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 2019

Date of Notification	Title	FSN
31 Jan 2019	WIP'ANIOS PREMIUM and WIP'ANIOS EXCEL, Laboratoires ANIOS (HSA 600:41/01-017/19/01_79) Local Contact: IDS Medical Systems (Singapore) Pte Ltd Contact No./Email: 6690 7339 / idsmedsgregulatory@idsmed.com	HSA 6004101-017-19-01_79 FSN_Redacted263 KB
30 Jan 2019	Specular Microscope CEM-530, Nidek Co., Ltd (HSA 600:41/01-334/19/01_64) Local Contact: Nidek Singapore Pte Ltd Contact No./Email: 6588 0389	HSA 6004101-334-19-01_64 FSN_Redacted1416 KB
30 Jan 2019	Terumo Needle (Neolus), Terumo (Philippines) Corporation (HSA 600:41/01-028/19/01_35) Local Contact: Terumo Singapore Pte Ltd Contact No./Email: 6291 3603	HSA 6004101-028-19-01_35_FSN (Revised)_Redacted3375 KB
30 Jan 2019	Minstrel, ArjoHuntleigh AB (HSA 600:41/01-065/19/01_38) Local Contact: Arjo South East Asia Pte. Ltd. Contact No./Email: 6202 7366 / singapore@arjo.com	HSA 6004101-065-19-01_38 FSN_Redacted244 KB
29 Jan 2019	MyLab Ultrasound Probes, Esaote S.p.A. (HSA 600:41/01-288/19/01_48) Local Contact: Medical Plus Pte Ltd Contact No./Email: 6271 6558 / admin@medicalplus-group.com	HSA 6004101-288-19-01_48 FSN_Redacted94 KB
29 Jan 2019	Cook Transseptal Needle, Cook Incorporated (HSA 600:41/01-013/19/03_62) Local Contact: Cook South East Asia Pte Ltd Contact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-19-03_62 FSN_Redacted73 KB
29 Jan 2019	Optetrak Logic CC Stem Extension, 22mm x 160mm, Exactech Inc (HSA 600:41/01-257/19/01_44) Local Contact: Exactech Pte Ltd Contact No./Email: 6273 0091	HSA 6004101-257-19-01_44 FSN_Redacted497 KB
28 Jan 2019	Burr, Oval, 12 Flute, 5.5mm x 13cm, Arthrex Inc. (HSA 600:41/01-333/19/01_76) Local Contact: Arthrex Singapore Pte Ltd Contact No./Email: 6714 1600	HSA 6004101-333-19-01_76 FSN_Redacted353 KB
26 Jan 2019	Convatec Rectal tube, Mini Vacuum Set, Convatec Limited (HSA 600:41/01-044/19/01_18) Local Contact: Optimal Medical Products Pte Ltd Contact No./Email: 6253 5247 / sales@optimalmedical.com.sg	HSA 6004101-044-19-01_18 FSN_Redacted428 KB
24 Jan 2019	Volcano s5. s5i, CORE and CORE Mobile systems with version 2.5 FFR/iFR software, Volcano Corporation (HSA 600:41/01-070/19/02_66) Local Contact: Transmedic Pte Ltd Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com	HSA 6004101-070-19-02_66 FSN_Redacted570 KB
21 Jan 2019	Edwards Commander Delivery System, Edwards Lifesciences LLC (HSA 600:41/01‐060/19/01_54) Local Contact: Edwards Lifesciences (Asia) Pte Ltd	HSA 6004101‐060-19-01_54 FSN1154 KB
17 Jan 2019	Percuvance^® Percutaneous Shaft 29cm and 36cm, Teleflex Medical (HSA 600:41/01-139/19/01_18) Local Contact: Teleflex Medical Asia Pte Ltd Contact No./Email: 6439 3046	HSA 6004101-139-19-01_18 FSN_Revised_Redacted220 KB
17 Jan 2019	2090 CareLinkTM Programmer, 29901 EncoreTM Programmer, and CareLink Network Application Software 2491, Medtronic Inc (HSA 600:41/01-009/19/02_62) Local Contact: Medtronic International Limited Contact No./Email: 6436 5077	HSA 6004101-009-19-02_62 FSN_Redacted369 KB
15 Jan 2019	LOGIQ P6 Model BT07 and BT09 Systems, GE Ultrasound Korea, Ltd (HSA 600:41/01-010/19/02_74) Local Contact: GE Healthcare Pte Ltd Contact No./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-19-02_74 FSN_Redacted279 KB
15 Jan 2019	bioMerieux VITEK 2 GN Card; bioMerieux VITEK 2 GP Card; bioMerieux VITEK 2 ANC Card; bioMerieux VITEK 2 Antimicrobial Automated Susceptibility Test, Biomerieux Inc (HSA 600:41/01-146/19/01_70) Local Contact: BIOMERIEUX SINGAPORE PTE. LTD	HSA 6004101-146-19_01_70 FSN_Redacted528 KB
14 Jan 2019	Abott Clinical Chemistry Magnesium Assay, Abbott Laboratories (HSA 600:41/01-005/19/01_59) Local Contact: Abott Laboratories Singapore Pte Ltd Contact No./Email: 6914 8001 / FSN_enquiry@abbott.com	HSA 6004101-005-19-01_59 FSN_Redacted235 KB
11 Jan 2019	TEXAS Bronchoscope Tube, Richard Wolf GmbH (HSA 600:41/01-119/19/01_51) Local Contact: Servicom Medical (Singapore) Pte Ltd Contact No./Email: 6224 8701 / inquiry@servicom.com.sg	HSA 6004101-119-19-01_51 FSN_Redacted73 KB
11 Jan 2019	Philips IntelliVue Multi-Measurement Module X3, Philips Medizin Systeme Boblingen GmbH (HSA 600:41/01-010/19/01_46) Local Contact: Philips Electronics (S) Pte Ltd Contact No./Email: 1800 744 5477	HSA 6004101-026-19-03_68 FSN_Redacted212 KB
11 Jan 2019	Centricity Universal Viewer (UV) Workstation, GE Healthcare (HSA 600:41/01-010/19/01_46) Local Contact: GE Healthcare Pte Ltd Contact No./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-19-01_46 FSN_Redacted109 KB
10 Jan 2019	ThermoScientific^TM Oxoid^TM Meropenem 32 M.I.C.E. Strip, Oxoid Limited (Thermo Fisher Scientific), (HSA 600:41/01-178/19/01_57) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact No./Email: 6499 9999 /cs.mbd.sg@thermofisher.com	HSA 6004101-178-19-01_57 FSN_Redacted145 KB
9 Jan 2019	Eclipse Treatment Planning System, Varian Medical Systems, Inc. (HSA 600:41/01-058/19/01_43) Local Contact: Varian Medical Systems Pacific, Inc. Contact No./Email: 6887 0028	HSA 6004101-058-19-01_43 FSN Redacted412 KB
9 Jan 2019	SL PLUS MIA Double Offset Adapter. RT 60/25MM, Smith & Nephew Orthopaedics AG (HSA 600:41/01-073/19/01_35) Local Contact: Smith & Nephew Pte Ltd Contact No./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-19-01_35 FSN75 KB
8 Jan 2019	BD Phoenix AST Indicator Solution, Becton Dickinson and Company (BD) (HSA 600:41/01-003/19/01_23) Local Contact: Becton Dickinson Holdings Pte Ltd (BD) Contact No./Email: 6432 2049	HSA 6004101-003-19-01_23 FSN_Redacted352 KB
8 Jan 2019	Mako Onlay Insert Extractor, Mako Surgical Corp. (HSA 600:41/01-070/19/01_66) Local Contact: Transmedic Pte Ltd Contact No./Email: 6477 6102 / Regional.PMS@transmedicgroup.com	HSA 6004101-070-19-01_66 FSN_Redacted115 KB
7 Jan 2019	Xper Flex Cardio Patient Monitoring System, INVIVO, a division of Philips Medical Systems (HSA 600 41/01-026/19/01_77) Local Contact: Philips Electronics (S) Pte Ltd Contact No./Email: 1800 744 5477	HSA 6004101-026-19-01_77 FSN_Redacted247 KB
7 Jan 2019	Bonesupport AB Cerament Bone Void Filler, Bonesupport AB (HSA 600:41/01-332/19/01_50) Local Contact: United Italian Trading Corporation(Pte) Ltd Contact No./Email: 6284 8889 / info@uitc.com.sg	HSA 6004101-332-19-01_50 FSN_Redacted1734 KB
7 Jan 2019	PHILIPS PAGEWRITER TC CARDIOGRAPHS (TC20/30/50/70), Philips Medical Systems (HSA 600:41/01-026/19/02_51) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact No./Email: 1800 744 5477	HSA 6004101-026-19-02_51 FSN_Redacted299 KB
7 Jan 2019	COOK Captura Disposable Biopsy Forceps, Wilson-Cook Medical, Inc. (HSA 600:41/01-013/19/02_38) Local Contact: Cook South East Asia Pte Ltd Contact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-19-02_38 FSN_Redacted97 KB
4 Jan 2019	Universa Ureteral Stent Set, C-Flex DP Ureteral Stent Set, Roadrunner Wire Guides, Urethral Dilator Set, Wire Guide, Cook Incorporated (HSA 600:41/01-013/19/01_71) Local Contact: Cook South East Asia Pte Ltd Contact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-19-01_71 FSN_Redacted199 KB
21Dec 2018	da Vinci Harmonic ACE Insert, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/27_38) Local Contact: Transmedic Pte Ltd Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-27_38 FSN (v2)134 KB This FSN is an update to the original FSN published in Dec 2018.
7 Nov2018	Nellix® EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V.(HSA 600:41/01-329/18/01_52) Local Contact: Qualtech Consultaing Corporation PTE LTD	HSA 6004101-329-18-01_52 FSN_Redacted38 KB This FSN is an update to the original FSN published in Nov 2018.
27 Sep 2018	buddy™ Disposable Set, Belmont Instrument Corporation (HSA 600:41/01-070/18/20_63) Local Contact: Transmedic Pte Ltd Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-20_63 FSN Corrected_Redacted186 KB This updated FSN replaces the original FSN published in Sep 2018.

Healthcare professional, Industry member, Medical devices

Published: 31 Jan 2019

Field Safety Notices

12 Dec 2019