Field Safety Notices

Field Safety Notice - Apr 2016

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 April 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
29 Apr 2016	Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/16/17_35) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-17_35 FSN [PDF, 71 KB] (opens in new tab)
29 Apr 2016	AssayTip/AssayCup for MODULAR ANALYTICS E170, MODULAR ANALYTICS EVO E170, cobas e601, cobas e602, Roche Diagnostics GmbH (HSA 600:41/01-016/16/06_20) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: 63716602	HSA 6004101-016-16-06_20 FSN [PDF, 357 KB] (opens in new tab)
28 Apr 2016	Digital Diagnost, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/13_37) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-13_37 FSN [PDF, 226 KB] (opens in new tab)
27 Apr 2016	Philips MX 16-Slice Computed Tomography X-ray System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/12_45) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-12_45 FSN [PDF, 449 KB] (opens in new tab)
27 Apr 2016	LYNOAMP BC, Sysmex Corporation (HSA 600:41/01-032/16/04_61) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: Goh.PeiJing@sysmex-ap.com	HSA 6004101-032-16-04_61 FSN [PDF, 37 KB] (opens in new tab)
26 Apr 2016	ARCHITECT STAT High Sensitive Troponin-I Reagent, Abbott Ireland (HSA 600:41/01-005/16/06_24) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 68859103	HSA 6004101-005-16-06_24 FSN [PDF, 36 KB] (opens in new tab)
26 Apr 2016	Insulin-Like Growth Factor (IGF-1) Assay, Siemens Healthcare Diagnostics Product Limited (HSA 600:41/01-022/16/20_60) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: 64907374	HSA 6004101-022-16-20_60 FSN [PDF, 75 KB] (opens in new tab)
25 Apr 2016	Biograph mCT and mCT Flow systems, Biograph TruePoint systems running PETsyngo 6.7.x software, Siemens Medical Solutions USA (HSA 600:41/01-022/16/19_25) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-19_25 FSN [PDF, 3623 KB] (opens in new tab)
25 Apr 2016	Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT and Brilliance iCT SP CT systems, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/11_19) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-11_19 FSN [PDF, 202 KB] (opens in new tab) HSA 6004101-026-16-11_19 FSN [PDF, 320 KB] (opens in new tab)
22 Apr 2016	Pump Tube, Richard Wolf GmbH (HSA 600:41/01-119/16/01_51) Local Contact: Servicom Medical (Singapore) Pte Ltd Contact no./Email: inquiry@servicom.com.sg	HSA 6004101-119-16-01_51-FSN [PDF, 274 KB] (opens in new tab)
22 Apr 2016	Digitoxin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/05_59) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-05_59 FSN [PDF, 467 KB] (opens in new tab)
22 Apr 2016	Discovery IGS 730 & Discovery IGS 740 systems, GE Medical Systems SCS (HSA 600:41/01-010/16/05_08) Local Contact: GE Healthcare Pte Ltd Contact no./Email: svc@ge.com	HSA 6004101-010-16-05_08 FSN [PDF, 649 KB] (opens in new tab)
22 Apr 2016	Aisys family of Anaesthesia devices, Datex-Ohmeda Inc (HSA 600:41/01-010/16/06_17) Local Contact: GE Healthcare Pte Ltd Contact no./Email: postmarket@ge.com	HSA 6004101-010-16-06_17 FSN [PDF, 74 KB] (opens in new tab)
22 Apr 2016	REVOLUTION CT COMPUTED TOMOGRAPHY X-RAY SYSTEM, GE Healthcare (HSA 600:41/01-010/16/07_18) Local Contact: GE Healthcare Pte Ltd Contact no./Email: postmarket@ge.com	HSA 6004101-010-16-07_18 FSN [PDF, 60 KB] (opens in new tab)
22 Apr 2016	Datascope Cardiosave™ Hybrid Intra-Aortic Balloon Pump (IABP) & Rescue IABP, Datascope Corp (HSA 600:41/01-017/16/02_54) Local Contact: IDS Medical Systems (Singapore) Pte Ltd Contact no./Email: 66907378	HSA 6004101-017-16-02_54 FSN [PDF, 82 KB] (opens in new tab)
22 Apr 2016	Battery Packs Used in Capnostream 20 and Capnostream 20p Patient Monitors, Medtronic Inc (HSA 600:41/01-046/16/05_48) Local Contact: Covidien Pte Ltd Contact no./Email: 64396974	HSA 6004101-046-16-05_48 FSN [PDF, 946 KB] (opens in new tab)
22 Apr 2016	Image Suite 3.0 & 4.0, Carestream Health Inc (HSA 600:41/01-187/16/01_09) Local Contact: Carestream Health Singapore Pte Ltd Contact no./Email: 65015007	HSA 6004101-187-16-01_09 FSN [PDF, 31 KB] (opens in new tab)
21 Apr 2016	Siemens RAPIDPoint® 500 System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/18_58) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-18_58 FSN [PDF, 21 KB] (opens in new tab)
21 Apr 2016	Ellipse™ Implantable Cardioverter Defibrillator, St Jude Medical (HSA 600:41/01-025/16/01_46) Local Contact: St Jude Medical (S) Pte Ltd Contact no./Email: 66432817	HSA 6004101-025-16-01_46 FSN [PDF, 28 KB] (opens in new tab)
21 Apr 2016	AV-Set ONLINEplus BVM 5008-R, Fresenius Medical Care (HSA 600:41/01-062/16/01_52) Local Contact: Fresenius Medical Care Singapore Pte Ltd Contact no./Email: 66813149	HSA 6004101-062_16-01_52 FSN [PDF, 2138 KB] (opens in new tab)
21 Apr 2016	Teleflex Medical Pleur-Evac Chest Drainage Systems, Teleflex Medical (HSA 600:41/01-139/16/04_56) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 64393043	HSA 6004101-139-16-04_56 FSN [PDF, 445 KB] (opens in new tab)
20 Apr 2016	Alcon LenSx Laser System, Alcon LenSx Inc (HSA 600:41/01-135/16/02_50) Local Contact: Alcon Pte Ltd Contact no./Email: vigilance.alconSG@alcon.com	HSA 6004101-135-16-02_50 FSN [PDF, 133 KB] (opens in new tab)
20 Apr 2016	ID-Papain, DiaMed GmbH (HSA 600:41/01-027/16/04_57) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262	HSA 6004101-027-16-04_57 FSN [PDF, 143 KB] (opens in new tab)
20 Apr 2016	CDI® Blood Parameter Monitoring System 500, BPM Sensor Head Assembly Thermistor, Terumo Cardiovascular Systems (HSA 600:41/01-028/16/03_40) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 62913603	HSA 6004101-028-16-03_40 FSN [PDF, 197 KB] (opens in new tab)
20 Apr 2016	Bravo pH Monitoring System, Given Imaging Inc (HSA 600:41/01-046/16/04_36) Local Contact: Covidien Pte Ltd Contact no./Email: 64396974	HSA 6004101-046-16-04_36 FSN [PDF, 876 KB] (opens in new tab)
20 Apr 2016	Bard Encor Probes, SenoRx Inc (HSA 600:41/01-050/16/04_41) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 65805987	HSA 6004101-050-16-04_41 FSN [PDF, 161 KB] (opens in new tab)
20 Apr 2016	Uni-Gold LUA Plus, Trinity Biotech (HSA 600:41/01-111/16/01_34) Local Contact: Unison Collaborative Pte Ltd Contact no./Email: regulatory@unisoncoll.com	HSA 6004101-111-16-01_34 FSN [PDF, 2181 KB] (opens in new tab)
19 Apr 2016	Arietta 60 & Arietta 70, Hitachi Aloka Medical Ltd (HSA 600:41/01-054/16/02_33) Local Contact: Hitachi Medical Systems (S) Pte Ltd Contact no./Email: 66020110	HSA 6004101-054-16-02_33 FSN [PDF, 1643 KB] (opens in new tab)
19 Apr 2016	PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters, Biosense Webster Inc (HSA 600:41/01-002/16/16_35) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-16_35 FSN [PDF, 101 KB] (opens in new tab)
19 Apr 2016	cobas EGFR Mutation Test v2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/04_31) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-16-04_31 FSN [PDF, 281 KB] (opens in new tab)
19 Apr 2016	MobileDiagnost wDR2, Philips Medical Systems (HSA 600:41/01-026/16/10_37) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-16-10_37 FSN [PDF, 129 KB] (opens in new tab)
19 Apr 2016	Leksell Gamma Knife® Perfexion™, Elekta Instrument AB (HSA 600:41/01-101/16/01_45) Local Contact: Elekta Pte Ltd Contact no./Email: elekta_global_pms@elekta.com	HSA 6004101-101-16-01_45 FSN [PDF, 88 KB] (opens in new tab)
18 Apr 2016	BENDING/CUTTING PLIERS WITH NOSE, FOR LOCK PLATES 2.0, Synthes GmbH (HSA 600:41/01-002/16/14_19) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-14_19 FSN [PDF, 78 KB] (opens in new tab)
18 Apr 2016	CIDEX Activated Glutaraldehyde Solution, Advanced Sterilization Products (HSA 600:41/01-002/16/15_54) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-16-15_54 FSN [PDF, 274 KB] (opens in new tab)
15 Apr 2016	UniCel Coulter Cellular Analysis System - DxH 800, DxH 600, DxH Slidemaker Stainer, Beckman Coulter Inc. (HSA 600:41/01-052/16/03_22) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-16-03_22 FSN [PDF, 74 KB] (opens in new tab)
15 Apr 2016	IRISpec CA/CB/CC, Iris International (HSA 600:41/01-052/16/04_23) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-16-04_23 FSN [PDF, 172 KB] (opens in new tab)
15 Apr 2016	Access ClearVue™ Prone Breast device, Qfix (HSA 600:41/01-227/16/01_18) Local Contact: QT Instruments (S) Pte Ltd Contact no./Email: 6303 9833	HSA 6004101-227-16-01_18 FSN [PDF, 495 KB] (opens in new tab)
14 Apr 2016	da Vinci S Surgical System / da Vinci Si Surgical System / da Vinci Xi Surgical System, Intuitive Surgical (HSA 600:41/01-070/16/10_08) Local Contact: Transmedic Pte Ltd Contact no./Email: regulatory@transmedicgroup.com (opens in new tab)	HSA 6004101-070-16-10_08 FSN [PDF, 404 KB] (opens in new tab)
14 Apr 2016	Integra 3 Micromanipulator, Research Instruments Limited (HSA 600:41/01-210/16/01_17) Local Contact: LabIVF Asia Pte Ltd Contact no./Email: sales@labivf.com (opens in new tab)	HSA 6004101-210-16-01_17 FSN [PDF, 3357 KB] (opens in new tab)
14 Apr 2016	3.5mm Locking Screws - Stardrive®, Self·Tapping & Hex Drive, Self·Tapping, Synthes GmbH (HSA 600:41/01-002/16/13_09) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6827 6135	HSA 6004101-002-16-13_09 FSN [PDF, 81 KB] (opens in new tab)
12 Apr 2016	Baxter Colleague CXE Volumetric Infusion Pump, Baxter Healthcare SA (HSA 600:41/01-001/16/02_46) Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact no./Email: chai_hwee_corynn_tan@baxter.com (opens in new tab)	HSA 6004101-001-16-02_46 FSN [PDF, 338 KB] (opens in new tab)
12 Apr 2016	Lotus Valve System, Boston Scientific (HSA 600:41/01-007/16/02_48) Local Contact: Boston Scientific Asia Pacific Pte. Ltd. Contact no./Email: 6418 8888	HSA 6004101-007-16-02_48 FSN [PDF, 632 KB] (opens in new tab)
12 Apr 2016	Hickman and Leonard Central Venous Catheter kits, Bard Access Systems, Inc. (HSA 600:41/01-050/16/03_56) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 6580 5988	HSA 6004101-050-16-03_56 FSN [PDF, 1259 KB] (opens in new tab)
11 Apr 2016	VITROS® 3600 Immunodiagnostics System & VITROS® 5600 Integrated System, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/12_20) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6827 6079	HSA 6004101-002-16-12_20 FSN [PDF, 131 KB] (opens in new tab)
08 Apr 2016	Ossur Lil’ Angel Halo Vest, Ossur hf (HSA 600:41/01-053/16/02_43) Local Contact: Humedical Pte Ltd Contact no./Email: gerwin@humedical.com.sg	HSA 6004101-053-16-02_43 FSN [PDF, 100 KB] (opens in new tab)
08 Apr 2016	Miami J Cervical Collars, Ossur hf (HSA 600:41/01-053/16/01_52) Local Contact: Humedical Pte Ltd Contact no./Email: 6872 1738	HSA 6004101-053-16-01_52 FSN [PDF, 333 KB] (opens in new tab)
08 Apr 2016	BIRMINGHAM HIP™ RESURFACING Extraction Kit (instrument), Smith & Nephew Orthopaedics (HSA 600:41/01-073/16/12_50) Local Contact: Smith & Nephew Pte Limited Contact no./Email: 6672 5446	HSA 6004101-073-16-12_50 FSN [PDF, 71 KB] (opens in new tab)
07 Apr 2016	CA090 Direct Drive Clip Applier, Applied Medical (HSA 600:41/01-163/16/02_41) Local Contact: Ikon Medical Pte Ltd Contact no./Email: 6336 5813	HSA 6004101-163-16-02_41 FSN [PDF, 116 KB] (opens in new tab)
06 Apr 2016	Ossur Miami J Cervical Collars, Ossur hf (HSA 600:41/01-294/16/02_40) Local Contact: Ossur JWC Holding Pte Ltd Contact no./Email: enquiries@ossur.com	HSA 6004101-294-16-02_40 FSN [PDF, 830 KB] (opens in new tab)
06 Apr 2016	Draeger D-Vapor and D-Vapor 3000, Draeger Medical South East Asia Pte Ltd (HSA 600:41/01-063/16/01_36) Local Contact: Draeger Medical SEA Pte Ltd Contact no./Email: dsa.singapore@draeger.com	HSA 6004101-063-16-01_36 FSN [PDF, 8986 KB] (opens in new tab)
06 Apr 2016	Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage & Cartilage Custom, Rebound Air Walker & Diabetic Walker, Back Support Suspenders, Extreme Custom, Unloader Custom (XT & Lite) & Custom, Ossur hf (HSA 600:41/01-294/16/01_45) Local Contact: Ossur JWC Holding Pte Ltd Contact no./Email: enquiries@ossur.com	HSA 6004101-294-16-01_45 FSN [PDF, 830 KB] (opens in new tab)
05 Apr 2016	Essure ® ESS-305, Bayer Healthcare LLC (HSA 600:41/01-066/16/01_49) Local Contact: Bayer South East Asia Pte Ltd Contact no./Email: medinfo.singapore@bayer.com	HSA 6004101-066-16-01_49 FSN [PDF, 37 KB] (opens in new tab)
04 Apr 2016	LifeCycle for Prenatal Screening, Wallac Oy (HSA 600:41/01-127/16/01_59) Local Contact: Perkin Elmer Singapore Pte Ltd Contact no./Email: 68681670	HSA 6004101-127-16-01_59 FSN [PDF, 1823 KB] (opens in new tab)
01 Apr 2016	Philips IntelliSpace Portal software versions 5.0, 6.0, 7.0, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/08_37) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5466	HSA 6004101-026-16-08_37 FSN [PDF, 59 KB] (opens in new tab)
01 Apr 2016	Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/16_44) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-16_44 FSN [PDF, 1116 KB] (opens in new tab)
01 Apr 2016	SOMATOM Definition FORCE with VA50A, VA50A_SP2, Siemens Healthcare GmbH (HSA 600:41/01-022/16/15_29) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-15-29 FSN [PDF, 1784 KB] (opens in new tab)
01 Apr 2016	Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/17_33) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-16-17_33 FSN_Redacted [PDF, 1078 KB] (opens in new tab)