Field Safety Notices

Field Safety Notice - Oct 2016

Audiences

Healthcare professional

Industry member

Product type

Medical devices

31 October 2016

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 Oct 2016	Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/51_45) Local Contact: Siemens Healthcare Pte ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-51_45 FSN [PDF, 1548 KB] (opens in new tab)
31 Oct 2016	LMA MAD Nasal Intranasal Mucosal Atomization Device, Wolf Tory Medical, Inc (HSA 600:41/01-139/16/05_25) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 64390000	HSA 6004101-139-16-05_25 FSN [PDF, 428 KB] (opens in new tab)
31 Oct 2016	Axiom Artis Systems and Artis Zee Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/16/50_19) Local Contact: Siemens Healthcare Pte ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-50_19 FSN [PDF, 1419 KB] (opens in new tab) HSA 6004101-022-16-50_19 FSN [PDF, 1730 KB] (opens in new tab)
27 Oct 2016	SOMA TOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH (HSA 600:41/01-022/16/49_46) Local Contact: Siemens Healthcare Pte ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-49_46 FSN [PDF, 3284 KB] (opens in new tab)
27 Oct 2016	AssayTip/AssayCup, Roche Diagnostic GmbH (HSA 600:41/01-016/16/18_38) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-18_38 FSN [PDF, 192 KB] (opens in new tab)
27 Oct 2016	Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/37_48) Local Contact: Philips Electronics (S) Pte ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-37_48 FSN [PDF, 208 KB] (opens in new tab)
27 Oct 2016	X-Force™ Nephrostomy Balloon Dilation Catheter Kit With Inflation Device, C.R. Bard, Inc (HSA 600:41/01-050/16/09_56) Local Contact: Bard Singapore Pte Ltd Contact no./Email: Complaints.Singapore@crbard.com	HSA 6004101-050-16-09_56 FSN [PDF, 403 KB] (opens in new tab)
27 Oct 2016	Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/38_17) Local Contact: Philips Electronics (S) Pte ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-38_17 FSN [PDF, 241 KB] (opens in new tab)
26 Oct 2016	One Lambda LABType SSO and HD Typing Tests, One Lambda, Inc (HSA 600:41/01-033/16/07_34) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: regulatory@biomed.com.sg	HSA 6004101-033-16-07_34 FSN [PDF, 147 KB] (opens in new tab)
26 Oct 2016	Nellix EndoVascular Aneurysm Sealing System, Endologix, Inc (HSA 600:41/01-057/16/05_54) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net	HSA 6004101-057-16-05_54 FSN [PDF, 901 KB] (opens in new tab)
25 Oct 2016	SynReam Reaming Rod, Synthes GmbH (HSA 600:41/01-002/16/35_63) Local Contact: Johnson & Johnson Pte ltd Contact no./Email: 67504213	HSA 6004101-002-16-35_63 FSN [PDF, 2097 KB] (opens in new tab)
25 Oct 2016	Knee Navigation System, Brainlab AG (HSA 600:41/01-047/15/09_51) Local Contact: Brainlab Limited (Singapore Branch) Contact no./Email: 67341701	HSA 6004101-047-15-09_51 FSN [PDF, 311 KB] (opens in new tab)
21 Oct 2016	Fujifilm Synapse 4.0, FUJIFILM CORPORATION (HSA 600:41/01-173/16/03_41) Local Contact: Fujifilm Asia Pacific Pte Ltd Contact no./Email: 63809933	HSA 6004101-173-16-03_41 FSN [PDF, 152 KB] (opens in new tab)
21 Oct 2016	Bard® Fluoro-4 Silicone Figure Four Coil, InLay, InLay VersaFit, InLay Optima Ureteral Stent, C.R. Bard, Inc (HSA 600:41/01-050/16/08_44) Local Contact: Bard Singapore Pte Ltd Contact no./Email: Complaints.Singapore@crbard.com	HSA 6004101-050-16-08_44 FSN [PDF, 282 KB] (opens in new tab)
20 Oct 2016	Nihon Kohden Cardiolife AED Automated External Defibrillator, Nihon Kohden Corporation (HSA 600:41/01-074/16/01_35) Local Contact: Nihon Kohden Singapore Pte Ltd Contact no./Email: 63762210	HSA 6004101-074-16-01_35 FSN [PDF, 1650 KB] (opens in new tab)
20 Oct 2016	ADVIA Centaur CA 19-9, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/48_31) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-48_31 FSN [PDF, 615 KB] (opens in new tab)
19 Oct 2016	EZ-Tip, Research Instruments Ltd (HSA 600:41/01-210/16/02_33) Local Contact: LabIVF Asia Pte Ltd Contact no./Email: sales@labivf.com	HSA 6004101-210-16-02_33 FSN [PDF, 111 KB] (opens in new tab)
19 Oct 2016	Philips Achieva 3.0T and Ingenia 3.0T MR, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/16/36_25) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-16-36_25 FSN [PDF, 245 KB] (opens in new tab)
19 Oct 2016	Monaco RTP System, IMPAC Medical Systems, Inc (HSA 600:41/01-101/16/08_45) Local Contact: Elekta Pte Ltd Contact no./Email: elekta_global_pms@elekta.com	HSA 6004101-101-16-08_45 FSN [PDF, 63 KB] (opens in new tab)
18 Oct 2016	Vygon Lectroguard IV Extension Tube, Vygon SA (HSA 600:41/01-051/16/01_19) Local Contact: Star Medical Co Pte Ltd Contact no./Email: sales@starmedical.com	HSA 6004101-051-16-01_19 FSN [PDF, 355 KB] (opens in new tab)
17 Oct 2016	Fujifilm Ultrasonic Video Endoscope, Fujifilm Corporation (HSA 600:41/01-173/16/02_36) Local Contact: Fujifilm Asia Pacific Pte Ltd Contact no./Email: 63809933	HSA 6004101-173-16-02_36 FSN [PDF, 50 KB] (opens in new tab)
17 Oct 2016	M.I Tech Choostent Covered Esophageal Stent, M.I. Tech Co Ltd (HSA 600:41/01-305/16/01_49) Local Contact: Vitramed Singapore Pte Ltd Contact no./Email: michael.lim@vitramed.com	HSA 6004101-305-16-01_49 FSN [PDF, 4652 KB] (opens in new tab)
14 Oct 2016	VITROS Chemistry Products Calibrator Kit 25, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/02_22) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 64861151	HSA 6004101-303-16-02_22 FSN [PDF, 338 KB] (opens in new tab)
14 Oct 2016	Bard SafeStep Huber Neede Set, Bard Access Systems, Inc. (HSA 600:41/01-050/16/07_08) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 65805988	HSA 6004101-050-16-07_08 FSN [PDF, 201 KB] (opens in new tab)
14 Oct 2016	ADVIA® Chemistry Direct BilirubinAssay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/47_23) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-47_23 FSN [PDF, 276 KB] (opens in new tab)
13 Oct 2016	GE BRIVO OEC 715/785/865, GE Hangwei Medical Systems Co., Ltd (HSA 600:41/01-010/16/16_62) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668	HSA 6004101-010-16-16_62 FSN [PDF, 291 KB] (opens in new tab)
13 Oct 2016	Ortho-Clinical VITROS Immunodiagnostic Products Intact PTH Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/01_65) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 64861151	HSA 6004101-303-16-01_65_FSN [PDF, 157 KB] (opens in new tab)
13 Oct 2016	Standard Offset Cup Impactor With Pom-C Handle, Greatbatch Medical (HSA 600:41/01-014/16/14_56) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA 6004101-014-16-14_56 FSN [PDF, 389 KB] (opens in new tab)
12 Oct 2016	Dialog+ Dialyzer machine, B. Braun Avitum AG (HSA 600:41/01-012/16/10_48) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-16-10_48 FSN [PDF, 4150 KB] (opens in new tab)
11 Oct 2016	ARCHITECT Lactic Acid, Abbott Laboratories (HSA 600:41/01-005/16/10_61) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 68859103	HSA 6004101-005-16-10_61 FSN [PDF, 26 KB] (opens in new tab)
11 Oct 2016	Fortify™, Fortify Assura™, Quadra Assura™,Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™, St Jude Medical (HSA 600:41/01-025/16/02_46) Local Contact: St Jude Medical (Singapore) Pte Ltd Contact no./Email: 66432800	HSA 6004101-025-16-02_46 FSN [PDF, 58 KB] (opens in new tab)
10 Oct 2016	SenTec Digital Monitoring System (SMD), SenTec AG (HSA 600:41/01-199/16/02_54) Local Contact: Junnimed Services Pte Ltd Contact no./Email: 65467737	HSA 6004101-199-16-02_54 FSN [PDF, 301 KB] (opens in new tab)
10 Oct 2016	Boston Scientific Guider Softip Catheter XF, Boston Scientific Corporation (HSA 600:41/01-014/16/13_52) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: 93679174	HSA 6004101-014-16-13_52 FSN [PDF, 33 KB] (opens in new tab)
7 Oct 2016	ID-DiaCell I-II, DiaMed GmbH (HSA 600:41/01-027/16/11_60) Local Contact:Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA 6004101-027-16-11_60 FSN [PDF, 1560 KB] (opens in new tab)
7 Oct 2016	ICU TegoTM Needle-Free Access Device Connector, ICU Medical, Inc (HSA 600:41/01-145/16/02_51) Local Contact:Medquest Marketing Pte Ltd Contact no./Email: 68051250	HSA 6004101-145-16-02_51 FSN [PDF, 349 KB] (opens in new tab)
6 Oct 2016	ADVIA Centaur Vitamin D Total, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/46_57) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-46_57 FSN [PDF, 107 KB] (opens in new tab)
6 Oct 2016	IBA Proton Therapy Systems, Ion Beam Applications S.A. (HSA 600:41/01-070/16/20_40) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com	HSA 6004101-070-16-20_40 FSN [PDF, 254 KB] (opens in new tab)
6 Oct 2016	Low Profile Abutments, Biomet 3i (HSA 600:41/01-181/16/03_44) Local Contact: Asia Implant Support & Services Contact no./Email: admin@implant.com.sg	HSA 6004101-181-16-03_44 FSN [PDF, 166 KB] (opens in new tab)
6 Oct 2016	ARCTIC SUN® 5000 Temperature Management System, C.R. Bard, Inc. (HSA 600:41/01-050/16/06_50) Local Contact: Bard Singapore Pte Ltd Contact no./Email: Singapore@crbard.com	HSA 6004101-050-16-06_50 FSN [PDF, 606 KB] (opens in new tab)
6 Oct 2016	Pipeline embolization device,Alligator retrieval device,Marathon microcatheter stylets,UltraFlow HPC microcatheter stylets andXcelerator hydrophilic guidewire, Micro Therapeutics Inc dba eV3 Neurovascular (HSA 600:41/01-046/16/09_41) Local Contact: Covidien Private Limited Contact no./Email: 64396974	HSA 6004101-046-16-09_41 FSN [PDF, 2482 KB] (opens in new tab)
6 Oct 2016	Tina-quant HbA1c Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/16_59) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-16_59 FSN [PDF, 287 KB] (opens in new tab)
5 Oct 2016	Clearify Visualization System, Covidien llc (HSA 600:41/01-046/16/08_49) Local Contact: Covidien Private Limited Contact no./Email: 64396974	HSA 6004101-046-16-08_49 FSN [PDF, 1542 KB] (opens in new tab)
28 Jun 2016	API 3200MD LC/MS/MS system, 3200MD Qtrap LC/MS/MS system, Triple Quad 4500MD LC/MS/MS system and Qtrap LC/MS/MS system, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/03_38) Local Contact: AB SCIEX Pte Ltd Contact no./Email: 63043722	HSA 6004101-255-16-03_38 FSN [PDF, 150 KB] (opens in new tab)
25 May 2016	da Vinci Xi 5 mm-8 mm Universal Cannula Seal, da Vinci Xi 12 mm & Stapler Universal Cannula Seal, Intuitive Surgical Inc (HSA 600:41/01-070/16/15_29) Local Contact: Transmedic Pte Ltd Contact No.: 64776101	HSA 6004101-070-16-15_29 FSN [PDF, 4825 KB] (opens in new tab)