Field Safety Notices

Field Safety Notice - Sep 2015

30 September 2015

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

Date of Notification	Title	FSN
29 Sep 2015	ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/53_34) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-53_34 FSN [PDF, 9 KB] (opens in new tab)
28 Sep 2015	Modularis Variostar, Siemens AG (HSA 600:41/01-022/15/52_55) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-52_55 FSN [PDF, 1281 KB] (opens in new tab)
28 Sep 2015	Patient Browser and Content Manager, BrainLab AG (HSA 600:41/01-047/15/07_56) Local contact: BrainLab Limited (Singapore Branch) Contact no./ Email: sg.sales@brainlab.com	HSA 6004101-047-15-07_56 FSN [PDF, 949 KB] (opens in new tab)
28 Sep 2015	Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/08_17) Local contact: Elekta Pte Ltd Contact no./ Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-15-08_17 FSN [PDF, 122 KB] (opens in new tab)
25 Sep 2015	ADVIA Chemistry Alkaline Phosphatase, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/51_31) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-51_31 FSN [PDF, 19 KB] (opens in new tab)
23 Sep 2015	Sentinel Diagnostics Ammonia Ultra Assay, Sentinel CH SpA (HSA 600:41/01-005/15/05_23) Local contact: Abbott Laboratories (S) Pte Ltd Contact no./ Email: FSN_Enquiry@abbott.com	HSA 6004101-005-15-05_23 FSN [PDF, 19 KB] (opens in new tab)
23 Sep 2015	Cholesterol FS, Creatinine PAP FS, HDL-C Immuno FS, LDL-C Select FS, NEFA FS, Phospholipids FS, Triglycerides FS, Uric acid FS TOOS, Diasys Diagnostics Systems GmbH (HSA 600:41/01-032/15/02_24) Local contact: Sysmex Asia Pacific Pte Ltd Contact no./ Email: RA@sysmex-ap.com	HSA 6004101-032-15-02_24 FSN [PDF, 81 KB] (opens in new tab) HSA 6004101-032-15-02_24 FSN [PDF, 2424 KB] (opens in new tab)
21 Sep 2015	EnVision FLEX/HRP visualization reagent, Dako North America Inc (HSA 600:41/01-086/15/04_61) Local contact: SPD Scientific Pte Ltd Contact no./ Email: 63039870	HSA 6004101-086-15-04_61 FSN [PDF, 78 KB] (opens in new tab)
17 Sep 2015	da Vinci Si Single-Site Gripping Instruments, Intuitive Surgical (HSA 600:41/01-070/15/20_44) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-20_44 FSN [PDF, 553 KB] (opens in new tab)
16 Sep 2015	Zimmer Natural Nail CM Long-Cephalomedullary Nails, Zimmer GmbH (HSA 600:41/01-008/15/10_51) Local contact: Zimmer Pte Ltd Contact no./ Email: 68547081	HSA 6004101-008-15-10_51 FSN [PDF, 102 KB] (opens in new tab)
16 Sep 2015	HeartMate II® LVAS System Controller, Thoratec Corporation (HSA 600:41/01-070/15/19_52) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-19_52 FSN [PDF, 136 KB] (opens in new tab)
15 Sep 2015	cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC, Roche Diagnostics GmbH (HSA 600:41/01-016/15/16_38) Local contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./ Email: sg.regulatory@roche.com	HSA 6004101-016-15-16_38 FSN [PDF, 489 KB] (opens in new tab)
14 Sep 2015	LFIT V40 Tapers Vitallium Femoral Heads, Howmedica Osteonics Corp (HSA 600:41/01-014/15/09_33) Local contact: Stryker Singapore Pte Ltd Contact no./ Email: 65009507	HSA 6004101-014-15-09_33 FSN [PDF, 96 KB] (opens in new tab)
14 Sep 2015	Da Vinci Xi Surgical system installed with P4 software, Intuitive Surgical (HSA 600:41/01-070/15/18_35) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-18_35 FSN [PDF, 453 KB] (opens in new tab)
10 Sep 2015	Anspach G1 Dissection Tools, Anspach Effort Inc (HSA 600:41/01-002/15/37_17) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-37_17 FSN [PDF, 5445 KB] (opens in new tab)
10 Sep 2015	Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts, Liko AB (HSA 600:41/01-076/15/02_18) Local contact: Radiance Medical Systems Contact no./ Email: 63162712	HSA 6004101-076-15-02_18 FSN [PDF, 904 KB] (opens in new tab)
09 Sep 2015	Application Instrument for Sternal ZIPFLIX, Synthes GmbH (HSA 600:41/01-002/15/36_55) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-36_55 FSN [PDF, 118 KB] (opens in new tab)
09 Sep 2015	Axiom Artis, Siemens AG (HSA 600:41/01-022/15/50_48) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-50_48 FSN [PDF, 1050 KB] (opens in new tab)
08 Sep 2015	HeartStart MRx Defibrillator/ Monitor & HeartStart FR3 Defibrillator, Philips Medical Systems (HSA 600:41/01-026/15/29_08) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 18007445477	HSA 6004101-026-15-29_08 FSN [PDF, 134 KB] (opens in new tab)
08 Sep 2015	Access Free T3 Assay, Beckman Coulter Inc (HSA 600:41/01-052/15/07_31) Local contact: Beckman Coulter Singapore Pte Ltd Contact no./ Email: 63407126	HSA 6004101-052-15-07_31 FSN [PDF, 31 KB] (opens in new tab)
08 Sep 2015	Novocastra Lyophilized Mouse Monoclonal Antibody CD10 Reagents, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/04_34) Local contact: Leica Microsystems (SEA) Pte Ltd Contact no./ Email: 65505975	HSA 6004101-126-15-04_34 FSN [PDF, 1999 KB] (opens in new tab)
07 Sep 2015	Cannulated Headless Compression Screw, Synthes GmbH (HSA 600:41/01-002/15/35_46) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-35_46 FSN [PDF, 3497 KB] (opens in new tab)
07 Sep 2015	Bayer Medical Care Medrad® Mark 7 Arterion Injection System, Bayer Medical Care Inc (HSA 600:41/01-069/15/01_54) Local contact: O'Connor's Singapore Pte Ltd Contact no./ Email: enquiries@oconnors.wbl.com.sg	HSA 6004101-069-15-01_54 FSN [PDF, 89 KB] (opens in new tab)
04 Sep 2015	MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/07_53) Local contact: Elekta Pte Ltd Contact no./ Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-15-07_53 FSN [PDF, 128 KB] (opens in new tab)
03 Sep 2015	Discovery & SIGNA Systems, GE Medical Systems LLC (HSA 600:41/01-010/15/16_51) Local contact: GE Healthcare Pte Ltd Contact no./ Email: postmarket@ge.com	HSA 6004101-010-15-16_51 FSN [PDF, 332 KB] (opens in new tab)
03 Sep 2015	Elekta Xio RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/06_44) Local contact: Elekta Pte Ltd Contact no./ Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-15-06_44 FSN [PDF, 62 KB] (opens in new tab)
03 Sep 2015	*KimVent Closed Suction Systems, Halyard Health Inc (HSA 600:41/01-259/15/01_52)** Local contact: Halyard Singapore Pte Ltd Contact no./ Email: 65596280	HSA 6004101-259-15-01_52 FSN [PDF, 1232 KB] (opens in new tab)
02 Sep 2015	Biotrue ONEday Contact Lens, Bausch & Lomb Incorporated (HSA 600:41/01-030/15/04_50) Local contact: Bausch & Lomb (Singapore) Pte Ltd Contact no./ Email: 68349112	HSA 6004101-030-15-04_50 FSN [PDF, 108 KB] (opens in new tab)
02 Sep 2015	chromID™ S. aureus agar, Biomerieux SA (HSA 600:41/01-146/15/03_22) Local contact: Biomerieux Singapore Pte Ltd Contact no./ Email: registration.my@biomerieux.com	HSA 6004101-146-15-03_22 FSN [PDF, 385 KB] (opens in new tab)
01 Sep 2015	Allura Xper FD, Philips Medical Systems Nederland BV (HSA 600:41/01-026/15/28_37) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 18007445477	HSA 6004101-026-15-28_37 FSN [PDF, 112 KB] (opens in new tab)
01 Sep 2015	Spectra Optia Apheresis System, Terumo BCT Inc (HSA 600:41/01-155/15/01_35) Local contact: Terumo BCT (Asia Pacific) Ltd Contact no./ Email: 67739051	HSA 6004101-155-15-01_35 FSN [PDF, 216 KB] (opens in new tab)