Field Safety Notices

Field Safety Notice - Jan 2015

31 January 2015

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

NOTIFICATION	TITLE	FSN
30 Jan 2015	Engstrom Carestation and Engstrom Pro, Datex-Ohmeda, Inc (HSA 600:41/01-010/15/01_02) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-01_02 FSN [PDF, 49 KB] (opens in new tab)
30 Jan 2015	Cobas KRAS Mutation Kit, Roche Diagnostics GmbH (HSA 600:41/01-016/15/02_11) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-02_11 FSN [PDF, 100 KB] (opens in new tab)
30 Jan 2015	Elekta Synergy, Elekta Synergy S and Elekta Infinity, Elekta Limited (HSA 600:41/01-101/15/03_11) Local contact: Elekta Pte Ltd	HSA 6004101-101-15-03_11 FSN [PDF, 268 KB] (opens in new tab)
29 Jan 2015	Puritan Bennett 980 Ventilator System, Covidien llc (HSA 600:41/01-046/15/01_03) Local contact: Covidien Private Limited	HSA 6004101-046-15-01_03 FSN [PDF, 684 KB] (opens in new tab)
29 Jan 2015	Endo GIA™ Auto Suture Universal Articulating Loading Unit, Covidien llc (HSA 600:41/01-046/15/02_02) Local contact: Covidien Private Limited	HSA 6004101-046-15-02_02 FSN [PDF, 247 KB] (opens in new tab)
29 Jan 2015	Harmonic ACE Curved Shears, Intuitive Surgical Inc (HSA 600:41/01-070/15/01_01) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-01_01 FSN [PDF, 336 KB] (opens in new tab)
29 Jan 2015	Maquet Servo-i Ventilator systems, Maquet Critical Care AB (HSA 600:41/01-081/15/01_11) Local contact: Maquet South East Asia Pte Ltd	HSA 6004101-081-15-01_11 FSN [PDF, 156 KB] (opens in new tab)
29 Jan 2015	FORUM Viewer, Carl Zeiss Meditec Ag (HSA 600:41/01-136/15/01_07) Local contact: Carl Zeiss Pte Ltd	HSA 6004101-136-15-01_07 FSN [PDF, 236 KB] (opens in new tab)
28 Jan 2015	ADVIA Centaur Systems Progesterone, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/07_07) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-07_07 FSN [PDF, 142 KB] (opens in new tab)
26 Jan 2015	Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/05_09) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-05_09 FSN [PDF, 218 KB] (opens in new tab)
26 Jan 2015	Clinitek Novus Analyzer, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/06_07) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-06_07 FSN [PDF, 256 KB] (opens in new tab)
23 Jan 2015	Defibrillation Electrodes for children (used with Schiller Fred Easyport), Schiller AG (HSA 600:41/01-056/15/01_02) Local contact: Gold Lite Pte Ltd	HSA 6004101-056-15-01_02 FSN [PDF, 998 KB] (opens in new tab)
22 Jan 2015	Single Limb Circuit for Pneupac DEMAND type Ventilators, with PEEP Valve, Smiths Medical International Ltd (HSA 600:41/01-017/15/01_01) Local contact: IDS Medical Systems (Singapore) Pte Ltd	HSA 6004101-017-15-01_01 FSN [PDF, 303 KB] (opens in new tab)
22 Jan 2015	Lantis Oncology Information System, Siemens AG (HSA 600:41/01-022/15/04_07) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-04_07 FSN [PDF, 49 KB] (opens in new tab)
21 Jan 2015	BRAHMS NSE Kryptor, Thermo Fisher Scientific BRAHMS GmbH (HSA 600:41/01-138/15/01_11) Local contact: Dyamed Biotech Pte Ltd	HSA 6004101-138-15-01_11 FSN [PDF, 5094 KB] (opens in new tab)
21 Jan 2015	Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables, Trumpf Medizin Systeme GmbH + Co KG (HSA 600:41/01-266/15/01_08) Local contact: Trumpf Medical Pte Ltd	HSA 6004101-266-15-01_08 FSN [PDF, 217 KB] (opens in new tab) HSA 6004101-266-15-01_08 FSN Attachment [PDF, 157 KB] (opens in new tab)
20 Jan 2015	LFIT V40 Femoral Head, Howmedica Osteonics Corp (HSA 600:41/01-014/15/01_11) Local contact: Stryker Singapore Pte Ltd	HSA 6004101-014-15-01_11 FSN [PDF, 23 KB] (opens in new tab)
19 Jan 2015	FiberOptix Intra-Aortic Balloon, Arrow International Inc (HSA 600:41/01-139/15/01_11) Local contact: Teleflex Medical Asia Pte Ltd	HSA 6004101-139-15-01_11 FSN [PDF, 156 KB] (opens in new tab)
16 Jan 2015	Accu-Chek Tenderlink, Unomedical a/s (HSA 600:41/01-016/15/01_09) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-01_09 FSN [PDF, 138 KB] (opens in new tab)
16 Jan 2015	Digital Mammography System Amulet/ Amulet F/ Amulet Innovality, Fujifilm Corporation (HSA 600:41/01-173/15/01_01) Local contact: Fujifilm Asia Pacific Pte Ltd	HSA 6004101-173-15-01_01 FSN [PDF, 94 KB] (opens in new tab)
14 Jan 2015	MiniCap with Povidone-Iodine Solution, Baxter Healthcare Corporation (HSA 600:41/01-001/15/01_03) Local contact: Baxter Healthcare (Asia) Pte Ltd	HSA 6004101-001-15-01_03 FSN [PDF, 58 KB] (opens in new tab)
14 Jan 2015	Syngo Plaza, Siemens AG (HSA 600:41/01-022/15/02_08) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-02_08 FSN [PDF, 73 KB] (opens in new tab)
14 Jan 2015	APERTO Lucent receiver coil, Hitachi Medical Corporation (HSA 600:41/01-054/15/01_11) Local contact: Hitachi Medical Systems (S) Pte Ltd	HSA 6004101-054-15-01_11 FSN [PDF, 30 KB] (opens in new tab)
12 Jan 2015	Electrode insert for BISON graspers, Sutter Medizintechnik GmbH (HSA 600:41/01-264/15/01_11) Local contact: Easmed Asia Pte Ltd	HSA 6004101-264-15-01_11 FSN [PDF, 2090 KB] (opens in new tab)
09 Jan 2015	ARTIS Haemodialysis System & Evosys Dialysis System, Gambro Dasco SpA (HSA 600:41/01-011/15/01_01) Local contact: Gambro Singapore Pte Ltd	HSA 6004101-011-15-01_01 FSN [PDF, 1170 KB] (opens in new tab)
09 Jan 2015	ABL90 FLEX, Radiometer Medical Aps (HSA 600:41/01-219/15/02_09) Local contact: Radiometer S.E.A Pte Ltd	HSA 6004101-219-15-02_09 FSN [PDF, 128 KB] (opens in new tab)
08 Jan 2015	Heartware Ventricular Assist System, HeartWare Inc (HSA 600:41/01-207/15/01_07) Local contact: Singcare Medical Pte Ltd	HSA 6004101-207-15-01_07 FSN [PDF, 496 KB] (opens in new tab)
06 Jan 2015	Focal Workstation RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/01_15) Local contact: Elekta Pte Ltd	HSA 6004101-101-15-01_15 FSN [PDF, 53 KB] (opens in new tab)
06 Jan 2015	Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/02_15) Local contact: Elekta Pte Ltd	HSA 6004101-101-15-02_15 FSN [PDF, 53 KB] (opens in new tab)
06 Jan 2015	Waterlase iPlus Dental Laser System, Biolase Technology, Inc (HSA 600:41/01-103/15/01_11) Local contact: SA Dental Supply Pte Ltd	HSA 6004101-103-15-01_11 FSN [PDF, 102 KB] (opens in new tab)
06 Jan 2015	Platinum, Baccara Platinum, Platinum dRF, Baccara Platinum dRF and Agil FPD, Apelem (HSA 600:41/01-196/15/01_11) Local contact: Medical Imaging Systems Pte Ltd	HSA 6004101-196-15-01_11 FSN [PDF, 1604 KB] (opens in new tab)
06 Jan 2015	AQT90 FLEX Test Kit Box, Radiometer Medical Aps (HSA 600:41/01-219/15/01_11) Local contact: Radiometer S.E.A Pte Ltd	HSA 6004101-219-15-01_11 FSN [PDF, 38 KB] (opens in new tab)
05 Jan 2015	VITROS® Rubella IgM Reagent Packs, Ortho Clinical Diagnostics (HSA 600:41/01-002/15/01_11) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-01_11 FSN [PDF, 225 KB] (opens in new tab)
05 Jan 2015	Medtronic Interstim® Stimulation System, Medtronic, Inc (HSA 600:41/01-009/15/01_08) Local contact: Medtronic International Limited	HSA 6004101-009-15-01_08 FSN [PDF, 32 KB] (opens in new tab)
05 Jan 2015	EndoBarrier® Gastrointestinal Liner with Delivery System, GI Dynamics Inc (HSA 600:41/01-263/15/01_11) Local contact: Emergo Singapore Consulting Pte Ltd	HSA 6004101-263-15-01_11 FSN [PDF, 140 KB] (opens in new tab)
02 Jan 2015	RAPIDPoint 405, RAPID Point 500, RAPIDLab 1245 and RAPIDLab 1265, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/01_03) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-01_03 FSN [PDF, 183 KB] (opens in new tab)
02 Jan 2015	HBA Sperm Hyaluronan Binding Assay, Biocoat Inc (HSA 600:41/01-262/15/01_08) Local contact: Neuvital Pte Ltd	HSA 6004101-262-15-01_08 FSN [PDF, 321 KB] (opens in new tab)