Field Safety Notices

Field Safety Notice - Apr 2017

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 April 2017

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Table caption

Date of Notification	Title	FSN
30 Apr 2017	ARIES System barcode scanners, Luminex Corporation (HSA 600:41/01-148/17/01_23) Local Contact: DKSH Singapore Pte Ltd Contact no./Email:66597374	HSA 6004101-148-17-01_23 FSN [PDF, 307 KB] (opens in new tab)
28 Apr 2017	Cook Biodesign 1-Layer Tissue Graft and Cook Biodesign 4-Layer Tissue Graft, Cook Biotech Incorporated (HSA 600:41/01-013/17/02_40) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-17-02_40 FSN_Redacted [PDF, 156 KB] (opens in new tab)
28 Apr 2017	DigitalDiagnost 3. 1.x, Philips Medical Systems (HSA 600:41/01-026/17/08_25) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-17-08_25 FSN_Redacted [PDF, 95 KB] (opens in new tab)
27 Apr 2017	RAPIDPOINT® 500 BLOOD GAS ANALYZER WITH V2.4 SOFTWARE, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/14_31) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-17-14_31 FSN [PDF, 18 KB] (opens in new tab)
26 Apr 2017	Philips V60 Ventilator, Respironics California Inc. (HSA 600:41/01-026/17/07_48) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-17-07_48 FSN_Redacted [PDF, 230 KB] (opens in new tab)
26 Apr 2017	Cardinal Health Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems, Cardinal Health (HSA 600:41/01-145/17/02_18) Local Contact: Medquest Marketing Pte Ltd Contact no./Email: 6805 1250	HSA 6004101-145-17-02_18 FSN_Redacted [PDF, 533 KB] (opens in new tab)
25 Apr 2017	ABSORB Bioresorbable Vascular Scaffold System, Absorb GT1 Bioresorbable Vascular Scaffold System, Abbott Vascular (HSA 600:41/01-005/17/05_49) Local Contact: Abbott Laboratories (S) Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-17-05_49 FSN [PDF, 62 KB] (opens in new tab)
24 Apr 2017	CADD® ADMINISTRATION DEVICE, Smiths Medical ASD, Inc. (HSA 600:41/01-017/17/01_19) Local Contact: IDS Medical Systems (S) Pte Ltd Contact no./Email: 6690 7378	HSA 6004101-017-17-01_19 FSN_Redacted [PDF, 344 KB] (opens in new tab)
21 Apr 2017	VITEK® 2 IDENTIFICATION / ANTIMICROBIAL SUSCEPTIBILITY TEST CARDS, Biomerieux Inc (HSA 600:41/01-146/17/06_67) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: 6801 6700	HSA 6004101-146-17-06_67 FSN [PDF, 216 KB] (opens in new tab)
21 Apr 2017	Medivance Arctic Sun® 5000 Temperature Management System, Medivance, Inc (HSA 600:41/01-050/17/01_54) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6580 5988 / Complaints.Singapore@crbard.com	HSA 6004101-050-17-01_54 FSN_Redacted [PDF, 159 KB] (opens in new tab)
21 Apr 2017	Exeter Femoral Stem Size 0, Howmedica Ostenics Corp (HSA 600:41/01-014/17/02_45) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA 6004101-014-17-02_45 FSN_Redacted [PDF, 27 KB] (opens in new tab)
20 Apr 2017	ACCESS BR MONITOR, Beckman Coulter Inc (HSA 600:41/01-052/17/04_65) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-17-04_65 FSN_Redacted [PDF, 107 KB] (opens in new tab)
19 Apr 2017	Roche Diagnostics Multiplate ADPtest and Roche Diagnostics Multiplate ASPItest, Roche Diagnostics GmbH (HSA 600:41/01-016/17/07_58) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-17-07_58 FSN [PDF, 374 KB] (opens in new tab)
19 Apr 2017	Abbott Architect SHBG reagents, Abbott GmbH & Co.KG (HSA 600:41/01-005/17/04_61) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-17-04_61 FSN [PDF, 105 KB] (opens in new tab)
19 Apr 2017	Infant Warmer System, Ohmeda Medical (HSA 600:41/01-010/16/12_37) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-16-12_37 FSN update_Redacted [PDF, 358 KB] (opens in new tab)
18 Apr 2017	Hemotherm CE Dual Reservoir Cooler-Heater, Cincinnati Sub-Zero Products, LLC (HSA 600:41/01-021/17/01_01) Local Contact: Thermal International (S) Pte Ltd Contact no./Email: Email: 6225 2911 / sales@thermal.com.sg	HSA 6004101-021-17-01_01 FSN_Redacted [PDF, 955 KB] (opens in new tab)
17 Apr 2017	Teleflex Medical Arrow EZ-IO 45mm 15ga Intraosseous Vascular Access Needle Set, Teleflex Medical (HSA 600:41/01-309/17/01_18) Local Contact: Aris Integrated Medical Pte Ltd Contact no./Email: 6462 4043 / info@aris-im.com	HSA 6004101-309-17-01_18 FSN_Redacted [PDF, 26 KB] (opens in new tab)
17 Apr 2017	Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents, Beckman Coulter Inc. (HSA 600:41/01-052/17/03_60) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-17-03_60 FSN_Redacted [PDF, 206 KB] (opens in new tab)
17 Apr 2017	AMO WhiteStar Signature System (Vitrectomy Cutters), Abbott Medical Optics, Inc (HSA 600:41/01-018/17/02_46) Local Contact: AMO Singapore Pte Ltd Contact no./Email: 6844 8833	HSA 6004101-018-17-02_46 FSN_Redacted [PDF, 58 KB] (opens in new tab)
17 Apr 2017	AMO Healon Ophthalmic Viscosurgical Devices (OVDs), Abbott Medical Optics, Inc (HSA 600:41/01-018/17/01_54) Local Contact: AMO Singapore Pte Ltd Contact no./Email: 6844 8833	HSA 6004101-018-17-01_54_FSN_Redacted [PDF, 130 KB] (opens in new tab)
13 Apr 2017	SynchroMed II Implantable Drug Infusion Pump, Medtronic Inc. (HSA 600:41/01-009/17/06_63) Local Contact: Medtronic International Limited Contact no./Email: 6436 5000	HSA 6004101-009-17-06_63 FSN_Redacted [PDF, 6991 KB] (opens in new tab)
12 Apr 2017	Axiom Sensis XP System & Sensis Family System, Siemens Healthcare GmbH; Siemens AG (HSA 600:41/01-022/17/13_51) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-17-13_51 FSN_Redacted [PDF, 449 KB] (opens in new tab)
12 Apr 2017	Bausch & Lomb Laseredge Knife, Bausch & Lomb Incorporated (HSA 600:41/01-030/17/01_37) Local Contact: Bausch & Lomb (Singapore) Pte Ltd Contact no./Email: 6834 9112	HSA 6004101-030-17-01_37 FSN updated_Redacted [PDF, 724 KB] (opens in new tab)
11 Apr 2017	Ortho Reagent Red Blood Cell (RRBC) products, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/04_60) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA 6004101-303-16-04_60 FSN (v2)_Redacted [PDF, 1211 KB] (opens in new tab) HSA 6004101-303-16-04_60 FSN (v3)_Redacted [PDF, 275 KB] (opens in new tab)
11 Apr 2017	da Vinci Xi Vessel Sealer/da Vinci Si Vessel Sealer, Intuitive Surgical, Inc (HSA 600:41/01-070/17/09_46) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-17-09_46 FSN [PDF, 298 KB] (opens in new tab)
10 Apr 2017	ADVIA Centaur Insulin Reagent, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/12_58) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-17-12_58 FSN [PDF, 109 KB] (opens in new tab)
07 Apr 2017	bioMerieux ETEST ETP32 (Ertapenem), bioMerieux SA (HSA 600:41/01-146/17/04_34) Local Contact: bioMerieux Singapore Pte Contact no./Email: 6801 6700	HSA 6004101-146-17-04_34 FSN [PDF, 112 KB] (opens in new tab)
07 Apr 2017	Boston Scientific Jetstream Atherectomy System, Boston Scientific Corporation (HSA 600:41/01-070/17/08_41) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 /regulatory@transmedicgroup.com	HSA 6004101-070-17-08_41 FSN_Redacted [PDF, 112 KB] (opens in new tab)
07 Apr 2017	ETEST OX 256, BioMerieux SA (HSA 600:41/01-146/17/05_59) Local Contact: BioMerieux Singapore Pte Ltd Contact no./Email: 6801 6706	HSA 6004101-146-17-05_59 FSN [PDF, 96 KB] (opens in new tab)
07 Apr 2017	Zimmer Segmental System and Zimmer VerSys® Hip System Beaded HipProsthesis, Zimmer Inc (HSA 600:41/01-008/17/04_41) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7250	HSA 6004101-008-17-04_41 FSN [PDF, 219 KB] (opens in new tab)
05 Apr 2017	INFX-8000, INFX-9000/ XIDF-AWS80, Toshiba Medical System Corporation (HSA 600:41/01-064/17/01_33) Local Contact: Toshiba Medical System Pte Ltd Contact no./Email: 6272 9722	HSA 6004101-064-17-01_33 FSN_Redacted [PDF, 1572 KB] (opens in new tab)
05 Apr 2017	CONMED Corporation Hyfrecator 2000 Electrosurgical Units, CONMED Corporation (HSA 600:41/01-119/17/01_40) Local Contact: Servicom Medical (Singapore) Pte Ltd Contact no./Email: 6224 8701	HSA 6004101-119-17-01_40 FSN_Redacted [PDF, 2152 KB] (opens in new tab)
05 Apr 2017	Olympus® ACTERA Endoscopy System, Duodenovideoscope, Olympus Medical Systems Corp. (HSA 600:41/01-004/17/03_50) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com	HSA 6004101-004-17-03_50 FSN_Redacted [PDF, 1448 KB] (opens in new tab)
05 Apr 2017	Olympus Endoscope Reprocessor OER-AW, Olympus Medical Systems Corp. (HSA 600:41/01-004/17/02_37) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com	HSA 6004101-004-17-02_37 FSN_Redacted [PDF, 1624 KB] (opens in new tab)
05 Apr 2017	NEWPORT HT70 AND NEWPORT HT70 PLUS VENTILATORS, Newport Medical Instruments, Inc (HSA 600:41/01-046/17/03_49) Local Contact: Covidien Pte Ltd Contact no./Email: 6439 6974	HSA 6004101-046-17-03_49 FSN_Redacted [PDF, 1856 KB] (opens in new tab)
04 Apr 2017	Thoractec HeartMate II LVAS Pocket System Controller, Thoratec Corporation (HSA 600:41/01-070/17/07_52) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-17-07_52 FSN_Redacted [PDF, 122 KB] (opens in new tab)