automatic External Defibrillators
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
SA070949
Medtronic Paceart System Software - 2006 1st Edition
SA070950 Siemens Biograph 2, Biograph 6 and Biograph 16
Health Canada
37173
Type II
2007/09/19
2919 1362
Health Canada
37033
Type II
2007/09/19
Siemens Ltd.
2810 7533
116
SA070951
Smiths Medical Portex Perfit Percutaneous Dilational
SA070952 Smiths Medical Portex Epidural and Spinal Needle Set
SA070953
Smiths Medical Graseby MS26 Syringe Driver
SA070954 Siemens Lithoskop
SA070955 Draeger Medical Babylog 8000
Health Canada
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
Health Canada
37262
Type II
2007/09/19
Siemens Ltd.
2810 7533
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
SA070956
Draeger Medical D-Vapor
SA070960 Invacare Action 2000 wheelchairs (blue frame)
SA070961
Invacare Action 3 wheelchairs
SA070962 Philips Isolation Transformer
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
Z-1234-2007
Class II
2007/09/20
2876 7525
Ltd
N/A
Action
2007/09/21
2960 7128
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
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
SA070963 Boston Scientific Advanced Bionics Patient Controller SC-5400
(Joystick Controller)
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
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
SA070971 Smiths CADD Medication Cassette Reservoir
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
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
117
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
MHRA
2007/009/012/291/004
FSCA
2007/09/27
N/A
N/A
SA070982 Sorin SR Single Chamber Pacemakers
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
118
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
SA070806 GE Healthcare Extended Range Transmitter (Catalog Part
1004070 , 1003991)
SA070807
Tyco Kendall Curity Suprapubic Catheter Sets
SA070810
SA070811
SA070812
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
MHRA
2007/007/012/051/003
FSCA
2007/08/06
3157 7244
2802 2900
MHRA
2007/007/019/291/018
FSCA
2007/08/06
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
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
Ltd.
SA070808 Fresenius Medical Care HD Catheters
SA070809
Source of
Information*
Goodwin Healthcare
Ltd.
Performance Health Products AXXIS, Comfort and V-Trak
FDA
Z-1057-2007 to Z-1062-2007
Class II
2007/08/06
N/A
N/A
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
2876 7525
SA070819 Philips Brilliance 40/64 CT Scanners
MHRA
2007/007/024/291/007
FSCA
2007/08/07
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
119
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
Health Canada
36560
Type II
2007/08/09
Siemens Ltd.
2810 7533
SA070830
Siemens Sonoline Antares and Acusion Antares Premium Edition
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
Health Canada
35738
Type II
2007/08/09
N/A
N/A
SA070833
Radiometer D711 Reference Membrane ABL7XX
SA070834 Getinge Castle Steam Sterilizers
SA070835
SA070836
SA070837
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
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
120
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
FDA
Z-1175-2007 to Z-1177-2007
Class II
2007/08/23
N/A
N/A
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
SA070863 Hill-Rom TotalCare Duo 2
MHRA
MDA/2007/065
MDA
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
Health Canada
36531
Type II
2007/08/28
2356 7033
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
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
121
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
122
MDCO Ref.
No.
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
SA070713 Integra Neurosciences Elektrotm ET630 and ET621
MHRA
2007/007/003/291/024
FSCA
2007/07/06
N/A
N/A
SA070701 Abbott m2000sp Instrument and m1000 Instrument
SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters
SA070714
Boston Scientific VASOVIEWR UniportR Plus EVH System w/
Bisector VasoView 7xB Bisector
Ltd
N/A
Action
2007/07/09
2960 7128
SA070715
Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FS
Chemistry System - Software
Health Canada
35306
Type II
2007/07/10
2738 2818
SA070716
Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin Panel
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
123
SA070725 Chiltern Wispa Attachment Handle
Health Canada
34860
Type I
2007/07/10
N/A
N/A
SA070726 Airox Legendair Ventilator
Health Canada
35588
MHRA
2007/006/028/061/010
Type I
2007/07/10
Forever Health Medical Instrument Ltd
2770 9922
FSCA
2007/07/10
AMO Asia Limited
2480 3330
MHRA
2006/008/017/301/002
FSCA
2007/07/10
N/A
N/A
SA070729 AIDAPT Coniston Swivel Bathers
MHRA
2007/003/002/401/004
FSCA
2007/07/11
N/A
N/A
SA070730 AIDAPT Solo Bed Rail
MHRA
2007/004/024/291/010
FSCA
2007/07/11
N/A
N/A
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
Terumo Perfusion System 8000 Roller Pump, Model 8000 and
SA070733
Perfusion System 9000 Roller Pump Model 9000
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
MHRA
2007/007/009/061/005
SA070727 AMO VISX WaveScan WaveFront Systems
SA070728
SA070731
Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum
610, 1107
GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800
mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system
SA070740 Instersurgical Solus Flexible Wire-Reinforced Airway
SA070741 Boston Scientific 6 French Guider Catheter
SA070742
Arizant Ranger Standard Flow Blood/Fluid Warming Disposable
Sets
SA070743 Siemens CENTRA Active BTE Hearing Instrument
SA070744 BD Trypticase Soy Agar dehydrated culture media
SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth
SA070746 Boston Scientific Mach 1 Guide Catheter
Ltd
MHRA
2007/006/029/601/004
MHRA
2007/004/018/601/810
BD
MHRA
2007/007/005/051/003
Ltd
N/A
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
124
SA070751
GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 CArm Fluoroscopic X-Ray System
FDA
Z-0989-2007 to Z-0990-2007
Class II
2007/07/19
2783 1838
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
Teleflex Medical Capio PGA Suture and Polyester Non-Absorbable
SA070768
Suture
Health Canada
36080
Type II
2007/07/25
N/A
N/A
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
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
SA070775
Medtronic N'Vision InterStim-B Software, N'Vision Clinician
Programmer, InterStim iCon Patient Programmer, InterStim
Implantatble Neurostimuator, InterStim II Implantable
Neurostimulator
125
SA070776
Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD
volumetric infusion pumps
FDA
Class I
126
2007/07/27
2807 8555
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
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
Clearview HCG Test Kits (Product Code 500158, Kit Lot no.
SA070611
HG0050)
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
MHRA
2007/004/011/051/001
FSCA
MHRA
2007/005/031/051/010
FSCA
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
SA070612 Siemens AG Sienet Magicstore
Health Canada
35431
Type II
SA070613 Fujifilm FCR Velocity U and DR Velocity UFP
Health Canada
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
SA070617 Bio-Rad Gelose MRSA Select REF63747, LOT7C1025
Health Canada
35132
Type II
MHRA
2007/005/009/061/008
FSCA
2007/06/08
2007/06/11
2007/06/12
2007/06/12
2007/06/12
2007/06/12
2007/06/12
2007/06/12
SA070618
Invivo Precess (3160 Series) MRI Compatible Patient Monitoring
System
SA070619 WALLACH T-00337 Anorectal Tip
SA070620 BD Microtainer Safety Flow Lancets
MHRA
MHRA
2007/005/031/051/005
MDA/2007/049
127
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
SA070628 Siemens Medical c.cam Gamma Camera, Model 9VIR1200
SA070629 Hawaii Medical NeatNick Sweeping Action Hell Lancet
FDA
FDA
FDA
Z-0905-2007
Z-0906-2007
Z-0926-2007 to Z-0927-2007
Class II
Class II
Class II
SA070630 Sunrise Medical Groove Power Wheelchairs
MHRA
2007/004/017/601/805
FSCA
SA070631 Schiller Easyport Defibrillators
MHRA
2007/006/005/051/020
FSCA
SA070632 B Braun Intrapur Neonat Lipid I.V. Filter
MHRA
2007/006/012/061/008
FSCA
MHRA
2007/005/018/601/919
FSCA
Ltd
N/A
Action
SA070635 Biomet 3i EP Healing Abutment
FDA
Z-0922-2007
Class II
SA070636 Biomet 3i disposable twist drills
FDA
Z-0959-2007
Class II
SA070633
Smith & Nephew PERI-LOC 2.5mm Self Tapping Locking Cortex
Screw
SA070634 Boston Scientific Transend EX Guidewire
SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement
SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier
SA070639 Zoll Lifecor Electrode Belt
FDA
FDA
Z-0960-2007 to Z-0965-2007
Z-0935-2007
Class II
Class II
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
FDA
Z-0936-2007
Class II
SA070640 Bio-Diagnostics GBM Quantitative ELISA Kit
MHRA
2007/005/025/061/005
FSCA
SA070641 Thoratec TLC-II Portable VAD Driver
MHRA
2007/006/013/061/001
FSCA
Bausch & Lomb
(Hong Kong) Ltd.
N/A
Action
2007/06/21
FSCA
2007/06/22
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
MHRA
Health Canada
Health Canada
2007/003/029/601/731
35442
Type II
35427
Type I
128
2007/06/21
2007/06/21
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
2007/06/27
Ltd.
N/A
2007/06/27
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
Abbott ARCHITECT i2000 Processing Module (List# 08C89-01,
SA070657
3M74-01, 1G06-01 & 3L77-01)
SA070658 Steris QFC1728 and QFC1729 Quick Connects
SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit
MHRA
FDA
FDA
2006/012/007/601/455
Z-0950-2007 to Z-0953-2007
Z-0967-2007
FSCA
Class II
Class II
2007/06/25
2007/07/26
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
Class II
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
SA070662 Medtronic Biphasic LIFEPAK 500 AEDs
SA070663 Oasis Medical Premier Edge Disposable Knives
SA070664 Cyberonics VNS Therapy Leads (Model 300, 302, 303)
MHRA
MHRA
Cyberonics
2007/006/026/291/010
FSCA
2007/006/026/291/013
FSCA
N/A
Action
129
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
SA070503 Endoart EasyBand
Boston Scientific NexStentR Carotid Stent and Monorail Delivery
SA070504
System
Local Agent
Agent Contact
Telephone No
FSCA
Date of Issue
(YYYY/MM/DD)
2007/05/02
N/A
N/A
Class II
2007/05/03
N/A
N/A
N/A
N/A
2960 7128
Kong
2738 2818
2240 6260
2007/004/020/291/007
FSCA
2007/05/03
Boston Scientific (HK)
Ltd
N/A
Action
2007/05/03
MHRA
2007/05/04
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
SA070508 Baxter UV Flash Compact Device
MHRA
2007/005/002/061/009
FSCA
2007/05/09
28078556
SA070509 Hill-Rom AvantGuard Electtic Bed
MHRA
2006/009/004/291/005
FSCA
2007/05/09
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
BioMerieux BacT/ALERT Classic System Software, Blood Culturing
SA070510
System
Toshiba Nemio XG, Ultrasound system SSA-590A with version 1.5
SA070511
software
B.Braun HyperFormer Pump Dispensing Set (Catalog No V9900SA070512
02)
Instrumentation Laboratory GEM Premier 4000 Laboratory
SA070513
Analyzer
SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator
SA070515
American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitro
diagnostic
Tyco Healthcare SealGuard TracheoSoft and SealGuard
SA070516
TracheoSoft PERC
SA070517
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
FDA
Z-0773-2007 to Z-0776-2007
Class II
FDA
Z-0771-2007
Class II
FDA
Z-0783-2007
Class II
FDA
FDA
FDA
Z-0778-2007
Z-0772-2007
Z-0779-2007
Class II
Class II
Class II
MHRA
2006/011/016/291/003
FSCA
MHRA
2007/003/029/291/013
FSCA
MHRA
MDA/2007/035
Medical Device Alert
MHRA
2007/05/07
2007/05/07
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2007/05/10
2645 8703
2007/05/10
2007/05/11
MDA/2007/034
2007/05/11
Medtronic
International, Ltd.
N/A
Action
2007/05/11
MHRA
2006/010/012/301/003
FSCA
Health Canada
34992
Type I
130
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
SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter
Boston Scientific System Drape (IVUS motor drive sterile plastic
SA070530
cover)
SA070531 Medical Wire and Equipment Customers Microrings
SA070532 Arjo Maxi Move Patient Lift with Scale
SA070533 Ethicon Gynecare PROLIFT Total Pelvic Repair System
SA070534 CIBASoft Visitint Soft Contact Lenses
Health Canada
Health Canada
Health Canada
Ltd
Ltd
MHRA
FDA
FDA
FDA
34868
Type II
34958
Type II
34918
Type II
Action
Action
N/A
N/A
2007/005/003/061/014
Z-0796-2007 to Z-0799-2007
Z-0795-2007
Z-0793-2007
FSCA
Class II
Class II
Class II
SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor
MHRA
2007/005/002/061/006
FSCA
SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp
MHRA
2007/005/011/291/002
FSCA
SA070537 BD FACSCanto and FACSCanto II Software
MHRA
2007/005/010/291/006
FSCA
SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A
MHRA
2007/005/010/061/013
FSCA
SA070539 Olympus Triglyceride Reagent
SA070540
DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-1890-180 & NDC-18-110-180)
SA070541 Conor Medsystems CoStar drug-eluting coronary stents
SA070542
Homecraft Rolyan Bathmaster 2000, Bathmaster Classic,
Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls)
SA070543 Nightingale Pro Axis and Pro Axis Plus
SA070544 MEDEX DPS Kids Kit (Pediatric) Secure System
SA070545 BREAS PV403 PEEP
Viasys all paediatric ventilator breathing systems containing water
SA070546
trap
SA070547 Abbott FLEXIFLO DURA-PEG Kit
SA070548 Cranex Tome panoramic x-ray unit
MHRA
2007/005/010/061/009
FSCA
MHRA
2007/004/025/291/018
FSCA
Johnson & Johnson
N/A
N/A
2007/05/14
2007/05/14
2007/05/14
2007/05/14
2007/05/14
2007/05/14
2007/05/15
2007/05/15
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
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
2376 1805
2376 1805
N/A
N/A
Biotronik Hong Kong
2877 6787
N/A
N/A
MHRA
MDA/2007/039
MHRA
MDA/2007/038
2007/05/22
N/A
N/A
FSCA
2007/05/22
2317 0988
N/A
N/A
2893 0873
2806 4201
Umedco
2765 8222
MHRA
MHRA
MHRA
MHRA
FDA
2007/005/016/291/014
2007/005/014/061/009
MDA/2007/037
2007/005/014/061/019
Z-0816-2007
131
FSCA
FSCA
Class II
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
SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs
MHRA
2007/004/010/301/003
FSCA
2007/05/25
SA070554 Draeger Medical Primus anaesthetic workstation
MHRA
MDA/2007/040
MHRA
2007/05/25
2007/002/001/301/001
FSCA
2007/05/25
Abbott Laboratories
Ltd.
N/A
Action
2007/05/25
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
SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger
SA070556 Abbott ARCHITECT STAT Troponin-I test products
SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution
2783 1838
2356 7033
N/A
Limited
N/A
2485 7510
2877 3077
N/A
N/A
GNB Technologies (China) Ltd
N/A
2806 4201
2485 7510
2007/05/28
AMO Asia Limited
Limited
N/A
2007/05/28
N/A
N/A
2480 3330
N/A
SA070560 Randox Laboratories Assayed Bovine Serum
Health Canada
34276
Type II
SA070561 B.Braun Ultrasite Horizon Pump IV Set
Health Canada
34874
Type II
2007/05/28
2277 6125
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
SA070562 Dentsply Protper Obturators
Health Canada
34652
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
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.
SA070567 BIODIS VerifyNow P2Y12
SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760
SA070569 BD Infusion Therapy System (Angiocath Catheter)
Health Canada
35032
Type II
2007/05/28
2007/05/28
2007/05/28
Health Canada
35003
Type II
MHRA
2007/003/026/291/004
FSCA
2007/05/29
Action
Action
2007/05/29
Medtronic
International, Ltd.
BD
N/A
N/A
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
N/A
N/A
N/A
N/A
SA070573 CP Medical Surgical Suture
SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem
FDA
Z-0807-2007
Class II
2007/05/31
MHRA
2007/005/022/061/006
FSCA
2007/05/31
132
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
Health Canada
33329
Type II
2007/04/10
2783 1838
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
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
SA070409 (1) Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800
(5) 9800
SA070410 GE Healthcare - Instatrak 3500 System
SA070408
133
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
SA070423
Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circular
stapler
Johnson & Johnson
Medical Hong Kong
N/A
N/A
2007/04/10
2738 2818
SA070424
Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITY
and VITALITY 2 (ICD)
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
SA070430 Siemens syngo Dynamics 5.0 Workplace
FDA
Z-0652-2007
Class II
2007/04/11
Siemens Ltd.
2810 7533
Zimmer NexGen Complete Knee Solution Minimally Invasive
SA070431
Solutions MIS Technology Femoral Finishing Guid
FDA
Z-0647-2007 to Z-0651-2007
Class II
2007/04/11
2992 0968
SA070432 Terumo Perfusion System 8000 Base, Model 8000
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
2866 0811
2541 1041
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
SA070434 BD 366358 LANSCET SFL GREEN
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
Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no
SA070437
7D71-30 and 7D71-20)
SA070435
SA070440
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
SA070441
Cenorin ThermaSure Medical Device Drying Cabient series 130,
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
Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001SA070443
761)
FDA
Z-0701-2007
Class II
2007/04/12
N/A
N/A
FDA
SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0
Z-0720-2007 to Z-0721-2007
Class II
2007/04/12
N/A
N/A
Boston Scientific Percutaneous Track Kit with Amplaz Dilator and
SA070445
Sheath Kit
Ltd
N/A
Action
2007/04/16
2960 7128
SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System
Ltd
N/A
Action
2007/04/16
2960 7128
134
Ltd
N/A
Action
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
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
Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP
SA070457
450 Test, CE-IVD, M/N4381866190
FDA
Z-0734-2007 to Z-0735-2007
Class II
2007/04/19
2485 7510
SA070458 Bio-Rad tox/See Drug Screen Test
FDA
Z-0733-2007
Class II
2007/04/19
2789 3300
AMS DURA-II Distal Tips and Universal Tips (Product no 72009340
SA070459
and 72009361)
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
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
Health Canada
34613
Type II
2007/04/23
SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators
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
SA070451
SA070453 All Shelhigh medical devices
SA070454
Ortho- Clinical Diagnostics VITROS Immunodiagnostics Products
HBsAg Reagent Pack (Cat# 6801322)
SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200)
SA070466 Teleflex Medical Infant Nasal CPAP System
FDA
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
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
135
SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363)
SA070479
Sunrise Medical DeVibiss PD1000A Pulse Dose Oxygen
Conserving Cylinder and 535D-X CF Continuous Flow Cylinder
SA070480 BIO-RAD EVOLIS SYSTEMS
FDA
Z-0749-2007 to Z-0751-2007
Class II
2007/04/27
Siemens Ltd.
2810 7533
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
Sanko Medical Systems (H.K.) Ltd.
2384 0688
Health Canada
34725
Type II
2007/04/30
Siemens Ltd.
2810 7533
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
西安西京醫療用品有限公司"希健醫用" Extracorporeal circulating
SA070491
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
136
Monthly Summary of Medical Device Safety Alerts - March 2007
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA070301 Taut Intraducer Peritoneal Catheter
FDA
Z-0428-2007
Class II
2007/03/01
N/A
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
SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625
FDA
Z-0554-2007
Class II
2007/03/01
N/A
N/A
SA070305 Arjo - Sara Active Sling, patient Lift
FDA
Z-0424-2007 to Z-0426-2007
Class II
2007/03/01
2508 9553
MHRA
2007/001/025/081/004
2007/03/01
N/A
N/A
2007/03/01
BD
2575 8668
2007/03/02
N/A
N/A
MDCO Ref.
No.
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
Field Safety Corrective
Action
Action
Action
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)
137
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)
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
2738 2894
VBM Medizintechnik GmbH - 13g Jet Ventilation Catheter Ref 30SA070332
02-013-1 and 30-02-913-1
MHRA
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
SA070335 Hamilton Medical Galileo Classic and Gold ventilators
SA070336
Siemens Medical Solutions AXIOM Artis MP, Angiographic x-ray
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
MHRA
Ltd
2007/003/007/601/661
N/A
Action
Action
2738 2894
Action
Action
MDA/2007/023
MHRA
138
SA070346
Smith & Nephew RF DENERVATION PROBE (ITEM CODE
7210271; DESCRIPTOR 10 CM, LOT# 602561)
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)
SA070364
BD human IL-15 recombinant protein (Mat. No. 554630) and
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
2007/003/012/081/010
Action
2007/03/16
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
MHRA
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
34385
Class II
2007/03/21
2807 8556
Action
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
2007/03/21
2393 9511
2007/03/21
N/A
N/A
Z-0594-2007
Class II
2007/03/21
N/A
N/A
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
Health Canada
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
MHRA
2006/003/014/291/019
FDA
BD
MHRA
2007/001/017/291/001
SA070369 GE Healthcare OEC 9800
MHRA
2006/010/013/291/005
MHRA
2007/001/016/081/010
BD
N/A
MHRA
2007/003/021/081/002
Zeiss Reusable Sensor 2PS20 or EPS01 used with Pentasys
Phacoemulsificator
BD Vacutainer Safety-Lock Blood Collection Set with Pre-Attached
SA070371
Holders
SA070372 Puritan Bennett 840 Ventilator System
2541 1041
FDA
Smith & Nephew InterTan Subtrochanteric Lag Screw Driver
SA070368
(Product Code: 71674068)
SA070370
2645 8703
139
Action
Action
Action
Action
Action
2738 2894
2645 8703
SA070373
SA070374
SA070375
SA070376
SA070377
SA070378
Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3,
length tubing (batches C8218)
Boston Scientific Polarcath Peripheral Dilatation System Inflation
Unit
Viasys VELA Ventilator
BioMerieux BacT/ALERT FA Culture Bottles
BioMerieux BacT/VIEW C.30 a Software update (P/N 514515-1)
diagnostic data management system
Gebauer - Salivart Oral Moisturizer
MHRA
2007/003/020/601/694
Ltd
FDA
FDA
Z-0638-2007
Z-0643-2007
Action
Action
Class II
Class II
FDA
Z-0644-2007
Class II
FDA
Z-0497-2007
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
N/A
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
140
2007/03/28
N/A
N/A
2007/03/29
2960 7128
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
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
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)
Diagnostic Chemicals Ltd. - Salicylate - SL, in vitro diagnostic, Cat.
SA070203
No 511-20 (Lot#29892)
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
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ
SA070211
Coating, sterile REF FUS-095013-DL
FDA
Z-0377-2007
Class II
2007/02/01
2007/02/02
2393 9511
(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
N/A
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
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
SA070217 Varian Medical - CT/MR Ring & Tandem Applicator Set
MHRA
2007/001/031/121/003
Action
2007/02/07
2783 1838
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
SA070215
141
SA070221 GE Healthcare - Innova 2100 IQ
Health Canada
33717
Type II
2007/02/07
2783 1838
SA070222 Fisher and Paykel Healthcare - Infant Evaqua Breathing Circuits
Health Canada
33803
Type II
2007/02/07
Tokibo Co. (Hong Kong) Ltd
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
Health Canada
33201
Type II
2007/02/07
VISX Incorporated (HK)
N/A
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
Toshiba - Digital Fluorography System (Model or Catalog # DFPSA070229
8000D)
Health Canada
33121
Type II
2007/02/07
2384 0688
VISX Incorporated - Wavescan Wavefront System (Model/Catalog
SA070226
HS-1)
SA070227
Dentalez Inc. Stardental Division - Solara Replacement Turbine
(Model/Catalog#263739, Lot#170510)
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
SA070241 Invacare C800 Series ceiling track
MHRA
MDA/2007/016
2007/02/13
Direct Health Ltd
2528 1109
SA070242 Medtronic - Vitatron T and C pacemakers
MHRA
2007/002/001/081/008
Action
2007/02/14
2919 1362
Abbott - ARCHITECT i2000 Processing Module (List#08C89-01 &
3M74-01; Temp Controller Board Par#78560-109&7856-109)
FDA
Z-0415-2007 to Z-0416-2007
Class II
2007/02/15
2806 4201
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)
FDA
Z-0399-2007 to Z-0400-2007
Class II
2007/02/15
Stryker China Ltd
2518 6988
SA070243
142
SA070245
Cytomics FC500 and FC500 MPL with CXP Software version 2.0 &
2.1
FDA
Z-0418-2007 to Z-0420-2007
Class II
2007/02/15
2240 6260
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
MHRA
MDA/2007/017
2007/02/15
Welch Allyn
N/A
2007/02/15
2877 3077
2007/02/15
2783 1838
2007/02/15
N/A
N/A
SA070247 Welch Allyn PIC50 External Defibrillator/ Monitor
SA070248 Draeger Infinity monitor with Infinity docking station(IDS)
MHRA
MDA/2007/018
SA070249 GE Healthcare - Ventilator - Engstom Ventilator
MHRA
2007/002/008/601/579
SA070250 Thoratec Corporation - thoratec VAD Dual Drive Console
MHRA
2007/002/005/081/012
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
SA070257 Philips Medical System - Brilliance CT Big Bore System, Main Unit
Health Canada
33815
Type II
2007/02/21
2876 7525
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
2738 6162
SA070256
SA070262
Adaltis Inc. - Detect-HCV V.3 (Model/Catalog# HCA-702B;
Lot/Serial# 6770192, 6770192F)
GE Healthcare - Precision RX/I Fluoroscopic X-Ray System
(Model/Catalog#S1303JJ/JK/JL/JM)
GE Healthcare - Precision 500D (Model/Catalog#S0915KE,
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)
SA070263
SA070266
American medical System- AMS700 Penile Prosthesis (Part no:
72402987; Lot 475485004)
Smith&Nephew - Peri-Loc Lateral- Proximal Locking Plate, Right
SA070267 (Product codes: 71800508 & 71800513) (Lots# 06CM17723 &
06CN15086)
33595
Type II
2007/02/21
Kong
MHRA
2007/002/014/401/013
Action
2007/02/21
N/A
N/A
MHRA
2007/002/015/081/004
Action
2007/02/21
Cemma Enterprise Co Ltd
2412 2310
MHRA
2007/001/016/081/012
Action
2007/02/21
Health Canada
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
143
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
Clearview Simplify D- Dimer( Product code 505285; Kit Lot
SA070274
numbers: PT030A & PT031A)
MHRA
2007/002/020/291/014
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
2007/02/26
N/A
N/A
Action
Action
Action
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)
144
Monthly Summary of Medical Device Safety Alerts - January 2007
MDCO Ref.
No.
SA070101
Terumo Advanced Perfusion System 1, Model 801763; Model
801764
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
FDA
Z-0306-2007 & Z-307-2007
Class II
2007/01/03
2866 0811
N/A
N/A
N/A
N/A
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
SA070108 GE Healthcare Technologies (Prev Datex Ohmeda) Aisys
MHRA
2006/010/023/601/367
2007/01/04
2783 1838
SA070109 Siemens AG Magicsas/Sienet IWM
Health Canada
33372
Action
Action
Action
Type II
2007/01/08
Siemens Ltd.
2870 7533
Smiths Medical ASD Inc. Bivona Laryngectomy Tube, Long (Lot
SA070110
1263830)
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
Health Canada
33320
Type II
2007/01/08
2317 0988
SA070111 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips
FDA
Z-0266-2007
Class I
2007/01/10
2738 6080
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
Kong
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,
DLY-KS330-NA & DLY-KS330-SD
FDA
Z-044-2007
Class II
2007/01/10
3157 7244
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
Bard Composix Kugel Large Sized Patches
Philips Medical Systems HeatStart FR2+ Defibrillator,
Edwards LifeSciences-Swan-Ganz, Thermodilution Venous
SA070116 Infusion 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
145
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
FDA
Z-0482-2007
Class II
2007/01/17
2508 9553
FDA
Z-0486-2007
Class II
2007/01/17
Socofar Ltd
2861 3261
SA070129
Arjo - BHM Reacher for Portable Ceiling Lifts (Model: Part
#700.08310-24' and Part #700.08320-36')
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
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
Health Canada
33587
Type II
2007/01/22
2877 3077
Health Canada
33400
Type II
2007/01/22
N/A
N/A
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 TSX101A/8)
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
146
Roche Diagnostics GMBH - Tina-Quant Gen 2 Albumin (ALBT2) R2
and Immunoglobulin G (IGGT) Assay
SA070147 GE Healthcare - Advantx LCN, Advantx LCLP and Innova 4100
SA070146
I-Flow Corp. - ON-Q Painbuster, 100ml x 2ml/hr (Model or
SA070148
Catalog#PM012 )(Lot or Serial # 662449, 662742)
SA070149
Airox Legendair Ventilator (Lot or Serial# All Airox Legendair
Ventilator LE030007, EXPECT LE020007, LE021009)
SA070150 GE Healthcare -Apex Pro/ApexPro CH Telemetry System
2007/01/22
Limited
2783 1838
Type I
2007/01/22
N/A
N/A
33211
Type I
2007/01/22
N/A
N/A
MHRA
2006/012/021/601/481
Action
2007/01/22
2783 1838
Health Canada
32922
Type II
2007/01/22
Health Canada
33046
Type II
Health Canada
33058
Health Canada
2485 7510
SA070151
Interventional Technologies Europe Ltd. - 1 cm Peripheral Cutting
Balloon
Health Canada
33497
Type II
2007/01/22
N/A
N/A
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
FDA
Z-0351-2007 to Z-0353-2007
Class II
2007/01/25
2814 4829
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
SA070154 Varian Medical - On Board Imager CBCT
Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry
SA070155 Systems, Automated Clinical Chemistry Analyzer - human serum,
plasma and urine tests
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#102042/118351/121457/134481/136591/142538/146675/1511
68/155746)
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
147

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