Field Safety Notices

Field Safety Notice - Feb 2019

Audiences

Healthcare professional

Industry member

Product type

Medical devices

28 February 2019

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Table caption

Date of Notification	Title	FSN
28 Feb 2019	Autolith Touch EHL Extender Cable, Northgate (HSA 600:41/01-007/19/01_71) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com	HSA 6004101-007-19-01_71 FSN_Redacted [PDF, 167 KB] (opens in new tab)
28 Feb 2019	Model 37751 Rechargers, Medtronic Inc (HSA 600:41/01-009/19/03_66) Local Contact: Medtronic International Limited Contact no./Email: 6439 6932	HSA 6004101-009-19-03_66 FSN_Redacted [PDF, 170 KB] (opens in new tab)
27 Feb 2019	Philips BV Vectra, Philips India Limited (HSA 600:41/01-026/19/06_79) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-06_79 FSN_Redacted [PDF, 1443 KB] (opens in new tab)
26 Feb 2019	CELL‐DYN EMERALD, Abbott Laboratories (HSA 600:41/01-005/19/05_57) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-05_57 FSN_Redacted [PDF, 110 KB] (opens in new tab)
26 Feb 2019	SpeedLock PEEK 3.4mm Knotless Fixation Device, ArthroCare Corporation (HSA 600:41/01-073/19/04_46) Local Contact: Smith & Nephew Pte Limited Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-19-04_46 FSN [PDF, 163 KB] (opens in new tab)
26 Feb 2019	Philips MultiDiagnost-Eleva with Flat Detector; Allura Xper systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/19/05_62) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-05_62 FSN_Redacted [PDF, 295 KB] (opens in new tab)
26 Feb 2019	Baha 5 Sound Processor Tamper-proof Battery Door 3pcs, Cochlear Bone Anchored Solutions AB (HSA 600:41/01-171/19/01_18) Local Contact: Cochlear Ltd Contact no./Email: 6553 3814	HSA 6004101-171-19-01_18 FSN [PDF, 173 KB] (opens in new tab)
26 Feb 2019	Covidien Force TriVerse™ Electrosurgical Device (10' cord), Covidien llc (HSA 600:41/01-046/19/01_68) Local Contact: Covidien Private Limited Contact no./Email: 6439 6974	HSA 6004101-046-19-01_68 FSN_Redacted [PDF, 243 KB] (opens in new tab)
25 Feb 2019	Inferior Vena Cava (IVC) Filter, William Cook Europe ApS (HSA 600:41/01-013/19/04_46) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6812 7461 / SNG-RegulatoryAffairs@CookMedical.com	HSA 6004101-013-19-04_46 FSN_Redacted [PDF, 325 KB] (opens in new tab)
25 Feb 2019	CELL-DYN Emerald 22 AL, Abbott Laboratories Diagnostics Division (HSA 600:41/01-005/19/04_31) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-04_31 FSN_Redacted [PDF, 102 KB] (opens in new tab)
22 Feb 2019	ICU Medical ChemoClave Closed Vial Spike, ICU Medical Inc (HSA 600:41/01-145/19/01_52) Local Contact: Medquest Marketing Pte Ltd Contact no./Email: 6805 1250	HSA 6004101-145-19-01_52 FSN_Redacted [PDF, 995 KB] (opens in new tab)
22 Feb 2019	SmartStitch PerfectPasser Connector, ArthroCare Corporation (HSA 600:41/01-073/19/03_68) Local Contact: Smith & Nephew Pte Limited Contact no./Email: 6270 0552 /singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-19-03_68 FSN [PDF, 86 KB] (opens in new tab)
21 Feb 2019	Philips InteIliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/04_64) Local Contact: Philips Electronics (Singapore) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-19-04_64 FSN_Redacted [PDF, 1155 KB] (opens in new tab)
21 Feb 2019	ARIES® HSV 1&2 Assay (50-10017), ARIES® Extraction Kit (50-10026), Luminex Coporation (HSA 600:41/01-033/19/03_59) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com	HSA 6004101-033-19-03_59_FSN [PDF, 616 KB] (opens in new tab)
19 Feb 2019	DIASPECT HEMOGLOBIN T-LOW ANALYZER, Diaspect Medical GmbH (HSA 600:41/01-033/19/02_67) Local Contact:Biomed Diagnostics Pte Ltd Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com	HSA 6004101-033-19-02_67 FSN_Redacted [PDF, 13909 KB] (opens in new tab)
19 Feb 2019	COMBIVISC and COMBIVISC MULTIPACK 5-PACK, Z-HYALCOAT MULTIPACK 10-PACK, Hyaltech Ltd (HSA 600:41/01-136/19/01_50) Local Contact: Carl Zeiss Pte Ltd Contact no./Email: 67419600 / info@zeiss.com.sg	HSA 6004101-136-19-01_50 FSN_Redacted [PDF, 1012 KB] (opens in new tab)
15 Feb 2019	xTAG Gastrointestinal Panel, Luminex Molecular Diagnostics Inc (HSA 600:41/01-148/19/02_61) Local Contact: DKSH Singapore Pte Ltd Contact no./Email: 6471 1466 / hec-ra.sin@dksh.com	HSA 6004101-148-19-02_61 FSN_Redacted [PDF, 152 KB] (opens in new tab)
15 Feb 2019	ARIES HSV 1&2 Assay, ARIES Bordetella Assay, ARIES Extraction Kit, Luminex Corporation (HSA 600:41/01-148/19/01_61) Local Contact: DKSH Singapore Pte Ltd Contact no./Email: 6471 1466 / hec-ra.sin@dksh.com	HSA 6004101-148-19-01_61 FSN_Redacted [PDF, 5718 KB] (opens in new tab)
15 Feb 2019	Modular Head Disimpactor, Adler Mediequip Pvt Ltd (HSA 600:41/01-073/19/02_63) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-19-02_63 FSN [PDF, 83 KB] (opens in new tab)
15 Feb 2019	LIFEPAK 15 Monitor/Defibrillators, Physio Control (HSA 600:41/01-056/19/01_63) Local Contact: Gold Lite Pte Ltd Contact no./Email: 6273 0487	HSA 6004101-056-19-01_63 FSN_Redacted [PDF, 110 KB] (opens in new tab)
13 Feb 2019	Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/03_78) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-03_78 FSN [PDF, 319 KB] (opens in new tab)
11 Feb 2019	ARCHITECT Estradiol Reagent Kit and Alinity i Estradiol Reagent Kit, Abbott GmbH & Co. KG, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/19/02_73) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com	HSA 6004101-005-19-02_73 FSN [PDF, 308 KB] (opens in new tab)
11 Feb 2019	Elecsys Anti-HAV IgM, Roche Diagnostics GmbH (HSA 600:41/01-016/19/01_75) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-19-01_75 FSN [PDF, 94 KB] (opens in new tab)
07 Feb 2019	ADVIA Chemistry XPT Sample Probe Cover for Aptio by Siemens, Aptio by Inpeco and FlexLab Automation Interfaces, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/19/02_49) Local Contact: Siemens Healthcare Pte. Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-19-02_49 FSN [PDF, 92 KB] (opens in new tab)
04 Feb 2019	SPD Clearblue Digital Home Ovulation Test 10s, SPD Swiss Precision Diagnostics GmbH (HSA 600:41/01-277/19/01_31) Local Contact: Mcpherson's Consumer Products Pte Ltd Contact no./Email: 6521 6820 / contact@mcpher.com.sg	HSA 6004101-277-19-01_31 FSN_Redacted [PDF, 532 KB] (opens in new tab)
01 Feb 2019	Senographe Crystal Nova, GE Ultrasound Korea Ltd (HSA 600:41/01-010/19/03_52) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-19-03_52 FSN_Redacted [PDF, 132 KB] (opens in new tab)
01 Feb 2019	UNISEPTA FOAM 2 WIPES, USF Healthcare S.A. (HSA 600:41/01-335/19/01_44) Local Contact: Raydent Supplies (S) Pte Ltd Contact no./Email: 6741 5411	HSA 6004101-335-19-01_44 FSN_Redacted [PDF, 526 KB] (opens in new tab)
21 Dec 2018	da Vinci Harmonic ACE Insert, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/27_38) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regional.pms@transmedicgroup.com	HSA 6004101-070-18-27_38 FSN [PDF, 166 KB] (opens in new tab) This FSN is an update to the original FSN published in Dec 2018.