Field Safety Notices

Field Safety Notice - Jan 2019

31 January 2019

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

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_Redacted [PDF, 263 KB] (opens in new tab)
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_Redacted [PDF, 1416 KB] (opens in new tab)
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)_Redacted [PDF, 3375 KB] (opens in new tab)
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_Redacted [PDF, 245 KB] (opens in new tab)
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_Redacted [PDF, 95 KB] (opens in new tab)
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_Redacted [PDF, 73 KB] (opens in new tab)
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_Redacted [PDF, 498 KB] (opens in new tab)
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_Redacted [PDF, 353 KB] (opens in new tab)
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_Redacted [PDF, 429 KB] (opens in new tab)
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_Redacted [PDF, 570 KB] (opens in new tab)
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 FSN [PDF, 1155 KB] (opens in new tab)
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_Redacted [PDF, 221 KB] (opens in new tab)
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_Redacted [PDF, 370 KB] (opens in new tab)
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_Redacted [PDF, 279 KB] (opens in new tab)
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_Redacted [PDF, 528 KB] (opens in new tab)
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_Redacted [PDF, 235 KB] (opens in new tab)
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_Redacted [PDF, 74 KB] (opens in new tab)
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_Redacted [PDF, 212 KB] (opens in new tab)
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_Redacted [PDF, 110 KB] (opens in new tab)
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_Redacted [PDF, 146 KB] (opens in new tab)
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 Redacted [PDF, 413 KB] (opens in new tab)
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 FSN [PDF, 75 KB] (opens in new tab)
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_Redacted [PDF, 353 KB] (opens in new tab)
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_Redacted [PDF, 115 KB] (opens in new tab)
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_Redacted [PDF, 248 KB] (opens in new tab)
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_Redacted [PDF, 1735 KB] (opens in new tab)
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_Redacted [PDF, 299 KB] (opens in new tab)
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_Redacted [PDF, 98 KB] (opens in new tab)
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_Redacted [PDF, 199 KB] (opens in new tab)
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) [PDF, 135 KB] (opens in new tab) 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_Redacted [PDF, 39 KB] (opens in new tab) 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_Redacted [PDF, 186 KB] (opens in new tab) This updated FSN replaces the original FSN published in Sep 2018.