Field Safety Notices

Field Safety Notice - Jul 2015

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 July 2015

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Table caption

Date of Notification	Title	FSN
31 Jul 2015	ADVIA Centaur XPT System (HSA 600:41/01-022/15/39_23) Local contact: Siemens Healthcare Pte Ltd	HSA 6004101-022-15-39_23 FSN [PDF, 86 KB] (opens in new tab)
31 Jul 2015	RAPIDPoint® 500 Blood Gas Analyzer (HSA 600:41/01-022/15/40_24) Local contact: Siemens Healthcare Pte Ltd	HSA 6004101-022-15-40_24 FSN [PDF, 133 KB] (opens in new tab)
31 Jul 2015	Fixation kit N20, used with TCM CombiM and Philips TcG10 (HSA 600:41/01-219/15/04_43) Local contact: Radiometer S.E.A Pte Ltd	HSA 6004101-219-15-04_43 FSN [PDF, 20 KB] (opens in new tab)
27 Jul 2015	Medtronic EnVeo R Loading System (HSA 600:41/01-009/15/10_51) Local contact: Medtronic International Limited	HSA 6004101-009-15-10_51 FSN [PDF, 2202 KB] (opens in new tab)
27 Jul 2015	iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips (HSA 600:41/01-052/15/03_22) Local contact: Beckman Coulter Singapore Pte Ltd	HSA 6004101-052-15-03_22 FSN [PDF, 206 KB] (opens in new tab)
24 Jul 2015	EVair Compressor (HSA 600:41/01-010/15/14_50) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-14_50 FSN [PDF, 177 KB] (opens in new tab)
24 Jul 2015	Rival™ PTA Balloon Dilatation Catheter (HSA 600:41/01-050/15/04_41) Local contact: Bard Singapore Pte Ltd	HSA 6004101-050-15-04_41 FSN [PDF, 188 KB] (opens in new tab)
23 Jul 2015	LightSpeed 16 (MDAS Only) (HSA 600:41/01-010/15/13_40) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-13_40 FSN [PDF, 75 KB] (opens in new tab)
22 Jul 2015	Puritan Bennett 980 series Ventilator System (HSA 600:41/01-046/15/07_35) Local contact: Covidien Private Limited	HSA 6004101-046-15-07_35 FSN [PDF, 1166 KB] (opens in new tab)
21 Jul 2015	Siemens Dimension® Creatinine Flex® reagent cartridge (HSA 600:41/01-022/15/38_20) Local contact: Siemens Healthcare Pte Ltd	HSA 6004101-022-15-38_20 FSN [PDF, 79 KB] (opens in new tab)
21 Jul 2015	MedCOMP Hemo-Cath LT and Hemo-Cath ST Hemodialysis Catheters (HSA 600:41/01-278/15/02_37) Local contact: SingMed Healthcare Systems	HSA 6004101-278-15-02_37 FSN [PDF, 64 KB] (opens in new tab)
20 Jul 2015	Signa line of products - MR ACGD Cabinet FRU X Gradient Cable (HSA 600:41/01-010/15/12_32) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-12_32 FSN [PDF, 209 KB] (opens in new tab)
16 Jul 2015	Neptune 2 Rover - Ultra diverter valve assembly (HSA 600:41/01-014/15/07_29) Local contact: Stryker Singapore Pte Ltd	HSA 6004101-014-15-07_29 FSN [PDF, 33 KB] (opens in new tab)
16 Jul 2015	Shimadzu Safire 17 Digital Radiographic System (HSA 600:41/01-281/15/01_33) Local contact: Shimadzu (Asia Pacific) Pte Ltd	HSA 6004101-281-15-01_33 FSN [PDF, 73 KB] (opens in new tab)
15 Jul 2015	SURESHOT Humeral 3.2 MM AO Drills (HSA 600:41/01-073/15/07_25) Local contact: Smith & Nephew Pte Ltd	HSA 6004101-073-15-07_25 FSN [PDF, 79 KB] (opens in new tab)
15 Jul 2015	Sorin Mitroflow Aortic Pericardial Heart Valve (HSA 600:41/01-095/15/02_19) Local contact:Sorin Group Asia Pte Ltd	HSA 6004101-095-15-02_19 FSN [PDF, 300 KB] (opens in new tab)
14 Jul 2015	Synthes RIA System (HSA 600:41/01-002/15/28_08) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-28_08 FSN [PDF, 36 KB] (opens in new tab)
14 Jul 2015	EASYPUMP II LT 60-30-S (HSA 600:41/01-012/15/06_17) Local contact: B. Braun Singapore Pte Ltd	HSA 6004101-012-15-06_17 FSN [PDF, 68 KB] (opens in new tab)
14 Jul 2015	AMICA Probe(Part of HS AMICA Ablation System) (HSA 600:41/01-280/15/01_18) Local contact: Asiamed Healthcare Systems Pte Ltd	HSA 6004101-280-15-01_18 FSN [PDF, 2022 KB] (opens in new tab)
13 Jul 2015	Volcano s5 and CORE Series (HSA 600:41/01-070/15/13_09) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-13_09 FSN [PDF, 171 KB] (opens in new tab)
13 Jul 2015	Delfia Xpress PLGF Kit (HSA 600:41/01-127/15/03_07) Local contact: Perkin Elmer Singapore Pte Ltd	HSA 6004101-127-15-03_07 FSN [PDF, 219 KB] (opens in new tab)
10 Jul 2015	Nihon Kohden Central Monitors CNS 6201 series (HSA 600:41/01-074/15/01_58) Local contact: Nihon Kohden Singapore Pte Ltd	HSA 6004101-074-15-01_58 FSN [PDF, 649 KB] (opens in new tab)
09 Jul 2015	BrainLab iPlan RT Dose version 4.0 and 4.1 (HSA 600:41/01-047/15/04_18) Local contact: BrainLab Limited (Singapore Branch)	HSA 6004101-047-15-04_18 FSN [PDF, 572 KB] (opens in new tab)
09 Jul 2015	Evita Infinity V500, Babylog VN500 and Evita V300 (HSA 600:41/01-063/15/02_37) Local contact: Draeger Medical SEA Pte Ltd	HSA 6004101-063-15-02_37 FSN [PDF, 7404 KB] (opens in new tab)
08 Jul 2015	ADVIA Chemistry Acetaminophen reagent (HSA 600:41/01-022/15/37_32) Local contact: Siemens Healthcare Pte Ltd	HSA 6004101-022-15-37_32 FSN [PDF, 79 KB] (opens in new tab)
08 Jul 2015	Philips HeartStart XL+ Defibrillator/Monitor (HSA 600:41/01-026/15/24_54) Local contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-15-24_54 FSN [PDF, 83 KB] (opens in new tab)
07 Jul 2015	Roche Diagnostics Reflotron Uric Acid (HSA 600:41/01-016/15/13_45) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-13_45 FSN [PDF, 1234 KB] (opens in new tab)
07 Jul 2015	Cobas b 123 Fluid Pack, Cobas b 123 <4> POC system (HSA 600:41/01-016/15/14_20) Local contact: Roche Diagnostics Asia Pacific Pte Ltd	HSA 6004101-016-15-14_20 FSN [PDF, 1427 KB] (opens in new tab)
07 Jul 2015	Philips Allura systems (HSA 600:41/01-026/15/23_17) Local contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-15-23_17 FSN [PDF, 292 KB] (opens in new tab)
06 Jul 2015	VITROS® 5,1 FS Chemistry System (HSA 600:41/01-002/15/27_18) Local contact: Johnson & Johnson Pte Ltd	HSA 6004101-002-15-27_18 FSN [PDF, 85 KB] (opens in new tab)
06 Jul 2015	Precision 500D Classical R & F system, Precision Rxi 23A/32A Analog system, Precision Rxi Digital system and Precision Mpi (HSA 600:41/01-010/15/11_19) Local contact: GE Healthcare Pte Ltd	HSA 6004101-010-15-11_19 FSN [PDF, 722 KB] (opens in new tab)
03 Jul 2015	3D Optical Coherence Tomography 3D OCT-1(HSA 600:41/01-193/15/01_34) Local contact: Topcon Singapore Medical Pte Ltd	HSA 6004101-193-15-01_34 FSN [PDF, 1497 KB] (opens in new tab)
03 Jul 2015	Ceiling Supply Unit klinoPORT (HSA 600:41/01-279/15/01_47) Local contact: Bio-Pointe Pte Ltd	HSA 6004101-279-15-01_47 FSN [PDF, 391 KB] (opens in new tab)
02 Jul 2015	Medtronic 23mm Engager Transcatheter Aortic Bioprosthesis (HSA 600:41/01-009/15/09_20) Local contact: Medtronic International Limited	HSA 6004101-009-15-09_20 FSN [PDF, 2422 KB] (opens in new tab)
02 Jul 2015	ACUSON S series (HSA 600:41/01-022/15/35_17) Local contact: Siemens Healthcare Pte Ltd	HSA 6004101-022-15-35_17 FSN [PDF, 876 KB] (opens in new tab)
02 Jul 2015	CLINITEK Novus® Analyzer (HSA 600:41/01-022/15/36_16) Local contact: Siemens Healthcare Pte Ltd	HSA 6004101-022-15-36_16 FSN [PDF, 79 KB] (opens in new tab)
02 Jul 2015	BrainLab Cranial IGS System (HSA 600:41/01-047/15/03_18) Local contact: BrainLab Limited (Singapore Branch)	HSA 6004101-047-15-03_18 FSN [PDF, 543 KB] (opens in new tab)
02 Jul 2015	i-STAT PT/INR Cartridges (HSA 600:41/01-070/15/12_19) Local contact: Transmedic Pte Ltd	HSA 6004101-070-15-12_19 FSN [PDF, 31 KB] (opens in new tab)
01 Jul 2015	Cook LapSac Surgical Tissue Pouch (HSA 600:41/01-013/15/02_42) Local contact: Cook South East Asia Pte Ltd	HSA 6004101-013-15-02_42 FSN [PDF, 216 KB] (opens in new tab)
01 Jul 2015	Orsiro Sirolimus Eluting Coronary Stent System (HSA 600:41/01-269/15/03_44) Local contact: Biotronik Asia Pacific Pte Ltd	HSA 6004101-269-15-03_44 FSN [PDF, 75 KB] (opens in new tab)