Field Safety Notices

Field Safety Notice - Nov 2015

30 November 2015

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

Date of Notification	Title	FSN
30 Nov 2015	Artis Zee Family System and Artis Q Family System, Siemens AG (HSA 600:41/01-022/15/61_48) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-61_48 FSN [PDF, 564 KB] (opens in new tab)
30 Nov 2015	Synthes Synex, Mathys Medical Ltd (HSA 600:41/01-002/15/53_17) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-15-53_17 FSN [PDF, 917 KB] (opens in new tab)
27 Nov 2015	Boston Scientific ACUITY Pro Guide Catheter, Boston Scientific Corporation (HSA 600:41/01-007/15/06_55) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 64188888	HSA 6004101-007-15-06_55 FSN [PDF, 3692 KB] (opens in new tab)
27 Nov 2015	ADVIA Centaur XPT, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/60_38) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-60_38 FSN [PDF, 51 KB] (opens in new tab)
26 Nov 2015	Miethke proGAV Programmable Shunt System, Christoph Miethke GmbH & Co. KG (HSA 600:41/01-012/15/08_46) Local Contact: B Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-15-08_46 FSN [PDF, 8798 KB] (opens in new tab)
25 Nov 2015	CareSens N Blood Glucose Monitoring System, i-SENs Inc (HSA 600:41/01-186/15/01_34) Local Contact: Kingston Medical Supplies Pte Ltd Contact no./Email: 67453922	HSA 6004101-186-15-01_34 FSN [PDF, 1761 KB] (opens in new tab)
24 Nov 2015	Syngo X Workplace, Siemens AG (HSA 600:41/01-022/15/59_53) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-59_53 FSN [PDF, 123 KB] (opens in new tab)
24 Nov 2015	Factor VIII Chromogenic Assay, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/15/03_24) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: 62213629	HSA 6004101-032-15-03_24 FSN [PDF, 22 KB] (opens in new tab)
24 Nov 2015	Oxoid Antimicrobial Susceptibility Testing Disc - Gentamicin CN10, Oxoid Limited (HSA 600:41/01-178/15/05_22) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999992	HSA 6004101-178-15-05_22 FSN [PDF, 76 KB] (opens in new tab)
20 Nov 2015	Thin-Flex Venous Cannula, Edwards Lifesciences LLC (HSA 600:41/01-060/15/03_50) Local Contact: Edwards Lifesciences (Asia) Pte Ltd Contact no./Email: 96567562	HSA 6004101-060-15-03_50 FSN [PDF, 206 KB] (opens in new tab)
20 Nov 2015	Dimension Integrated Chemistry Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/58_20) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-58_20 FSN [PDF, 87 KB] (opens in new tab)
20 Nov 2015	Stardrive Locking Screw, Self-tapping, Synthes GmbH (HSA 600:41/01-002/15/51_41) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-51_41 FSN [PDF, 1061 KB] (opens in new tab)
20 Nov 2015	B. Braun Dialog+ Dialyzer Machine, B. Braun Avitum AG (HSA 600:41/01-012/15/07_40) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-15-07_40 FSN [PDF, 2204 KB] (opens in new tab)
19 Nov 2015	AcroMetrix HBV control, Life Technologies Corporation (HSA 600:41/01-285/15/01_59) Local Contact: Fisher Scientific Pte Ltd Contact no./Email: 68736006	HSA 6004101-285-15-01_59 FSN [PDF, 49 KB] (opens in new tab) HSA 6004101-285-15-01_59 FSN [PDF, 49 KB] (opens in new tab)
18 Nov 2015	Birmingham Hip Modular Head, monoblock version, Smith & Nephew Orthopaedics Ltd (HSA 600:41/01-073/15/12_25) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-12_25 FSN [PDF, 96 KB] (opens in new tab)
18 Nov 2015	LeMaitre Single Lumen and Over-the-Wire Embolectomy Catheters, LeMaitre Vascular Inc. (HSA 600:41/01-057/15/05_19) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net	HSA 6004101-057-15-05_19 FSN [PDF, 42 KB] (opens in new tab) HSA 6004101-057-15-05_19 FSN [PDF, 43 KB] (opens in new tab)
17 Nov 2015	Reflection Spherical Head Screw, Smith & Nephew Inc (HSA 600:41/01-073/15/11_18) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-11_18 FSN [PDF, 53 KB] (opens in new tab)
17 Nov 2015	ADVIA Centaur and ADVIA Centaur XP Instruments, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/57_38) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-57_38 FSN [PDF, 36 KB] (opens in new tab)
16 Nov 2015	ARCTIC SUN 5000 Temperature Management System, Bard Medical Division / Medivance Inc (HSA 600:41/01-050/15/05_56) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 65805988	HSA 6004101-050-15-05_56 FSN [PDF, 1748 KB] (opens in new tab)
16 Nov 2015	Provide® Protection Caps, Provide Impression Copings, Biomet 3i (HSA 600:41/01-181/15/02_17) Local Contact: Asia Implant Support & Services Contact no./Email: admin@implant.com.sg	HSA 6004101-181-15-02_17 FSN [PDF, 37 KB] (opens in new tab)
13 Nov 2015	Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml, Oxoid Limited (HSA 600:41/01-178/15/04_31) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999999	HSA 6004101-178-15-04_31 FSN [PDF, 77 KB] (opens in new tab)
13 Nov 2015	ATB Densitometer control & Densimat, Biomerieux SA (HSA 600:41/01-146/15/04_34) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: sg.qara@ext.biomerieux.com	HSA 6004101-146-15-04_34 FSN [PDF, 337 KB] (opens in new tab)
12 Nov 2015	Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/15/38_54) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-15-38_54 FSN [PDF, 221 KB] (opens in new tab)
11 Nov 2015	Virtuoso v5.4 and v5.5, Ventana Medical Systems Inc (HSA 600:41/01-016/15/17_23) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-15-17_23 FSN [PDF, 305 KB] (opens in new tab)
09 Nov 2015	Siemens Somatom Definition AS, Siemens AG (HSA 600:41/01-022/15/56_53) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-56_53 FSN [PDF, 1888 KB] (opens in new tab)
6 Nov 2015	Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/15/37_44) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-15-37_44 FSN [PDF, 217 KB] (opens in new tab)
6 Nov 2015	ADVIA Chemistry Hemoglobin A1c_3 (A1c_3 and A1c_3M), Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/55_22) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-55_22 FSN [PDF, 27 KB] (opens in new tab)
05 Nov 2015	CXI Support Catheter, Cook Incorporated (HSA 600:41/01-013/15/06_41) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6287 7888	HSA 6004101-013-15-06_41 FSN [PDF, 23 KB] (opens in new tab)
05 Nov 2015	Baylis ProTrack Microcatheter, Baylis Medical (HSA 600:41/01-057/15/04_50) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net	HSA 6004101-057-15-04_50 FSN [PDF, 345 KB] (opens in new tab)
05 Nov 2015	Toshiba whole-body X-ray CT scanner - TSX-303A, Toshiba Medical System Corporation (HSA 600:41/01-064/15/03_51) Local Contact: Toshiba Medical Systems Asia Pte Ltd Contact no./Email: 62729766	HSA 6004101-064-15-03_51 FSN [PDF, 12 KB] (opens in new tab)
05 Nov 2015	VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/49_59) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-49_59 FSN [PDF, 185 KB] (opens in new tab)
05 Nov 2015	Oxoid antimicrobial susceptibility testing disc-Cefoxitin FOX30, Oxoid Limited (HSA 600:41/01-178/15/03_61) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999999	HSA 6004101-178-15-03_61 FSN [PDF, 74 KB] (opens in new tab)
04 Nov 2015	InSync III CRT-P, Medtronic Cardiac Rhythm Heart (HSA 600:41/01-009/15/17_40) Local Contact: Medtronic International Limited Contact no./Email: 64365000	HSA 6004101-009-15-17_40 FSN [PDF, 63 KB] (opens in new tab)
03 Nov 2015	CAVITY SpineWand Device, 8-gauge, ArthroCare Corporation (HSA 600:41/01-073/15/10_49) Local Contact: Smith & Nephew Pte Limited Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-10_49 FSN [PDF, 81 KB] (opens in new tab)
03 Nov 2015	Xper Flex Cardio Physiomonitoring System, Witt Biomedical Corporation (HSA 600:41/01-026/15/36_35) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-15-36_35 FSN [PDF, 85 KB] (opens in new tab)
03 Nov 2015	Attachment for acetabular and medullary reaming, Synthes GmbH (HSA 600:41/01-002/15/47_19) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-47_19 FSN [PDF, 64 KB] (opens in new tab)
03 Nov 2015	USS II Polyaxial screws, USS Variable Axis Screws, Universal Reduction screws, Synthes GmbH (HSA 600:41/01-002/15/48_33) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-48_33 FSN [PDF, 1049 KB] (opens in new tab)
02Nov 2015	Baxter Vented Paclitaxel Set, Baxter Healthcare SA (HSA 600:41/01-001/15/03_25) Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact no./Email: 68262616	HSA 6004101-001-15-03_25 FSN [PDF, 375 KB] (opens in new tab)
02 Nov 2015	IOL Master 500, Carl Zeiss Meditec Ag (HSA 600:41/01-136/15/02_18) Local Contact: Carl Zeiss Pte Ltd Contact no./Email: 67419600	HSA 6004101-136-15-02_18 FSN [PDF, 834 KB] (opens in new tab)