Field Safety Notices

Field Safety Notice - Jul 2015

31 July 2015

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
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)