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 - Nov 2015

Date of Notification	Title	FSN
30 Nov 2015	Artis Zee Family System and Artis Q Family System, Siemens AG (HSA 600:41/01-022/15/61_48) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-61_48 FSN564 KB
30 Nov 2015	Synthes Synex, Mathys Medical Ltd (HSA 600:41/01-002/15/53_17) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276459	HSA 6004101-002-15-53_17 FSN916 KB
27 Nov 2015	Boston Scientific ACUITY Pro Guide Catheter, Boston Scientific Corporation (HSA 600:41/01-007/15/06_55) Local Contact: Boston Scientific Asia Pacific Pte Ltd Contact no./Email: 64188888	HSA 6004101-007-15-06_55 FSN3691 KB
27 Nov 2015	ADVIA Centaur XPT, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/60_38) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-60_38 FSN50 KB
26 Nov 2015	Miethke proGAV Programmable Shunt System, Christoph Miethke GmbH & Co. KG (HSA 600:41/01-012/15/08_46) Local Contact: B Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-15-08_46 FSN8797 KB
25 Nov 2015	CareSens N Blood Glucose Monitoring System, i-SENs Inc (HSA 600:41/01-186/15/01_34) Local Contact: Kingston Medical Supplies Pte Ltd Contact no./Email: 67453922	HSA 6004101-186-15-01_34 FSN1760 KB
24 Nov 2015	Syngo X Workplace, Siemens AG (HSA 600:41/01-022/15/59_53) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-59_53 FSN123 KB
24 Nov 2015	Factor VIII Chromogenic Assay, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/15/03_24) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: 62213629	HSA 6004101-032-15-03_24 FSN21 KB
24 Nov 2015	Oxoid Antimicrobial Susceptibility Testing Disc - Gentamicin CN10, Oxoid Limited (HSA 600:41/01-178/15/05_22) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999992	HSA 6004101-178-15-05_22 FSN75 KB
20 Nov 2015	Thin-Flex Venous Cannula, Edwards Lifesciences LLC (HSA 600:41/01-060/15/03_50) Local Contact: Edwards Lifesciences (Asia) Pte Ltd Contact no./Email: 96567562	HSA 6004101-060-15-03_50 FSN206 KB
20 Nov 2015	Dimension Integrated Chemistry Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/58_20) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-58_20 FSN86 KB
20 Nov 2015	Stardrive Locking Screw, Self-tapping, Synthes GmbH (HSA 600:41/01-002/15/51_41) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-51_41 FSN1060 KB
20 Nov 2015	B. Braun Dialog+ Dialyzer Machine, B. Braun Avitum AG (HSA 600:41/01-012/15/07_40) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933	HSA 6004101-012-15-07_40 FSN2203 KB
19 Nov 2015	AcroMetrix HBV control, Life Technologies Corporation (HSA 600:41/01-285/15/01_59) Local Contact: Fisher Scientific Pte Ltd Contact no./Email: 68736006	HSA 6004101-285-15-01_59 FSN149 KB HSA 6004101-285-15-01_59 FSN249 KB
18 Nov 2015	Birmingham Hip Modular Head, monoblock version, Smith & Nephew Orthopaedics Ltd (HSA 600:41/01-073/15/12_25) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-12_25 FSN95 KB
18 Nov 2015	LeMaitre Single Lumen and Over-the-Wire Embolectomy Catheters, LeMaitre Vascular Inc. (HSA 600:41/01-057/15/05_19) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net	HSA 6004101-057-15-05_19 FSN142 KB HSA 6004101-057-15-05_19 FSN242 KB
17 Nov 2015	Reflection Spherical Head Screw, Smith & Nephew Inc (HSA 600:41/01-073/15/11_18) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-11_18 FSN53 KB
17 Nov 2015	ADVIA Centaur and ADVIA Centaur XP Instruments, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/57_38) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-57_38 FSN35 KB
16 Nov 2015	ARCTIC SUN 5000 Temperature Management System, Bard Medical Division / Medivance Inc (HSA 600:41/01-050/15/05_56) Local Contact: Bard Singapore Pte Ltd Contact no./Email: 65805988	HSA 6004101-050-15-05_56 FSN1748 KB
16 Nov 2015	Provide® Protection Caps, Provide Impression Copings, Biomet 3i (HSA 600:41/01-181/15/02_17) Local Contact: Asia Implant Support & Services Contact no./Email: admin@implant.com.sg	HSA 6004101-181-15-02_17 FSN36 KB
13 Nov 2015	Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml, Oxoid Limited (HSA 600:41/01-178/15/04_31) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999999	HSA 6004101-178-15-04_31 FSN77 KB
13 Nov 2015	ATB Densitometer control & Densimat, Biomerieux SA (HSA 600:41/01-146/15/04_34) Local Contact: Biomerieux Singapore Pte Ltd Contact no./Email: sg.qara@ext.biomerieux.com	HSA 6004101-146-15-04_34 FSN336 KB
12 Nov 2015	Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/15/38_54) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477	HSA 6004101-026-15-38_54 FSN221 KB
11 Nov 2015	Virtuoso v5.4 and v5.5, Ventana Medical Systems Inc (HSA 600:41/01-016/15/17_23) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com	HSA 6004101-016-15-17_23 FSN305 KB
09 Nov 2015	Siemens Somatom Definition AS, Siemens AG (HSA 600:41/01-022/15/56_53) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-56_53 FSN1887 KB
6 Nov 2015	Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/15/37_44) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-15-37_44 FSN217 KB
6 Nov 2015	ADVIA Chemistry Hemoglobin A1c_3 (A1c_3 and A1c_3M), Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/55_22) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com	HSA 6004101-022-15-55_22 FSN26 KB
05 Nov 2015	CXI Support Catheter, Cook Incorporated (HSA 600:41/01-013/15/06_41) Local Contact: Cook South East Asia Pte Ltd Contact no./Email: 6287 7888	HSA 6004101-013-15-06_41 FSN23 KB
05 Nov 2015	Baylis ProTrack Microcatheter, Baylis Medical (HSA 600:41/01-057/15/04_50) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net	HSA 6004101-057-15-04_50 FSN344 KB
05 Nov 2015	Toshiba whole-body X-ray CT scanner - TSX-303A, Toshiba Medical System Corporation (HSA 600:41/01-064/15/03_51) Local Contact: Toshiba Medical Systems Asia Pte Ltd Contact no./Email: 62729766	HSA 6004101-064-15-03_51 FSN12 KB
05 Nov 2015	VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/49_59) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-49_59 FSN185 KB
05 Nov 2015	Oxoid antimicrobial susceptibility testing disc-Cefoxitin FOX30, Oxoid Limited (HSA 600:41/01-178/15/03_61) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999999	HSA 6004101-178-15-03_61 FSN73 KB
04 Nov 2015	InSync III CRT-P, Medtronic Cardiac Rhythm Heart (HSA 600:41/01-009/15/17_40) Local Contact: Medtronic International Limited Contact no./Email: 64365000	HSA 6004101-009-15-17_40 FSN62 KB
03 Nov 2015	CAVITY SpineWand Device, 8-gauge, ArthroCare Corporation (HSA 600:41/01-073/15/10_49) Local Contact: Smith & Nephew Pte Limited Contact no./Email: Singapore.surgicalsale@smith-nephew.com	HSA 6004101-073-15-10_49 FSN81 KB
03 Nov 2015	Xper Flex Cardio Physiomonitoring System, Witt Biomedical Corporation (HSA 600:41/01-026/15/36_35) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477	HSA 6004101-026-15-36_35 FSN84 KB
03 Nov 2015	Attachment for acetabular and medullary reaming, Synthes GmbH (HSA 600:41/01-002/15/47_19) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-47_19 FSN63 KB
03 Nov 2015	USS II Polyaxial screws, USS Variable Axis Screws, Universal Reduction screws, Synthes GmbH (HSA 600:41/01-002/15/48_33) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135	HSA 6004101-002-15-48_33 FSN1048 KB
02Nov 2015	Baxter Vented Paclitaxel Set, Baxter Healthcare SA (HSA 600:41/01-001/15/03_25) Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact no./Email: 68262616	HSA 6004101-001-15-03_25 FSN374 KB
02 Nov 2015	IOL Master 500, Carl Zeiss Meditec Ag (HSA 600:41/01-136/15/02_18) Local Contact: Carl Zeiss Pte Ltd Contact no./Email: 67419600	HSA 6004101-136-15-02_18 FSN833 KB

Healthcare professional, Industry member, Medical devices

Published: 30 Nov 2015

Field Safety Notices

13 Jul 2020