Field Safety Corrective Actions (FSCA) include removals of medical devices from the market or any other corrective action on devices in use. In general, the product owner (otherwise known as legal manufacturer) implements FSCAs by sending a Field Safety Notice (FSN) to inform operators and users about risks of medical devices. It includes advice on what action should be taken to protect the health or the safety of patients, users or other persons. For example, FSNs may contain information from the product owner that they are voluntarily recalling specific lots of a medical device.

Please note that FSNs are issued by the product owner, registrant or importer of medical devices pursuant to the requirements under the Health Products Act (Cap. 122D). These persons take full responsibility for all information contained in the FSN.

If you receive a FSN from a product owner, registrant or importer, you must always act on it. The Health Sciences Authority makes FSNs publicly available for information only.

If you have a specific question on a FSN, please contact* the product owner, registrant or importer (as the case may be).

*Any contact information provided for each FSCA is correct as at the date of the FSCA notification to the Health Sciences Authority.

Field Safety Notice - Feb 2019

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_Redacted167 KB
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_Redacted170 KB
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_Redacted1443 KB
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_Redacted110 KB
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 FSN163 KB
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_Redacted294 KB
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 FSN173 KB
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_Redacted243 KB
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_Redacted324 KB
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_Redacted101 KB
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_Redacted995 KB
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 FSN85 KB
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_Redacted1154 KB
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_FSN615 KB
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_Redacted13908 KB
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_Redacted1012 KB
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_Redacted152 KB
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_Redacted5717 KB
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 FSN82 KB
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_Redacted109 KB
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 FSN319 KB
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 FSN308 KB
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 FSN93 KB
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 FSN91 KB
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_Redacted532 KB
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_Redacted131 KB
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_Redacted526 KB
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 FSN166 KB This FSN is an update to the original FSN published in Dec 2018.

Healthcare professional, Industry member, Medical devices

Published: 28 Feb 2019

Field Safety Notices

12 Dec 2019