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 - Dec 2016

DATE OF NOTIFICATION

TITLE

FSN

30 Dec 2016

UniCel® DxH 800 Coulter® Cellular Analysis System, UniCel® DxH 600 Coulter® Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/16/14_65)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126

 HSA 6004101-052-16-14-65 FSN74 KB

30 Dec 2016

Workstation power cable assembly on certain OEC MiniView 6800, OEC 9800, OEC 9900 systems, GE OCE Medical Systems, Inc (HSA 600:41/01-010/16/24_17)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668

 HSA 6004101-010-16-24_17 FSN416 KB

29 Dec 2016

Datascope Cardiosave Intra-Aortic Balloon Pump (IABP), Datascope Corp (HSA 600:41/01-017/16/08_56)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: kennethow@idsmed.com

 HSA 6004101-017-16-08_56 FSN117 KB

27 Dec 2016

Glucose-6 Phosphate Dehydrogenase (G-6-PDH) Kit, Trinity Biotech (HSA 60041/01-212/16/01_59)
Local Contact: B-Com Impact Pte Ltd
Contact no./Email: 62501716

 HSA 6004101-212-16-01_59 FSN94 KB

27 Dec 2016

Ortho-Clinical VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-303/16/08_60)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151

 HSA 6004101-303-16-08_60 FSN3516 KB

27 Dec 2016

MEDPOR Facial and Oculoplastic Sizer Set, TLS and SPG Drain Systems, Stryker Leibinger GmbH & Co. KG (HSA 600:41/01-014/16/16_48)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com

 HSA 6004101-014-16-16_48 FSN130 KB

23 Dec 2016

Certofix Duo, Certofix Trio, Drucafix, B Braun Melsungen AG (HSA 600:41/01-012/16/12_63)
Local Contact: B Braun Singapore Pte Ltd
Contact no./Email: 62130933

 HSA 6004101-012-16-12_63 FSN444 KB

21 Dec 2016

Philips DuraDiagnost & DuraDiagnost Compact X-ray system, Philips Healthcare (Suzhou) Co., Ltd (HSA 600:41/01-026/16/41_51)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-41_51 FSN481 KB

21 Dec 2016

Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/40_40)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477

 HSA 6004101-026-16-40_40 FSN96 KB

21 Dec 2016

Synthes Reamer/Irrigator/Aspirator (RIA) System, Synthes GmbH (HSA 600:41/01-002/16/38_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 67504213

 HSA 6004101-002-16-38_44 FSN71 KB

19 Dec 2016

Impactor for PFNA Blade, Synthes GmbH (HSA 600:41/01-002/16/37_35)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 67504213

 HSA 6004101-002-16-37_35 FSN98 KB

16 Dec 2016

UniCel DxC Synchron Wash Concentrate II, Beckman Coulter Inc. (HSA 600:41/01-052/16/13_57)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 64188888

 HSA 6004101-052-16-13_57 FSN38 KB

16 Dec 2016

IMAGER™II ANGIOGRAPHIC CATHETER, Boston Scientific Corporation (HSA 600:41/01-007/16/07_25)
Local Contact: Boston Scientific Asia Pacific
Contact no./Email: Singapore_FSCA_Query@bsci.com

 HSA 6004101-007-16-07_25 FSN178 KB

15 Dec 2016

ID-DC-Screening II, DiaMed GmbH (HSA 600:41/01-027/16/15_24)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262

 HSA 6004101-027-16-15_24 FSN659 KB

15 Dec 2016

ID -DiaPanel and ID- DiaPanel P, DiaMed GmbH (HSA 600:41/01-027/16/16_38)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262

 HSA 6004101-027-16-16_38 FSN1681 KB

15 Dec 2016

Siemens Biograph mCT & Siemens Biograph mCT Flow, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/16/55_18)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-55_18 FSN4478 KB

13 Dec 2016

iPlan RT, iPlan RT Dose and BrainSCAN, BrainLab AG (HSA 600:41/01-047/16/01_17)
Local Contact: BrainLab Limited (Singapore Branch)
Contact no./Email: 67341701

 HSA 6004101-047-16-01_17 FSN446 KB

13 Dec 2016

Carestation 600 Series Anesthesia Systems, GE Medical Systems China Co., Ltd (HSA 600:41/01-010/16/23_08)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668

 HSA 6004101-010-16-23_08 FSN299 KB

12 Dec 2016

VITROS Chemistry Products UPRO Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/07_23)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151

 HSA 6004101-303-16-07_23 FSN456 KB

12 Dec 2016

Draeger Oxylog 3000 and Draeger Oxylog 3000 plus, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/04_09)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 68729288

 HSA 6004101-063-16-04_09 FSN2798 KB

12 Dec 2016

Nanostim Leadless Cardiac Pacemaker, St Jude Medical Cardiac Rhythm Management Division (HSA 600:41/01-025/16/02_64)
Local Contact: St Jude Medical (S)Pte Ltd
Contact no./Email: 66432817

 HSA 6004101-025-16-02_64 FSN254 KB

10 Dec 2016

Artis Zee Family System, Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/54_56)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-54_56 FSN172 KB

9 Dec 2016

Smith & Nephew Vulcan Electro RF System (Split Electrode Ground Pad), Smith & Nephew Inc (HSA 600:41/01-073/16/29_48)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-29_48 FSN57 KB

9 Dec 2016

BioPlex 2200 ToRC IgM Calibrator Set and Control Set, Clinical Diagnostics Group (HSA 600:41/01-027/16/14_22)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262

 HSA 6004101-027-16-14_22 FSN950 KB

8 Dec 2016

ORTHO VISION Analysers with Software Version 3.6.0 and below, Ortho Clinical Diagnostics (HSA 600:41/01-303/16/06_60)
Local Contact: Ortho Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151

 HSA 6004101-303-16-06_60 FSN435 KB

8 Dec 2016

PreciControl Varia Level 2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/20_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-20_61 FSN286 KB

7 Dec 2016

Galeo Pro Coronary Guidewire, Concert Medical LLC (HSA 600:41/01-269/16/01_46)
Local Contact: Biotronik Asia Pacific Pte Ltd
Contact no./Email: 66325992

 HSA 6004101-269-16-01_46 FSN758 KB

7 Dec 2016

Software EyeSuite Version i.8.2.1.0 in Connection with DICOM, Haag Streit AG (HSA 600:41/01-110/16/04_54)
Local Contact: Mandarin Opto-Medic Co Pte Ltd
Contact no./Email: 67478777

 HSA 6004101-110-16-04_54 FSN5600 KB

6 Dec 2016

Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™, Medtronic Inc (HSA 600:41/01-009/16/18_52)
Local Contact: Medtronic International Limited
Contact no./Email: 64365077

 HSA 6004101-009-16-18_52 FSN487 KB

5 Dec 2016

SynReam Flexible Shaft, Flexible Shaft Ø 7.0mm, long, Mathys Medical Ltd (HSA 600:41/01-002/16/36_63)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: jgoh5@its.jnj.com

 HSA 6004101-002-16-36_63 FSN47 KB

5 Dec 2016

Abbott ARCHITECT Active-B12 Reagent Kit, Abbott GmbH & Co KG (HSA 600:41/01-005/16/12_58)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: FSN.enquiry@abbott.com

 HSA 6004101-005-16-12_58 FSN26 KB

5 Dec 2016

Boston Scientific INGEVITY MRI Leads, Boston Scientific Corporation (HSA 600:41/01-007/16/06_44)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: Singapore_FSCA_Query@bsci.com

 HSA 6004101-007-16-06_44 FSN109 KB

1 Dec 2016

CarePlus incubator, Giraffe Exam Light, Giraffe Incubator, Giraffe OmniBed, Giraffe Spot PT, IWS, Panda Warmer, Giraffe Bedded Warmer, Ohmeda Medical (HSA 600:41/01-010/16/22_49)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com

 HSA 6004101-010-16-22_49 FSN225 KB
Healthcare professional, Industry member, Medical devices
Published:

Field Safety Notices

12 Dec 2019