Field Safety Notices

Field Safety Notice - Apr 2018

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 April 2018

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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)