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 - Jan 2018

Date of Notification	Title	FSN
30 Jan 2018	Philips SureSigns VSi, SureSigns VS2+ Vital Signs Monitor, Philips Medical Systems (HSA 600:41/01-026/18/07_18) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email:1800 744 5477	HSA 6004101-026-18-07_18 FSN_Redacted33 KB
30 Jan 2018	Acuson SC2000 Ultrasound System, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/18/03_56) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-03_56 FSN109 KB
29 Jan 2018	Philips Avent uGrow Smart Ear Thermometer, SCH740, Philips Consumer Lifestyle B.V (HSA 600:41/01-026/18/05_51) Local Contact: Philips Electronics (S) Pte Ltd	HSA 6004101-026-18-05_51 FSN1348 KB
26 Jan 2018	Philips HeartStart MRx and FR3 Monitor/Defibrillator and HeartStart FR3 AED Used With Q-CPR Meter or CPR Sensor, Philips Medical Systems (HSA 600:41/01-026/18/06_46) Local Contact: Philips Medical Systems Contact no./Email: 1800 744 5477	HSA 6004101-026-18-06_46 FSN85 KB
26 Jan 2018	C/M HUMERAL ASSEMBLY 4’’ XSMALL, Zimmer Inc. (HSA 600:41/01-008/18/02_46) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com	HSA 6004101-008-18-02_46 FSN71 KB
26 Jan 2018	Medtronic O-Arm Imaging System, Medtronic Inc (HSA 600:41/01-009/18/01_50) Local Contact: Medtronic International Ltd Contact no./Email: 6436 5000	HSA 6004101-009-18-01_50 FSN_Redacted1317 KB
24 Jan 2018	ORTHOSCAN MOBILE DI; ORTHOSCAN FD-OR; ORTHOSCAN FD PULSE, Orthoscan Inc. (HSA 600:41/01-215/18/01_44) Local Contact: Ziehm Imaging Singapore Pte Ltd Contact no./Email:6391 8600 / singapore@ziehm.com	HSA 6004101-215-18-01_44 FSN264 KB
24 Jan 2018	ProGrade 1x, Philips Medical System DMC GmbH (HSA 600:41/01-026/18/04_40) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-04_40 FSN_Redacted2403 KB
24 Jan 2018	Terumo Advanced Perfusion System 1: Flowmeter Module [802018], Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/18/02_50) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 6291 3603	HSA 6004101-028-18-02_50 FSN_Redacted122 KB
23 Jan 2018	bioMerieux Etest Antimicrobial Susceptibility Testing, bioMerieux S.A. (HSA 600:41/01-146/18/02_60) Local Contact: BioMerieux Singapore Pte Ltd Contact no./Email: 6801 6700	HSA 6004101-146-18-02_60 FSN412 KB
22 Jan 2018	Truvidia Wireless Receiver, TRUMPF Medizin Systeme GmbH + Co. KG (HSA 600:41/01-182/18/01_45) Local Contact: Hill-Rom Services Pte Ltd Contact no./Email: 6594 5200	HSA 6004101-182-18-01_45 FSN_Redacted91 KB
22 Jan 2018	Mako RIO System - Ethernet to Fiber Optic Converter, MAKO Surgical Corp. (HSA 600:41/01-070/18/01_35) Local Contact: Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-18-01_35 FSN_Redacted110 KB
22 Jan 2018	Iqon Spectral CT Version 4.7.2, Philips Medical Systems (Cleveland), Inc. (HSA 600:41/01-026/18/03_37) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-03_37 FSN_1_Redacted2876 KB
22 Jan 2018	Mako Onlay Insert Extractor, MAKO Surgical Corp. (HSA 600:41/01-070/18/02_25) Local Contact:Transmedic Pte Ltd Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com	HSA 6004101-070-18-02_25 FSN_Redacted108 KB
19 Jan 2018	VITROS® Immunodiagnostic Products TSH Reagent Packs, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/02_59) Local Contact: Ortho-Clinical Diagnostics Singapore Pte. Ltd. Contact no./Email: 6486 1151	HSA 6004101-303-18-02_59 FSN_Redacted152 KB
17 Jan 2018	BD Phoenix NMIC panel/NMIC/ID panel, Becton Dickinson and Company (HSA 600:41/01-003/18/01_59) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 6432 2011	HSA 6004101-003-18-01_59 FSN224 KB
17 Jan 2018	Medfusion® Syringe Pump Model Series 3500 and 4000, Smiths Medical ASD, Inc (HSA 600:41/01-017/18/01_25) Local Contact: IDS Medical Systems (S) Pte Ltd	HSA 6004101-017-18-01_25 FSN_Redacted185 KB
17 Jan 2018	Triathlon TS Baseplates Sizes 3 and 4, Howmedica Ostenics Corp (HSA 600:41/01-014/18/02_44) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: asean.pms@stryker.com	HSA 6004101-014-18-02_44 FSN29 KB
17 Jan 2018	Artis One system, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/18/02_18) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-02_18 FSN_Redacted1382 KB
17 Jan 2018	Andago Handrails, Hocoma AG (HSA 600:41/01-286/18/01_48) Local Contact: Hocoma Pte Ltd Contact no./Email: 6513 0580 / info.sin@hocoma.com	HSA 6004101-286-18-01_48 FSN_Redacted2884 KB
16 Jan 2018	LEGION RK/HK HEMI SZ 3-4 LTMD/RTLA 5MM, Smith & Nephew Inc. (HSA 600:41/01-073/18/01_64) Local Contact:Smith & Nephew Pte. Ltd. Contact no./Email: singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-18-01_64 FSN174 KB
16 Jan 2018	SIGMA HP PFJ Cemented Trochlear Implants, DePuy Orthopaedics, Inc. (HSA 600:41/01-002/18/01_71) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 6918 8304	HSA 6004101-002-18-01_71 FSN_Redacted216 KB
11 Jan 2018	8.0MM X 90MM DRI-LOK THREADED CANNULA, Stryker Endoscopy (HSA 600:41/01-014/18/01_43) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com	HSA-6004101-014-18-01_43 FSN_Redacted133 KB
10 Jan 2018	CARESCAPE Central Station (CSCS) software version 2.0.2, GE Medical Systems Information Technologies (HSA 600:41/01-010/18/01_64) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 6277 7668 / svc@ge.com	HSA 6004101-010-18-01_64 FSN_Redacted301 KB
09 Jan 2018	Ortho Clinical VITROS Chemistry Products VANC Reagent; Ortho Clinical Diagnostics VITROS Chemistry Products ASO Reagent, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/01_70) Local Contact: Ortho Clinical Diagnostics Singapore Pte Ltd Contact no./Email: 6486 1151	HSA-6004101-303-18-01_70 FSN_Redacted467 KB
09 Jan 2018	5214 Maquet Volista StanOP, Triop and Access cupolas, Maquet SAS (HSA 600:41/01-081/18/01_62) Local Contact: Maquet South East Asia Pte Ltd Contact no./Email: 6296 1992	HSA 6004101-081-18-01_62 FSN1655 KB
08 Jan 2018	Vascutek Gelatin Sealed Products, Vascutek Ltd (HSA 600:41/01-028/18/01_48) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 6291 3603	HSA 6004101-028-18-01_48 FSN_Redacted942 KB
08 Jan 2018	Philips IntelliVue Information Center (PIIC) iX, Philips Medical Systems (HSA 600:41/01-026/18/02_56) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-02_56 FSN_Redacted113 KB
08 Jan 2018	BIOPLEX INSTRUMENT DETECTOR CLEAN PACK, Bio-Rad Laboratories, Inc (HSA 600:41/01-027/18/01_57) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 6490 4262	HSA-6004101-027-18-01_57 FSN647 KB
05 Jan 2018	Human Fetal Hemoglobin FITC Conjugate, Life Technologies Corporation (HSA 600:41/01-220/18/01_34) Local Contact: Life Technologies Pte Ltd Contact no./Email: Tel: 63629574	HSA 6004101-220-18-01_34 FSN43 KB
05 Jan 2018	mini VIDAS and VIDAS, BioMerieux S.A. (HSA 600:41/01-146/18/01_31) Local Contact: BioMerieux Singapore Pte Ltd Contact no./Email: 6801 6700	HSA 6004101-146-18-01_31 FSN_Redacted242 KB
05 Jan 2018	Cyclosporine, DHEA-SO4, Folate and HBc IgM Assays, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/01_38) Local Contact: Siemens Healthcare Pte. Ltd Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com	HSA 6004101-022-18-01_38 FSN104 KB
05 Jan 2018	Trabecular Metal Stems, Zimmer Inc. (HSA 600:41/01-008/18/01_35) Local Contact: Zimmer Pte Ltd Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com	HSA 6004101-008-18-01_35 FSN_Redacted100 KB
04 Jan 2018	Philips Brilliance Computed Tomography X-Ray System, Philips Medical Systems Inc (HSA 600:41/01-026/18/01_43) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-18-01_43 FSN_Redacted788 KB
03 Jan 2018	W & H Implantmed Surgical Drive Unit, W&H Dentalwerk Burmoos GmbH (HSA 600:41/01-320/18/01_52) Local Contact: Sonax Business Solutions Contact no./Email: 6348 0480 / nypraxreg@gmail.com	HSA 6004101-320-18-01_52 FSN91 KB
02 Jan 2018	Menicon O2 CARE, Menicon Co., Ltd (HSA 600:41/01-319/18/01_46) Local Contact: Menicon Singapore Sales Pte Ltd. Contact no./Email: 64114778 / cnquiry@menicon.com.sg	HSA 6004101-319-18-01_46 FSN_Redacted2192 KB

Healthcare professional, Industry member, Medical devices

Published: 31 Jan 2018

Field Safety Notices

12 Dec 2019