Field Safety Notices

Field Safety Notice - Apr 2015

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 April 2015

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Table caption

Date of Notification	Title	FSN
30 Apr 2015	Palindrome Precision SI Chronic Catheter, Palindrome SI Chronic Catheter, Palindrome Precision HSI Chronic Catheter and Palindrome HIS Chronic Catheter, Covidien llc (HSA 600:41/01-046/15/04_17) Local contact: Covidien Private Limited	HSA 6004101-046-15-04_17 FSN [PDF, 774 KB] (opens in new tab)
30 Apr 2015	AVEA ® ventilator, CareFusion (HSA 600:41/01-056/15/02_18) Local contact: Gold Lite Pte Ltd	HSA 6004101-056-15-02_18 FSN [PDF, 137 KB] (opens in new tab)
30 Apr 2015	Magellan Robotic System, Hansen Medical (HSA 600:41/01-057/15/03_09) Local contact: Somnotec (S) Pte Ltd	HSA 6004101-057-15-03_09 FSN [PDF, 961 KB] (opens in new tab)
29 Apr 2015	J&J Coated VICRYL Polyglactin 910 Absorbable Suture, Johnson & Johnson International (HSA 600:41/01-002/15/16_01) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-16_01 FSN [PDF, 599 KB] (opens in new tab)
29 Apr 2015	ADVIA Chemistry Amylase Reagent, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/22_20) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-22_20 FSN [PDF, 142 KB] (opens in new tab)
29 Apr 2015	ID-LISS/Coombs, Bio-Rad DiaMed GmbH (HSA 600:41/01-027/15/02_08) Local contact: Bio-Rad Laboratories (Singapore) Pte Ltd	HSA 6004101-027-15-02_08 FSN [PDF, 161 KB] (opens in new tab)
28 Apr 2015	D-Dimer Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/15/08_16) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-08-16 FSN [PDF, 1213 KB] (opens in new tab)
28 Apr 2015	ExacTrac 6.x Patient Positioning System, BrainLab AG (HSA 600:41/01-047/15/02_09) Local contact: BrainLab Limited (Singapore Branch)	HSA 6004101-047-15-02_09 FSN [PDF, 161 KB] (opens in new tab)
28 Apr 2015	Zefon InfuseIT Disposable Pressure lnfusors, Zefon International lnc (HSA 600:41/01-051/15/01_17) Local contact: Star Medical Co Pte Ltd	HSA 6004101-051-15-01_17 FSN [PDF, 2933 KB] (opens in new tab)
27 Apr 2015	NexGen CRA/LCCK/RHK 5mm Distal Femoral Augment, Size F, Zimmer Inc (HSA 600:41/01-008/15/04_08) Local contact: Zimmer Pte Ltd	HSA 6004101-008-15-04_08 FSN [PDF, 146 KB] (opens in new tab)
24 Apr 2015	Accu-Chek Spirit Combo Insulin Pump and Accu-Chek Spirit Pump, Roche Diagnostics GmbH (HSA 600:41/01-016/15/07_20) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-07_20 FSN [PDF, 1231 KB] (opens in new tab)
24 Apr 2015	IMMULITE 2000 and IMMULITE 2000 Xpi, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/20_18) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-20_18 FSN [PDF, 136 KB] (opens in new tab)
24 Apr 2015	Siemens BCS and BCS XP System, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-022/15/21_19) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-21_19 FSN [PDF, 141 KB] (opens in new tab)
23 Apr 2015	Medtronic Synchromed II Programmable Pump (20ml and 40ml), Medtronic Inc (HSA 600:41/01-009/15/05_01) Local contact: Medtronic International Limited	HSA 6004101-009-15-05_01 FSN [PDF, 230 KB] (opens in new tab)
23 Apr 2015	OPTI blood gas analyser, OPTI Medical Systems Inc (HSA 600:41/01-033/15/02_17) Local contact: Biomed Diagnostics Pte Ltd	HSA 6004101-033-15-02_17 FSN [PDF, 47 KB] (opens in new tab)
23 Apr 2015	Chroma Coronary Bare Metal Stent System, Biosensors Europe SA (HSA 600:41/01-223/15/02_16) Local contact: Biosensors Interventional Technologies Pte Ltd	HSA 6004101-223-15-02_16 FSN [PDF, 319 KB] (opens in new tab)
22 Apr 2015	ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/15_19) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-15_19 FSN [PDF, 71 KB] (opens in new tab)
22 Apr 2015	Revaclear 400 dialyser, Gambro Dialysatoren GmbH (HSA 600:41/01-011/15/03_08) Local contact: Gambro Singapore Pte Ltd	HSA 6004101-011-15-03_08 FSN [PDF, 2195 KB] (opens in new tab)
22 Apr 2015	Hitachi X-ray Radiography/Fluoroscopy System, POPULUS Ti, Hitachi Medical Corporation (HSA 600:41/01-054/15/02_18) Local contact: Hitachi Medical Systems (S) Pte Ltd	HSA 6004101-054-15-02_18 FSN [PDF, 105 KB] (opens in new tab)
22 Apr 2015	Elekta Synergy, Synergy S, Infinity, Axxesse and Versa HD, Elekta Limited (HSA 600:41/01-101/15/04_20) Local contact: Elekta Pte Ltd	HSA 6004101-101-15-04_20 FSN [PDF, 33 KB] (opens in new tab)
21 Apr 2015	Toshiba Whole-body X-ray CT scanner with optional CT fluoroscopy, Toshiba Medical System Corporation (HSA 600:41/01-064/15/01_16) Local contact: Toshiba Medical Systems Asia Pte Ltd	HSA 6004101-064-15-01-16 FSN [PDF, 13 KB] (opens in new tab)
21 Apr 2015	Battery packs for deltastream MDC console and iLA activve console, Medos Medizintechnik AG (HSA 600:41/01-112/15/01_17) Local contact: Rainbow Care Pte Ltd	HSA 6004101-112-15-01_17 FSN [PDF, 134 KB] (opens in new tab)
21 Apr 2015	Biolox Delta Ceramic Head, Biomet UK Ltd (HSA 600:41/01-183/15/02_09) Local contact: JJ Medsurg Pte Ltd	HSA 6004101-183-15-02_09 FSN [PDF, 2523 KB] (opens in new tab)
20 Apr 2015	Connecting Screw for Insertion of DHS Blade, Synthes GmbH (HSA 600:41/01-002/15/14_19) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-14_19 FSN [PDF, 111 KB] (opens in new tab)
20 Apr 2015	Ki67-MM1 Bond Ready To Use and Ki67-MM1 Concentrate, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/01_20) Local contact: Leica Microsystems (SEA) Pte Ltd	HSA 6004101-126-15-01_20 FSN [PDF, 275 KB] (opens in new tab)
17 Apr 2015	Cobas b 123 < 4 > POC system, Roche Diagnostics GmbH (HSA 600:41/01-016/15/06_18) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-06_18 FSN [PDF, 1385 KB] (opens in new tab)
17 Apr 2015	Morce Power Plus Electronic Morcellator, Richard Wolf GmbH (HSA 600:41/01-119/15/01_08) Local contact: Servicom Medical (Singapore) Pte Ltd	HSA 6004101-119-15-01_08 FSN [PDF, 1380 KB] (opens in new tab)
17 Apr 2015	VITEK 2, VITEK 2 Compact, VITEK MS - MYLA V 3.X servers, Biomerieux SA (HSA 600:41/01-146/15/02_17) Local contact: Biomerieux Singapore Pte Ltd	HSA 6004101-146-15-02_17 FSN [PDF, 317 KB] (opens in new tab)
16 Apr 2015	Medtronic Neuromodulation Deep Brain Stimulation System extensions, Medtronic, Inc (HSA 600:41/01-009/15/04_19) Local contact: Medtronic International Limited	HSA 6004101-009-15-04_19 FSN [PDF, 650 KB] (opens in new tab)
16 Apr 2015	Dimension Integrated Chemistry Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/19_08) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-19_08 FSN [PDF, 93 KB] (opens in new tab)
15 Apr 2015	Olympus® EVIS Exera III Endoscopy System, Olympus Medical Systems Corp (HSA 600:41/01-004/15/02_09) Local contact: Olympus Singapore Pte Ltd	HSA 6004101-004-15-02_09 FSN [PDF, 61 KB] (opens in new tab)
15 Apr 2015	Centricity PACS-IW and Centricity PACS-IW with Universal Viewer, GE Healthcare (HSA 600:41/01-010/15/08_16) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-08-16 FSN [PDF, 62 KB] (opens in new tab)
15 Apr 2015	Alaris® System PC Unit, CareFusion (HSA 600:41/01-087/15/02_18) Local contact: Scanmed Technology (S) Pte Ltd	HSA 6004101-087-15-02_18 FSN [PDF, 308 KB] (opens in new tab)
15 Apr 2015	BTE Primus RS, BTE Technologies Inc (HSA 600:41/01-273/15/01_20) Local contact: Omega Scientific Pte Ltd	HSA 6004101-273-15-01_20 FSN [PDF, 348 KB] (opens in new tab)
14 Apr 2015	Synthes Angular Stable Locking System, Synthes GmbH (HSA 600:41/01-002/15/11_01) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-11_01 FSN [PDF, 797 KB] (opens in new tab)
14 Apr 2015	VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and VITROS 5600 Integrated System, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/12_19) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-12_19 FSN_1 [PDF, 201 KB] (opens in new tab) HSA 6004101-002-15-12_19 FSN_2 [PDF, 196 KB] (opens in new tab)
14 Apr 2015	Oscillating Saw Attachment, Synthes GmbH (HSA 600:41/01-002/15/13_17) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-13_17 FSN [PDF, 90 KB] (opens in new tab)
14 Apr 2015	Compact Airway Modules E/M-CAiOVX, GE Finland Oy (HSA 600:41/01-010/15/07_18) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-07_18 FSN [PDF, 392 KB] (opens in new tab)
13 Apr 2015	Baxter Sodium Chloride Irrigation USP 0.9%, Baxter Healthcare Pty Ltd (HSA 600:41/01-001/15/02_02) Local contact: Baxter Healthcare (Asia) Pte Ltd	HSA 6004101-001-15-02_02 FSN [PDF, 315 KB] (opens in new tab)
13 Apr 2015	Fresenius Medical Care haemodialysis bloodline for 4008 dialysis machine, Fresenius Medical Care (Jiangsu) Pte Ltd (HSA 600:41/01-062/15/02_16) Local contact: Fresenius Medical Care Singapore Pte Ltd	HSA 6004101-062-15-02-16 FSN [PDF, 148 KB] (opens in new tab)
10 Apr 2015	Persona Anterior Referencing Locking Boom Femoral Sizer, Zimmer Inc (HSA 600:41/01-008/15/03_08) Local contact: Zimmer Pte Ltd	HSA 6004101-008-15-03_08 FSN [PDF, 245 KB] (opens in new tab)
10 Apr 2015	da Vinci surgical system drapes, Intuitive Surgical Inc (HSA 600:41/01-070/15/06_17) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-06_17 FSN [PDF, 424 KB] (opens in new tab)
10 Apr 2015	Autostainer instruments using HercepTest, Dako Denmark A/S (HSA 600:41/01-086/15/01_09) Local contact: SPD Scientific Pte Ltd	HSA 6004101-086-15-01_09 FSN [PDF, 315 KB] (opens in new tab)
10 Apr 2015	Natus neoBLUE Blanket LED Phototherapy System - fiberoptic pads, Natus Medical Incorporated (HSA 600:41/01-113/15/01_11) Local contact: Equip Medical Pte Ltd	HSA 6004101-113-15-01_11 FSN [PDF, 21 KB] (opens in new tab)
10 Apr 2015	AQT90 FLEX Analyzer, Radiometer Medical Aps (HSA 600:41/01-219/15/03_01) Local contact: Radiometer S.E.A Pte Ltd	HSA 6004101-219-15-03_01 FSN [PDF, 137 KB] (opens in new tab)
09 Apr 2015	Bard Max-Core Disposable Core Biopsy System, Bard Peripheral Vascular Inc (HSA 600:41/01-050/15/02_16) Local contact: Bard Singapore Pte Ltd	HSA 6004101-050-15-02-16 FSN [PDF, 179 KB] (opens in new tab)
09 Apr 2015	Titan™ Stabilizer and Titan™ 360 Stabilizer: Suction Tubing Clip, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-272/15/01_09) Local contact: Elletech Pte Ltd	HSA 6004101-272-15-01_09 FSN [PDF, 92 KB] (opens in new tab)
07 Apr 2015	Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/06_08) Local contact: IDS Medical Systems (Singapore) Pte Ltd	HSA 6004101-017-15-06_08 FSN [PDF, 84 KB] (opens in new tab)
02 Apr 2015	Nellix EndoVascular Aneurysm Sealing System, Endologix Inc (HSA 600:41/01-057/15/02_02) Local contact: Somnotec (S) Pte Ltd	HSA 6004101-057-15-02_02 FSN [PDF, 81 KB] (opens in new tab)
02 Apr 2015	Allset Gold DRB 1-13 High Res, DRB 1-13 SSP Unitray 12 Tests and DRB 1-13 SSP Unitray W/TAQ 12 Tests, Life Technologies Corporation (HSA 600:41/01-220/15/01_11) Local contact: Life Technologies Holdings Pte Ltd	HSA 6004101-220-15-01_11 FSN [PDF, 168 KB] (opens in new tab)