Field Safety Notices

Field Safety Notice - Jan 2016

31 January 2016

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Table caption

Date of Notification	Title	FSN
29 Jan 2016	Accu-Chek Inform II Base Unit, Handheld Base Unit, Roche HBU/BU Control Panel, Accu-Chek Inform II meter+RF, Accu-Chek Inform II meter, CoaguChek XS Pro Int'l, CoaguChek XS Plus Int'l, Roche Diagnostics GmbH (HSA 600:41/01-016/16/02_31) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-02_31 FSN [PDF, 852 KB] (opens in new tab)
27 Jan 2016	Ellipse Nordlys/Sirius, Ellipse A/S (HSA 600:41/01-288/16/01_33) Local Contact: Aradigm Pte Ltd Contact no./Email: 64635993	HSA 6004101-288-16-01_33 FSN [PDF, 29 KB] (opens in new tab)
27 Jan 2016	LEGION Screw-On Hemi Stepped Tibial Wedge, 5mm Sz 5-6 Lt-Lat/Rt-Mdl, Smith & Nephew Inc (HSA 600:41/01-073/16/03_19) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-03-19 FSN [PDF, 79 KB] (opens in new tab)
27 Jan 2016	Haemonetics MCS+ System, Haemonetics Automated Cell Processor ACP 215, Haemonetics Corporation (HSA 600:41/01-070/16/02_29) Local Contact: Transmedic Pte Ltd Contact no./Email: 64776101	HSA 6004101-070-16-02_29 FSN [PDF, 199 KB] (opens in new tab)
27 Jan 2016	Eclipse™ Treatment Planning System, Varian Medical Systems Inc (HSA 600:41/01-058/16/01_25) Local Contact: Varian Medical Systems Pacific Inc Contact no./Email: 68870028	HSA 6004101-058-16-01_25 FSN [PDF, 242 KB] (opens in new tab)
26 Jan 2016	iChemVELOCITY Urine Chemistry Strips, Iris Diagnostics (HSA 600:41/01-052/16/02_22) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 63407126	HSA 6004101-052-16-02_22 FSN [PDF, 171 KB] (opens in new tab)
26 Jan 2016	Trilogy 100, Trilogy 200, and Trilogy 202 units with software versions 13.2.04 or 13.2.05 or 14.0.00 or 14.1.01, Respironics Inc (HSA 600:41/01-026/16/04_18) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-04_18 FSN [PDF, 97 KB] (opens in new tab)
26 Jan 2016	ARCHITECT STAT High Sensitive Troponin-I Reagent Kit, Abbott Ireland (Diagnostics Division) (HSA 600:41/01-005/16/01_24) Local Contact: Abbott Laboratories Singapore Ltd Contact no./Email: 68859103	HSA 6004101-005-16-01_24 FSN [PDF, 32 KB] (opens in new tab)
26 Jan 2016	VITROS® 4600 Chemistry System, VITROS® 5600 Chemistry System, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/16/02_23) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-16-02_23 FSN [PDF, 137 KB] (opens in new tab) HSA 6004101-002-16-02_23 FSN [PDF, 118 KB] (opens in new tab)
25 Jan 2016	Leica M525 OH4 / M720 OH5 Surgical Microscopes with 400W Illumination, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/16/01_56) Local Contact: Leica Microsystems (SEA) Pte Ltd Contact no./Email: 65505999	HSA 6004101-126-16-01_56 FSN [PDF, 196 KB] (opens in new tab)
25 Jan 2016	BrightView, BrightView X, BrightView XCT, BrightView XCT Upgrade, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/16/02_48) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-02_48 FSN [PDF, 166 KB] (opens in new tab)
25 Jan 2016	cobas® b 123 POC System, Roche Diagnostics GmbH (HSA 600:41/01-016/16/01_20) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-01_20 FSN [PDF, 574 KB] (opens in new tab)
22 Jan 2016	LCP Distal Tibial Plate & Expert™ A2FN, Synthes GmbH (HSA 600:41/01-002/16/01_55) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-01_55 FSN [PDF, 75 KB] (opens in new tab)
22 Jan 2016	HP cosmos Medical treadmill ergometer, h/p/cosmos Sports & Medical GmbH (HSA 600:41/01-039/16/02_54) Local Contact: United BMEC Pte Ltd Contact no./Email: 63052525	HSA 6004101-039-16-02_54 FSN [PDF, 806 KB] (opens in new tab)
21 Jan 2016	Single Lumen Central Venous, Femoral Artery Pressure Monitoring & Radial Artery Pressure Monitoring Catheter Sets, Cook Incorporated (HSA 600:41/01-013/16/01_44) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 62877888	HSA 6004101-013-16-01_44 FSN [PDF, 157 KB] (opens in new tab)
20 Jan 2016	HF440 devices with fifth pump option, Infomed SA (HSA 600:41/01-070/16/01_52) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-01_52 FSN [PDF, 206 KB] (opens in new tab)
19 Jan 2016	Puritan Bennett™ 980 Ventilator System, Covidien llc (HSA 600:41/01-046/16/01_41) Local Contact: Covidien Private Limited Contact no./Email: 64396974	HSA 6004101-046-16-01_41 FSN [PDF, 897 KB] (opens in new tab)
19 Jan 2016	DYONICS RF Broadnose 90 Wand, Smith & Nephew Inc (HSA 600:41/01-073/16/02_50) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-02_50 FSN [PDF, 55 KB] (opens in new tab)
19 Jan 2016	ED-530XT Duodenoscope for Treatment, Fujifilm Corporation (HSA 600:41/01-173/16/01_40) Local Contact: Fujifilm Asia Pacific Pte Ltd Contact no./Email: support@fujifilm.com.sg	HSA 6004101-173-16-01_40 FSN [PDF, 78 KB] (opens in new tab)
18 Jan 2016	BCS/ BCS XP with Dade Innovin, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-022/16/03_61) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-03_61 FSN [PDF, 92 KB] (opens in new tab)
15 Jan 2016	BEAVER 4.0mm Banana Blade, Smith & Nephew Inc (HSA 600:41/01-073/16/01_36) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-16-01_36 FSN [PDF, 83 KB] (opens in new tab)
14 Jan 2016	ADVIA CENTAUR ENHANCED ESTRADIOL, IMMULITE 1000/IMMULITE 2000 ESTRADIOL [CC 16-03], Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/02_60) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-02_60 FSN [PDF, 104 KB] (opens in new tab)
14 Jan 2016	Multipolar Bipolar Cup, CPT Femoral Stem, Versys Beaded Fullcoat Femoral Stem, Metasul Head, CoCr Head, NexGen Femoral Component, Natural-Knee Flex Femoral Component, Zimmer Unicompartmental Knee Femoral Component and 4 more devices, Zimmer Inc. (HSA 600:41/01-032/16/01_59) Local Contact: Zimmer Pte Ltd Contact no./Email: 68547081	HSA 6004101-008-16-03_35 FSN [PDF, 69 KB] (opens in new tab)
13 Jan 2016	INNOVANCE PFA P2Y, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/16/01_59) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: 62213629	HSA 6004101-032-16-01_59 FSN [PDF, 22 KB] (opens in new tab)
12 Jan 2016	T34 Ambulatory Syringe Pump, Caesarea Medical Electronics Ltd (HSA 600:41/01-287/16/01_33) Local Contact: Progress Healthcare Pte Ltd Contact no./Email: 62975955	HSA 6004101-287-16-01_33 FSN [PDF, 444 KB] (opens in new tab)
12 Jan 2016	Philips IntelliVue Measurement Modules (X1, X2), Philips Medical Systems Boblinger GmbH (HSA 600:41/01-026/16/01_19) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 7445477	HSA 6004101-026-16-01_19 FSN [PDF, 39 KB] (opens in new tab)
12 Jan 2016	PRN 50-M+ Digital Writer, GSI Group (HSA 600:41/01-010/16/01_29) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-16-01_29 FSN [PDF, 86 KB] (opens in new tab)
11 Jan 2016	Phadia EliA SmDp Well, Phadia AB (HSA 600:41/01-033/16/01_57) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 62984347	HSA 6004101-033-16-01_57 FSN [PDF, 164 KB] (opens in new tab)
08 Jan 2016	Guide Wire(s) and K-Wire(s) and Intramedullary Pin Metaizeau, Stryker Trauma GmbH (HSA 600:41/01-014/16/01_18) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: 65009507	HSA 6004101-014-16-01_18 FSN [PDF, 196 KB] (opens in new tab)
07 Jan 2016	Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead, Medtronic Inc. (HSA 600:41/01-009/16/01_17) Local Contact: Medtronic International Limited Contact no./Email: 64365000	HSA 6004101-009-16-01_17 FSN [PDF, 4199 KB] (opens in new tab)
06 Jan 2016	Sulcoflex Toric, Rayner Intraocular Lenses Ltd. (HSA 600:41/01-110/16/01_48) Local Contact: Mandarin Opto-Medic Co Pte Ltd Contact no./Email: 67478777	HSA 6004101-110-16-01_48 FSN [PDF, 3170 KB] (opens in new tab)
05 Jan 2016	9131 Defibrillation Electrode, Cardiac Science Corporation (HSA 600:41/01-089/16/01_46) Local Contact: Progressive Industrial Equipment Co. Contact no./Email: 62827722	HSA 6004101-089-16-01_46 FSN [PDF, 511 KB] (opens in new tab)
05 Jan 2016	ADVIA Centaur Systems PSA, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/01_58) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-01_58 FSN [PDF, 85 KB] (opens in new tab)
05 Jan 2016	FRED easy AED, Schiller Medical (HSA 600:41/01-056/16/01_54) Local Contact: Gold Lite Pte Ltd Contact no./Email: 62730487	HSA 6004101-056-16-01_54 FSN [PDF, 1391 KB] (opens in new tab)
04 Jan 2016	COULTER® S-CAL® Calibrator Kits, Beckman Coulter Inc (HSA 600:41/01-052/16/01_38) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-16-01_38 FSN [PDF, 113 KB] (opens in new tab)
04 Jan 2016	NexGen Precoat Tibial Plate & NexGen Option Tibial Plate, Zimmer Inc (HSA 600:41/01-008/16/01_45) Local Contact: Zimmer Pte Ltd Contact no./Email:6854 7081	HSA 6004101-008-16-01_45 FSN [PDF, 140 KB] (opens in new tab)
20 Nov 2015	Evita Infinity V500, Babylog VN500 and Evita V300, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/15/03_37) Local Contact: Draeger Medical SEA Pte Ltd Contact no./Email: dsa.singapore@draeger.com	HSA 6004101-063-15-03_37 FSN [PDF, 4217 KB] (opens in new tab)