Field Safety Notices

Field Safety Notice - Apr 2016

30 April 2016

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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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	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	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	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)