Field Safety Corrective Actions (FSCA) include removals of medical devices from the market or any other corrective action on devices in use. In general, the product owner (otherwise known as legal manufacturer) implements FSCAs by sending a Field Safety Notice (FSN) to inform operators and users about risks of medical devices. It includes advice on what action should be taken to protect the health or the safety of patients, users or other persons. For example, FSNs may contain information from the product owner that they are voluntarily recalling specific lots of a medical device.

Please note that FSNs are issued by the product owner, registrant or importer of medical devices pursuant to the requirements under the Health Products Act (Cap. 122D). These persons take full responsibility for all information contained in the FSN.

If you receive a FSN from a product owner, registrant or importer, you must always act on it. The Health Sciences Authority makes FSNs publicly available for information only.

If you have a specific question on a FSN, please contact* the product owner, registrant or importer (as the case may be).

*Any contact information provided for each FSCA is correct as at the date of the FSCA notification to the Health Sciences Authority.

Field Safety Notice - Jan 2015

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 HSA 6004101-266-15-01_08 FSN Attachment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Healthcare professional, Industry member, Medical devices

Published: 31 Jan 2015

Field Safety Notices

12 Dec 2019