Major Safety Alerts in May 2012 - Department of Health ... with software versions, R.01.00, R.02.00 and R.03.01 MHRA 2012/004/024/081/014 FSN Philips Electronics Hong Kong Ltd 28215364

Date of Issue

(YYYY/MM/D

D)

Description of ProductSource of

Information*Reference No. by Source

Alert Type by

SourceLocal Agent

Agent Contact

Telephone No.

2012/05/02St. Jude Medical Brio™ (Deep Brain Stimulator), Product Code: 65-6788,

Affected lot number: up to 13854243MHRA 2012/003/027/081/027 FSN

St. Jude Medical (Hong

Kong) Ltd.2996 7688

2012/05/02HSIN Ten Enterprise Electro Reflex Energizer, Product Code: SR001A2,

Affected lot number: from 828015484 to 828015813Health Canada 73289 Type III N.A. N.A.

2012/05/02Terumo Spectra Optia® Apheresis System, all Serial Numbers with Software

Version 5 or higherMHRA 2011/005/025/401/004 FSN

Terumo China (Hong

Kong) Ltd.28660811

2012/05/02Topcon Medical Laser Systems Topcon PASCAL and PASCAL Streamline,

2RG Sofrware v2.01 Endpoint Management EnableMHRA 2012/004/024/081/016 FSN N.A. N.A.

2012/05/02Nobel Biocare AB 30 Degree Multi-Unit Abutment Nobelactive Int RP 3.5mm,

Model no.: 34369, Lot no.: 464886Health Canada 72651 Type III Nobel Biocare Asia Ltd. 28238923

2012/05/02 Maquet Magnus Carbon Fibre Table Top, model no.: 1180.16F5 Health Canada 72980 Type IIIMAQUET Hong Kong

Limited23939511

2012/05/02Philips Medical Systems Brilliance 64 Slice CT System - Main Unit, Model no.:

4550 110 00921Health Canada 72982 Type III

Philips Electronics

Hong Kong Ltd28215364

2012/05/02

Vapotherm A) Insolare Nasal Cannula (Infant), Imi1300

B) Insolare Nasal Cannula (Intermediate Infant), Imi1300B

C) Insolare Nasal Cannula (Premature), Imn1100A

D) Insolare Nasal Cannula (Neonatal), Imn1100B

E) Single Prong Nasal Cannula (Infant), Isolo1300

Health Canada 73249 Type III N.A. N.A.

2012/05/02Beckman Coulter Access Total T4 Reagent (Access System, Dxi 600 System

and Dxi 800 System) Model no: 33800Health Canada 73246 Type III

Beckman Coulter Hong

Kong Ltd

2240 6150 &

22406229

2012/05/02Beckman Coulter Beckman Coulter AU2700, AU5400 and Immunochemistry

System - Urinary/CSF Protein Assay, Model no.: OSR6170, OSR6270Health Canada 73302 Type III


Kong Ltd

2240 6150 &

22406229

2012/05/02 Wright Medical Technology Inc. Dynasty Biofoam Shell Health Canada 72874 Type IIHong Kin Medical

Instrument Limited2357 0397

2012/05/02Invacare Corporation TDX SP Power Wheelchair [Model No.: TDXSP-CG,

TDXSP-CG-GT, TDXSP-MCG, TDXSP--MCG-GT]Health Canada 72976 Type II Direct Health Ltd. 25281109

2012/05/02

Carefusion 209, Inc. DBA Carefusion A) Nicolet EDX System Software [Model

No.: 828-050000, 828-062900] version 2.9.2; B) Nicolet EEG Software [Model

No.: 828-063500, 828-063600] version 2.9.2

Health Canada 71318 Type IICareFusion Hong Kong

Ltd.

28918730 &

28348066

2012/05/02

Zimmer Inc. A) Nexgen Complete Knee Solution - CR (Cruciate Retaining)

Articular Surface; B) Nexgen Complete Knee Solution - Articular Surface

Anterior Constrained; C) Crosslinked Polyethylene Articular Surfaces - A-B/3-4

Striped Yellow; D) Crosslinked Polyethylene Articular Surfaces - A-B/1-2 Purple

Health Canada 72851 Type IIZimmer PTE Ltd. (Hong

Kong branch)2992 0968

2012/05/02Cordis (a Johnson & Johnson company) Cordis S.M.A.R.T. Transhepatic Biliary

StentHealth Canada 73373 Type II

Johnson & Johnson

(Hong Kong) Ltd27375562

2012/05/02 Kerr Corporation Freedom Cordless LED Headlight Health Canada 72749 Type II N.A. N.A.

2012/05/02 Ormco Corporation Arch Hooks Health Canada 72992 Type IISybron Dental

SpecialtiesN.A.

2012/05/02 Innovatek Medical Inc BioStrip LH Ovulation Test Health Canada 72936 Type II N.A. N.A.

2012/05/02BioRad/ DiaMed GmbH IH-Com Full kit version (Data Management and Result

Interpretation Software) (Product Ref: 009000)MHRA 2012/004/023/291/009 FSN Bio-Rad Pacific Ltd. 2272 8926

2012/05/02 Doctors Research Group Kryptonite Bone Cement® MHRA 2012/004/024/081/008 FSN N.A. N.A.

2012/05/02Dr Arabin GmbH & Co.KG Cerclage Pessaries Type ASQ (perforated),

Model/Part no.: ASQ 70/21/35, Affected lot no.: W 33/11/2MHRA 2012/004/023/291/001 FSN N.A. N.A.

Major Safety Alerts in May 2012

*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;

Health Canada = Health Canada, Canada

http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con149861.pdf

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php




















2012/05/02 Ethicon Products PDS® Cord, and PDS® Cord II MHRA 2012/004/024/601/002 FSNJohnson & Johnson

(Hong Kong) Ltd.2738 6027

2012/05/02Fannin NI Ltd LIP W11183 Legionella Medium + BCYE Growth Supplement

(Affected lot no.: 1463779807)MHRA 2012/004/013/081/024 FSN N.A. N.A.

2012/05/02 Life Technologies Corporation SeCore GSSP Set MHRA 2012/004/023/291/005 FSNInvitrogen Hong Kong

Limited N.A.

2012/05/02 Orascoptic Laser Loupes (shipped since 2008) MHRA 2012/004/020/291/015 FSN N.A. N.A.

2012/05/02Philips Healthcare Easy Diagnost Eleva DRF, System code.: 706037 (all

EasyDiagnost 4.0 with either one or two detectors)MHRA 12/004/017/081/023 FSN

Philips Electronics


2012/05/02Philips Healthcare HeartStart MRx monitor/defibrillators, Model/ Part no.:

M3536A with software versions, R.01.00, R.02.00 and R.03.01MHRA 2012/004/024/081/014 FSN

Philips Electronics


2012/05/02 Siemens Healthcare Diagnostics ADVIA Centaur® HCV kit (Ref no. 03438099) MHRA 12/004/025/601/002 FSNSiemens Healthcare

Diagnostic Limited

2870 7533 /

2870 7888

2012/05/03 Elekta XVI (X-Ray Volume Imaging system) R4.5 Elekta Ltd 200 01 507 047 FSN Elekta Ltd 2891 2208

2012/05/04 Hill-Rom Affinity Four Birthing BedSolar-Med

LimitedMod 471 FSN Solar-Med Limited 24250926

2012/05/08 Advanced Sterilization Products

Johnson &

Johnson Medical

(HK)

N.A. FSNJohnson & Johnson

Medical (HK)2738 6027

2012/05/09

Hager & Werken GmbH & Co. KG Brilliant—Mouth mirror No.4 [Model no.:

605400 Lot no: MD-4/31] MHRA 2012/004/003/401/013 FSN N.A. N.A.

2012/05/09 Jenx Headrest brackets MHRA 2012/003/027/601/007 FSN N.A. N.A.

2012/05/09 Mast Group Cephalexin 30ug Cartridges Discs [CFX30C; Lot no: 298700] MHRA 2012/005/001/601/012 FSN N.A. N.A.

2012/05/09McKesson Medical Imaging Company Horizon Medical Imaging (HMI) [versions

11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8]MHRA 2012/004/013/081/006 FSN N.A. N.A.

2012/05/09 Water Pik Inc SinuSense™ Water Pulsator nasal irrigation devices FDA N.A.Firm Press

ReleaseN.A. N.A.

2012/05/09Zimmer NexGen PRI Femoral and Provisional Impactor/Extractor (00-5901-026-

00) and the replacement jaw assembly (00-5901-026-40)MHRA 2012/005/003/081/001 FSN

Zimmer PTE Ltd. (Hong


2012/05/09Ceraver CERAPLUG, all batches sizes 1 to 6, references 4501-4502-4503-

4504-4505-4507MHRA 2012/004/020/291/024 FSN N.A. N.A.

2012/05/09Computerized Medical Systems (CMS) XiO Release 4.30, Reference no.:

33941MHRA 2012/005/003/081/007 FSN Elekta Ltd 2891 2208

2012/05/09Ortho-Clinical Diagnostics Inc. Vitros® 5600 integrated system software version

1.6 and belowMHRA

2012/004/030/601/002 Ortho Clinical

Diagnostics 2737 5504

2012/05/09Plasma Surgical Ltd Single Use Handpieces for the PlasmaJet® Neutral

Plasma Surgery SystemMHRA 2012/004/027/601/009 N.A. N.A.

2012/05/10 Endoscope accessory holder- all manufacturers MHRA MDA/2012/024 MDA N.A. N.A.

2012/05/11 Liberation treatment for multiple sclerosis FDA N.A. Press Release N.A. N.A.

2012/05/14 Terumo CVS Sarns™ Antegrade Cardioplegia Cannula Firm initiated AA-2012-007-RFirm Initiated

Field Action

TERUMO CHINA (H.K.)

LTD.28660811

2012/05/15Wassenburg Medical Devices Wassenburg Automatic Endoscope Reprocessor

(Model no. WD440 & WD440PT)MHRA 2012/003/021/401/014 FSN N.A. N.A.

2012/05/15

Sigma International General Medical Apparatus Spectrum Infusion Pump with

Master Drug Library - Sigma Spectrum MDL Editor Software, 'MDL Editor

Software v6.2.4

Health Canada 73493 Type IIIBaxter Healthcare Ltd.

(Hong Kong)2807 8516

2012/05/15 BioHorizon Implant Systems BioHorizons 0.050 One-Piece Hex Driver Health Canada 73517 Type III N.A. N.A.

2012/05/15 BioMet 3i Incise Coping CBZR0102 Health Canada 72143 Type III N.A. N.A.

2012/05/15Steris A) Steris 5085 Surgical Table

B) Steris 5085SRT Surgical TableHealth Canada 73453 Type III N.A. N.A.












http://www.fda.gov/Safety/Recalls/ucm303172.htm






http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con152634.pdf

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm


http://www.hc-sc.gc.ca/dhp-mps/alt_formats/xls/compli-conform/recall-retrait/list/md-im_recalls-retrait_apr-june_2012-eng.xls




2012/05/15Roche Diagnostics A) Reduced On-Board Stability Sample Cleaner 1

B) Reduced On-Board Stability Sample Cleaner 2Health Canada 73305 Type III

Roche Diagnostics

(Hong Kong) Ltd2485 7510

2012/05/15Kensey Nash Corp Collagen Dental Membrane [Model No.: 20650-01, 20650-

02, 20650-03]Health Canada 72842 Type I N.A. N.A.

2012/05/15Terumo CVS Cardiovascular Procedure Kit (X-Coated Perfusion Pack) [Model

No.: 73673, 73679]Health Canada 73480 Type I

TERUMO CHINA (H.K.)

LTD.28660811

2012/05/15GE Healthcare (Japan Corporation) Discovery Magnetic Resonance Imaging

[Discovery MR750W 3.0T]Health Canada 73368 Type II

GE Medical Systems

Hong Kong Ltd.2783 1838

2012/05/15

Shimadzu Corporation A) Mobile X-Ray System Mobile DaRt Evolution and

RAD Speed

B) Digital Radiography CXDI Wireless

Health Canada 71582 Type II N.A. N.A.

2012/05/15

Bomimed Inc A) RespondPRO Adult and Child Resusitator - Feather Flex

Disposable Manual Resusiators; B) RespondPRO Adult and Child Resusitator -

Disposable Resuscitator

Health Canada 73105 Type II Bomimed Inc N.A.

2012/05/15

Berchtold Medizin-Elektronik GMBH Operon Surgical Table Model D850

(Affected lot no.: 3501110-S10032, 3501110-S10040, 3501110-S10074,

3501110-S10075, 3501110-S10077, 3501110-S10145, 3501110-S10270)


2012/05/15Roche Diagnostics GmbH A) Salicylate for Roche Cobas Integra, c311, c501,

and c502; B) Salicylate for Roche Cobas Integra, c311, c501, and c502Health Canada 73276 Type III

Roche Diagnostics


2012/05/15

Roche Diagnostics GmbH A) Cobas Integra C-Reactive Protein

(Latex)(CRPL2) Appl. for C.F.A.S. B) Cobas Integra C-Reactive Protein (Latex)

High Sensitive (CRPHS) C) 24K Irrigation System - Remote Control D) Cobas

C-111 C-Reactive Protein (High Sensitive Assay) E) C-Reactive Protein Gen.3

(CRPL3) F) Hitachi Tina-Quant C-Reative Protein(Latex) High Sensitive Assay

(CRP) G) CRPL3 (C-Reactive Protein Gen. 3) for Cobas C701 Analyzer H)

CRPHS (Cardiac C-Reactive Protein (Latex) High Sensitive)

Health Canada 73277 Type IIIRoche Diagnostics


2012/05/15Baxter Healthcare SA Baxter pump compatible blood set (Product code: VMC-

9609, Affected Lot no: 11K21V628)MHRA 2012/005/009/291/018 FSN Baxter Healthcare Ltd 2807 8516

2012/05/15 Becton Dickinson BD Gram Crystal Violet 250ml and BD Gram Stain Kit MHRA 2012/005/009/291/015 FSN BD 25758668

2012/05/15 DePuy (a Johnson & Johnson company) DePuy DeltaMotion Acetabular Cup MHRA 2012/005/009/081/021 FSNJohnson & Johnson


2012/05/15 Mini Crosser A/S Mini Crosser M1 scooters produced before 14/12-2010 MHRA 2011/012/012/081/003 FSN N.A. N.A.

2012/05/15PaloDEx Group Oy/ Instrumentarium Dental Instrumentarium OP-300 (Model:

1.14 and 1.15)MHRA 2012/005/002/081/014 FSN N.A. N.A.

2012/05/15Siemens Healthcare Diagnostics LabPro V4.11 (Compact Disc part no.: 9800-

3900, 9800-3906 or 9800-3918)MHRA 2012/005/008/601/004 FSN

Siemens Healthcare

Diagnostic Limited

2870 7533/2870-

7827

2012/05/16DePuy (a Johnson & Johnson company) Side Fire Needle, part of Confidence

Spinal Cement SystemFirm initiated N.A.

Firm Initiated

Field Action

Johnson & Johnson


2012/05/17 Ormco Corporation Enlight UnidoseSybron Dental

SpecialitiesNA

Firm Initiated

Field Action

Sybron Dental

SpecialtiesN.A.

2012/05/17 Endeavour Industries Pty Ltd Quad (4 X Point) Walking Stick TGA N.A. Alerts N.A. N.A.

2012/05/17Varian Medical Systems TrueBeam and TrueBeam STx Versions 1.0 through

1.5

Varian Medical

SystemsCP-07227

Firm Initiated

Field ActionN.A. N.A.
















http://www.tga.gov.au/safety/alerts-device-quad-walking-stick-120517.htm

Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

Agent Contact

Telephone No.

2012/04/03 Philips Healthcare Brilliance 64 or Ingenuity CT with Software Version 3.5.1 MHRA 2012/003/027/081/018 FSNPhilips Electronics


2012/04/03Welch Allyn VSM 200 & 300 series, SPOT Vital Signs, SPOT Lxi Power Cords

& TransformersMHRA 2012/001/011/401/014 FSN N.A. N.A.

2012/04/03 Wescott Medical Limited Weflow3 Hi-Flo Irrigation Set MHRA 2012/003/023/601/004 FSN N.A. N.A.

2012/04/03

Concateno FirstStep hCG Pregnancy Test (FHC-300) [Model/Part no.: FHC-

300; Affected lot no.: All lot numbers] MHRA 2012/003/022/081/001 FSN Concateno N.A.

2012/04/03 GBUK Healthcare TenderTip 24 & 72 Hour Closed Suction MHRA 2012/003/021/601/001 FSN GBUK Healthcare N.A.

2012/04/03Meditech Systems Ltd 22X150S X-tendable catheter mount + elbow [Affected

lot no: S21121101 & L09111108]MHRA 2012/002/007/601/004 FSN Meditech Systems Ltd N.A.

2012/04/03 Merck Serono Merck Serono auto-injector Easypod™ MHRA 2012/003/001/291/003 FSNMerck Pharmaceutical

(HK) Ltd.23896278

2012/04/03

Finsbury Orthopaedics, Stryker Orthopaedics MITCH TRH acetabular

cups/MITCH TRH modular heads (Finsbury Orthopaedics) when implanted with

uncemented Accolade femoral stems (Stryker Orthopaedics)

MHRA MDA/2012/016 MDA Stryker China Ltd 25186911

2012/04/03Agfa Healthcare DX-D 10G, DX-D 10C, DX-D 20G & DX-D 20C - Digital

detectors (connected via cable) for Direct Digital imaging size 35*43cmMHRA 2012/003/013/081/007 FSN

AGFA Hong Kong

Limited2555 9421

2012/04/03 Codman & Shurtleff MEDSTREAM pump MHRA 2012/002/006/081/002 FSNJohnson & Johnson


2012/04/05 Animas Corporation One Touch Ping Insulin Pump Health Canada 72558 Type IIIJohnson & Johnson


2012/04/05 Oxoid Company Brilliance Clarity UTI Plates (MP0324) Health Canada 71096 Type IIThermo Fisher

Scientific (Hong Kong) 2885 4613

2012/04/05

Beckman Coulter, Inc. A) Unicel DXI 600 Access Immunoassay System -

Instrument Class 2

B) Unicel DXI 600 Access Immunoassay System - Instrument Class 3

C) Unicel DXC 880I Synchron Access Clinical Analyzer

D) Unicell DXI 800 Access Immunoassay - Analyzer-Class 3

E) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II

F) Unicel DXC 660I Synchron Access Clincal Analyzer

G) Unicel DXC 660I Synchron Access Clincal Analyzer

H) Unicel DXC 680I Synchron Access Clincal Analyzer

I ) Unicel DXC 860I Synchron Access Clincal Analyzer

J) Unicel DXI 800 Access Immunoassay Sys-Instrument W/ Spot B Gantry

Class 2

K) Unicel DXI 800 Access Immunoassay Sys-Instrument W/ Spot B Gantry

Health Canada 71627 Type IIBeckman Coulter Hong

Kong Ltd2240 6150

2012/04/05Baxter Healthcare SA A) Homechoice APD Systems

B) Homechoice Pro APD SystemsHealth Canada 71838 Type III Baxter Healthcare Ltd 2807 8516

2012/04/05 Beckman Coulter Coulter ACT 5 Diff Autoloader Hematology Analyzer (175356) Health Canada 72299 Type IIIBeckman Coulter Hong

Kong Ltd2240 6150

2012/04/05Carl Zeiss OPMI Lumera 700 Opthalmic Surgical Microscope (305953-9900-

000 and305953-9920-000)Health Canada 72041 Type III

Carl Zeiss Far East Co.,

Ltd2991 2845

2012/04/05 Stryker Orthopeadics Trident Offset Cup Impactor T6318 [All Lots Numbers] Health Canada 72438 Type I Stryker China Ltd 2518 6915

Major Safety Alerts in April 2012










http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON149600http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON149601










2012/04/05Becton Dickinson and Company BD BBL Fildes Enrichment [Model No.:

211866; Lot No.: 1186346, 1229762]Health Canada 72043 Type II BD 25758668

2012/04/05Elekta Business Area Software Sys. ATA Computerized Medical Sys. Inc.

Monaco [Version 3.10.00]Health Canada 72466 Type II Elekta Ltd 2891 2208

2012/04/05

Supersonic Imagine A) SuperSonic Aixplorer Ultrasound System - Main Unit

[SSIP90019]

B) SuperSonic Aixplorer Ultrasound System - Linear Probe [SSIP09002]

C) SuperSonic Aixplorer Ultrasound System - Curved Array Probe [SSIP90030]

D) SuperSonic Aixplorer Ultrasound System - Probe SE12-3 [SSIP90068]

Health Canada 71571 Type IIPrism Technologies

Limited27863233

2012/04/05 Oxoid Limited Oxoid XLS Agar Health Canada 71097 Type IIThermo Fisher

Scientific (Hong Kong)

(852) 2885 4613

Ext 166

2012/04/05Codman and Shurtleff Inc. Codman I.C.P. Express Monitoring System -

Microsensor KitHealth Canada 72434 Type II

Johnson & Johnson


2012/04/05 BrainLAB A) Microscope Integration Kit Zeiss; B) Microscope Integration Leica Health Canada 66443 Type II BrainLAB Ltd 2417 1881

2012/04/10 Healthtronics CRYO-206V and CRYO-206F Procedure Kit FDA Z-1275-2012 Class II N.A. N.A.

2012/04/10

Christie Medical Holding 1) VeinViewer (R) by Luminetx, Model Number VV1.0,

Part No: P00399-L; 2) VeinViewer (R) by Luminetx, Model Number VV1.1 GS,

Part No. P00800-L

FDA Z-1280-2012 to Z-1281-2102 Class II N.A. N.A.

2012/04/11Edwards Lifesciences Edwards Lifesciences Ascendra2 Transapical Delivery

SystemMHRA 2012/003/015/081/024 FSN

Goodman Medical

Supplies Ltd.2332 4455

2012/04/11DePuy Orthopeadics DePuy Attune Impaction Handle (Model/Part no.:

254401010)MHRA 2012/004/002/081/025 FSN

Johnson & Johnson


2012/04/11DePuy Orthopeadics DePuy Fenestrated Open Alignment Guide (Model/Part

no.: 279726401)MHRA 2012/003/013/081/009 FSN

Johnson & Johnson


2012/04/11 Beckman Coulter Access Immunoassay Systems, Vitamin B12 Reagent Kit MHRA 2012/003/028/601/004 FSNBeckman Coulter Hong

Kong Ltd2240 6150

2012/04/11Baxter Healthcare SA Homechoice Disposable Sets (Model no.: R5C4455,

R5C4478, R5C4479, R5C4479E) and Manifold Sets (Model no.: R5C4427)MHRA 2012/004/004/081/004 FSN Baxter Healthcare Ltd 2807 8516

2012/04/11

Stryker Medical Epic Critical Care beds, Epic Zoom Critical Care beds and

Secure II beds.

Catagloue no.: 2030, 2040, 2031, 3002, 3221Affected lot no: Devices

manufactured between 1st September 2004 and 30th November 2007

MHRA 2012/003/030/291/010 FSN Stryker China Ltd 2518 6915

2012/04/11Siemens Healthcare Diagnostics Ltd lratus® CS Acute Care'" NT• proBNP

TestPak reagent (CPBNPM)MHRA 2012/003/030/601/003 FSN

Siemens Healthcare

Diagnostic Limited2870 7533

2012/04/11Siemens Healthcare Diagnostics Ltd Dimension Vista® Total Prostate Specific

Antigen (TPSA) Flex® reagent cartridge (K6451)MHRA 2012/004/003/601/006 FSN

Siemens Healthcare


2012/04/11 Teleflex Hudson RCI BiteGard® oral bite block MHRA 2012/004/003/081/025 FSN N.A. N.A.

2012/04/11 Rocket Medical Rocket® Pleuraseal IV(4) Chest Drainage Bottle MHRA 2012/003/028/601/002 FSN N.A. N.A.

2012/04/11 Woodway Gmbh Medical PPS series treadmills MHRA 2012/003/027/081/016 FSN N.A. N.A.

2012/04/11

Greiner Bio-One A) Item No. 450235 VACUETTE® QUICKSHIELD Complete

PLUS - Safety Tube Holder with 21G x 1" VISIO PLUS Needle;

B) Item No. 450239 VACUETTE® QUICKSHIELD Complete PLUS - Safety

Tube Holder with 21G x 1.5" VISIO PLUS Needle;

MHRA 2012/004/002/081/006 FSN Mekim Ltd 27748337

2012/04/11

IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol

Stent Peripheral Vascular System (6F and 7F)MHRA 2012/004/003/081/012 FSN IntegMed Limited 3527 3062

2012/04/11Instrumentation Laboratory HemosIL von Willebrand Factor Activity (Part No.

0020004700)MHRA 2012/004/003/081/021 FSN N.A. N.A.

2012/04/11 Ipsogen BCR-ABL Mbcr IS-MMR DX Kit , ref FQPP-10-MMR-DX-CE MHRA 2012/003/028/081/020 FSN N.A. N.A.







http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm299000.htm

















2012/04/11Ethicon Endo-Surgery Harmonic® hand piece Harmonic® Blue hand piece and

Blue test tip_HPBLUE, HP054MHRA 2012/004/002/081/020 FSN

Johnson & Johnson

(HK) Ltd.N.A.

2012/04/12 Air- or gas-pressurised spray devices for application of sprayable fibrin

sealants used for intra-operative haemostasis.MHRA MDA/2012/019 MDA N.A. N.A.

2012/04/14 Oral swabs with a foam head MHRA MDA/2012/020 MDA N.A. N.A.

2012/04/17Philips Healthcare Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64,

Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CTMHRA 2012/004/011/081/029 FSN

Philips Electronics


2012/04/17 Philips Healthcare Allura systems. Actuator Monitor Ceiling Suspension (MCS) MHRA 2012/004/011/081/014 FSNPhilips Electronics


2012/04/17 Stryker Orthopaedics Restoration Modular Cone Body Trials MHRA 2012/004/010/081/009 FSN Stryker China Ltd 2518 6915

2012/04/17 Gambro Industries Prismaflex/Prisma ST 100/150 Sets [Ref.: MEY-2012-01] MHRA 2012/004/010/081/020 FSNGambro Hong Kong

Ltd.2839 9713

2012/04/17 GE Medical Systems READY View application software (GE Ref: 80139) MHRA 2012/004/016/291/002 FSNGE Medical Systems


2012/04/17 Ormco Corporation Damon 3MX Bicuspid BracketsSybron Dental

SpecialitiesNA

Firm Initiated

Field Action

Sybron Dental

SpecialtiesN.A.

2012/04/17Abbott Diagnostics Ltd ARCHITECT STAT Troponin-I, List Number 2K41-28,

Lot 74264UN11MHRA 12/004/012/601/005 FSN

Bio-Asia Diagnostics Co

Ltd., Abbott

Laboratories Ltd.

Bio Asia:

27870906,

Abbott: 2593

2211

2012/04/17Abbott Point of Care i-STAT® PT/INR cartridge with List Numbers 04J50-01,

04J50-02, 03P89-24 (All lots beginning with R11 and R12)MHRA 2012/003/030/291/006 FSN


Ltd., Abbott

Laboratories Ltd.

Bio Asia:

27870906,

Abbott: 2593

2211

2012/04/18Varian Medical Systems 4D Integrated Treatment Console (4DITC) v8.6 or 8.8

in combination with treatment planning systems

Varian Medical

SystemsCP-03063

Firm Initiated

Field Action

Varian Medical Systems

Pacific Inc.2724 2836

2012/04/18Varian Medical Systems 4D Integrated Treatment Console (4DITC) versions

8.1.3 to 8.8

Varian Medical

SystemsCP-03556

Firm Initiated

Field Action



2012/04/19

Baxa Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold

under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber

EVA Halobag, and Baxa Calibration Bags

FDA Z-1420-2012 Class II JASPO Limited 27130007

2012/04/19Pharmaceutical Innovations Other-Sonic Generic Ultrasound Transmission Gel

manufactured June through December 2011FDA N.A. N.A. N.A. N.A.

2012/04/19

Siemens Siemens ADVIA Centaur Cortisol Assay, Model/Part no.: 04610138 (1

0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1

0335503)- 250 REFFDA Z-1390-2012 Class II

Siemens Healthcare


2012/04/19 Ergolet ApS Ergolet N.A.Firm Initiated


2012/04/20

Siemens AG A) Mevatron Linear Accelerators [Model No.: 4504200]

B) Oncor Expression Digital Linear Accelerator [Model No.: 7360717]

C) Artiste MV-Linear Accelerator - Main Unit [Model No.: 8139789]

D) Oncor Impression 3D Plus [Model No.: 5857912]

Health Canada 72876 Type ISiemens Healthcare


2012/04/20Biomerieux, Inc. Vitek 2 AST-GN27 card [Model No.: 22245; Lot No.:

267215010]Health Canada 72386 Type II bioMerieux China Ltd. 2195 9348

2012/04/20 Elekta Limited MLCi and MLCi2 radiation heads Elekta Ltd 200 01 403 002Firm Initiated

Field ActionElekta Ltd 28912208

2012/04/20

Siemens AG A) Mevatron Linear Accelerators; B) Oncor Expression Digital

Linear Accelerator; C) Artiste MV - unité principale d'accélérateur linéaire; D)

Oncor Impression 3D Plus

Health Canada 72450 Type IISiemens Healthcare


2012/04/20Smiths Medical ASD Inc CADD High Volume Administration Sets (Model/Part

no.: 21-7081v-01 and 21-7381-01)Health Canada 72657 Type II N.A. N.A.


http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con149680.pdf

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON149697









../AppData/Local/Temp/AppData/Local/Temp/[email protected]/News (Medical Device): http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm (MedWatch): http:/www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm






2012/04/20

SuperSonic Imagine A) SuperSonic Aixplorer Ultrasound System - Main Unit;

B) SuperSonic Aixplorer Ultrasound System - Linear Probe; C) SuperSonic

Aixplorer Ultrasound System - Curved Array Probe; D) SuperSonic Aixplorer

Ultrasound System - Probe SE12-3


Limited27863233

2012/04/20 Vascutek Ltd Vascutek Gelweave Vascular Prothesis (Model/Part no.: 732030) Health Canada 72862 Type IIKeymax Technology

(HK) Ltd. 3150 8413

2012/04/20 Medtronic N'Vision Application Card Health Canada 72742 Type IIMedtronic International

Ltd29191362

2012/04/20 Gemoscan Canada Hemocode Blood Collection Kit Health Canada 72297 Type III N.A. N.A.

2012/04/20 Roche Diagnostics Online DAT Benzodiazepines II for Cobas Integra Analyzers Health Canada 72332 Type IIIRoche Diagnostics


2012/04/20GE Medical Systems A) Brivo XR285AMX X-Ray System; B) Optima

XR220AMX X-Ray System; C) Optima XR200AMX X-Ray System Health Canada 72650 Type III

GE Medical Systems


2012/04/20

Ortho-Clinical Diagnostics Inc. A) VITROS 5600 Integrated System (6802413) -

Instrument

B) VITROS 5600 Integrated System (6802413)

C) VITROS 4600 Chemistry System (6802445) - Hardware

Health Canada 72655 Type IIIOrtho Clinical


2012/04/20

Beckman Coulter Inc. A) Unicel DXC 600i Synchron Access Clinical System

Incubator Belt

B) Access 2 Immunoassay System Incubator Belt

C) Access 2 Immunoassay System Incubator Belt

D) Synchron LXI 725 Clinical System Incubator Belt

Health Canada 72451 Type IIIBeckman Coulter Hong

Kong Ltd

2240 6150 &

22406229

2012/04/20Beckman Coulter Inc. A) Unicel DXC 800 Pro

B) Unicel DXC 880iHealth Canada 72547 Type III


Kong Ltd

2240 6150 &

22406229

2012/04/20 Siemens AG Syngo Mammocad Health Canada 72852 Type IIISiemens Healthcare


2012/04/20 2-Channel Vacuum Unit Health Canada 72754 Type III ITO Company Limited N.A.

2012/04/20Stryker Medical Impression 1.5 Non-Powered Support Surface_2981-000-997,

2981-000-999Health Canada 72850 Type III Stryker China Ltd 2518 6915

2012/04/23 Smith & Nephew Trauma Pins and Drills (various models)Smith & Nephew

HKR1207

Firm Initiated

Field ActionSmith & Nephew Ltd. 2648 7700

2012/04/23 Q-MED Macrolane MHRA NA NA Q-MED International Ltd 22380908

2012/04/24Cameron Health Cameron Health SQ‐RX® Pulse Generator, Model Number

1010MHRA 2012/004/002/081/002 FSN N.A. N.A.

2012/04/24

Galil Medical 17G Cryoablation Needle Holder FPRPR4014 (FSCA identifier:

PAF12-02); [Model no.: FPRPR4014; Affected lot no.: N7729-XXX; N7890-

XXX; N7975-XXX; N8185-XXX; and N9438-XXX]MHRA 2012/004/012/601/006 FSN Galil Medical N.A.

2012/04/24 GE Healthcare Rear Pedestal Air Supply Hose on Optima MR450w with GEM MHRA 2012/003/027/081/005 FSNGE Medical Systems


2012/04/24Gen-Probe GTI Diagnostics Inc LIFECODES® Pak12G® [Various Lot

Numbers]MHRA 2012/004/017/081/016 FSN bioMerieux China Ltd. 2195 9348

2012/04/24Siemens AXIOM Artis or Artis Zee operated in conjunction with a wireless foot

switchMHRA 2011/011/021/081/014 FSN

Siemens Healthcare

Diagnostic Limited

2870 7533 /

2870 7888

2012/04/24 Gen-Probe GTI Diagnostics Lifecodes Quikscreen QS12G MHRA 2012/004/017/081/014 FSN N.A. N.A.

2012/04/24Likvor AB Celda tools_CT001-SV-02, CT001-EN-02, CT001-DA-02, CT001-FI-

02MHRA 2012/004/017/081/001 FSN N.A. N.A.

2012/04/24M.A. Arain & Brothers (Pvt) Ltd Laryngoscope battery handles_670160-000030

and 670160-000040_041511MHRA 2012/004/016/081/021 FSN N.A. N.A.

2012/04/24Pennine Healthcare Procedure packs containing Sarns™ Soft-Flow™ aortic

cannula with angled tip manufactured by TerumoMHRA 2012/003/013/081/005 FSN N.A. N.A.

2012/04/24Philips Healthcare DigitalDiagnost with software version 2.x and the image

stitching optionMHRA 2012/004/018/081/017 FSN

Philips Electronics


2012/04/24Beckman Coulter UniCel® DxH™ 800 Coulter® Cellular Analysis System, PN

629029MHRA 2012/004/013/601/002 FSN


Kong Ltd

2240 6150 &

22406229















http://www.mhra.gov.uk/NewsCentre/CON149797












2012/04/24Biomet 3i Dental Full Osseotite® Tapered Certain® Implant, item no IFNT611;

lot no 2011110798MHRA 2012/004/013/081/012 FSN Ositek (HK), Inc. Ltd

3157

1757/81216601

2012/04/25 Bayer HealthCare MEDRAD® CONTINUUM PUMP AND TUBING SET

Prism

Technologies

Limited

NAFirm-initiated

FSCA

Prism Technologies

Limited27863233

2012/04/27Philips Medical Systems Brilliance Workspace IntelliSpace Portal, M/N 728269

(System Code: 881001, Software release 4.0.0)FDA Z-1337-2012 Class II

Philips Electronics


2012/04/27

MOOG Non-DEHP Microbore Administration Sets, Epidural Administration Sets

(Model no: 340-4114, 340-4115, 340-4126, 340-4127, 340-4128, 340-4128v,

340-4130, 340-4130v, 340-413, 340-4137, 340-4144, 340-4162, 340-4164, 340-

4165, 340-4166, 340-4168, 340-4169 and 340-4123)

FDA Z-1401-2012 to Z-1419-2012 Class IIMoog Controls Hong

Kong Ltd.2635 3200

2012/04/27 BD Diagnostics BD PrepMate Syringing Pipette BD NAFirm Initiated

Field ActionBD 25758668

2012/04/30BD Diagnostics BD Phoenix System Software, Cat. No. 448035/448046, and

BD Phoenix Update Disks (PUD), Cat. No. 441107/448047BD NA

Firm Initiated

Field ActionBD 25758668




Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

Agent Contact

Telephone No.

2012/03/02

Ascension Orthopedics, Inc Ascension Orthopedics First Choice Partial Ulnar

Head System ("DRUJ System") (Model/Part no.: DRUJ-610-1445-WW, DRUJ-

610-1455-WW, DRUJ-610-1465-WW, DRUJ-610-1645-WW, DRUJ-610-1655-

WW, DRUJ-610-1665-WW, DRUJ-610-1745-WW, DRUJ-610-1755-WW,

DRUJ-610-1765-WW, DRUJ-610-1945-WW, DRUJ-610-1955-WW, and DRUJ-

610-1965-WW)

FDA Z-1060-2012 Class II N.A. N.A.

2012/03/02Alere San Diego Strep A Rapid Test Cassette (K031784), IST-502 Cassettes;

Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist CassettesFDA Z-1074-2012 to Z-1075-2012 Class II N.A. N.A.

2012/03/02

Varian Medical Systems Varian 52-leaf Standard MLC multileaf collimator; 52-

leaf Millennium MLC multileaf collimator (Model/Part no.: H52, H54, H56, HHM) FDA Z-1090-2012 Class IIVarian Medical Systems


2012/03/02

Accuray CyberKnife Robotic Radiosurgery System with 4D Planning procedure

option of MultiPlan Treatment Planning System (Model/Part no.: versions 3.0,

3.1, 3.5.1, 3.5.2 and 3.5.3)

FDA Z-1098-2012 Class II Accuray Asia Ltd 2247 8628

2012/03/06 Philips Medical Systems HeartStart FR3 Carry Case MHRA2012/002/029/291/010

FSNPhilips Electronics


2012/03/06Philips Medical Systems HeartStart FR3 Automated External Defibrillators

Mandatory Software UpdateMHRA

2012/002/028/291/006FSN

Philips Electronics


2012/03/06Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc, SXT25

(Sulphamethoxazole\Trimethoprim), CT0052B, Lot 1114277MHRA 2012/002/027/601/004 FSN

Thermo Fisher

Scientific (HK) 2885 4613

2012/03/06 Aesculap AG Columbus Rev F Tibia Offset Cemented MHRA 2012/002/029/081/018 FSN N.A. N.A.

2012/03/06Beckman Coulter UK Ltd Coulter TruColor Giemsa Stain, Coulter TruColor May-

Grunwald StainMHRA 2012/002/024/601/003 FSN


Kong Ltd2240 6150

2012/03/06 Bio-Rad Medical Diagnostics GnbH Biotestcell- I11, I11E MHRA 2012/002/027/291/013 FSN N.A. N.A.

2012/03/06 GE Healthcare GEHC Infinia Nuclear Medicine systems MHRA 2012/003/002/291/007 FSNGE Medical Systems

Hong Kong Ltd.21006318

2012/03/06 Fujifilm Medical Systems Fujifilm FDR-1000AWS, FDR-2000AWS MHRA 2012/002/016/291/012 FSN N.A. N.A.

2012/03/06Interlerad Medical Systems INTELEPACS Versions 3.2.1 and up [reference:

EW241135]MHRA 2012/002/028/291/013 FSN

Interlerad Medical

SystemsN.A.

2012/03/06Roche Diagnostics Ltd Cobas c-pack MULTI [cobas c311 cobas c 501 cobas c

502]MHRA

2011/011/018/401/009FSN

Roche Diagnostics


2012/03/06Sybron Dental Specialities AlgiNot FS Volume (Model/Part no.: 34683, 34682;

Affected lot number: 1‐1017)MHRA 2012/002/027/081/019 FSN N.A. N.A.

2012/03/06 Siemens Healthcare Diagnostics Enzygnost® HBsAg 6.0 MHRA 2012/002/022/601/006 FSNSiemens Healthcare

Diagnostic Limited

2870 7533/2870-

7827

2012/03/06 Thermo Fisher Scientific Oxoid Ready Poured Plate, CLED Agar MHRA 2012/002/028/601/003 FSNThermo Fisher


2012/03/06Medtronic, Inc EnTrust(r) D153DRG, D153VRC, D153ATG, D154VRC,

D154DRG and D154ATG and Escudo D144DRG, D144VRCMedtronic N.A.

Firm Initiated

Field Action

Medtronic International

Ltd29191362

2012/03/07 Standard Diagnostics, Inc SD Bioline HIV 1/2 v3.0 WHO N.A.Information

UpdateBio-Asia 2787 0906

2012/03/07 Varian Medical Systems 4D Integrated Treatment Console and TrueBeamVarian Medical

SystemsCP-05708

Firm Initiated


2012/03/07Varian Medical Systems Eclipse Treatment Planning System Eclipse Treatment

Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0

Varian Medical

SystemsCP-07007

Firm Initiated


Major Safety Alerts in March 2012




















http://www.who.int/diagnostics_laboratory/procurement/120106_final_update_info_sd_bioline_hiv_rtd.pdf

2012/03/08

Canon Inc. A) CXDI-55C Digital Radiography Imager

B) CDXI-55G Digital Radiography X-Ray Imager

C) Digital Radiography CXDI Wireless

Health Canada 71624 Type III Cannon Hong Kong 3191-2333

2012/03/08Siemens Healthcare Diagnostics, Inc Dimension Vista System-Magnesium

AssayHealth Canada 71628 Type III

Siemens Healthcare


2012/03/08 Medtronic, Inc ENT Spear Tip Blades, ENT Upcutting Blades Health Canada 71623 Type IIIMedtronic International

Ltd29191362

2012/03/08Supersonic Imagine Aixplorer Ultrasound System (SSIP90019 and SSIP09002

(SL15-4), version 4.X)Health Canada 71652 Type III

Prism Technologies

Limited27863233

2012/03/08Cinncinnati Sub-Zero Products Steri-Probe Rectal / Esophageal Temperature

Probe (Model no..: 491B)Health Canada 68314 Type II N.A. N.A.

2012/03/08 Siemens Healthcare Diagnostics Factor VIII Chromogenic Assay Health Canada 71092 Type IIISiemens Healthcare


2012/03/08 GE Healthcare Innova 4100IQ Health Canada 71317 Type IIIGE Medical Systems


2012/03/08 3M Health care Optreoz Sterilizer (Model no.: 125-Z) Health Canada 71321 Type III 3M Hong Kong Ltd 2806 6111

2012/03/08 Roche Diagnostics Ltd. Cobas Ampliprep Sample Tubes Health Canada 71298 Type IIIRoche Diagnostics


2012/03/08 Thermor Ltd. Bios Rollator [Model: 56001; Lot No.: 1110-13870] Health Canada 71445 Type I Thermor Ltd. N.A.

2012/03/08

Bomimed Inc A) Air-Flex Anesthesia Mask - Neonatal (OL-081105-00); B) Air-

Flex Anesthesia Mask - Infant (OL-081110-00); C) Air-Flex Anesthesia Mask -

Child (OL-081120-00); D) Air-Flex Anesthesia Mask - Adult (OL-081130-00, OL-

081140-00, OL-081150-00); [Lot No: 072111]

Health Canada 71414 Type II Bomimed Inc N.A.

2012/03/08

Varian Medical Systems EMC issue : A) Eclipse Ocular Proton Planning V1.1

(TPA001075000) ; B) Eclipse Smart Segmentation (TPA001094000); C)

Rapidarc, Also known as Dose Dynamic Arc / Volumet (UP9001); D) Eclipse

TPS V8.8 (100042024);

Health Canada 70975 Type IIVarian Medical Systems


2012/03/08

Varian Medical Systems MLC issue : A) Eclipse Ocular Proton Planning V1.1

(TPA001075000) ; B) Eclipse Smart Segmentation (TPA001094000); C)

Rapidarc, Also known as Dose Dynamic Arc / Volumet (UP9001); D) Eclipse

TPS V8.8 (100042024);

Health Canada 70976 Type IIVarian Medical Systems


2012/03/08Cinncinnati Sub-Zero Products 115 Volt Warmair 135 Convective Warming Unit

06186, 86186Health Canada 71305 Type II

Cinncinnati Sub-Zero

ProductsN.A.

2012/03/08

Varian Medical Systems A) Varisource IX Afterloader

B) Varisource IX(T) (Transportable) Afterloader

C) Varisource Series 200 HDR Afterloader Health Canada 71514 Type II



2012/03/08

Radiometer Medical APS BL80 Flex (with Flex or Basic software)

Model/Part no.: 393-839, 903-227

Affected lot number: 304157, 304160, 304162 through to 305409,

Signal Data Board >May 2011

Health Canada 71558 Type IIRadiometer China

(RCHN)N.A.

2012/03/08

Diasorin Inc. ETI-VCA-IGG

Model/Part no.: P001606A

Affected lot number: 3010580B, 3010580B/1Health Canada 71681 Type II N.A. N.A.

2012/03/08

Supersonic Imagine Aixplorer Ultrasound System

Model/Part no.: SSIP90019, SSIP09002 (SL15-4), SSIP90055 (SLV16-5)

SSIP90030 (SC6-1), SSIP90068


Limited27863233

http://hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php


















2012/03/08 Coloplast A/S Self-Cath Catheter Health Canada 71495 Type IIColoplast (Hong Kong)

Ltd3628 7428

2012/03/08ARES Trading S.A. (An affiliate of Merck KGAA Darmstadt, Germany)

RebiSmart Auto-InjectorHealth Canada 71481 Type II

Merck Pharmaceutical

(HK) Ltd.23896278

2012/03/08 Smith & Nephew Inc., Endoscopy Division Biosure HA Interference Screw Health Canada 71323 Type II Smith & Nephew Ltd. 26458706

2012/03/08 Nobel Biocare AB Nobelactive RP 5x15mm Health Canada 71368 Type II Nobel Biocare Asia Ltd. 28238923

2012/03/08 Smith & Nephew Inc Universal Femoral Head, 32mm+12 Health Canada 71444 Type II Smith & Nephew Ltd. 26458706

2012/03/08 Boston Scientific SoloistTM Single Needle Electrode Boston Scientific 90748268-FAFirm Initiated

Field ActionBoston Scientific 29607136

2012/03/09B. Braun Medical B. Braun Infusomat Space Pump - US Version Infusion pump

(Model no.: 8713050U)FDA Z-1015-2012 Class I

B. Braun Medical Hong

Kong2529 2009

2012/03/09Philips Medical Systems Philips Intellispace Portal, Release 4.0.0.

Mandatory Software UpdateFDA Z-1125-2012 Class II

Philips Electronics


2012/03/09 Zeiss, Carl Inc. Carl Zeiss Microimaging Laser-TIRF and DirectFRAP FDA Z-1129-2012 Class IICarl Zeiss Far East Co.,

Ltd2991 2845

2012/03/09 Terumo Soft-Flow Aortic Cannula with angled tip Terumo AA-2011-027-RFirm Initiated

Field Action

Terumo China (Hong

Kong) Ltd.28660811

2012/03/09Terumo CDI™ Blood Parameter Monitoring System: System Battery

MaintenanceTerumo AA-2011-019-C

Firm Initiated

Field Action

Terumo China (Hong

Kong) Ltd.28660811

2012/03/09Varian Medical Systems Varian brand ARIA Radiation Oncology, ARIA versions

10.0.39 and below, Reference/FSCA Identifier: CP-06070,FDA Z-0713-2012 Class II



2012/03/09AngioDynamics Inc Angiodynamics DuraMax Chronic Hemodialysis Catheter

Set (with Cuff from Tip) various modelsFDA Z-0718-2012 to Z-0733-2012 Class II AngioDynamics Inc 3127 5507

2012/03/13Medtronic, Inc ATLANTIS™ / PREMIER® / VERTEX ® 876-460, 6860460 and

6905712MHRA 2012/003/002/081/021 FSN

Medtronic International

Ltd29191362

2012/03/13 P3 Medical Laryngeal airway masks (silicone, reinforced), lot number 11C01 MHRA 2011/009/028/401/004 FSN N.A. N.A.

2012/03/13 Siemens AG Siemens syngo.plaza, version VA20C_HF01 MHRA 2012/003/005/081/005 FSNSiemens Healthcare


2012/03/13Siemens AG Siemens syngo.plaza with USB dongle and archive license,

version VA20B_HF04MHRA 2012/003/005/081/004 FSN

Siemens Healthcare


2012/03/13Thermo Fisher Scientific Oxoid Ready Poured Plate BrillianceTM MRSA 2 Agar

PO1210A, Lot Number 1203789.MHRA 2012/003008/601/001 FSN

Thermo Fisher


2012/03/13 ArjoHuntleigh Auto Logic Pump Units and PCBAs MHRA 2012/001/017/081/007 FSNArjo Huntleigh (Hong

Kong) Ltd.2508 1416

2012/03/13 BioLytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kits MHRA 2012/001/020/401/011 FSN N.A. N.A.

2012/03/13 Biomet T.E.S.S. Glenoid Anatomic Polyethylene Inlay MHRA 2012/003/007/291/004 FSN N.A. N.A.

2012/03/13 Critical Diagnostics Presage® ST2 Assay kits MHRA 2012/003/007/081/011 FSN Critical Diagnostics N.A.

2012/03/13

DiaSorin Inc. ETI-VCA-G

Model/Part no.: P001606

Affected lot no: 3010580A, 3010580A/1, 3010580A/2MHRA 2012/002/020/081/025 FSN DiaSorin Inc. N.A.

2012/03/13Medex/ Guerbet Laboratories IV administration sets [KSB/I/S] & [KSB/PI/S];

Compatible with the SBI CT injector (SBI 5002-CT) in two-bad mode MHRA 2012/001/024/081/020 FSN Hind Wing Co. Ltd 2541 0909

2012/03/14 Acclarent Inc. Acclarent Inspira AIR Balloon Dilation System, size 18x40mm FDA NA Class I N.A. N.A.

2012/03/16Abbott Molecular Inc HCV Genotype II m2000 System ROW Combined

Application CD-ROM Version 3.0

Abbott Molecular

IncN.A.

Firm Initiated

Field ActionAbbott Laboratories Ltd. 2593 2211

2012/03/16Siemens AG ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT

Therapist Workspace, version 4.1FDA Z-1092-2012 Class II

Siemens Healthcare


2012/03/16GE Healthcare GE eXplore Locus Micro CT cabinet x-ray system Model: RS9-

80; Part no.: 5134163FDA Z-0833-2012 Class II

GE Medical Systems


2012/03/16Microsoft Corporation Health Solutions Group Microsoft Amalga - previously

known as Microsoft Amalga Unified Intelligence System (UIS) 2009FDA Z-1082-2012 Class II N.A. N.A.






















http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm295488.htm




2012/03/16Siemens AG Siemens mMLC (Moduleaf) safety bar and trolley label

Model/ Part no.: 110V/60Hz 7334043 & 220V/60Hz 7334050FDA Z-1184-2012 Class II

Siemens Healthcare


2012/03/20 Varian Medical Systems All FastPlan versions (Possible error in CT)Varian Medical

SystemsCP-07299

Firm Initiated

Field Action



2012/03/20Varian Medical Systems Eclipse™ treatment planning system, Versions 7.3,

8.0, 8.1, 8.2, 8.6, 8.9 and 10.0

Varian Medical

SystemsCP-07504

Firm Initiated

Field Action



2012/03/20Waldemar Link GmbH Trial Neck XXL, length 65mm – Instrument for the MP

Reconstruction Prosthesis (Model/Part no.: 131-394/26; 131-394/35)MHRA 2012/003/008/081/001 FSN N.A. N.A.

2012/03/20 Philips Healthcare MultiDiagnost Eleva II, product code 708032, PBL 4.1.x MHRA 2012/003/012/291/006 FSNPhilips Electronics


2012/03/20Smith & Nephew Inc TRIGEN META Semi-Extended Drill Guides, Product code

71654524MHRA 2012/003/009/081/004 FSN Smith & Nephew Ltd. 2648 7700

2012/03/20

Thermo Fisher Scientific Oxid Antimicrobial Susceptiability Testing Disc CN30

GENTAMICNMHRA 2012/003/009/601/009 FSN

Thermo Fisher


2012/03/20Abbott Diagnostics Ltd i-STAT cTnI cartridge (List no.: 06F15-03, 06F15-04,

03P90-25, 600-9009-25)MHRA 2012/003/013/081/004 FSN


Ltd., Abbott

Laboratories Ltd.

Bio Asia:

27870906,

Abbott: 2593

2211

2012/03/20BrainLAB All Brainlab BrainSCAN and iPlan RT treatment planning software

versionsMHRA 2012/003/013/291/002 FSN BrainLAB Ltd 2417 1881

2012/03/20 Immucor Inc. Galileo Echo Blood Bank Analyzer Cat No.: 0087000 MHRA 2012/003/012/291/001 FSN Uninet Technology LTD 2838 8423

2012/03/20 Medtronic, Inc SynchroMed® II Pump [Medtronic reference : FA535] MHRA 2012/003/012/081/006 FSNMedtronic International

Ltd29191362

2012/03/20

One Lambda Inc. Micro SSP™ Allele Specific HLA Class I DNA Typing Tray –

AB [Model no.: SSP1-AB; Lot Number: 003, batch 007] MHRA 2012/003/009/081/027 FSNMDSS GmbH

(Germany)N.A.

2012/03/20

One Lambda Inc. Micro SSP™ Allele Specific HLA Class I DNA Typing Tray -

B*35 [Model no.: SSPR1-35; Lot Number: 002, batch 004] MHRA 2012/003/012/291/002 FSNMDSS GmbH

(Germany)N.A.

2012/03/21 Beckman Coulter Inc. Prealbumin (Model no. OSR6175) Health Canada 71442 Type IIIBeckman Coulter Hong

Kong Ltd

2240 6150 &

22406229

2012/03/21 Siemens AG Axiom Luminos DRF System-Main Unit Health Canada 71452 Type IIISiemens Healthcare


2012/03/21

GE Medical Systems Information Technologies, Inc. CIC Pro Clinical

Information Center (Model/Part no.: CIC-XXXX-XXXXX-XXXXX*) Health Canada 71826 Type IIIGE Medical Systems


2012/03/21

Supersonic Imagine Aixplorer System - Linear Probe (SL-15-4) (Model/Part no.:

SSIP09002 (SL15-4)) Health Canada 71677 Type IIIPrism Technologies

Limited27863233

2012/03/21

CardianBCT Inc. A) Cobe Trima Blood Collection System

B) Trima Accel LRS Platelet, Plasma, RBC Set

C) Trima Accel Enhanced Platelet, Plasma, RBC Set

D) Trima Accel LRS Platelet, Plasma, RBC, and TLR Filter Set

Health Canada 71626 Type IICaridianBCT (Hong

Kong) Ltd

22830710 / 86

13311251372

2012/03/21

Liebel-Flarsheim Company A) Y Tubing Optistar/Coiled Extension Tubing

B) Optistar Mr. Injection System

C) Optistar Le Contrast Delivery System

Health Canada 71635 Type II

Covidien Hong Kong

Limited90379434 (Ms

Cathy HO)

2012/03/21 Hologic SecurView DX Diagnostic Workstation, Software Version 7.3.0 Health Canada 71960 Type IIPrism Technologies

LimitedN.A.

2012/03/21 Lifescan Onetouch Verio IQ Blood Glucose Meters 011-838 Health Canada 71989 Type IIJohnson & Johnson













http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php








2012/03/21Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products ALT Slides

(1655281)Health Canada 71454 Type III

Ortho Clinical


2012/03/21 Kerr Corporation Tytin FC Fast Set Capsules Health Canada 71184 Type III N.A. N.A.

2012/03/21

Philips Medical Systems (Cleveland) Inc A) Brilliance 40-64 Slice CT System-

Workspace Portal; B) Brilliance 6/1016 Slice CT Sytem - Extended Brilliance

Workspace Portal; C) Brilliance 40-64 Slice CT System - Extended Brilliance

Workspace Portal; D) Brilliance ICT System - Extended Brilliance Workspace

Portal; E) Intellispace Portal DX

Health Canada 71630 Type IIPhilips Electronic Hong

Kong Ltd2821 5480

2012/03/21

Waverley Glen Systems - Division of Prism Medical Ltd. A) Waverley Glen

Griffin Lifts equipped with the "Griffin Reacher Arm Carabiner"; B) TP Lifts

equipped with the "Griffin Reacher Arm Carabiner"


2012/03/21 DMX-Works Inc Digital Motion X-Ray System D100S, D100M Health Canada 71852 Type II N.A. N.A.

2012/03/21 Smithys Medical ASD, Inc. Medfusion 4000 Syringe Pump Health Canada 71618 Type II N.A. N.A.

2012/03/21Roche Diagnostics Ltd. PSM Software version 2.02.02C [Model #:4944607001;

Lot: version 2.02.02C]Health Canada 72199 Type I

Roche Diagnostics


2012/03/21

Cardinal Health A) Cardiac Catheterization Pack [Model: SAN30LHTGB]; B)

Custom Sterile Radical Prostate Pack [Model: SOT30RPVRF] Health Canada 71614 Type II Cardinal Health N.A.

2012/03/21 Metrex Research Pinnacle Cure Sleeves [Model: 4511; Lot: 20008270110] Health Canada 68638 Type IISybron Dental

SpecialtiesN.A.

2012/03/21Capintec Inc. Radioisotope Dose Calibrator CRC 25R [Model: CRC 25R; Lot:

270333]Health Canada 71594 Type II Capintec Inc. N.A.

2012/03/21 Philips Medical Systems Intellispace Portal DX Health Canada 71839 Type IIIPhilips Electronics


2012/03/21Ormco Corporation Medium Absorbent Points

Model/Part no.: 16218, Affected lot number: 7200905Health Canada 72009 Type III

Citicon (Hong Kong)

Ltd., D & R DentalN.A.

2012/03/21Biomerieux BV NucliSENS Magnetic Silica ref 280133

Health Canada 71179 Type III bioMerieux China Ltd. 2195 9348

2012/03/21

Nobel Biocare AB Nobelreplace CC RP 5.0X8MM

Model: 36710

Affected lot number: 462574

Health Canada 72044 Type III Nobel Biocare Asia Ltd. 28238923

2012/03/2192000) lot no.255830, 262143, 262838, 259628, 259954

B) Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 92008 Model (92008 )lot

no. 259403NA


2012/03/21

Philips Healthcare Philips HeartStart MRx monitor/defibrillator, Model/Part no.:

M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M4, M3536M5,

M3536M6

Philips

HealthcareCIL 86100108 N.A.

Philips Electronic Hong

Kong Ltd2821 5480

2012/03/21 Terumo Terumo Advanced Perfusion System 1:6” Roller Pump Occlusion Terumo AA-2011-015-CUrgent Medical

Device Recall

Terumo China (Hong

Kong) Ltd.28660811

2012/03/21 Boston Scientific Imager II Catheter (Urology) Boston Scientific 90752558-FAUrgent Medical

Device RecallBoston Scientific 29607136

2012/03/21 Boston Scientific Imager II Angiographic Catheter (Peripheral Intervention) Boston Scientific 90752558 Ver AAUrgent Medical

Device RecallBoston Scientific 29607136

2012/03/23 Philips Healthcare HeartStart XL+ (861290) Defibrillator/MonitorPhilips

HealthcareCIL 86100109 N.A.


Kong Ltd2821 5480

2012/03/26

Clarity Medical Systems Inc., Pleasanton, CA Retcam3 & Retcam Shuttle with

version 6.0 software.

A)Model number RC3, part number 21-100500

B)Model number RCS, part number 20-000300




../AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/AppData/Local/Temp/Rar$DI77.944/:http:/www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php














2012/03/27DePuy Mitek Anchor Bone Implanted Ligament [Affected lot number: 3549274,

3549296, 3549732, 3549621,3549273, 3547740]MHRA 2012/003/022/081/022 FSN

Johnson & Johnson


2012/03/27

OptiMed GmbH AltaFlow Measuring Catheter pigtail 5F(1.67mm) x 110cm

[Model no.:1080-4100; Lot number: 6000073905] MHRA 2012/003/019/081/012 FSN OptiMed GmbH N.A.

2012/03/27

QRS Diagnostic QRS Diagnostic Universal ECG 12 Lead IEC ECG Devices

[Model/Part no.: Z-7000-0400] MHRA 2012/002/014/601/003 FSN QRS Diagnostic N.A.

2012/03/27

Ranier Technology Limited Cadisc™ -L Distractor [Model/Part no.:RTI-010-

0305 (P000946); Lot number: S1008003, S1102189] MHRA 2012/003/016/291/006 FSNRanier Technology

Limited N.A.

2012/03/27 Siemens Healthcare Diagnostics, Inc MAGNETOM ESSENZA MHRA 2012/003/015/291/002 FSNSiemens Healthcare


2012/03/27The Spectranetics Corporation 12 Fr SLS II Laser Sheath [Model/Part no.: 500-

001]MHRA 2012/003/015/291/016 FSN

The Spectranetics

CorporationN.A.

2012/03/27

Venner Medical Venner™ A.P. Advance ™ Video Laryngoscope Difficult Airway

Blade (DAB) [Model/Part no.: 700170;Lot number: FM10080006, FM10110007,

FM11010001]MHRA 2011/007/011/601/004 FSN Venner Medical N.A.

2012/03/27Waters Corporation ACQUITY Sample Organizer [Model/Part no.: 186015020]

MHRA 2012/003/020/081/004 FSN Waters Corporation N.A.

2012/03/27Biomerieux BV BacT/ALERT® Blood Collection Adapter Cap

A) 279012, B) 210361MHRA 2012/003/015/291/001 FSN bioMerieux China Ltd. 2195 9348

2012/03/27 Diagmed Healthcare Ltd Indigo Carmin Sterile MHRA 2011/009/019/081/013 FSN N.A. N.A.

2012/03/27

Ethicon Endo-Surgery ECHELON™ 60 ENDOPATH® STAPLER Endoscopic

Linear Cutter (Straight)

A) ECHELON™ 60 ENDOPATH® STAPLER Endoscopic Linear Cutter

(Straight, 340mm)

B) ECHELON™ 60 ENDOPATH® STAPLER Compact Endoscopic Linear

Cutter (Straight, 280mm)

C) ECHELON™ 60 ENDOPATH® STAPLER Long EndoscopiC Linear Cutter

(Straight, 440mm)

MHRA 2012/003/019/081/014 FSNJohnson & Johnson


2012/03/27 Abbott Aliquoter Module connected to FlexLab 3.6 MHRA 2012/003/022/081/021 FSN Abbott Laboratories Ltd. 2593 2211

2012/03/27

Meditech Systems Ltd 22835XMMS Bacterial / viral HME filter with X-tendable

catheter mount + elbow MHRA 2012/002/007/601/003 FSN N.A. N.A.

2012/03/30 Roche Diagnostics Ltd. Elecsys 2010 Analyzer Software version 06-07 FDA Z-1218-2012 Class IIRoche Diagnostics


2012/03/30

Smith & Nephew RENASYS Port Foam Dressing Kit Port [Model/Part no.:

66800694] FDA Z-0875-2012 Class II Smith & Nephew Ltd. 2648 7700

2012/03/30Kerr Corporation 1) Artiste Nano-Hybrid Affected Product; 2) Flow Tec Nano-

Hybrid Flowable Affected ProductFDA Z-0989-2012, Z-0990-2012 Class II N.A. N.A.

2012/03/30Philips Healthcare 1) Philips MultiDiagnost Eleva II Software Version R4.1.x

Model: 708032; 2) Philips MultiDiagnost Eleva FD, Software R5.1.x Model: FDA Z-1196-2012, Z-1197-2012 Class II

Philips Electronics


2012/03/30Smith & Nephew 560P High Definition Camera Control Unit; [Product

code:72201919; Batch No. BBS1203 &BBS1450]Smith & Nephew N.A.

Firm-initiated

Class II RecallSmith & Nephew Ltd. 2648 7700

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON146746

















Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

Agent Contact

Telephone No.

2012/02/01 Polyurethane-coated breast implants MHRA N.A. News N.A. N.A.

2012/02/01

Philips Healthcare TumorLOC in Brilliance CT Big Bore, Extended Brilliance

Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI

TF Big Bore

Philips

HealthcareCLE11-003

Firm Initiated

Field Action

Philips Electronics


2012/02/01 Abbott Molecular Inc Abbott Molecular Bar Code Scanner User's GuideAbbott Molecular

IncN.A.

Firm Initiated


2012/02/01Cordis (a Johnson & Johnson company) Cordis S.M.A.R.T. ® CONTROL®

Nitinol Stent System

Johnson &

Johnson (Hong

Kong) Ltd

N.A.Firm Initiated

Field Action

Johnson & Johnson


2012/02/02 Maquet Critical Care AB Servo-I Ventilator System (64 87 800 E407E) Health Canada 70581 Type IIMAQUET Hong Kong

Limited23939511

2012/02/02GE Healthcare Discovery NM/CT 670 (Mode no.: 5376204-XX / lot 21048 and

20158)Health Canada 70427 Type II

GE Medical Systems

Hong Kong Ltd.

2783 1838/

2100 6318

2012/02/02 Toshiba Medical Systems Corporation Radrex Radiographic System - Main Unit Health Canada 70422 Type IIISanko Medical Systems

(HK) LTD23840688

2012/02/02 Oxoid Limited Amoxicillin + Clavulanic Acid 30ug disc Health Canada 70182 Type IIThermo Fisher

Scientific (Hong Kong)

(852) 2885 4613

Ext 166

2012/02/02

Siemens AG Axiom Aristos FX Plus ( X-Ray Tubes) [Model/Part no.: 10093864;

Serial Number:1324] Health Canada 70421 Type IISiemens Healthcare


2012/02/02 Kimberly-Clark MIC Gastro-Enteric Feeding Tube, 22F Health Canada 70252 Type IIKimberly-Clark (Hong

Kong) Limited 2334 3361

2012/02/02

Greiner Bio-One Vacuette 4mL EDTA K2 Tubes [Model/Part no.: 454209; Lot

number: B051111] Health Canada 66418 Type II Mekim Ltd 27748337

2012/02/02

Tripath Imaging, Inc. (1)BD FocalPoint Slide Profiler, module: 799-00256-XX,

lot: 00178R, 00382, 00383, 00386, 0442-0445, 0451, 0453 & (2)BD FocalPoint

Slide Profiler (refurbished), module: 799-00256-XX, lot: 0037R

Health Canada 70423 Type IIIBecton Dickinson Asia

Limited (BD)

25758668 Ext

252

2012/02/02Roche Diagnostics GMBH Hemoglobin A1C (HBA1C), module: 5336163190,

lot: All lotsHealth Canada 70703 Type III

Roche Diagnostics


2012/02/06 Novomedicus 1) The Artificial Bur Patch; 2) The Artificial Bur HypoPack FDA Z-0919-2012 to Z-0920-2012 Class II N.A. N.A.

2012/02/06

Gulf Medical Fiberoptics, Inc. Surgical Headlight Model Numbers: GMF-H001,

GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and

GMF-H106


2012/02/06 GE Ultrasound Korea GE LOGIQ P6 Ultrasound System FDA Z-0834-2012 Class IIGE Medical Systems


2012/02/06Chien Ti Enterprise Co., Ltd Leo 3-Wheel Scooter and Leo Scooter, Model #

LEO-4BFDA Z-0774-2012 Class II

Chien Ti Enterprise Co.,

LtdN.A.

2012/02/07 Hill-Rom NP150 viscoelastic mattress MHRA 2012/001/030/081/012 FSN N.A. N.A.

2012/02/07

Philips Healthcare MultiDiagnost Eleva FD, Product code: 708037, Software

release: PBL 6.1.1 MHRA 2012/002/001/181/002 FSNPhilips Electronics


2012/02/07Philips Healthcare MultiDiagnost Eleva II R6.1.1, product code 708036

MHRA 2012/002/001/181/001 FSNPhilips Electronics


Major Safety Alerts in February 2012



http://www.mhra.gov.uk/NewsCentre/CON140879

















2012/02/07Sorin Group Deutschland GmbH Sorin Group perfusion system – Pump Speed

ControlMHRA 2012/001/030/081/002 FSN IntegMed Limited 3527 3062

2012/02/07Wescott Medical Limited Sae-Flo MD Extension Set with Y-Connector,

Catalogue No.:WEPCA200AY, Lot: 2011-1510MHRA 2012/001/020/601/001 FSN Wescott Medical Ltd N.A.

2012/02/07Beckman Coulter UK Ltd IMMAGE® Immunochemistry Systems Rheumatoid

Factor (RF) ReagentMHRA 2012/001/031/601/008 FSN


Kong Ltd2240 6150

2012/02/07Biomet Merck France SARL Vanguard ROCC-Reamer, Vanguard ROCC-

Finned Punch TowerMHRA 2012/001/027/081/005 FSN N.A. N.A.

2012/02/07 Advanced Sterilization Products STERRAD® 200 System MHRA 2012/001/031/081/002 FSNJohnson & Johnson


2012/02/08 North American Rescue, LLC FDA N.A.Firm Press

ReleaseN.A. N.A.

2012/02/09Sorin Group Deutschland GmbH Revolution Centrifugal Blood Pump with PC

CoatingHealth Canada 70430 Type III IntegMed Limited 3527 3062

2012/02/09 Roche Diagnostics GMBH Urisys 1800 and Process System Manager Health Canada 70706 Type IIIRoche Diagnostics


2012/02/09 Keymed Olympus Endoscopic Flushing Pump System - Irrigation Tube Health Canada 70184 Type IIIOlympus Hong Kong

and China Ltd2170 5678

2012/02/09 Toshiba Medical Systems Corporation Ultimax-I X-Ray Systems Health Canada 70195 Type IIISanko Medical Systems

(HK) LTD23840688

2012/02/09

Airway Surgical Appliances Ltd. A) 20-30 mm/hg below Knee ;

B) 20-30 mm/hg above Knee;

C) 20-30 mm/hg Pantyhose;

D) 30-40 mm/hg Knee High;

E) 30-40 mm/hg above Knee


2012/02/09 Beckman Coulter Inc. RF Latex Calibrator Health Canada 70580 Type IIIBeckman Coulter Hong

Kong Ltd2240 6150

2012/02/09Health Canada Non-Invasive Ventilation Devices (CPAP, VPAP/BiPAP) - Risk

of Being Used as Life-supporting Ventilators Health Canada NA

Advisory to

Health

Professionals

N.A. N.A.

2012/02/09 Zoll Medical Corporation Pedi-Padz Reduced Energy Electrode Health Canada 70567 Type IISuburfarm Investment

& Trading Co., Ltd.2780 9421

2012/02/09 Greiner Bio-One 5ml Lithium Heparin Sep. Venous Blood Collection Tube Health Canada 70122 Type II Mekim Ltd 27748337

2012/02/09 Patterson Medical Supply, Inc. Bur U-Sharp Carbide FG Health Canada 70069 Type IIPatterson Medical

Supply, Inc.N.A.

2012/02/10

Steris Corporation STERIS SYSTEM 1E Liquid Chemical Sterilant Processing

System, Model/Part no.: Model P6500 FDA Z-0869-2012 Class IISwedish Trading Co.

Ltd.

Ms Chiu 6199

0634

Ms Cheung

2953 5154

2012/02/10Vision-Sciences, Inc. 1) Vision Sciences Battery Charger, Lithium Ion

2) Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2)FDA Z-0928-2012 to Z-0929-2012 Class II N.A. N.A.

2012/02/10

Alere San Diego Alere Cholestech LDX Analyzer, Model/Part no.: 10-004, 14-

874, 14-875 FDA Z-0964-2012 Class II N.A. N.A.

2012/02/10 Hitachi Cobas c501/ 502 laboratory analyser MHRA MDA/2012/004 MDARoche Diagnostics


2012/02/13 Handheld dental X-ray units FDA N.A.

Press

Release/MedWa

tch

N.A. N.A.

2012/02/13 BD PrepStain Vacuum Pump BD N.A.Firm Initiated

Field ActionBD 2575 8668













http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/ventilation_nth-aah-eng.php







http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON143596

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291373.htm;http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291539.htm

2012/02/13 Boston Scientific Wingspan Stent System and Gateway PTA Balloon Catheter Boston Scientific N.A.Firm Initiated

Field Action

Synapse Therapeutic

Ltd.31881638

2012/02/14 Salter Labs 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve FDA Z-0803-2012 Class I N.A. N.A.

2012/02/14 Varian VariSeed MHRA 2012/002/001/291/015 FSNVarian Medical Systems


2012/02/14Nikkiso Octo Nova® HEMOFIL TRATION DEVICE (GE-F076-00, GE-F076-10,

GE-F090-00, GE-F091-00)MHRA 2012/002/007/081/002 FSN Baxter Healthcare Ltd 2807 8516

2012/02/14

Philips Healthcare Philips IntelliVue Patient Monitors: MP20 (M8001A), MP30

(M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70

(M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600

(865242), MX700 (865241) MX800 (865240)

MHRA 2012/002/009/081/006 FSNPhilips Electronics


2012/02/14 Ranier Technology Limited Cadisc-L total lumbar disc replacement MHRA 2012/002/006/291/013 FSNRanier Technology

LimitedN.A.

2012/02/14Smith & Nephew Orthopaedics Ltd SpatialFrame.com software, product code

71070401, version 4.1.1MHRA 2012/002/006/081/007 FSN Smith & Nephew Ltd. 2648 7700

2012/02/14 Varian Medical Systems PaxScan 4336R power cable MHRA 2012/002/006/081/018 FSNVarian Medical Systems


2012/02/14 CaridianBCT CaridianBCT Trima Accel® Disposable Tubing Sets MHRA 2012/002/008/081/004 FSNCaridianBCT (Hong

Kong) Ltd

22830710 / 86

13311251372

2012/02/14 GE Healthcare mlBG-dilution set MHRA 2012/002/003/291/014 FSNGE Medical Systems


2012/02/14 Alcon Laboratories Ltd Alcon AcrySof® CACHET® Phakic Lens MHRA 2012/002/007/081/016 FSN Alcon Hong Kong, Ltd. 25680636

2012/02/14Beckman Coulter UK Ltd Floor Cabinet for UniCel DxH Slidemaker Stainer

Cellular Analysis SystemMHRA 2012/002/003/601/002 FSN


Kong Ltd2240 6150

2012/02/14 Biomet UK Ltd AGC Patella Button 34mm MHRA 2012/002/002/291/036 FSN N.A. N.A.

2012/02/16 NEMSCHOFF Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 FDA Z-0832-2012 Class I N.A. N.A.

2012/02/21Covidien Disposable imaging device accessories, Syringe, MR w/laternal flow

needle; Y Tubing, MR, with single check valve; Coiled Extension TubingMHRA 2012/002/016/081/010 FSN

Tyco Healthcare

(HKSAR) Ltd3157 7220

2012/02/21Varian Dual Varian Clinac® accelerators with Mark or Millennium MLC and

BrainLAB m3 MLCMHRA 2012/002/015/081/005 FSN



2012/02/21

Vascutek Anaconda and Anaconda ONE-LOK Stent Graft Systems (Model no.:

B19, B21, B23, B28, B30, B32, B34

)

MHRA 2012/002/016/291/005 FSNKeymax Technology

(HK) Ltd. 3150 8413

2012/02/21 The Helping Hand Company Hoist Turntable Mk 6 Part number RA8330 MHRA 2012/002/014/291/009 FSN N.A. N.A.

2012/02/21Thermo Fisher Scientific Oxoid Ready Poured Plate, PO0120A, CLED Agar,

Lot number 1200138.MHRA 2012/002/009/601/006 FSN

Thermo Fisher


2012/02/21Thermo Fisher Scientific Oxoid Ready Poured Plate, PO0152A, Mueller Hinton

Agar (4mm depth), Lot number 1201920MHRA 2012/002/009/601/013 FSN

Thermo Fisher


2012/02/21Hospira Inc. Lifecare™ 5000 IV Pump Set [0F8259701, 0G8689701,

0P7419701]MHRA 2012/002/015/081/001 FSN Hospira Limited 2898 2886

2012/02/21

Intuitive Surgical Inc Intuitive Surgical ® da Vinci S Surgical Systems [Model

no.: da Vinci S® Surgical System IS 2000, da Vinci Si® Surgical System IS

3000, da Vinci Si-e® Surgical System]

MHRA 2012/002/010/081/001 FSN Chindex N.A.

2012/02/21Ropox A/S Hudson Shower bed [Article: 40-25023-XX, 40-25026-XX, 40-

25029]MHRA 2012/002/001/291/005 FSN Ropox A/S N.A.

2012/02/21 Activate Ltd Corgi Class Chair MHRA 2010/003/023/401/012 FSN N.A. N.A.

2012/02/21 Balt Extrusion BALTACCI Infusion Catheters MHRA 2012/002/001/291/019 FSN N.A. N.A.

2012/02/21 Biosense Webster Inc Carto 3 Systems MHRA 2012/002/015/081/004 FSNJohnson & Johnson


2012/02/23 Sybron Dental Specialities Buchanan Medium PluggersSybron Dental

SpecialitiesN.A. FSN N.A. N.A.

2012/02/23Sybron Dental Specialities K3 Gutta Percha, Part No.: 825-0625 & Lot No.:

042511

Sybron Dental

SpecialitiesN.A. FSN Citicon (Hong Kong) Ltd 21274683


























2012/02/24 Zimmer Natural-Knee II Durasul All-Poly Patella FDA Z-0848-2012 to Z-0855-2012 Class IIZimmer PTE Ltd. (Hong


2012/02/24Beckman Coulter UK Ltd Clinical Chemistry Analyzers (AU400, AU600,

AU2700 and AU5400)FDA Z-0974-2012 to Z-0977-2012 Class II


Kong Ltd2240 6150

2012/02/24

Philips Medical Systems Software version 4.0 Beta 2 in

1) Brilliance 64 Computed Tomography System, Model #728231 and

2) Ingenuity CT computed Tomography System, Model #728326 FDA Z-0360-2012 to Z-0361-2012 Class II

Philips Electronics


2012/02/24Allen Medical Systems, Inc. Allen C-Flex Head Positioning System [Catalog

No.:A-70700 and A-70701-2]FDA Z-0655-2012 Class II

Allen Medical Systems,

Inc.N.A.

2012/02/24Biomet Microfixation, Inc. IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM

(6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATEDFDA Z-0447-2012 Class II N.A. N.A.

2012/02/28Sorin CRM SonRtip endocardial pacing lead with contractility sensor,

Model/Part no.: PS55DMHRA 2012/002/023/291/005 FSN

Innotronik Hong Kong

Limited2877 6787

2012/02/28Roche Diagnostics GMBH Troponin I Elecsys cobas e, Troponin I STAT

Elecsys cobas e 100MHRA 2012/002/021/291/009 FSN

Roche Diagnostics


2012/02/28 Roche Diagnostics GMBH cobas c-pack MULTI MHRA 2012/002/016/081/014 FSNRoche Diagnostics


2012/02/28 Abbott Point of Care Inc i-STAT cTnI, BNP, and CK-MB cartridge MHRA 2012/002/021/081/006 FSN


Ltd., Abbott

Laboratories Ltd.

Bio Asia:

27870906,

Abbott: 2593

2211

2012/02/28Aesculap AG/ B Braun S4 Cervical Occiput Screw Remover, S4 Cervical

Occiput Screw Removal ShaftMHRA 2012/002/023/291/006 FSN N.A. N.A.

2012/02/28 Bard Limited MRI Implanted Port MHRA 2012/002/020/081/018 FSNSenrex International

Ltd.23118938

2012/02/28 B Braun Medical Inc. SUSI instruments (various models and lots) MHRA 2012/002/020/081/020 FSNB. Braun Medical Hong

Kong2529 2009

2012/02/28

Biomet UK Ltd Vanguard Tibial Resection Tower & Vanguard Distal Cut Block

Lot 2561334 and Lot 2561329]MHRA 2012/002/016/081/019 FSN N.A. N.A.

2012/02/28

GE Healthcare OEC® 9800, OEC® FluoroTrak 9800 Plus & OEC® 9800MD

Motorized C-arm System MHRA 2012/002/023/081/006 FSNGE Medical Systems


2012/02/28

Thoratec HeartMate II® Left Ventricular Assist System (HM II LVAS) Sealed

Outflow Graft Short Bend Relief (Catalog No. 104692) and Thoratec HeartMate

II Sealed Outflow Graft (Catalog No. 103393).

Firm initiated N.A. FSNTransmedic China

Limited2107 4668

2012/02/29 Mizuho Orthopedic Systems Swivel Adapter Assembly, Headrest (Plastic) Health Canada 71131 Type II Keymax Technologies31508913/3150

8289

2012/02/29Arrow International A) Epidural Catheterization Kit

B) Peripherally Inserted Central Catheter Seldinger Access KitHealth Canada 71094 Type II

Cemma Enterprise Co.,

Ltd2412 2310

2012/02/29 Scottcare Corporation TeleSentry Model TS01 Health Canada 71132 Type II N.A. N.A.

2012/02/29Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products dHDL Slides

(Model/Part no.: 680 1895, 680 2469)Health Canada 71324 Type II

Ortho Clinical


2012/02/29 Immucor Inc. WBCORQC (Model/Part no.: 0066090, lot number: 236123) Health Canada 70667 Type III Uninet Technology Ltd. 2838 8423

2012/02/29 Beckman Coulter Inc. Access Hybritech Free PSA (Part no.: 37210) Health Canada 67750 Type IIIBeckman Coulter Hong

Kong Ltd2240 6150

2012/02/29Beckman Coulter Inc. Manual Immunoassay DHEA RIA Test Kit (Part no.: DSL-

8900)Health Canada 71083 Type III


Kong Ltd2240 6150

2012/02/29Beckman Coulter Inc. Flow-Set Fluorospheres (Part no.: 6607007; Lot number:

7524018F, 7524019F)Health Canada 71084 Type III


Kong Ltd2240 6150























2012/02/29

Siemens Healthcare Diagnostics A) Rapidpoint 400 System

B) 850/855 Blood Gas System - Control Reagents

C) 840-845 Blood Gas System - Control Reagents

D) 348 System - Reagents

E) 860-865 Blood Gas System - Control Reagents

F) RapidQC Complete Level 1

G) RapidQC Complete Level 3

Health Canada 71089 Type IIISiemens Healthcare


2012/02/29

Life Technologies Corporation (Invitrogen) A) Invitrogen CW High Res Unitray

SSP Kits

B) Invitrogen Allset Gold SSP CW High Res Kits

Health Canada 71115 Type IIIInvitrogen Hong Kong

Limited N.A.

2012/02/29Alba Bioscience Limited FetalScreen II Fetal Maternal Hemorrhage Screening

TestHealth Canada 71080 Type III Alba Bioscience Limited N.A.

2012/02/29 Beckman Coulter, Inc. ACTIVE Aldosterone RIA Health Canada 71088 Type IIIBeckman Coulter Hong

Kong Ltd2240 6150

2012/02/29

Beckman Coulter, Inc. A) Access Immunoassay System Access Accutni

Reagent

B) Unicel DXI 600 Access Accutni Reagent


Kong Ltd2240 6150

2012/02/29 Contura International A/S Bulkamid Urethroscope Health Canada 71253 Type IIIContura International

A/SN.A.

2012/02/29Roche Diagnostics GMBH A) Tina-Quant IGG Gen2

B) Tina-Quant IGG Gen2Health Canada 71169 Type III

Roche Diagnostics


2012/02/29 Becton Dickinson and Company BBL Lysine Iron Agar Health Canada 71099 Type III BD 25758668

2012/02/29

Siemens Healthcare Diagnostics Products Limited A) Immulite System CK-MB

Assay

B) Immulite 2500 System CK-MB Assay

C) Immulite System Turbo CK-MB Assay

D) Immulite 2000 System CK-MB Assay



2012/02/29

Siemens Healthcare Diagnostics Inc. A) 850-855 Blood Gas System - Control

Reagents

B) 840-845 Blood Gas System - Control Reagents

C) 348 System - Reagents

D) 860-865 Blood Gas System - Control Reagents

E) CVM Controls



2012/02/29

HowMedica Osteonics Corporation Partnership Definition PM Hip Stem -

Cemented (Model No.: 6265-3-101, 6265-3-102, 6265-3-103,

6265-3-104, 6265-3-105, 6265-3-106, 6265-3-107)

Health Canada 70640 Type II Stryker China Ltd 2518 6915

2012/02/29Stryker Orthopeadics Accolade RASP Handle (Model No.: 1020-1400; Lot

Number: P5E93)Health Canada 70655 Type II Stryker China Ltd 2518 6915

2012/02/29GE Medical Systems, LLC A) VMX Mobile X-ray, B) VMX Plus Mobile X-ray

SystemsHealth Canada 70843 Type II

GE Medical Systems


2012/02/29 Innovacon, Inc Innovacon Strep A Rapid Test Device (Throat Swab) Health Canada 69394 Type II N.A. N.A.

2012/02/29 Agfa Healthcare N.V. Impax for Cardiology- Clinical Review Station Health Canada 71095 Type IIAGFA Hong Kong

Limited2555 9421

2012/02/29Enginivity LLC (a GE Healthcare company) Enflow IV Fluid/ Blood Warming

SystemHealth Canada 71100 Type II

GE Medical Systems


2012/02/29 Haag-Streit, AG Octopus 900 Basic, Octopus 900 Pro Health Canada 68860 Type II The VITA CO. Ltd. 2548 7483

2012/02/29 Beckman Coulter, Inc Coulter PrepPlus Health Canada 71085 Type IIBeckman Coulter Hong

Kong Ltd2240 6150



















Date of Issue

(YYYY/MM/D

D)



Alert Type by

SourceLocal Agent

Agent Contact

Telephone No.

2012/01/03Biomet Orthopedics Discovery Elbow System Humeral Condyle Kit-

Hexalobular [Part No: 114700; Lot No: 797550]MHRA 2011/012/021/081/012 FSN N.A. N.A.

2012/01/03Beckman Coulter SYNCHRON System(s) Multi Calibrator Diskette (Ref No:

442648; Lot No: M002642G)MHRA 2011/012/020/601/008 FSN


Kong Ltd2240 6150

2012/01/03GE Healthcare Definium 8000 and Discovery XR650 Patient Barrier (Ref: FMI

10856)MHRA 2011/012/021/081/014 FSN

GE Medical Systems

Hong Kong Ltd.

2783 1838/

2100 6318

2012/01/03 GE Healthcare GE OEC Fluorostar 7900 (Ref: FMI 15116) MHRA 2011/012/022/081/013 FSNGE Medical Systems

Hong Kong Ltd.

2783 1838/

2100 6318

2012/01/03 HeartWare Inc HeartWare Ventricular Assist System MHRA 2011/012/007/081/021 FSN HeartWare Inc N.A.

2012/01/03 Karl Storz Endoscopy (UK) Ltd Single-Use Gas Filter 031122-25 MHRA 2011/011/022/291/001 FSN

KARL STORZ

Endoscopy China Hong

Kong office

28652411

2012/01/03 Maquet Cardiovascular MAQUET HANAULUX G8 MHRA 2011/012/021/081/018 FSNMAQUET Hong Kong

Limited23939511

2012/01/03 Spacelabs Healthcare Inc Ultraview SL Command Module MHRA 2011/012/019/081/002 FSNSchmidt Bio Med Tech

(H.K.) 2620 8329

2012/01/03St. Jude Medical Eon™ (Model 65-3716), Eon Mini™ (Model 65-3788) and

Brio™ (Model 65-6788) MHRA 2011/012/019/081/010 FSN

St. Jude Medical (Hong

Kong) Ltd.2996 7688

2012/01/03 Stryker Orthopaedics X-Change III Connector 0943-5-000 MHRA 2011/011/008/291/013 FSN Stryker China Ltd 2518 6915

2012/01/03 Stryker Orthopaedics TRIDENT 10 Degree Poly Inserts MHRA 2011/011/008/291/022 FSN Stryker China Ltd 2518 6915

2012/01/03 SynCardia Systems, Inc. Freedom Driver System 595000-001 MHRA 2011/012/019/291/002 FSN N.A. N.A.

2012/01/03Microgenics Corporation (Thermo Fisher Scientific) CardioImmune XL Cardiac

Marker Control, Level L, Level 1, Level 2, Level 3, Multi-pack, Sample Pack.MHRA 2011/012/020/081/023 FSN

Thermo Fisher


2012/01/03 OptiMed GmbH Cemento Plus MHRA 2011/012/013/081/007 FSN N.A. N.A.

2012/01/03Philips Healthcare GEMINI TF 16 and GEMINI TF 64 PET/CT Systems

Software Versions 3.5.1 and 3.5.1.1MHRA 2011/008/031/401/008 FSN


Kong Ltd2821 5480

2012/01/03RMS UK RES-Q-VAC Suction Unit with FSP (Bacteria) Fileter and Soft

YankauerMHRA 2011/010/025/081/002 FSN N.A. N.A.

2012/01/03Roche Diagnostics GmbH COBAS® TaqMan® HIV-1 Test, version 2.0 for use

with the High Pure System, CE-IVDMHRA 2011/012/015/291/021 FSN

Roche Diagnostics


2012/01/03 Siemens Healthcare Diagnostics Ltd CLiNITEK Status System MHRA 2011/012/016/601/001 FSNSiemens Healthcare


2012/01/03 Thermo Fisher Scientific Oxoid M.I.C Evaluator Strips, Teicoplanin (MA0118) MHRA 2011/012/021/601/002 FSNThermo Fisher


2012/01/03

Thomas Medical Products Thomas Medical Products: 1) 7F SafeSheath

Tearaway Kit – 13cm; 2) 9F SafeSheath Tearaway Kit – 13cm; 3) Transvalvular

Insertion Tool Kit; 4) SafeSheath® Sealing Adapter Kit; 5) SafeSheath® Sealing

Adapter Kit with Wing Extension Kit

MHRA 2011/001/025/081/023 FSNGE Medical Systems

Hong Kong Ltd.

2783 1838/

2100 6318

2012/01/03TRUMPF Medical Systems Sterilisable Handle ALC in Surgical lighting systems

iLED and TruLight (Material number: 1583966)MHRA 2011/012/019/601/001 FSN N.A. N.A.

2012/01/03Varian Varian Treatment versions 6.6.5034, 6.6.5042, 6.6.5046, 6.6.5048,

6.6.5051 and 6.6.5052MHRA 2011/012/013/081/004 FSN



2012/01/05Philips Healthcare All Brilliance CT Big Bore systems having the software

versions 3.5.0.17401 and 3.5.1.17002MHRA 2011/012/022/291/004 FSN


Kong Ltd2821 5480

Major Safety Alerts in January 2012


























2012/01/05 Siemens Healthcare Diagnostics Ltd Dimension Vista® Software Version 3.4 MHRA 2011/012/021/601/003 FSNSiemens Healthcare


2012/01/05 Ikaria Ikaria INOmax DS Drug Delivery System FDA N.A. Class I N.A. N.A.

2012/01/06 Wallac PerkinElmer Genetic Screening Processor (GSP 2021-0010) FDA Z-0603-2012 Class II N.A. N.A.

2012/01/10 Columbia Medical Ultimate Bath Chair H88489, H88519 and H88521 MHRA 2010/005/021/401/008 FSN N.A. N.A.

2012/01/10

Oridion Medical Surestream CO2 Sampling Lines: SureLine Adult, SureLine

Pediatric, SureVentLine, Sure VentLine H Set, SureLine O2 Adult (Part

Numbers 010976, 010977, 010986, 010987, 010979)

MHRA 2011/009/016/401/011 FSN N.A. N.A.

2012/01/10 QIAGEN GmbH 8-Rod Covers (Lot No. CH_1104624 and CH_1105182) MHRA 2011/012/020/081/013 FSN N.A. N.A.

2012/01/10Sybron Dental Specialities Vector TAS Modular Driver (601-0007) and Vector

TAS Kit (includes 1 Vector TAS Modular Driver) (601-0010)MHRA 2012/001/005/121/012 FSN N.A. N.A.

2012/01/10 SynCardia Systems, Inc. SynCardia Companion 2 Driver System MHRA 2011/012/022/081/009 FSN N.A. N.A.

2012/01/10ArjoHuntleigh Lifeguard® LG20 and LG50 patient trolleys (stretchers) ; [Serial

Numbers: P064867 to P100186 inclusive]MHRA 2011/006/027/601/001 FSN

Arjo Huntleigh (Hong

Kong) Ltd.2508 1416

2012/01/10 DiaMed GmBH IH-1000 [Product REF: 001000V; Software version: 01.03.04] MHRA 2011/012/030/081/002 FSN Bio-Rad Pacific Ltd. 2272 8926

2012/01/10DePuy International Ltd DePuy Universal Femoral Sleeve Distal Porous 34 MM

[Model No.: 129453225; Lot numbers: 115369 and 115369A]MHRA 2012/001/005/181/004 FSN

Johnson & Johnson


2012/01/10 Haemonetics Corporation Haemonetics cardioPAT® MHRA 2011/009/009/081/011 FSNHaemonetics (Hong

Kong) Limited2868 9218

2012/01/10Johnson & Johnson Medical Ltd ACUVUE® OASYS® (senofilcon A) Brand

Contact LensesMHRA 2011/012/030/081/003 FSN

Johnson & Johnson


2012/01/10 Instrumentation Lab (UK) Ltd ACL TOP® Family MHRA 2011/011/030/401/006 FSN Vastec Medical Limited 28971912

2012/01/10Newdeal Integra Life Pre-Amp Transducer Cable for the Camino® Advanced

Monitor (CAM01) and the Multi-Parameter Monitor (MPM1) Part Number: PAC1 MHRA 2011/010/021/081/014 FSN N.A. N.A.

2012/01/12Professional Disposables International PDI Electrode Prep Pads in Spacelabs

Hook-up kitsFDA Z-0262-2012 Class II N.A. N.A.

2012/01/12PerMedics, Inc. Odyssey A radiation treatment planning system (Versions 4.4

through 4.7)FDA Z-0345-2012 Class II N.A. N.A.

2012/01/12 Midmark Corp Midmark M11 Ultra Steam Sterilizer FDA Z-0597-2012 Class IIAssociated Medical

Supplies Company, Ltd.26049389

2012/01/12

Siemens Healthcare Diagnostics, Inc (1) Dimension(R) Vista(R) V-LYTE(R)

Standard A (K820), (2) Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt

Bridge (K825), (3) Dimension(R) Vista(R) V-LYTE(R) Diluent (K835)

FDAZ-0644-2012, Z-0645-2012, Z-

0646-2012Class II

Siemens Healthcare


2012/01/12 Spacelabs Healthcare Lifescreen ECG Screening System V3 FDA Z-0520-2012 Class IISchmidt Bio Med Tech

(H.K.) 2620 8329

2012/01/12Given Image Bravo® pH Monitoring System, part number FGS‐0312 (5‐Pak) or

FGS‐0313 (Singles)Firm initiated N.A. N.A.

Given Imaging (Asia)

Company Ltd.2989-0890

2012/01/13 Respironics Inc Respironics Trilogy 100 ventilators FDA N.A. Class I Celki Medical Company 2332 3366

2012/01/13Terumo CVS Modified cable to connect the system to an occluder for the Sarns

Modular Perfusion System 8000Firm initiated AA-2011-013-C

Firm Initiated

Field Action

TERUMO CHINA (H.K.)

LTD.28660811

2012/01/13Covidien PTE Ltd DUET TRS Universal Straight and Articulating Single Use

Loading Units (SULU) Firm initiated N.A.

Firm Initiated

Field Action

Covidien Hong Kong

Ltd

90379434 (Ms

Cathy HO)

2012/01/17 Stryker Orthopaedics Acetabular Reamer 44mm (Catalogue no. 2102-0444) MHRA 2012/001/011/081/010 FSN Stryker China Ltd 2518 6915

2012/01/17 Stryker Orthopaedics XIA 3 ANTI TORQUE KEY (Catalogue no. 48237026) MHRA 2012/001/005/121/004 FSN Stryker China Ltd 2518 6915

2012/01/17Leica Primary antibodies to CD4 (clone1F6), CD7 (clone LP15), Estrogen

Receptor (clone 6F11)MHRA 2012/001/010/601/008 FSN Leica Microsystems Ltd.

2963 8037/2564

6699

2012/01/17Natus Medical Incorporated ABaer® Hearing Screener with software version

5.0.17 or lowerMHRA 2012/001/010/081/016 FSN N.A. N.A.

2012/01/17NIHON KOHDEN NIHON KOHDEN Amp Units (JB-116B and JB-132B and

Extension Unit MS-110B) used for Neuromaster MEE-1000A MHRA 2012/001/010/081/008 FSN N.A. N.A.





















http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287575.htm; http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm287528.htm






2012/01/17Cefndy Healthcare (Rhyl) Cefndy Healthcare X220 & X221 (including X312 &

X313) Bariatric CommodesMHRA 2009/011/017/081/018 FSN

Cefndy Healthcare

(Rhyl)N.A.

2012/01/17

Fisher and Paykel Healthcare Ltd Fisher & Paykel Healthcare PT100

(myAIRVO) & PT101 (AIRVO) units [Part no.: PT100UK & PT101UK; Affected

lot number: 080101-110420]

MHRA 2011/012/005/081/001 FSNFisher & Paykel

Healthcare Limited

2116 0032 /

9171 8323

(Keith Mo)

2012/01/17

Karomed Ltd Karomed’s static mattresses and overlays [Product Model:

Transfoam, Transvisco, Transwave Supreme and Transvalue mattresses and

the Transvisco and Transpad overlay]

MHRA 2010/007/005/401/002 FSN Karomed Ltd N.A.

2012/01/17 Abbott ARCHITECT Active-B12 (Holotranscobalamin) MHRA 2012/001/006/601/001 FSN Abbott Laboratories Ltd. 2593 2211

2012/01/17 Alere Triage® 8 Panel for Drugs of Abuse Test Kit MHRA 2012/001/012/081/002 FSN N.A. N.A.

2012/01/17 Axis-Shield poC AS Afinion™ CRP (REF 1115013 and 1115014) MHRA 2012/001/010/081/010 FSN N.A. N.A.

2012/01/19 Agfa Corp. Agfa Computed Radiography Systems with DX-G Digitizer FDA Z-0591-2012 Class IIAGFA Hong Kong

Limited2555 9421

2012/01/19ConMed Corp. STAT2 I.V. Controller, Extension Set Gravity Flow Controller,

Primary Administration Set Gravity Flow Controller, Secondary Set Gravity Flow FDA

from Z-0629-2012 to Z-0635-

2012 Class II

Goodmark Medical

Supplies Ltd22429028

2012/01/19Biomet Inc. Biomet Series A Thin Patella, Standard Patella, and Asymmetrical

PatellaFDA

from Z-0695-2012 to Z-0704-

2012 Class II N.A. N.A.

2012/01/19GE Healthcare Ge LOGIQ E9 Diagnostic Ultrasound Systems running software

versions R3.1.0 and R3.1.1.FDA Z-0705-2012 Class II

GE Medical Systems


2012/01/19Philips Medical Systems (Cleveland) Inc. SKYlight Imaging Systems, Model

882050FDA Z-0607-2012 Class II


Kong Ltd2821 5480

2012/01/20Siemens Healthcare Diagnostics Dade Actin FSL Activated PTT Reagent

(Model no. B4219-1, B4219-2)Health Canada 70183 Type II

Siemens Healthcare


2012/01/20 GE Healthcare Patient Data Module (Model no. PDM-XXX-XXX-XXXX) Health Canada 69525 Type IIIGE Medical Systems


2012/01/20Ethicon Endo-Surgery Endopath ETS45 Endoscopic Linear Cutter (Model no.

ETS45)Health Canada 69531 Type III

Johnson & Johnson


2012/01/20 Seradyn Inc. Tobramycin Calibrators (Model no. 7F93-01) Health Canada 69168 Type IIIThermo Fisher


2012/01/20

Baxter Healthcare SA A) Acute Renal Dialysis Machine Aquarius System

(Model no. GEF09700);

B) Acute Renal Dialysis Machine Aquarius System - Platinum Software (Model

no. GEF08200)

Health Canada 69529\ Type III Baxter Healthcare Ltd 2807 8516

2012/01/20 Sorin Group Italia S.R.L. Cardiovascular Oxygenator Custom Packs Health Canada 69942 Type IIInnotronik Hong Kong

Limited2877 6787

2012/01/20 Siemens AG Mevatron Linear Accelerator Health Canada 69949 Type IISiemens Healthcare


2012/01/20Philips Medical Systems (Cleveland) Inc. Skylight Gamma Camera System

(2160-3000A)Health Canada 69952 Type II


Kong Ltd2821 5480

2012/01/20 Beckman Coulter Coulter ACT 5diff Fix Reagent (8547171) Health Canada 70194 Type IIBeckman Coulter Hong

Kong Ltd2240 6150

2012/01/20 Coopersurgical Inc Tis-U-Trap with Cannula-Curette Health Canada 70263 Type IIAnchor Medical

Services2735 8323

2012/01/20Beckman Coulter Inc. Access Total T3 Reagent


Kong Ltd2240 6150

2012/01/20

Ortho-Clinical Diagnostics Inc. Vistros Chemistry Products IGM Reagent and

Vistros Chemistry Products Vanc Reagent Health Canada 70181 Type IIIOrtho Clinical


2012/01/20 Toshiba Medical Systems Corporation RADEX-1 Health Canada 70234 Type IIISanko Medical Systems

(HK) LTD23840688

























2012/01/20

Roche Diagnostics GMBH Online TDM Theophylline (HIT. 911, 912, 917 and

MOD.P.) and Cobas Integra Theophylline for Cobas C Systems Health Canada 70082 Type IIIRoche Diagnostics


2012/01/20

Biomet Microfixation, Inc. Sternalock Blu Implant Tray [Model No.: 73-1300, 73-

1301, 73-1302; Lot No.: 032211, 042911, 100611, 249640, 280130, 280131,

312560, 031411, 011411]

Health Canada 69661 Type I N.A. N.A.

2012/01/20Siemens AG Artis Zee Multi-Purpose [Model No.: 10094139; Serial Number

157633]Health Canada 70411 Type I

Siemens Healthcare


2012/01/20HowMedica Osteonics Corporation Triathlon Mobile Bearing Knee Surgical

ProtocolHealth Canada 69276 Type II Stryker China Ltd 2518 6915

2012/01/20

Sorin Group Italia S.R.L. A) Ecc. O. Integrated Mini Bypass System with

Preconnected Tubing

B) Primo2x Oxygenator w Intergrated Hardshell Venous Reservoir

C) Synthesis Oxygenator w Heat Exchanger Arterial Filter and Venous

Reservoir

D) D903 Avant 2 Adult Hollow Fiber Oxygenator

E) Synergy Adult Intergrated Mini Bypass System

F) D905 EOS Pediatric Hollow Fiber Oxygenator

G) D905 Module Pediatric Hollow Fiber Oxygenator

H) Apex HP Phisio Smart Hollow Fiber Membrane Oxygenator

I) D903 Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w

Oxygenator

J) Primo2X Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w

Oxygenator

K) Synthesis Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w

Oxygenator

L) Synthesis Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

M) D901 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

N) D902 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

Health Canada 69647 Type IIInnotronik Hong Kong

Limited2877 6787

2012/01/20Integra Lifesciences Corporation DBA Integra Lifesciences Non-Sterile Step

Down Connector [Model No.: NL8600401]Health Canada 69651 Type II Milverton Limited 23678123

2012/01/21

Carefusion Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus

Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical

Stimulator License

FDA N.A. Type ICareFusion Hong Kong

Ltd.

28918730 &

28348066

2012/01/26

Varian Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module)

Release 10 (Client Build 10.0.28 or Build 10.0.34) MHRA 2012/001/013/291/009 FSNVarian Medical Systems


2012/01/26 Beckman Coulter UK Ltd Active Renin IRMA Test Kit DSL-25100 MHRA 2012/001/017/601/002 FSNBeckman Coulter Hong

Kong Ltd2240 6150

2012/01/26 Biomet UK Ltd Oxford revision stem MHRA 2012/001/017/081/011 FSN N.A. N.A.

2012/01/26Coloplast A/S Connectable Radio-Opaque Pusher CH/FR 07/ 40cm REF

YN2867 included in various kits-mainly ureteral stentsMHRA 2012/001/017/081/002 FSN

Coloplast (Hong Kong)

Ltd3628 7428

2012/01/26Smith & Nephew Orthopaedics Ltd Smith & Nephew Endoscopy Dyonics Power

ll Control Unit (Product code:72200873)MHRA 2012/001/018/291/004 FSN Smith & Nephew Ltd. 2648 7700

2012/01/26 Stryker Osteosynthesis T2 Arthrodesis Nail (left and right version) MHRA 2012/001/016/081/018 FSN Stryker China Ltd 2518 6915

2012/01/26 Transonic Systems Inc COstatus AV Loop [Model/Part no.: HCS3011] MHRA 2012/001/017/081/020 FSN Transonic Systems Inc N.A.

2012/01/30

Henry Schein, Inc. a) Maxcem Elite(TM) self-etch/self-adhesive resin cement,

Refill Kit, net wt. 10 g, REF/Part # 33872; b) CLEAR --- Refill Kit Contents: 2

Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10

Intra-oral tips Dental resin cement.FDA Z-0390-2012 Class II Henry Schein, Inc. N.A.
















2012/01/30

Varian Portal Vision, R-Arm with 4D Integrated Treatment Console [Model/Part

no.: H80, H81] FDA Z-0516-2012 Class IIVarian Medical Systems


2012/01/30ICU Medical, Inc Orbit and Orbit Micro Subcutaneous infusion set and IV Start

Kits Convenience kitFDA Z-0592-2012, Z-0593-2012 Class II N.A. N.A.

2012/01/30 Carefusion NicVue Software version 2.9.2 and 3.0.1 FDA Z-0737-2012 Class IICareFusion Hong Kong

Ltd.

28918730 &

28348066

2012/01/31Radiometer Medical APS ABL80 FLEX Analyzers configured with either FLEX

or BASIC softwareMHRA 2012/001/025/291/001 FSN

Radiometer China

(RCHN)6056 3846

2012/01/31 Siemens Healthcare Diagnostics Syringes for BEP® III MHRA 2012/001/020/601/009 FSNSiemens Healthcare


2012/01/31 Leica Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) MHRA 2012/001/026/601/002 FSN Leica Microsystems Ltd.2963 8037/2564

6699

2012/01/31

Coloplast A/S Speedicath Compact CH10 female catheters [Model/Part no.:

285800; Affected lot number: 2846651] MHRA 2011/010/010/081/013 FSNColoplast (Hong Kong)

Ltd3628 7428

2012/01/31 COMINOX s r l Strerilclave 6B Speedy MHRA 2011/007/025/291/030 FSN COMINOX s r l N.A.

2012/01/31 Elekta XVI R4.5 and R4.6 without iGuide ® MHRA 2012/001/025/291/002 FSN Elekta Ltd 2891 2208

2012/01/31

Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E;

CardioVive 92532 and 92533 (manufactured between July 1, 2011 and

December 30, 2011)

MHRA 2012/001/023/081/010 FSNPacific Medical Systems

Ltd21084005

2012/01/31Adin Dental Implant Systems Ltd Retaining Screw for TMATM WP/RP/NP

Trans Mucosal Abutment System 3mmMHRA 2012/001/017/081/018 FSN N.A. N.A.

2012/01/31Beckman Coulter UK Ltd AU2700/AU2700 Plus & AU5400 Clinical Chemistry

AnalyzersMHRA 2012/001/024/601/006 FSN


Kong Ltd2240 6150

2012/01/31 Biomet 3i Certain® Low Profile 17ﾟAngled Abutment MHRA 2012/001/023/081/008 FSN Ositek (HK), Inc. Ltd 3157-1757














Documents

Major Safety Alerts in May 2012 - Department of Health ... with software versions, R.01.00, R.02.00 and R.03.01 MHRA 2012/004/024/081/014 FSN Philips Electronics Hong Kong Ltd 28215364