Field Safety Notices

Field Safety Notice - Feb 2015

28 February 2015

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

Date of Notification	Title	FSN
27 Feb 2015	Abbott Architect Anti-HBc Assay, Abbott GmbH & Co KG (HSA 600:41/01-005/15/01_01) Local contact: Abbott Laboratories (S) Pte Ltd	HSA 6004101-005-15-01_01 FSN [PDF, 203 KB] (opens in new tab)
27 Feb 2015	Brivo, Signa, Optima and Discovery, GE Medical Systems LLC (HSA 600:41/01-010/15/04_02) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-04_02 FSN [PDF, 206 KB] (opens in new tab)
26 Feb 2015	Passeo-18 Peripheral Dilatation Balloon Catheter, Biotronik AG (HSA 600:41/01-269/15/01_01) Local contact: Biotronik Asia Pacific Pte Ltd	HSA 6004101-269-15-01_01 FSN [PDF, 21 KB] (opens in new tab)
25 Feb 2015	PKS PlasmaSORD Morcellator, Gyrus ACMI, Inc (HSA 600:41/01-004/15/01_11) Local contact: Olympus Singapore Pte Ltd	HSA 6004101-004-15-01_11 FSN [PDF, 76 KB] (opens in new tab)
25 Feb 2015	Carestream CS8100 X-Ray System, Carestream Health Inc (HSA 600:41/01-187/15/01_08) Local contact: Carestream Health Singapore Pte Ltd	HSA 6004101-187-15-01_08 FSN [PDF, 20 KB] (opens in new tab)
24 Feb 2015	IMMULITE 2000/ IMMULITE 2000 Xpi, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/15/10_11) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-10_11 FSN [PDF, 413 KB] (opens in new tab)
24 Feb 2015	Nanostim Leadless Pacemaker & Delivery System Catheter, St Jude Medical (HSA 600:41/01-025/15/01_11) Local contact: St Jude Medical (Singapore) Pte Ltd	HSA 6004101-025-15-01_11 FSN [PDF, 84 KB] (opens in new tab)
18 Feb 2015	BD Q-Syte Luer Access Split-Septum, Becton, Dickinson and Company (HSA 600:41/01-003/15/01_08) Local contact: Becton Dickinson Holdings Pte Ltd (BD)	HSA 6004101-003-15-01_08 FSN [PDF, 65 KB] (opens in new tab)
17 Feb 2015	Zenith Alpha™ Thoracic Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013/15/01_02) Local contact: Cook South East Asia Pte Ltd	HSA 6004101-013-15-01_02 FSN [PDF, 327 KB] (opens in new tab)
16 Feb 2015	AK 200 S and AK 200 ULTRA S Systems, Gambro Lundia AB (HSA 600:41/01-011/15/02_09) Local contact: Gambro Singapore Pte Ltd	HSA 6004101-011-15-02_09 FSN [PDF, 8 KB] (opens in new tab)
16 Feb 2015	Aesculap Sillar Templet, B Braun Medical Limited (HSA 600:41/01-012/15/02_03) Local contact: B Braun Singapore Pte Ltd	HSA 6004101-012-15-02_03 FSN [PDF, 226 KB] (opens in new tab)
13 Feb 2015	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump, Datascope Corp (HSA 600:41/01-017/15/03_01) Local contact: IDS Medical Systems (Singapore) Pte Ltd	HSA 6004101-017-15-03_01 FSN [PDF, 74 KB] (opens in new tab)
13 Feb 2015	ADVIA Chemistry System 1200, 1800/1650, and 2400, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/09_09) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-09_09 FSN [PDF, 112 KB] (opens in new tab)
12 Feb 2015	Elecsys CMV IgM, Roche Diagnostics GmbH (HSA 600:41/01-016/15/03_09) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-03_09 FSN [PDF, 1313 KB] (opens in new tab)
12 Feb 2015	LMA Supreme (New Cuff), The Laryngeal Mask Company Limited (HSA 600:41/01-139/15/03_11) Local contact: Teleflex Medical Asia Pte Ltd	HSA 6004101-139-15-03_11 FSN [PDF, 529 KB] (opens in new tab)
12 Feb 2015	Invacare® PerfectO2™ and Platinum® Concentrator, Invacare Corporation (HSA 600:41/01-267/15/01_02) Local contact: @AsiaCare Pte Ltd	HSA 6004101-267-15-01_02 FSN [PDF, 371 KB] (opens in new tab)
12 Feb 2015	BioCer TiO2Mesh Surgical Mesh Implant, BioCer Entwicklungs GmbH (HSA 600:41/01-268/15/01_08) Local contact: Pioneer Medident (SE Asia) Pte Ltd	HSA 6004101-268-15-01_08 FSN [PDF, 97 KB] (opens in new tab)
11 Feb 2015	ADVIA Chemistry Drug Calibrator I, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/08_11) Local contact: Siemens Pte Ltd	HSA 6004101-022-15-08_11 FSN [PDF, 86 KB] (opens in new tab)
11 Feb 2015	C-flex Aspheric, T-flex Aspheric, Sulcoflex Aspheric, Superflex Aspheric, M-flex Hydrophilic Acrylic Single Use IOL system packs, Rayner Intraocular Lenses Ltd (HSA 600:41/01-110/15/01_11) Local contact: Mandarin Opto-Medic Co Pte Ltd	HSA 6004101-110-15-01_11 FSN [PDF, 4267 KB] (opens in new tab)
10 Feb 2015	GE T-2100 Treadmill, GE Medical Systems Information Technologies (HSA 600:41/01-010/15/03_09) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-03_09 FSN [PDF, 145 KB] (opens in new tab)
09 Feb 2015	Proteus XR/a, GE Hualun Medical Systems Co Ltd (HSA 600:41/01-010/15/02_11) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-02_11 FSN [PDF, 246 KB] (opens in new tab)
09 Feb 2015	One Lambda LABType SSO Typing Tests and LABType HD Typing Tests, One Lambda Inc (HSA 600:41/01-033/15/01_11) Local contact: Biomed Diagnostics Pte Ltd	HSA 6004101-033-15-01_11 FSN [PDF, 123 KB] (opens in new tab)
09 Feb 2015	Xcela PICC and BioFlo PICC, Navilyst Medical Inc (HSA 600:41/01-057/15/01_02) Local contact: Somnotec (S) Pte Ltd	HSA 6004101-057-15-01_02 FSN [PDF, 95 KB] (opens in new tab)
09 Feb 2015	Hudson RCI Humidifier Adaptor, Teleflex Medical (HSA 600:41/01-139/15/02_07) Local contact: Teleflex Medical Asia Pte Ltd	HSA 6004101-139-15-02_07 FSN [PDF, 500 KB] (opens in new tab)
05 Feb 2015	SC/MSC Biolox Delta Ins.32MM 48/50 Sym, Aesculap AG (HSA 600:41/01-012/15/01_11) Local contact: B Braun Singapore Pte Ltd	HSA 6004101-012-15-01_11 FSN [PDF, 120 KB] (opens in new tab)
02 Feb 2015	CADD Medication Cassette Reservoir, Smiths Medical ASD Ltd (HSA 600:41/01-017/15/02_01) Local contact: IDS Medical Systems (Singapore) Pte Ltd	HSA 6004101-017-15-02_01 FSN [PDF, 45 KB] (opens in new tab)
02 Feb 2015	Salicylate Enzymatic Reagent Kit, Audit Diagnostics (HSA 600:41/01-052/15/01_11) Local contact: Beckman Coulter Singapore Pte Ltd	HSA 6004101-052-15-01_11 FSN [PDF, 247 KB] (opens in new tab)
02 Feb 2015	Mako Surgery RIO Standard System, MAKO Surgical Corp (HSA 600:41/01-070/15/02_07) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-02_07 FSN [PDF, 1415 KB] (opens in new tab)