Field Safety Notices

Field Safety Notice - Feb 2018

Audiences

Healthcare professional

Industry member

Product type

Medical devices

28 February 2018

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Table caption

Date of Notification	Title	FSN
27 Feb 2018	HeartStart FRx, HeartStart Onsite, HeartStart Home AEDs, Philips Medical Systems (HSA 600:41/01-026/18/10_62) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 774 5477	HSA 6004101-026-18-10_62 FSN [PDF, 204 KB] (opens in new tab)
27 Feb 2018	Versatex™ Monofilament Mesh 50 x 50 cm, Sofradim Production (HSA 600:41/01-046/18/02_40) Local Contact: Covidien Pte Ltd Contact no./Email: 6439 6933	HSA 6004101-046-18-02_40 FSN_Redacted [PDF, 675 KB] (opens in new tab)
27 Feb 2018	REMEL™ R30166601 - NEISSERIA MENINGITIDIS POLY A-D 2ML/VL; REMEL™ R30167001 - NEISSERIA MENINGITIDIS GROUP D 2ML/VL, Remel Europe Ltd (HSA 600:41/01-178/18/01_57) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com	HSA 6004101-178-18-01_57_FSN_Redacted [PDF, 226 KB] (opens in new tab)
26 Feb 2018	VITEK® 2 Compact 15; VITEK® 2 Compact 30 system; bioMerieux, Inc. (HSA 600:41/01-146/18/03_69) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: 6801 6700	HSA 6004101-146-18_03_69 FSN [PDF, 316 KB] (opens in new tab)
26 Feb 2018	Quick connect scale used with Maxi Sky 2 ceiling lifts, ArjoHuntleigh AB (HSA 600:41/01-065/18/01_56) Local Contact: Arjo South East Asia Pte. Ltd. Contact no./Email: Tel: 6202 7366 / singapore@arjo.com	HSA 6004101-065-18-01_56 FSN_Redacted [PDF, 257 KB] (opens in new tab)
23 Feb 2018	MeniCare SoR 70ML, Menicon Co., Ltd (HSA 600:41/01-319/18/02_46) Local Contact: Menicon Singapore Sales Pte Ltd. Contact no./Email: 6411 4778	HSA 6004101-319-18-02_46 FSN_Redacted [PDF, 7040 KB] (opens in new tab)
21 Feb 2018	COBAS B 221 <2> SYSTEM, COBAS B 221 <4> SYSTEM, COBAS B 221 <6> SYSTEM, AUTOQC MODULE COMPLETE COBAS B 221, Roche Diagnostics GmbH (HSA 600:41/01-016/18/02_67) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: 6272 7500 / sg.regulatory@roche.com	HSA 6004101-016-18-02_67 FSN [PDF, 607 KB] (opens in new tab)
21 Feb 2018	Flow QC Tubing, Transonic Systems Inc. (HSA 600:41/01-070/18/04_43) Local Contact: Transmedic Pte Ltd Contact no./Email:6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-18-04_43 FSN_Redacted [PDF, 5966 KB] (opens in new tab)
20 Feb 2018	Oncor Impression Plus, Siemens Healthcare GmbH (HSA 600:41/01-022/18/06_46) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-06_46 FSN [PDF, 33 KB] (opens in new tab)
20 Feb 2018	URF-P6/P6R, URF-V2/V2R URETERO-RENO ENDOSCOPES, Olympus Medical Systems Corp. (HSA 600:41/01-004/18/01_52) Local Contact: Olympus Singapore Pte Ltd Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com	HSA 6004101-004-18-01_52 FSN_Redacted [PDF, 1293 KB] (opens in new tab)
14 Feb 2018	Infinity Acute Care System (IACS), Infinity M540 patient monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/01_63) Local Contact: Draeger Singapore Pte Ltd Contact no./Email: 6872 9288 / draeger.sg@draeger.com	HSA 6004101-063-18-01_63 FSN_Redacted [PDF, 145 KB] (opens in new tab)
12 Feb 2018	Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/01_31) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-18-01_31 FSN [PDF, 136 KB] (opens in new tab)
12 Feb 2018	TEE probes: 6VT-D, 6Tc, 6Tc-RS, 9T, 9T-RS, 6T, 6T-RS, GE Vingmed Ultrasound AS (HSA 600:41/01-010/18/03_51) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-03_51 FSN_Redacted [PDF, 359 KB] (opens in new tab)
12 Feb 2018	Barrx™ 360 Express RFA Balloon Catheter, Covidien llc (HSA 600:41/01-046/18/01_44) Local Contact: Covidien Pte Ltd Contact no./Email: 6439 6933	HSA 6004101-046-18-01_44 FSN_Redacted [PDF, 131 KB] (opens in new tab)
12 Feb 2018	VeriQ Systems, VeriQ C Systems, MiraQ Systems, Medistim ASA (HSA 600:41/01-218/18/01_40) Local Contact: Perfusion Services and Supplies Pte Ltd Contact no./Email: 6398 0630	HSA 6004101-218-18-01_40 FSN_Redacted [PDF, 541 KB] (opens in new tab)
12 Feb 2018	Capio Suture Capturing Devices (SLIM, Standard, Open Access, RP), Uphold Vaginal Support System, Uphold LITE with Capio SLIM Vaginal Support System, Pinnacle Anterior Pelvic Floor Repair Kit, Pinnacle Posterior Pelvic Floor Repair Kit, Pinnacle LITE posterior with CAPIO SLIM Pelvic Floor Repair Kit, Boston Scientific Corporation (HSA 600:41/01-007/18/01_49) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 64188 888 / Singapore_FSCA_Query@bsci.com	HSA 6004101-007-18-01_49 FSN_Redacted [PDF, 1910 KB] (opens in new tab)
12 Feb 2018	VITROS Chemistry Products %A1c Performance Verifiers I&II, Ortho Clinical Diagnostics Inc (HSA 600:41/01-303/18/03_61) Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA 6004101-303-18-03_61 FSN_Redacted [PDF, 1567 KB] (opens in new tab)
09 Feb 2018	Allura Xper with FlexVision large screen monitor, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/09_37) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-09_37 FSN_Redacted [PDF, 105 KB] (opens in new tab)
09 Feb 2018	Invivo DynaCAD Software, Invivo Corporation (HSA 600:41/01-026/18/08_45) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 774 5477	HSA 6004101-026-18-08_45 FSN_Redacted [PDF, 295 KB] (opens in new tab)
09 Feb 2018	EXACTRAC VERSION 6.0 - 6.5, Brainlab AG (HSA 600:41/01-047/18/01_25) Local Contact: Brainlab Limited Contact no./Email: 6734 1701 / sg.regulatory@brainlab.com	HSA 6004101-047-18-01_25 FSN_Redacted [PDF, 70 KB] (opens in new tab)
09 Feb 2018	3M™ Surgical Clipper Professional 9681, 3M Health Care (HSA 600:41/01-031/18/01_35) Local Contact: 3M Technologies (S) Pte Ltd Contact no./Email: 6450 8846	HSA 6004101-031-18-01_35 FSN_Redacted [PDF, 221 KB] (opens in new tab)
07 Feb 2018	Somatom Emotion, Sensation, Spirit, Scope, Perspective, Siemens Healthcare GmbH (HSA 600:41/01-022/18/05_71) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-05_71 FSN-01a_Redacted [PDF, 8646 KB] (opens in new tab)
07 Feb 2018	Arctic Sun 5000 Temperature Management System, Bard Limited (HSA 600:41/01-050/18/01_66) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6580 5988 / Complaints.Singapore@crbard.com	HSA 6004101-050-18-01_66 FSN_Redacted [PDF, 3257 KB] (opens in new tab)
07 Feb 2018	BIO-CAL Temperature Controller, Medtronic Inc (HSA 600:41/01-009/18/02_18) Local Contact: Medtronic International Limited Contact no./Email: 6346 5077	HSA 6004101-009-18-02_18 FSN_Redacted [PDF, 1847 KB] (opens in new tab)
06 Feb 2018	Legion HK Distal Femoral Wedge SZ5 5mm, Smith & Nephew Inc. (HSA 600:41/01-073/18/02_56) Local Contact:Smith & Nephew Pte. Ltd. Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-02_56 FSN [PDF, 174 KB] (opens in new tab)
06 Feb 2018	VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody, Roche Diagnostics GmbH (HSA 600:41/01-016/18/01_58) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-18-01_58 FSN [PDF, 418 KB] (opens in new tab)
06 Feb 2018	ORBIT INCISOR PLUS EP-1 (6/BX), Smith & Nephew Inc (HSA 600:41/01-073/18/03_49) Local Contact: Smith & Nephew Pte. Ltd. Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-03_49 FSN [PDF, 118 KB] (opens in new tab)
06 Feb 2018	Somatom Emotion, Spirit/Power, Scope/Power, Perspective, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/18/04_68) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-04_68 FSN_Redacted [PDF, 4680 KB] (opens in new tab)
06 Feb 2018	Dornier Gemini, Dornier MedTech GmbH (HSA 600:41/01-161/18/01_64) Local Contact: Dornier MedTech Asia Pte Ltd Contact no./Email: 6572 6056 / asiaregulatory@dornier.com	HSA 6004101-161-18-01_64 FSN_Redacted [PDF, 966 KB] (opens in new tab)
05 Feb 2018	Triathlon TS Augments, Howmedica Ostenics Corp (HSA 600:41/01-014/18/03_45) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA 6004101-014-18-03_45 FSN_Redacted [PDF, 103 KB] (opens in new tab)
02 Feb 2018	Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/18/03_71) Local Contact: Transmedic Pte Ltd Contact no./Email: 6737 1945 / regulatory@transmedicgroup.com	HSA 6004101-070-18-03_71 FSN [PDF, 316 KB] (opens in new tab)
02 Feb 2018	Centricity Universal Viewer with PACS-IW foundation 6.0 and Centricity PACS-IW with Universal Viewer version 5.0, GE Healthcare (HSA 600:41/01-010/18/02_66) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-02_66 FSN_Redacted [PDF, 292 KB] (opens in new tab)