Field Safety Notices

Field Safety Notice - Jun 2017

Audiences

Healthcare professional

Industry member

Product type

Medical devices

30 June 2017

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Table caption

Date of Notification	Title	FSN
30 Jun 2017	Trauma, Guide Wires 70cm, Zimmer, Inc. (HSA 600:41/01-008/17/08_35) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7250	HSA 6004101-008-17-08_35 FSN_Redacted [PDF, 360 KB] (opens in new tab)
30 Jun 2017	Oxoid GC Agar, ThermoFisher Scientific (HSA 600:41/01-178/17/02_67) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com	HSA 6004101-178-17-02_67 FSN_Redacted [PDF, 158 KB] (opens in new tab)
30 Jun 2017	S-ICD system, Boston Scientific Corporation (HSA 600:41/01-007/17/07_37) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 6418 8888 / singapore_fsca_query@bsci.com	HSA 6004101-007-17-07_37 FSN_Redacted [PDF, 112 KB] (opens in new tab)
30 Jun 2017	Zimmer® M/DN® Intramedullary Fixation System; Zimmer® Natural Nail™ System, Zimmer, Inc. (HSA 600:41/01-008/17/06_25) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7250	HSA 6004101-008-17-06_25 FSN_Redacted [PDF, 450 KB] (opens in new tab)
30 Jun 2017	Trauma & Extremity Instruments (Drill bits and Screw taps), Zimmer Biomet, Inc. (HSA 600:41/01-008/17/07_19) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7250	HSA 6004101-008-17-07_19 FSN_Redacted [PDF, 372 KB] (opens in new tab)
30 Jun 2017	Cobas e411 analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/17/13_59) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-17-13_59_FSN [PDF, 207 KB] (opens in new tab)
30 Jun 2017	COULTER LH 750 ANALYZER, COULTER LH 780 ANALYZER, COULTER LH500 ANALYZER, COULTER HMX CP ANALYZERS, & COULTER HMX AL ANALYZERS, Beckman Coulter Inc. (HSA 600:41/01-052/17/08_34) Local Contact:Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-17-08_34_FSN_Redacted [PDF, 245 KB] (opens in new tab)
29 Jun 2017	ARCHITECT T-Update reagent, Abbott Laboratories (HSA 600:41/01-005/17/08_59) Local Contact: Abbott Laboratories Pte Ltd Contact no./Email: 6941 8000 / FSN@enquiry@abbott.com	HSA 6004101-005-17-08_59_FSN [PDF, 129 KB] (opens in new tab)
27 Jun 2017	Zenith Alpha Thoracic Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013/17/05_64) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com	HSA 6004101-013-17-05_64 FSN_Redacted [PDF, 425 KB] (opens in new tab)
23 Jun 2017	Beckman Coulter PK7300 Automated Microplate System, Beckman Coulter Inc (HSA 600:41/01-052/17/07_65) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 6340 7126	HSA 6004101-052-17-07_65_FSN_Redacted [PDF, 92 KB] (opens in new tab)
23 Jun 2017	DLP® Extension Line Adapters 20 in length, DLP® Antegrade/Retrograde Adapter, DLP® Cardioplegia Adapter with Pressure Port, DLP® Pressure Monitoring Extension Line Adapters and DLP® Pressure Disposable Pressure Display Sets, Medtronic Inc. (HSA 600:41/01-009/17/11_37) Local Contact: Medtronic International Ltd Contact no./Email: 6436 5077	HSA 6004101-009-17-11_37_FSN [PDF, 299 KB] (opens in new tab)
21 Jun 2017	ASP6025 Tissue Processor, Leica Biosystems Nussloch GmbH (HSA 600:41/01-126/17/01_61) Local Contact: Leica Microsystems (SEA) Pte Ltd Contact no./Email: 6550 5505	HSA 6004101-126-17-01_61 FSN_Redacted [PDF, 1287 KB] (opens in new tab)
21 Jun 2017	Datascope Intra-aortic Balloon Pumps, Datascope Corp (HSA 600:41/01-081/17/01_56) Local Contact: Maquet South East Asia Pte Ltd Contact no./Email: 6296 1992	HSA 6004101-081-17-01_56 FSN_Redacted [PDF, 93 KB] (opens in new tab)
19 Jun 2017	Alaris Pump module Model 8100, CareFusion (HSA 600:41/01-087/17/02_40) Local Contact: Scanmed Technology (S) Pte Ltd Contact no./Email: 6872 3660 / info@scanmed.com.sg	HSA 6004101-087-17-02_40_FSN_Redacted [PDF, 2267 KB] (opens in new tab)
15 Jun 2017	Stagbeetle Forceps Ratchet Lock, L 125mm, Synthes GmbH (HSA 600:41/01-002/17/07_54) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 7781	HSA 6004101-002-17-07_54 FSN_Redacted [PDF, 1170 KB] (opens in new tab)
15 Jun 2017	Alaris® PC unit model 8015, CareFusion 303 Inc (HSA 600:41/01-003/17/13_46) Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD) Contact no./Email: 6432 2048	HSA 6004101-003-17-13_46 FSN_Redacted [PDF, 451 KB] (opens in new tab)
15 Jun 2017	Boston Scientific Encore 26 Inflation Device, Boston Scientific Corporation (HSA 600:41/01-007/17/06_48) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com	HSA 6004101-007-17-06_48 FSN [PDF, 2789 KB] (opens in new tab)
15 Jun 2017	ACUSON S Family ultrasound, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/17/21_43) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-heathineers.com	HSA 6004101-022-17-21_43 FSN [PDF, 126 KB] (opens in new tab)
14 Jun 2017	Medtronic Navlock Tracker used with StealthStation S7, Medtronic Navigation, Inc (HSA 600:41/01-009/17/10_52) Local Contact: Medtronic International Ltd Contact no./Email: 6439 6932	HSA 6004101-009-17-10_52 FSN_Redacted [PDF, 353 KB] (opens in new tab)
13 Jun 2017	VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/08_60) Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD Contact no./Email: 6486 1151	HSA 6004101-303-17-08_60 FSN_Redacted [PDF, 2715 KB] (opens in new tab)
12 Jun 2017	Alaris Pump module Model 8100, Carefusion 303 Inc (HSA 600:41/01-003/17/12_49) Local Contact: Becton Dickinson Holdings Ptd Ltd Contact no./Email: 6432 2048	HSA 6004101-003-17-12_49 FSN_Redacted [PDF, 2269 KB] (opens in new tab)
12 Jun 2017	ARTIS, X-WORKPLACE, SENSIS AND ARCADIA SYSTEMS, Siemens Shenzhen Magnetic Resonance Ltd, Siemens Healthcare GmbH (HSA 600:41/01-022/17/20_63) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-17-20_63 FSN_Redacted [PDF, 1825 KB] (opens in new tab)
12 Jun 2017	ADVIA Centaur Systems Calibrator 30, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/19_59) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-17-19_59 FSN [PDF, 181 KB] (opens in new tab)
09 Jun 2017	ALARIS & ASENA (GS, GH, CC, TIVA, PK) SYRINGE PUMPS, CareFusion (HSA 600:41/01-087/17/01_19) Local Contact: Scanmed Technology (S) Pte Ltd Contact no./Email: 6872 3660 / info@scanmed.com.sg	HSA 6004101-087-17-01_19 FSN_Redacted [PDF, 138 KB] (opens in new tab)
09 Jun 2017	Pall Ultipor Breathing System Filter, Pall Medical (HSA 600:41/01-310/17/01_56) Local Contact: Pall Filtration Pte Ltd Contact no./Email: 63896500	HSA 6004101-310-17-01_56 FSN_Redacted [PDF, 216 KB] (opens in new tab)
08 Jun 2017	Thoratec HeartMate 3 Left Ventricular Assist System Implant Kit, Thoratec Corporation (HSA 600:41/01-070/17/11_51) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-17-11_51 FSN_Redacted [PDF, 28 KB] (opens in new tab)
08 Jun 2017	Astral 100 and Astral 150, Resmed Ltd (HSA 600:41/01-275/17/01_45) Local Contact: Resmed Asia Operations P/L (Singapore Branch) Contact no./Email: 6572 5936	HSA 6004101-275-17-01_45 FSN_Redacted [PDF, 1530 KB] (opens in new tab)
06 Jun 2017	BD Phoenix™ AP Instrument, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/11_50) Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD) Contact no./Email: 6432 2048	HSA 6004101-003-17-11-50 FSN_Redacted [PDF, 37 KB] (opens in new tab)
05 Jun 2017	Axiom Artis, Artis Zee and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/18_50) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-17-18_50 FSN_Redacted [PDF, 1596 KB] (opens in new tab)
05 Jun 2017	Pepsinogen II ELISA Kit, Biohit Oyj (HSA 600:41/01-086/17/01_38) Local Contact: SPD Scientific Pte Ltd Contact no./Email: 6303 9877 / operations@spdscientific.com	HSA 6004101-086-17-01-38 FSN_Redacted [PDF, 219 KB] (opens in new tab)
05 Jun 2017	LABScreen Multi, One Lambda, Inc (HSA 600:41/01-033/17/03_31) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com	HSA 6004101-033-17-03_31 FSN_Redacted [PDF, 306 KB] (opens in new tab)
05 Jun 2017	Multigent Creatinine (Enzymatic), Sentinel CH. SpA (HSA 600:41/01-005/17/07_23) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com	HSA 6004101-005-17-07_23 FSN [PDF, 100 KB] (opens in new tab)
02 Jun 2017	CARBON DIOXIDE (CO) / OXYGEN (O2) TERMINAL UNITS - DIN STANDARD, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/17/03_44) Local Contact: DRAEGER SINGAPORE PTE. LTD. Contact no./Email: 6872 9288 / draeger.sg@draeger.com	HSA 6004101-063-17-03_44 FSN [PDF, 4006 KB] (opens in new tab)
02 Jun 2017	Draeger Infinity Acute Care System (IACS), Draeger Medical Systems, Inc. (HSA 600:41/01-063/17/02_18) Local Contact: DRAEGER SINGAPORE PTE. LTD. Contact no./Email: 6872 9288 / draeger.sg@draeger.com	HSA 6004101-063-17-02-18 FSN [PDF, 567 KB] (opens in new tab)
02 Jun 2017	BD Hypodermic Syringes with Needles, Becton Dickinson and Company (BD) (HSA 600:41/01-003/17/10_50) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6432 2048	HSA 6004101-003-17-10_50 FSN_Redacted [PDF, 188 KB] (opens in new tab)
02 Jun 2017	Equinoxe Modular and Non-Modular Pilot Tip Reamers, Exactech Inc (HSA 600:41/01-257/17/02_54) Local Contact: Exactech Pte Ltd Contact no./Email: 6273 0091	HSA 6004101-257-17-02-54 FSN_Redacted [PDF, 228 KB] (opens in new tab)
01 Jun 2017	Boston Scientific Extractor Pro Retrieval Balloon Catheter, Boston Scientific Corporation (HSA 600:41/01-007/17/05_63) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email:6418 8888 / Singapore_FSCA_Query@bsci.com	HSA 6004101-007-17-05_63 FSN_Redacted [PDF, 40 KB] (opens in new tab)