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 2016

DATE OF NOTIFICATION

TITLE

FSN

30 Sep 2016

Xpert HIV-1 Viral Load, Cepheid (HSA 600:41/01-086/16/02_38)
Local Contact: SPD Scientific Pte Ltd
Contact no./Email: 63039870

 HSA 6004101-086-16-02_38 FSN145 KB

30 Sep 2016

Restylane Lidocaine 1ml, Q-Med AB (HSA 600:41/01-230/16/01_35)
Local Contact: Galderma Singapore Pte Ltd
Contact no./Email: 68389359

 HSA 6004101-230-16-01_35 FSN666 KB

29 Sep 2016

Welch Allyn MS3 Connex Spot Classic Mobile Stand & Power Supply, Welch Allyn Inc (HSA 600:41/01-006/16/01_37)
Local Contact: Welch Allyn Singapore Pte Ltd
Contact no./Email: 68709165

 HSA 6004101-006-16-01_37 FSN131 KB

28 Sep 2016

ABL90 FLEX Analyzer, Radiometer Medical Aps (HSA 600:41/01-219/16/03_34)
Local Contact: Radiometer S.E.A Pte Ltd
Contact no./Email: 63896027

 HSA 6004101-219-16-03_34 FSN62 KB

26 Sep 2016

Tubeset Standard of Diego Elite System, Gyrus ACMI, Inc (HSA 600:41/01-004/16/04_18)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: mes-ra.osp@olympus-ap.com

 HSA 6004101-004-16-04_18 FSN31 KB

26 Sep 2016

PrimaryDiagnost Digital Systems, Philips India Limited (HSA 600:41/01-026/16/35_25)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-35_25 FSN694 KB

23 Sep 2016

cobas c 111 analyzer & cobas c 111 analyzer with ISE, Roche Diagnostics GmbH (HSA 600:41/01-016/16/15_31)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-15_31 FSN663 KB

23 Sep 2016

Sofradim Parietex Plug and Patch System, and ProGrip Self-Gripping Polyester Mesh, Sofradim Production (HSA 600:41/01-046/16/07_17)
Local Contact: Covidien Private Limited
Contact no./Email: 64396974

 HSA 6004101-046-16-07_17 FSN494 KB

22 Sep 2016

Philips Mobile Diagnost wDR 1 & 2, Philips Medical Systems (HSA 600:41/01-026/16/34_08)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477

 HSA 6004101-026-16-34_08 FSN203 KB

21 Sep 2016

Instruments/Systems using rack trays, Roche Diagnostics GmbH (HSA 600:41/01-016/16/14_24)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-14_24 FSN824 KB

21 Sep 2016

5.2mm Suction Punch, Smith & Nephew Inc., Endoscopy Division (HSA 600:41/01-073/16/25_09)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-25_09 FSN63 KB

20 Sep 2016

GETINGE ED-FLOW AER & ED-FLOW SD AER, Getinge Lancer (HSA 600:41/01-224/16/01_64)
Local Contact: Getinge Singapore
Contact no./Email: 63967298

 HSA 6004101-224-16-01_64 FSN460 KB

19 Sep 2016

BD Hypodermic Syringes with Needles, Becton, Dickinson and Company (HSA 600:41/01-003/16/09_46)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 64322060

 HSA 6004101-003-16-09_46 FSN55 KB

19 Sep 2016

Philips IntelliVue MX40 Patient Wearable Monitor, Philips Medical Systems (HSA 600:41/01-026/16/32_43)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477

 HSA 6004101-026-16-32_43 FSN280 KB

19 Sep 2016

Philips BV 25, BV300, BV ENDURA, BV PULSERA & BV LIBRA X-ray Systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/16/33_54)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477

 HSA 6004101-026-16-33_54 FSN206 KB

16 Sep 2016

SPINOCATH G24/G29, SPINOCATH G22/G27, B. Braun Melsungen AG (HSA 600:41/01-012/16/09_50)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: press.sg@bbraun.com

 HSA 6004101-012-16-09_50_FSN143 KB

15 Sep 2016

RayStation (InverseArc 1.0), RaySearch Laboratories AB (HSA 600:41/01-070/16/19_40)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com

 HSA 6004101-070-16-19_40 FSN628 KB

14 Sep 2016

Dimension IRON, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/45_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-45_23 FSN90 KB

13 Sep 2016

RAPIDPoint® 400/405 Measurement Cartridge Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/44_22)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-44_22 FSN16 KB

8 Sept 2016

IMMULITE 1000, 2000, RUBELLA IGM, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/43_65)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-43_65 FSN102 KB

8 Sept 2016

Esaote MyLab Twice, Esaote S.p.a. (HSA 600:41/01-288/16/01_17)
Local Contact: Medical Plus Pte Ltd
Contact no./Email: admin@medicalplus-group.com

 HSA 6004101-288-16-01_17 FSN792 KB

8 Sept 2016

Viva CRT-D and Evera ICD, Medtronic Inc (HSA 600:41/01-009/16/15_45)
Local Contact: Medtronic International Limited
Contact no./Email: 64365077

 HSA 6004101-009-16-15_45 FSN328 KB

8 Sept 2016

OSSEOTITE Certain Implant 4 x 11.5mm, Biomet 3i (HSA 600:41/01-181/16/02_25)
Local Contact: Asia Implant Support & Services
Contact no./Email: 6223 2229

 HSA 6004101-181-16-02_25 FSN299 KB

5 Sept 2016

Monaco RTP System, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/07_08)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322

 HSA 6004101-101-16-07_08 FSN54 KB

2 Sept 2016

XR 6000, GE Hualun Medical Systems Co Ltd (HSA 600:41/01-010/16/15_09)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com

 HSA 6004101-010-16-15_09 FSN329 KB

2 Sept 2016

Concept Heatwave Electrode, 130mm x 2.3mm diameter, Conmed Corporation (HSA 600:41/01-302/16/01_56)
Local Contact: ConMed Singapore Pte Ltd
Contact no./Email: 6255 4868

 HSA 6004101-302-16-01_56 FSN84 KB

1 Sept 2016

LFITTM Anatomic CoCr V40TM Femoral Heads, Howmedica Osteonics Corp (HSA 600:41/01-014/16/12_46)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com

 HSA 6004101-014-16-12_46 FSN_Updated776 KB

1 Sept 2016

MAGIC (MAGnetic resonance image Compilation) on Signa Pioneer and systems running application software version DV25.1, GE MEDICAL SYSTEMS, LLC (HSA 600:41/01-010/16/14_54)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com

 HSA 6004101-010-16-14_54 FSN279 KB

26 Feb 2016

BD SurePath Preservative Collection Vial, BD Life Sciences (HSA 600/41:01-003/16/01_61)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 64322048

 HSA 6004101-003-16-01_61 FSN231 KB
Healthcare professional, Industry member, Medical devices
Published:

Field Safety Notices

12 Dec 2019