Field Safety Notices

Field Safety Notice - Jun 2017

30 June 2017

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

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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)