Field Safety Notices

Field Safety Notice - Oct 2015

31 October 2015

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

Date of Notification	Title	FSN
29 Oct 2015	Access CEA Reagent Kit, Beckman Coulter Inc (HSA 600:41/01-052/15/09_38) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 63047126	HSA 6004101-052-15-09_38 FSN [PDF, 95 KB] (opens in new tab)
27 Oct 2015	Revolution CT Scanners, GE Medical Systems LLC (HSA 600:41/01-010/15/21_56) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62773552	HSA 6004101-010-15-21_56 FSN [PDF, 72 KB] (opens in new tab)
27 Oct 2015	Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents, Beckman Coulter Inc (HSA 600:41/01-052/15/08_34) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 63407126	HSA 6004101-052-15-08_34 FSN [PDF, 98 KB] (opens in new tab)
26 Oct 2015	TheraSphere Y-90 Glass Microspheres Injection, Biocompatibles UK Ltd (HSA 600:41/01-263/15/03_48) Local Contact: Emergo Singapore Consulting Pte Ltd Contact no./ Email: 68325625	HSA 6004101-263-15-03_48 FSN [PDF, 1235 KB] (opens in new tab)
23 Oct 2015	Stryker 2-Stage and 3-Stage I.V. Poles, Stryker Medical (HSA 600:41/01-014/15/13_54) Local Contact: Stryker Singapore Pte Ltd Contact no./ Email: 65009501	HSA 6004101-014-15-13_54 FSN [PDF, 56 KB] (opens in new tab)
23 Oct 2015	VariSource™ iX Control Software, Varian Medical Systems (HSA 600:41/01-058/15/03_46) Local Contact: Varian Medical Systems Pacific Inc Contact no./ Email: 68870028, 66900714	HSA 6004101-058-15-03_46 FSN [PDF, 257 KB] (opens in new tab)
23 Oct 2015	Amphirion® Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter, Invatec S.p.A (HSA 600:41/01-009/15/16_55) Local Contact: Covidien Private Limited Contact no./ Email: 64365000	HSA 6004101-009-15-16_55 FSN [PDF, 115 KB] (opens in new tab)
22 Oct 2015	GENESIS II Constrained Articular Insert, Smith & Nephew Inc, Smith & Nephew Inc (HSA 600:41/01-073/15/09_53) Local Contact: Smith & Nephew Pte Ltd Contact no./ Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-09_53 FSN [PDF, 72 KB] (opens in new tab)
19 Oct 2015	Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer, GE Healthcare (HSA 600:41/01-010/15/19_41) Local Contact: GE Healthcare Pte Ltd Contact no./ Email: 62777668	HSA 6004101-010-15-19_41 FSN [PDF, 60 KB] (opens in new tab)
19 Oct 2015	Centricity PACS-IW, GE Healthcare (HSA 600:41/01-010/15/20_51) Local Contact: GE Healthcare Pte Ltd Contact no./ Email: 62777668	HSA 6004101-010-15-20_51 FSN [PDF, 62 KB] (opens in new tab)
19 Oct 2015	chronOS Inject Bone Void Filler, Synthes GmbH (HSA 600:41/01-002/15/46_49) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-46_49 FSN [PDF, 124 KB] (opens in new tab)
19 Oct 2015	Welch Allyn KleenSpec® Corded Illumination System, Welch Allyn Inc. (HSA 600:41/01-006/15/01_52) Local contact: HOYA Medical Singapore Pte Ltd Contact no./ Email: 64198153	HSA 6004101-006-15-01_52 FSN [PDF, 142 KB] (opens in new tab)
19 Oct 2015	HOYA Preloaded iSert Intraocular lenses (IOLs), HOYA Corporation Inc (HSA 600:41/01-206/15/01_36) Local contact: Welch Allyn Singapore Pte Ltd Contact no./ Email: 66810000	HSA 6004101-206-15-01_36 FSN [PDF, 160 KB] (opens in new tab)
16 Oct 2015	Sydney IVF PVP (K-SIPV), William A Cook Australia Pty Ltd (HSA 600:41/01-013/15/05_37) Local contact: Cook South East Asia Pte Ltd Contact no./ Email: 62877888	HSA 6004101-013-15-05_37 FSN [PDF, 135 KB] (opens in new tab)
16 Oct 2015	Philips Pinnacle 3 Radiation Therapy Planning System, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/15/34_35) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 18007445477	HSA 6004101-026-15-34_35 FSN [PDF, 142 KB] (opens in new tab)
16 Oct 2015	Unitek Victory Mini Tube Lower Left Buccal Tube, 3M Unitek Corporation (HSA 600:41/01-031/15/02_33) Local contact: 3M Technologies (S) Pte Ltd Contact no./ Email: 64508846	HSA 6004101-031-15-02_33 FSN [PDF, 45 KB] (opens in new tab)
15 Oct 2015	iPlan RT Image (below v4.1.2) / iPlan RT, BrainLab AG (HSA 600:41/01-047/15/08_19) Local contact: BrainLab Limited (Singapore Branch) Contact no./ Email: sg.sales@brainlab.com	HSA 6004101-047-15-08_19 FSN [PDF, 701 KB] (opens in new tab)
14 Oct 2015	ORTHO BioVue® System Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/45_22) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-45_22 FSN [PDF, 168 KB] (opens in new tab)
14 Oct 2015	ARIA® for Radiation Oncology, ARIA® Oncology Information System for Radiation Oncology, Varian Medical Systems, Inc. (HSA 600:41/01-058/15/02_48) Local contact: Varian Medical Systems Pacific, Inc. Contact no./ Email: 68870028	HSA 6004101-058-15-02_48 FSN [PDF, 158 KB] (opens in new tab)
14 Oct 2015	Allura Xper FD, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/15/32_56) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 1800 744 5477	HSA 6004101-026-15-32_56 FSN [PDF, 401 KB] (opens in new tab)
14 Oct 2015	Silimed Implants, Silimed Industria De Implantes Ltda (HSA 600:41/01-284/15/01_12) Local contact: Alpha-Health (Asia) Pte Ltd Contact no./ Email: 63396678	HSA 6004101-284-15-01_12 FSN [PDF, 118 KB] (opens in new tab)
14 Oct 2015	Giraffe Shuttle, Ohmeda Medical (HSA 600:41/01-010/15/17_17) Local contact: GE Healthcare Pte Ltd Contact no./ Email: svc@ge.com	HSA 6004101-010-15-17_17 FSN [PDF, 183 KB] (opens in new tab)
14 Oct 2015	Philips HeartStart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/15/33_29) Local contact: Philips Medical Systems Contact no./ Email: 1800 744 5477	HSA 6004101-026-15-33_29 FSN [PDF, 247 KB] (opens in new tab)
14 Oct 2015	MR Surgical Suite II MR system, GE Medical Systems LLC (HSA 600:41/01-010/15/18_25) Local contact: GE Healthcare Pte Ltd Contact no./ Email: postmarket@ge.com	HSA 6004101-010-15-18_25 FSN [PDF, 53 KB] (opens in new tab)
13 Oct 2015	Biosense Webster CARTOSOUND Module in conjunction with SOUNDSTAR eco 8F and eco 10F catheters, Biosense Webster Inc (HSA 600:41/01-002/15/44_46) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-44_46 FSN [PDF, 34 KB] (opens in new tab)
12 Oct 2015	ADVIA Chemistry XPT system, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/54_61) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-54_61 FSN [PDF, 87 KB] (opens in new tab)
12 Oct 2015	Urinary Metanephrines by HPLC, Bio-Rad Laboratories GmbH (HSA 600:41/01-027/15/03_23) Local contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./ Email: 6490 4262	HSA 6004101-027-15-03_23 FSN [PDF, 156 KB] (opens in new tab)
12 Oct 2015	Amicus Cell Separator, Fresenius Kabi AG (HSA 600:41/01-020/15/02_45) Local contact: Fresenius Kabi (Singapore) Pte Ltd Contact no./ Email: 68372552	HSA 6004101-020-15-02_45 FSN [PDF, 75 KB] (opens in new tab)
12 Oct 2015	Duracon Tibial Wedge Augments, Howmedica Osteonics Corp (HSA 600:41/01-014/15/12_54) Local contact: Stryker Singapore Pte Ltd Contact no./ Email: 65009507	HSA 6004101-014-15-12_54 FSN [PDF, 24 KB] (opens in new tab)
07 Oct 2015	STERRAD® NX® Sterilization System, Advanced Sterilization Products (HSA 600:41/01-002/15/42_52) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-42_52 FSN [PDF, 93 KB] (opens in new tab)
07 Oct 2015	ORTHO VISION™ Analyzer for ORTHO BioVue® Cassette, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/43_59) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-43_59 FSN [PDF, 107 KB] (opens in new tab)
07 Oct 2015	MiniMed® 640G Insulin pump, Medtronic Minimed (HSA 600:41/01-009/15/15_44) Local contact: Medtronic International Limited Contact no./ Email: 64365000	HSA 6004101-009-15-15_44 FSN [PDF, 210 KB] (opens in new tab)
07 Oct 2015	Triathlon MIS Modular Distal Capture, Howmedica Osteonics Corp (HSA 600:41/01-014/15/11_53) Local contact: Stryker Singapore Pte Ltd Contact no./ Email: 65009507	HSA 6004101-014-15-11_53 FSN [PDF, 50 KB] (opens in new tab)
06 Oct 2015	Exeter Small Tapered Pin Reamer and Exeter Large Tapered Pin Reamer, Howmedica Osteonics Corp (HSA 600:41/01-014/15/10_51) Local contact: Stryker Singapore Pte Ltd Contact no./ Email: 65009507	HSA 6004101-014-15-10_51 FSN [PDF, 39 KB] (opens in new tab)
05 Oct 2015	HARMONIC ACE+7 Shears with Advanced Haemostasis, Ethicon Endo-Surgery LLC (HSA 600:41/01-002/15/41_50) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-41_50 FSN [PDF, 313 KB] (opens in new tab)
02 Oct 2015	Medtronic Navigated Solera Screwdrivers, Medtronic Navigation Inc (HSA 600:41/01-009/15/14_36) Local contact: Medtronic International Limited Contact no./ Email: 64365000	HSA 6004101-009-15-14_36 FSN [PDF, 1616 KB] (opens in new tab)
02 Oct 2015	Brilliance 16-Slice (Air)/ 64 CT/ CT Big Bore, Ingenuity Core/ Ingenuity Core^128/ Flex, Philips Medical Systems Inc (HSA 600:41/01-026/15/31_37) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 18007445477	HSA 6004101-026-15-31_37 FSN [PDF, 316 KB] (opens in new tab)
02 Oct 2015	Narrow Right Angle Large Driver Tip and Narrow Right Angle Square Driver Tip, Biomet 3i (HSA 600:41/01-181/15/01_35) Local contact: Asia Implant Support & Services Contact no./ Email: admin@implant.com.sg	HSA 6004101-181-15-01_35 FSN [PDF, 56 KB] (opens in new tab)
01 Oct 2015	Sciatic Nerve Retractors, Synthes GmbH (HSA 600:41/01-002/15/39_29) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-39_29 FSN [PDF, 67 KB] (opens in new tab)
01 Oct 2015	VITROS® Chemistry Products Calibrator Kit 9, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/40_57) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-40_57 FSN [PDF, 123 KB] (opens in new tab)
01 Oct 2015	ConforMIS iTotal Knee Replacement Systems, ConforMIS Inc (HSA 600:41/01-263/15/02_33) Local contact: Emergo Consulting Pte Ltd Contact no./ Email: SEAvigilance@emergogroup.com	HSA 6004101-263-15-02_33 FSN [PDF, 142 KB] (opens in new tab)