Field Safety Notices

Field Safety Notice - Apr 2018

30 April 2018

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
30 Apr 2018	MagNA Pure 24 System, Roche Diagnostics GmbH (HSA 600:41/01-016/18/05_67) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-05_67 FSN [PDF, 378 KB] (opens in new tab)
30 Apr 2018	Intuitive Surgical’s da Vinci Xi Stapler 45 Blue and Green Reloads, Intuitive Surgical, Inc (HSA 600:41/01-070/18/06_35) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-18-06_35 FSN [PDF, 386 KB] (opens in new tab)
30 Apr 2018	Aurinio L 110, L 120, L 150 and L 160, Aurinio OR lights series, Trilux Medical GmbH & Co. KG (HSA 600:41/01-099/18/01_45) Local Contact: Leedon Technology Pte Ltd Contact no./Email: 6284 8382/ leedon28@singnet.com.sg	HSA 6004101-099-18-01_45 FSN_Redacted [PDF, 3054 KB] (opens in new tab)
28 Apr 2018	T2 Femur and Tibia Nailing System, Stryker Trauma GmbH (HSA 600:41/01-014/18/05_66) Local Contact: Stryker Singapore Pte Ltd	HSA 6004101-014-18-05_66 FSN_Redacted [PDF, 129 KB] (opens in new tab)
27 Apr 2018	Artis Zee Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/18/10_45) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-10_45 FSN_Redacted [PDF, 1100 KB] (opens in new tab)
27 Apr 2018	Covidien ENDO GIA™ UNIVERSAL Stapler and Duet TRS™ Single Use Loading Units with Tissue Reinforcement, Covidien Endo GIA™ Ultra Universal Stapler and Endo GIA™ Reload with Tri-Staple™ Technology, Covidien llc (HSA 600:41/01-046/18/05_18) Local Contact: Covidien Pte Ltd Contact no./Email: 6439 6933	HSA 6004101-046-18-05_18 FSN_Redacted [PDF, 4215 KB] (opens in new tab)
27 Apr 2018	Urisys 1100 , Roche Diagnostics GmbH (HSA 600:41/01-016/18/04_61) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-04_61 FSN [PDF, 119 KB] (opens in new tab)
26 Apr 2018	Elements Obturation Unit with Buchanan Heat Pluggers, SybronEndo (HSA 600:41/01-168/18/01_71) Local Contact: KaVo Dental Asia Pacific Pte Ltd Contact no./Email: 6296 1790	HSA 6004101-168-18-01_71 FSN_Redacted [PDF, 306 KB] (opens in new tab)
26 Apr 2018	CLARUS 500, Carl Zeiss Meditec Inc. (HSA 600:41/01-136/18/01_64) Local Contact: Carl Zeiss Pte. Ltd. Contact no./Email: 6741 9600 / info@zeiss.com.sg	HSA 6004101-136-18-01_64 FSN [PDF, 112 KB] (opens in new tab)
25 Apr 2018	Acid Concentrate for Bicarbonate Haemodialysis, Fresenius Medical Care Production Sdn Bhd (HSA 600:41/01-062/18/01_68) Local Contact: Fresenius Medical Care Singapore Pte Ltd Contact no./Email: 6837 3113	HSA 6004101-062-18-01_68 FSN_Redacted [PDF, 1283 KB] (opens in new tab)
25 Apr 2018	Bard Seeker Crossing Support Catheter, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/18/02_18) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6580 5988 / complaints.singapore@crbard.com	HSA 6004101-050-18-02_18 FSN_Redacted [PDF, 382 KB] (opens in new tab)
25 Apr 2018	ThermoScientific Oxoid OX1 Oxacillin, Oxoid Limited (HSA 600:41/01-178/18/02_34) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 6362 9390	HSA 6004101-178-18-02_34 FSN_Redacted [PDF, 117 KB] (opens in new tab)
24 Apr 2018	Alinity I HBsAg Calibrator, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/05_59) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN@enquiry@abbott.com	HSA 6004101-005-18-05_59 FSN [PDF, 99 KB] (opens in new tab)
24 Apr 2018	ASKINA CALGITROL PASTE 15 G, B. Braun Hospicare Ltd (HSA 600:41/01-012/18/02_56) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 6213 0933 / press.sg@bbraun.com	HSA 6004101-012-18-02_56 FSN [PDF, 53 KB] (opens in new tab)
24 Apr 2018	BD Vacutainer® EDTA Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/18/05_58) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6690 8423	HSA 6004101-003-18-05_58 FSN_Redacted [PDF, 208 KB] (opens in new tab)
24 Apr 2018	CPFA Coupled Plasma Filtration Adsorption™, Covidien llc (HSA 600:41/01-046/18/04_46) Local Contact: Covidien Pte Ltd Contact no./Email: Tel: 64396974	HSA 6004101-046-18-04_46 FSN_Redacted [PDF, 696 KB] (opens in new tab)
20 Apr 2018	5mm ENDOPATH® XCEL™ Trocars with Optiview Technology, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/04_63) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 8304	HSA 6004101-002-18-04_63 FSN_Redacted [PDF, 631 KB] (opens in new tab)
20 Apr 2018	AdvanceTM Low Profile PTA Balloon Dilatation Catheter, Cook Incorporated (HSA 600:41/01-013/18/04_51) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com	HSA 6004101-013-18-04_51 FSN_Redacted [PDF, 127 KB] (opens in new tab)
20 Apr 2018	CHISEL MICRO CURVED VULCAN INTEGRATED; CHISEL MICRO VULCAN ANGLED INTEGRATED, Smith & Nephew, Inc. (HSA 600:41/01-073/18/09_63) Local Contact: Smith & Nephew Pte Limited Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-09_63 FSN [PDF, 192 KB] (opens in new tab)
20 Apr 2018	Smith & Nephew TAYLOR SPATIAL FRAME External Fixator, Smith & Nephew, Inc. (HSA 600:41/01-073/18/10_50) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-10_50 FSN [PDF, 174 KB] (opens in new tab)
20 Apr 2018	SOMA TOM go.Up and SOMA TOM go.Now, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/18/09_46) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-09_46 FSN_Redacted [PDF, 2486 KB] (opens in new tab)
19 Apr 2018	1. Merlin PCS 3650 Software Upgrade Kit 2. Merlin@home Transmitter Software 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™) St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/18/01_51) Local Contact: St Jude Medical (Singapore) Pte Ltd Contact no./Email: 6643 2800	HSA 6004101-025-18-01_51 FSN_Redacted [PDF, 548 KB] (opens in new tab)
19 Apr 2018	Cardiovit AT-102 Plus, Schiller AG (HSA 600:41/01-056/18/02_50) Local Contact: Gold Lite Pte Ltd Contact no./Email: 6273 0487	HSA 6004101-056-18-02_50 FSN_Redacted [PDF, 470 KB] (opens in new tab)
18 Apr 2018	MyLab Twice, Esaote (HSA 600:41/01-288/18/01_64) Local Contact: Medical Plus Pte Ltd	HSA 6004101-288-18-01_64 FSN_Redacted [PDF, 107 KB] (opens in new tab)
17 Apr 2018	Portex Thoracic Catheter and Connecting Tube, Smiths Medical International, Ltd. (HSA 600:41/01-017/18/02_40) Local Contact: IDS Medical Systems (S) Pte Ltd	HSA 6004101-017-18-02_40 FSN [PDF, 323 KB] (opens in new tab)
17 Apr 2018	TerumoBCT Spectra Optia® Apheresis System, TerumoBCT (HSA 600:41/01-155/18/01_36) Local Contact: TERUMO BCT ASIA PTE. LTD Contact no./Email: 67739051 / apac.communications@terumobct.com	HSA 6004101-155-18-01_36 FSN_Redacted [PDF, 409 KB] (opens in new tab)
17 Apr 2018	Peri-Loc 3.5MM Posterolateral Distal Fibula Locking Plate, Smith & Nephew Inc. (HSA 600:41/01-073/18/08_43) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-08_43 FSN [PDF, 174 KB] (opens in new tab)
16 Apr 2018	Sciatic Nerve Retractors, Synthes GmbH (HSA 600:41/01-002/18/03_49) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 8304	HSA 6004101-002-18-03_49 FSN_Redacted [PDF, 253 KB] (opens in new tab)
13 Apr 2018	Various Arrow Products, Arrow International, Inc (HSA 600:41/01-139/18/01_35) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 6439 3046	HSA 6004101-139-18-01_35 FSN_Redacted [PDF, 316 KB] (opens in new tab)
13 Apr 2018	Bio-Rad DiaMed ID-Card LISS Coombs and Bio-Rad DiaMed ID-Card Anti-IgG, DiaMed GmbH (HSA 600:41/01-027/18/04_58) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA 60041-01-027-18-04_58 FSN_Redacted [PDF, 3445 KB] (opens in new tab)
12 Apr 2018	Connecting Tube – Female to Male Luer Lock, Cook Incorporated (HSA 600:41/01-013/18/03_35) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com	HSA 6004101-013-18-03_35 FSN_Redacted [PDF, 114 KB] (opens in new tab)
12 Apr 2018	Ethicon Generator Gen11, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/02_37) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 7781	HSA 6004101-002-18-02_37 FSN_Redacted [PDF, 531 KB] (opens in new tab)
12 Apr 2018	Flexor Tuohy Borst Side-Arm Introducer Shuttle SL, Cook Incorporated (HSA 600:41/01-013/18/02_62) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com	HSA 6004101-013-18-02_62 FSN_Redacted [PDF, 110 KB] (opens in new tab)
11 Apr 2018	Gentinge Volista StandOP and TRIOP, Maquet SAS (HSA 600:41/01-081/18/04_45) Local Contact: Maquet South East Asia Pte Ltd Contact no./Email: 6296 1992	HSA 6004101-081-18-04_45 FSN [PDF, 201 KB] (opens in new tab)
10 Apr 2018	ARCHITECT Total T4 Calibrators, Abbott Ireland, Diagnostics Division (HSA 600:41/01-005/18/04_38) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 / 8000 / FSN@enquiry@abbott.com	HSA 6004101-005-18-04_38 FSN [PDF, 109 KB] (opens in new tab)
10 Apr 2018	Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology, Covidien llc (HSA 600:41/01-046/18/03_66) Local Contact: Covidien Pte Ltd Contact no./Email: 6439 6933	HSA 6004101-046-18-03_66 FSN_Redacted [PDF, 1397 KB] (opens in new tab)
10 Apr 2018	BD Vacutainer Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/18/04_31) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6690 8423	HSA 6004101-003-18-04_31 FSN_Redacted [PDF, 294 KB] (opens in new tab)
10 Apr 2018	DISCOVERY IGS 730/740, INNOVA IGS 620/630/520/530/540 SYSTEMS, Datex-Ohmeda Inc. (HSA 600:41/01-010/18/08_25) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-08_25 FSN_Redacted [PDF, 467 KB] (opens in new tab)
09 Apr 2018	Pulsar-18, Peripheral self-expanding Nitinol stent system, Biotronik AG (HSA 600:41/01-269/18/01_37) Local Contact: Biotronik Asia Pacific Pte Ltd Contact no./Email: 6228 9869	HSA 6004101-269-18-01_37 FSN [PDF, 87 KB] (opens in new tab)
09 Apr 2018	Draeger Jaundice Meter, Model JM-103 & Draeger Jaundice Meter JM-105, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/04_71) Local Contact: Draeger Singapore Pte Ltd Contact no./Email: 6872 9288 / draeger.sg@draeger.com	HSA 6004101-063-18-04_71 FSN-01_Redacted [PDF, 5351 KB] (opens in new tab)
06 Apr 2018	Thoratec HeartMate III™ LVAS Implant Kit, Thoratec Corporation (HSA 600:41/01-070/18/05_68) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-18-05_68 FSN_Redacted [PDF, 69 KB] (opens in new tab)
06 Apr 2018	LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM, Leica Microsystems AG (HSA 600:41/01-126/18/01_64) Local Contact: Leica Instruments Pte Ltd Contact no./Email: 6550 5912	HSA 6004101-126-18-01_64 FSN_Redacted [PDF, 1462 KB] (opens in new tab)
06 Apr 2018	ADVIA® Chemistry Systems Urea Nitrogen (UN), Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/08_23) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-08_23 FSN [PDF, 130 KB] (opens in new tab)
05 Apr 2018	Heartware Left Ventricular Assist Device, HeartWare Inc. (HSA 600:41/01-263/18/01_18) Local Contact: Emergo Consulting Pte Ltd Contact no./Email: 6832 5625 / SEAvigilance@emergogroup.com	HSA 6004101-263-18-01_18 FSN_Redacted [PDF, 142 KB] (opens in new tab)
05 Apr 2018	Brilliance Big Bore/Ingenuity CT/Ingenuity Core/Ingenuity Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/18/14_52) Local Contact: Philips Electronics(s) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-14_52 FSN_Redacted [PDF, 518 KB] (opens in new tab)
05 Apr 2018	T2100 Treadmill Microflex drive, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/18/07_62) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-07_62 FSN_Redacted [PDF, 420 KB] (opens in new tab)
05 Apr 2018	PR4100 Magellan Software, Bio-Rad Laboratories Inc (HSA 600:41/01-027/18/03_70) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA 6004101-027-18-03_70 FSN [PDF, 93 KB] (opens in new tab)
04 Apr 2018	BD Vacutainer Plus Citrate Plasma Tube, Becton Dickinson & Company (HSA 600:41/01-003/18/03_70) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6690 8423	HSA 6004101-003-18-03_70 FSN_Redacted [PDF, 3237 KB] (opens in new tab)
03 Apr 2018	Legion CR High Flex XLPE, Smith & Nephew Inc. (HSA 600:41/01-073/18/07_40) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-07_40 FSN [PDF, 175 KB] (opens in new tab)
02 Apr 2018	Vivid and LOGIQ ultrasound systems, GE Vingmed Ultrasound / GE Medical Systems (HSA 600:41/01-010/18/06_56) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-06_56 FSN_Redacted [PDF, 308 KB] (opens in new tab)
02 Apr 2018	Apple Medical Hunt Secondary Cannula/ Trocar, CooperSurgical (HSA 600:41/01-057/18/01_46) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: 6844 0002 / info@somnotec.net	HSA 6004101-057-18-01_46 FSN_Redacted [PDF, 3499 KB] (opens in new tab)