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 - Mar 2015

Date of Notification	Title	FSN
31 Mar 2015	CIDEX OPA Solution Test Strips, Advanced Sterilization Products (HSA 600:41/01-002/15/10_01) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-10_01 FSN
31 Mar 2015	Nellix EndoVascular Aneurysm Sealing System, Endologix Inc (HSA 600:41/01-148/15/01_02) Local contact: DKSH Singapore Pte Ltd	HSA 6004101-148-15-01_02 FSN
30 Mar 2015	Oxoid Antimicrobial Testing Disc - CN10 Gentamicin, Oxoid Limited (HSA 600:41/01-178/15/01_07) Local contact: Thermo Scientific Microbiology Pte Ltd	HSA 6004101-178-15-01_07 FSN
27 Mar 2015	ADVIA Centaur XPT System, Siemens Healthcare Diagnostics (HSA 600:41/01-022/15/18_16) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-18-16 FSN
27 Mar 2015	Bard Conquest PTA Balloon Dilatation Catheter, Bard Peripheral Vascular Inc (HSA 600:41/01-050/15/01_09) Local contact: Bard Singapore Pte Ltd	HSA 6004101-050-15-01_09 FSN
27 Mar 2015	da Vinci® Xi™ Surgical System Patient Cart Arms, Intuitive Surgical Inc (HSA 600:41/01-070/15/05_11) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-05_11 FSN
27 Mar 2015	TeraRecon Aquarius Workstation, TeraRecon, Inc (HSA 600:41/01-271/15/01_11) Local contact: Tai Rui Technology Pte Ltd	HSA 6004101-271-15-01_11 FSN
26 Mar 2015	Edwards Fem-Flex II Femoral Arterial Cannula and Edwards Fem-Flex II Femoral Venous Cannula, Edwards Lifesciences LLC (HSA 600:41/01-060/15/01_02) Local contact: Edwards Lifesciences (Asia) Pte Ltd	HSA 6004101-060-15-01_02 FSN
25 Mar 2015	Persona Trabecular Metal™ Tibial Plate, all sizes, Zimmer Inc (HSA 600:41/01-008/15/02_11) Local contact: Zimmer Pte Ltd	HSA 6004101-008-15-02_11 FSN
25 Mar 2015	RaySearch Laboratories RayStation, RaySearch Laboratories AB (HSA 600:41/01-070/15/04_11) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-04_11 FSN
24 Mar 2015	ADVIA Chemistry Lipase, Siemens Healthcare Diagnostics (HSA 600:41/01-022/15/17_07) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-17_07 FSN
23 Mar 2015	Trauma DHS/DCS Impactor Tip, Synthes GmbH (HSA 600:41/01-002/15/09_09) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-09_09 FSN
23 Mar 2015	Homocysteine Enzymatic Assay, Roche Diagnostics GmbH (HSA 600:41/01-016/15/05_01) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-05_01 FSN
20 Mar 2015	ADVIA Centaur XPT System, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/16_16) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-16-16 FSN
20 Mar 2015	Trellis™ 6 and Trellis™ 8 Peripheral Infusion Systems, Medtronic, PLC (HSA 600:41/01-046/15/03_11) Local contact: Covidien Private Limited	HSA 6004101-046-15-03_11 FSN
20 Mar 2015	EOS™ X-Ray Imaging Acquisition System, EOS Imaging (HSA 600:41/01-238/15/01_08) Local contact: QST Technologies Pte Ltd	HSA 6004101-238-15-01_08 FSN
19 Mar 2015	Artis Q and Artis Q.zen family systems, Siemens AG (HSA 600:41/01-022/15/15_17) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-15_17 FSN
18 Mar 2015	ORTHO VISION™ Analyser for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/08_11) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-08_11 FSN
18 Mar 2015	Model 5392 Dual-Chamber External Pulse Generator, Medtronic, Inc (HSA 600:41/01-009/15/03_16) Local contact: Medtronic International Limited	HSA 6004101-009-15-03-16 FSN
18 Mar 2015	FX CorDiax High-Flux Dialysers and FX CorDiax Haemodiafilters, Fresenius Medical Care AG & Co KGaA (HSA 600:41/01-062/15/01_11) Local contact: Fresenius Medical Care Singapore Pte Ltd	HSA 6004101-062-15-01_11 FSN
17 Mar 2015	PFNA and PFNA-II Femoral Nails and PFNA-II Endcaps, Synthes GmbH (HSA 600:41/01-002/15/07_01) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-07_01 FSN
17 Mar 2015	MEDUMAT Transport, WEINMANN Emergency Medical Technology GmbH (HSA 600:41/01-039/15/01_02) Local contact: United BMEC Pte Ltd	HSA 6004101-039-15-01_02 FSN
17 Mar 2015	Biolox Delta Ceramic Head 36mm -4mm Neck, Biomet UK Ltd (HSA 600:41/01-183/15/01_11) Local contact: JJ Medsurg Pte Ltd	HSA 6004101-183-15-01_11 FSN
16 Mar 2015	Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue, Synthes GmbH (HSA 600:41/01-002/15/06_17) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-06_17 FSN
16 Mar 2015	ADVIA Centaur XPT System, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/14_16) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-14-16 FSN
13 Mar 2015	VITROS® 5,1 FS Chemistry System, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/05_09) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-022-15-05_09 FSN
13 Mar 2015	Hamilton-G5 and Hamilton-S1 ventilators, Hamilton Medical AG (HSA 600:41/01-248/15/01_02) Local contact: MeDeus (S) Pte Ltd	HSA 6004101-248-15-01_02 FSN
13 Mar 2015	Aurinio L50 Examination Light, Trilux Medical GmbH & Co KG (HSA 600:41/01-270/15/01_01) Local contact: BenAire Engineering Pte Ltd	HSA 6004101-270-15-01_01 FSN
12 Mar 2015	Pedicle Awl 4.0mm w/Canevasit Handle and Pedicle Awl 4.0mm w/Silicone Handle, Synthes GmbH (HSA 600:41/01-002/15/04_09) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-04_09 FSN
12 Mar 2015	Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/05_08) Local contact: IDS Medical Systems (Singapore) Pte Ltd	HSA 6004101-017-15-05_08 FSN
12 Mar 2015	ExacTrac 6.x Patient Positioning System, BrainLab AG (HSA 600:41/01-047/15/01_02) Local contact: BrainLab Limited (Singapore Branch)	HSA 6004101-047-15-01_02 FSN
10 Mar 2015	T2100 Treadmill, GE Medical Systems Information Techonologies (HSA 600:41/01-010/15/06_08) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-06_08 FSN
09 Mar 2015	CATALYS Precision Laser System, OptiMedica Corporation (HSA 600:41/01-018/15/01_01) Local contact: AMO Singapore Pte Ltd	HSA 6004101-018-15-01_01 FSN
06 Mar 2015	ACUSON S2000 Automated Breast Volume Scanner, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/15/13_11) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-13-11 FSN
05 Mar 2015	IMMULITE 2000/IMMULITE 2000 XPi Water and Liquid Waste Bottles, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/12_09) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-12_09 FSN
05 Mar 2015	GemLock Long Hex Driver, Zimmer Dental (HSA 600:41/01-214/15/01_11) Local contact: DentaCare Singapore Pte Ltd	HSA 6004101-214-15-01_11 FSN
05 Mar 2015	BioPath 035 Paclitaxel releasing over the wire (OTW) PTA balloon catheter, Biosensors Europe SA (HSA 600:41/01-223/15/01_11) Local contact: Biosensors Interventional Technologies Pte Ltd	HSA 6004101-223-15-01_11 FSN
04 Mar 2015	Sony LMD-1951MD Monitor used with SpyGlass, Boston Scientific Corporation (HSA 600:41/01-007/15/01_07) Local contact: Boston Scientific Asia Pacific Pte Ltd	HSA 6004101-007-15-01_07 FSN
04 Mar 2015	MAQUET CARDIOHELP System, Maquet Cardiopulmonary AG (HSA 600:41/01-017/15/04_02) Local contact: IDS Medical Systems (Singapore) Pte Ltd	HSA 6004101-017-15-04_02 FSN
03 Mar 2015	CODMAN® CERTAS™ Therapy Management System, Medos International SARL (HSA 600:41/01-002/15/03_11) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-03_11 FSN
03 Mar 2015	StealthStation AxiEM and Fusion EM, Medtronic Navigation, Inc (HSA 600:41/01-009/15/02_08) Local contact: Medtronic International Limited	HSA 6004101-009-15-02_08 FSN
03 Mar 2015	Artis One System, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/15/11_11) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-11-11 FSN
03 Mar 2015	da Vinci Si EndoWrist® One Vessel Sealer and da Vinci Xi EndoWrist® Vessel Sealer, Intuitive Surgical Inc (HSA 600:41/01-070/15/03_11) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-03_11 FSN
02 Mar 2015	Titanium Elastic Nail (TEN) Inserter, Synthes GmbH (HSA 600:41/01-002/15/02_09) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-02_09 FSN

Healthcare professional, Industry member, Medical devices

Published: 31 Mar 2015

Field Safety Notices

12 Dec 2019