Field Safety Notices

Field Safety Notice - Jun 2018

30 June 2018

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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Table caption

Date of Notification	Title	FSN
29 Jun 2018	Terumo® Advanced Perfusion System 1, Terumo Cardivascular Systems Corporation (HSA 600:41/01-028/18/03_71) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 62913603	HSA 6004101-028-18-03_71 FSN [PDF, 960 KB] (opens in new tab)
28 Jun 2018	Neonatal Flow Sensor Cable, Datex-Ohmeda Inc (HSA 600:41/01-010/18/15_64) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-15_64 FSN_Redacted [PDF, 387 KB] (opens in new tab)
27 Jun 2018	EnTrust® and Escudo® VR/DR/AT ICDs, Medtronic Inc (HSA 600:41/01-009/18/10_68) Local Contact: Medtronic International Limited Contact no./Email: 6436 5077	HSA 6004101-009-18-10_68 FSN_Redacted [PDF, 404 KB] (opens in new tab)
26 Jun 2018	Schiller Medical DEFIGARD Touch 7, Schiller Medical S.A.S. (HSA 600:41/01-056/18/03_71) Local Contact: Gold Lite Pte Ltd Contact no./Email: 62730487	HSA 6004101-056-18-03_71 FSN_Redacted [PDF, 241 KB] (opens in new tab)
26 Jun 2018	CARESCAPE Monitor B650, GE Healthcare Finland Oy (HSA 600:41/01-010/18/14_56) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668 / svc@ge.com	HSA 6004101-010-18-14_56 FSN_Redacted [PDF, 345 KB] (opens in new tab)
26 Jun 2018	Dialine ALAT (ALT/GPT), Dialine CK-MB, BioRex ALAT (ALT/GPT), Dialine Diagnostic Systems Pte Ltd, BioREX MANNHEIM Diagnostics (HSA 600:41/01-326/18/02_31) Local Contact: Dialine Diagnostic Systems Pte Ltd Contact no./Email: 6747 2009	HSA 6004101-326-18-02_31 FSN [PDF, 150 KB] (opens in new tab)
26 Jun 2018	Arctic Sun 5000 Temperature Management Systems, Medivance, Inc (HSA 600:41/01-050/18/04_62) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6580 5988 / Complaints.Singapore@crbard.com	HSA 6004101-050-18-04_62 FSN_Redacted [PDF, 435 KB] (opens in new tab)
26 Jun 2018	Arrow® HANDS-OFF® Thermodilution Catheter, Arrow International (HSA 600:41/01-139/18/02_51) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 6439 3046	HSA 6004101-139-18-02_51 FSN_Redacted [PDF, 153 KB] (opens in new tab)
26 Jun 2018	Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ Pacemakers, Medtronic Inc (HSA 600:41/01-009/18/09_38) Local Contact: Medtronic International Limited Contact no./Email: 6436 5077	HSA 6004101-009-18-09_38 FSN_Redacted [PDF, 258 KB] (opens in new tab)
26 Jun 2018	ATP Hexokinase FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01‐326/18/01_23) Local Contact: Dialine Diagnostic Systems Pte Ltd Contact no./Email: 6747 2009	HSA 6004101-326-18-01_23 FSN [PDF, 263 KB] (opens in new tab)
25 Jun 2018	MAC-LAB, CARDIOLAB, COMBOLAB AND SPECIALSLAB RECORDING SYSTEMS, GE Medical Systems Information Technologies (HSA 600:41/01‐010/18/13_66) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-13_66 FSN_Redacted [PDF, 331 KB] (opens in new tab)
22 Jun 2018	MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/18/19_68) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email:1800 744 5477	HSA 6004101-026-18-19_68 FSN_Redacted [PDF, 61 KB] (opens in new tab)
22 Jun 2018	Philips Digital Diagnost Radiography System, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/18/20_46) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-20_46 FSN_Redacted [PDF, 1251 KB] (opens in new tab)
22 Jun 2018	Single Chamber Temporary External Pacemaker 53401, Medtronic Inc (HSA 600:41/01-009/18/08_18) Local Contact: Medtronic International Limited Contact no./Email: 6436 5077	HSA 6004101-009-18-08_18 FSN_Redacted [PDF, 1156 KB] (opens in new tab)
21 Jun 2018	ArtisQ and Artis Pheno system, Siemens Healthcare GmbH (HSA 600:41/01-022/18/14_50) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-14_50 FSN Redacted [PDF, 2362 KB] (opens in new tab)
20 Jun 2018	Vigileo, Vigilance II and EV1000A Monitor, Edwards Lifesciences LLC (HSA 600:41/01-060/18/01_44) Local Contact: Edwards Lifesciences (Asia) Pte Ltd Contact no./Email: 8128 0211	HSA 6004101-060-18-01_44 FSN_Redacted [PDF, 1037 KB] (opens in new tab)
20 Jun 2018	LEGION HK TIBIAL BASE SZ 5 LEFT, Smith & Nephew, Inc. (HSA 600:41/01-073/18/15_46) Local Contact: SMITH & NEPHEW PTE LIMITED Contact no./Email:6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-15_46 FSN [PDF, 116 KB] (opens in new tab)
20 Jun 2018	Maestro 4000 Cardiac Ablation System Optional Foot Switch, Boston Scientific Corporation (HSA 600:41/01-007/18/04_63) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com	HSA 6004101-007-18-04_63 FSN_Redacted [PDF, 316 KB] (opens in new tab)
20 Jun 2018	Intertan 11.5mmx18cm 125D, Smith & Nephew, Inc.(HSA 600:41/01-073/18/14_50) Local Contact: SMITH & NEPHEW PTE LIMITED Contact no./Email:6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-14_50 FSN [PDF, 118 KB] (opens in new tab)
19 Jun 2018	Discovery MR750w, GE Healthcare (HSA 600:41/01-010/18/12_35) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-12_35 FSN_Redacted [PDF, 295 KB] (opens in new tab)
15 Jun 2018	Stryker Synchro² Guidewires, Stryker Neurovascular (HSA 600:41/01-070/18/09_37) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-18-09_37 FSN_Redacted [PDF, 1654 KB] (opens in new tab)
14 Jun 2018	Covidien Puritan-Bennett 800 Series Ventilator System, Covidien Newport e360 Ventilator, Covidien llc (HSA 600:41/01-046/18/08_44) Local Contact: Covidien Pte Ltd Contact no./Email: 6439 6974	HSA 6004101-046-18-08_44 FSN [PDF, 90 KB] (opens in new tab)
13 Jun 2018	Allura Xper, UNIQ and Centron, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/18_45) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-18_45 FSN Redacted [PDF, 1458 KB] (opens in new tab)
12 Jun 2018	B.Braun Novosyn® Absorbable Surgical Suture and B.Braun Safil® Absorbable Surgical Suture, B. Braun Surgical SA (HSA 600:41/01-012/18/03_43) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 6213 0933 / press.sg@bbraun.com	HSA 6004101-012-18-03_43 FSN Redacted [PDF, 863 KB] (opens in new tab)
12 Jun 2018	Cardinal Health Hydroline Trumpet Valves, Cardinal Health (HSA 600:41/01-307/18/01_18) Local Contact: Cardinal Health Singapore 225 Pte Ltd Contact no./Email: 6230 2362	HSA 6004101-307-18-01_18 FSN_Redacted [PDF, 69 KB] (opens in new tab)
12 Jun 2018	Neomed Enteral Feeding Tubes, NeoMed Inc (HSA 600:41/01-012/18/04_64) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 6213 0941	HSA 6004101-012-18-04_64 FSN_Redacted [PDF, 2969 KB] (opens in new tab)
11 Jun 2018	GE Healthcare A1 Panel for CT and CT/PET scanners, GE Healthcare (HSA 600:41/01-010/18/11_51) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668 / svc@ge.com	HSA 6004101-010-18-11_51 FSN_Redacted [PDF, 624 KB] (opens in new tab)
11 Jun 2018	VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/07_49) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA 6004101-303-18-07_49 FSN_Redacted [PDF, 2771 KB] (opens in new tab)
08 Jun 2018	150cm Y Extension Tube Dual Check Valve, Imaxeon Pty Ltd (HSA 600:41/01-069/18/01_66) Local Contact: O’Connor’s Singapore Pte Ltd Contact no./Email:6470 2000 / enquiries@oconnors.wbl.com.sg	HSA 6004101-069-18-01_66 FSN_Redacted [PDF, 111 KB] (opens in new tab)
07 Jun 2018	Volista Bracket, Maquet SAS (HSA 600:41/01-081/18/06_64) Local Contact: IDS Medical System (Singapore) Pte Ltd Contact no./Email: 6296 1992	HSA 6004101-081-18-06_64 FSN [PDF, 305 KB] (opens in new tab)
07 Jun 2018	Tina-quant IgG Gen.2 on cobas c 311/501/502 analyzers, Roche Diagnostics GmbH (HSA 600:41/01-016/18/10_67) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-10_67 FSN [PDF, 342 KB] (opens in new tab)
07 Jun 2018	Mega Power Electrosurgical Generator, Megadyne Medical Products Inc (HSA 600:41/01-325/18/01_71) Local Contact: GiGATT International Marketing Pte Ltd Contact no./Email: 65471713 / gigatt@gigatt.net	HSA 6004101-325-18-01_71 FSN Redacted [PDF, 14563 KB] (opens in new tab)
07 Jun 2018	qUAntify Control, qUAntify Plus Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/18/07_70) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA 6004101-027-18-07_70 FSN [PDF, 112 KB] (opens in new tab)
06 Jun 2018	Visera Elite II Video System Center OTV-S200 / OTV-S300, Olympus Medical Systems Corp (HSA 600:41/01-004/18/02_46) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com	HSA 6004101-004-18-02_46 FSN_Redacted [PDF, 1202 KB] (opens in new tab)
06 Jun 2018	CORAIL® AMT Neck Trials Surgical Instruments, Depuy (Ireland) (HSA 600:41/01-002/18/06_38) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 8304	HSA 6004101-002-18-06_38 FSN_Redacted [PDF, 370 KB] (opens in new tab)
06 Jun 2018	Suture Anchor Devices, Suture Passer Devices and Coblation Wands, Smith & Nephew Inc (HSA 600:41/01-073/18/13_35) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-13_35 FSN [PDF, 196 KB] (opens in new tab)
06 Jun 2018	Sysmex AUTOMATED HEMATOLOGY ANALYZER XN SERIES XN-10 AND XN-20, Sysmex Corporation (HSA 600:41/01-032/18/01_57) Local Contact: Sysmex Asia Pacific Pte. Ltd. Contact no./Email: 6221 3629 / RA@sysmex-ap.com	HSA 6004101-032-18-01_57 FSN_Redacted [PDF, 3833 KB] (opens in new tab)
05 Jun 2018	MRSA Select II agar, Bio-Rad (HSA 600:41/01‐027/18/06_61) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA 6004101-027-18-06_61 FSN_Redacted [PDF, 136 KB] (opens in new tab)
04 Jun 2018	GE Healthcare A1 Panel for Nuclear scanners, GE Medical Systems Israel, Functional Imaging (HSA 600:41/01-010/18/10_62) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-10_62 FSN_Redacted [PDF, 388 KB] (opens in new tab)
01 Jun 2018	FHC Depth Stop Adapter, FHC Inc (HSA 600:41/01‐009/18/07_54) Local Contact: Medtronic International Ltd Contact no./Email: 6439 5000	HSA 6004101009-18-07_54 FSN_Redacted [PDF, 616 KB] (opens in new tab)
01 Jun 2018	ALAT (GPT) FS (IFCC mod.), ATP Hexokinase FS, CK-MB FS, GLDH FS DGKC, DiaSys Diagnostic Systems Gmb (HSA 600:41/01-032/17/07_34) Local Contact: Sysmex Asia Pacific Pte. Ltd. Contact no./Email: 6221 3629 / RA@sysmex-ap.com	HSA 6004101-032-17-07_34 FSN [PDF, 267 KB] (opens in new tab)