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 - Sep 2015

Date of Notification	Title	FSN
29 Sep 2015	ADVIA Chemistry XPT System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/53_34) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-53_34 FSN9 KB
28 Sep 2015	Modularis Variostar, Siemens AG (HSA 600:41/01-022/15/52_55) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-52_55 FSN1280 KB
28 Sep 2015	Patient Browser and Content Manager, BrainLab AG (HSA 600:41/01-047/15/07_56) Local contact: BrainLab Limited (Singapore Branch) Contact no./ Email: sg.sales@brainlab.com	HSA 6004101-047-15-07_56 FSN949 KB
28 Sep 2015	Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/08_17) Local contact: Elekta Pte Ltd Contact no./ Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-15-08_17 FSN121 KB
25 Sep 2015	ADVIA Chemistry Alkaline Phosphatase, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/51_31) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-51_31 FSN18 KB
23 Sep 2015	Sentinel Diagnostics Ammonia Ultra Assay, Sentinel CH SpA (HSA 600:41/01-005/15/05_23) Local contact: Abbott Laboratories (S) Pte Ltd Contact no./ Email: FSN_Enquiry@abbott.com	HSA 6004101-005-15-05_23 FSN19 KB
23 Sep 2015	Cholesterol FS, Creatinine PAP FS, HDL-C Immuno FS, LDL-C Select FS, NEFA FS, Phospholipids FS, Triglycerides FS, Uric acid FS TOOS, Diasys Diagnostics Systems GmbH (HSA 600:41/01-032/15/02_24) Local contact: Sysmex Asia Pacific Pte Ltd Contact no./ Email: RA@sysmex-ap.com	HSA 6004101-032-15-02_24 FSN180 KB HSA 6004101-032-15-02_24 FSN22423 KB
21 Sep 2015	EnVision FLEX/HRP visualization reagent, Dako North America Inc (HSA 600:41/01-086/15/04_61) Local contact: SPD Scientific Pte Ltd Contact no./ Email: 63039870	HSA 6004101-086-15-04_61 FSN77 KB
17 Sep 2015	da Vinci Si Single-Site Gripping Instruments, Intuitive Surgical (HSA 600:41/01-070/15/20_44) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-20_44 FSN552 KB
16 Sep 2015	Zimmer Natural Nail CM Long-Cephalomedullary Nails, Zimmer GmbH (HSA 600:41/01-008/15/10_51) Local contact: Zimmer Pte Ltd Contact no./ Email: 68547081	HSA 6004101-008-15-10_51 FSN102 KB
16 Sep 2015	HeartMate II® LVAS System Controller, Thoratec Corporation (HSA 600:41/01-070/15/19_52) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-19_52 FSN136 KB
15 Sep 2015	cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC, Roche Diagnostics GmbH (HSA 600:41/01-016/15/16_38) Local contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./ Email: sg.regulatory@roche.com	HSA 6004101-016-15-16_38 FSN489 KB
14 Sep 2015	LFIT V40 Tapers Vitallium Femoral Heads, Howmedica Osteonics Corp (HSA 600:41/01-014/15/09_33) Local contact: Stryker Singapore Pte Ltd Contact no./ Email: 65009507	HSA 6004101-014-15-09_33 FSN96 KB
14 Sep 2015	Da Vinci Xi Surgical system installed with P4 software, Intuitive Surgical (HSA 600:41/01-070/15/18_35) Local contact: Transmedic Pte Ltd Contact no./ Email: regulatory@transmedicgroup.com	HSA 6004101-070-15-18_35 FSN452 KB
10 Sep 2015	Anspach G1 Dissection Tools, Anspach Effort Inc (HSA 600:41/01-002/15/37_17) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-37_17 FSN5445 KB
10 Sep 2015	Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts, Liko AB (HSA 600:41/01-076/15/02_18) Local contact: Radiance Medical Systems Contact no./ Email: 63162712	HSA 6004101-076-15-02_18 FSN903 KB
09 Sep 2015	Application Instrument for Sternal ZIPFLIX, Synthes GmbH (HSA 600:41/01-002/15/36_55) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-36_55 FSN117 KB
09 Sep 2015	Axiom Artis, Siemens AG (HSA 600:41/01-022/15/50_48) Local contact: Siemens Healthcare Pte Ltd Contact no./ Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-50_48 FSN1050 KB
08 Sep 2015	HeartStart MRx Defibrillator/ Monitor & HeartStart FR3 Defibrillator, Philips Medical Systems (HSA 600:41/01-026/15/29_08) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 18007445477	HSA 6004101-026-15-29_08 FSN134 KB
08 Sep 2015	Access Free T3 Assay, Beckman Coulter Inc (HSA 600:41/01-052/15/07_31) Local contact: Beckman Coulter Singapore Pte Ltd Contact no./ Email: 63407126	HSA 6004101-052-15-07_31 FSN30 KB
08 Sep 2015	Novocastra Lyophilized Mouse Monoclonal Antibody CD10 Reagents, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/04_34) Local contact: Leica Microsystems (SEA) Pte Ltd Contact no./ Email: 65505975	HSA 6004101-126-15-04_34 FSN1999 KB
07 Sep 2015	Cannulated Headless Compression Screw, Synthes GmbH (HSA 600:41/01-002/15/35_46) Local contact: Johnson & Johnson Pte Ltd Contact no./ Email: 68276135	HSA 6004101-002-15-35_46 FSN3497 KB
07 Sep 2015	Bayer Medical Care Medrad® Mark 7 Arterion Injection System, Bayer Medical Care Inc (HSA 600:41/01-069/15/01_54) Local contact: O'Connor's Singapore Pte Ltd Contact no./ Email: enquiries@oconnors.wbl.com.sg	HSA 6004101-069-15-01_54 FSN89 KB
04 Sep 2015	MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/07_53) Local contact: Elekta Pte Ltd Contact no./ Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-15-07_53 FSN128 KB
03 Sep 2015	Discovery & SIGNA Systems, GE Medical Systems LLC (HSA 600:41/01-010/15/16_51) Local contact: GE Healthcare Pte Ltd Contact no./ Email: postmarket@ge.com	HSA 6004101-010-15-16_51 FSN331 KB
03 Sep 2015	Elekta Xio RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/15/06_44) Local contact: Elekta Pte Ltd Contact no./ Email: Elekta_Global_PMS@elekta.com	HSA 6004101-101-15-06_44 FSN62 KB
03 Sep 2015	*KimVent Closed Suction Systems, Halyard Health Inc (HSA 600:41/01-259/15/01_52)** Local contact: Halyard Singapore Pte Ltd Contact no./ Email: 65596280	HSA 6004101-259-15-01_52 FSN1231 KB
02 Sep 2015	Biotrue ONEday Contact Lens, Bausch & Lomb Incorporated (HSA 600:41/01-030/15/04_50) Local contact: Bausch & Lomb (Singapore) Pte Ltd Contact no./ Email: 68349112	HSA 6004101-030-15-04_50 FSN107 KB
02 Sep 2015	chromID™ S. aureus agar, Biomerieux SA (HSA 600:41/01-146/15/03_22) Local contact: Biomerieux Singapore Pte Ltd Contact no./ Email: registration.my@biomerieux.com	HSA 6004101-146-15-03_22 FSN384 KB
01 Sep 2015	Allura Xper FD, Philips Medical Systems Nederland BV (HSA 600:41/01-026/15/28_37) Local contact: Philips Electronics (S) Pte Ltd Contact no./ Email: 18007445477	HSA 6004101-026-15-28_37 FSN111 KB
01 Sep 2015	Spectra Optia Apheresis System, Terumo BCT Inc (HSA 600:41/01-155/15/01_35) Local contact: Terumo BCT (Asia Pacific) Ltd Contact no./ Email: 67739051	HSA 6004101-155-15-01_35 FSN216 KB

Healthcare professional, Industry member, Medical devices

Published: 30 Sep 2015

Field Safety Notices

12 Dec 2019