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 2016

Date of Notification

Title

FSN

29 Jan 2016

Accu-Chek Inform II Base Unit, Handheld Base Unit, Roche HBU/BU Control Panel, Accu-Chek Inform II meter+RF, Accu-Chek Inform II meter, CoaguChek XS Pro Int'l, CoaguChek XS Plus Int'l, Roche Diagnostics GmbH (HSA 600:41/01-016/16/02_31)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-02_31 FSN852 KB

27 Jan 2016

Ellipse Nordlys/Sirius, Ellipse A/S (HSA 600:41/01-288/16/01_33)
Local Contact: Aradigm Pte Ltd
Contact no./Email: 64635993

 HSA 6004101-288-16-01_33 FSN29 KB

27 Jan 2016

LEGION Screw-On Hemi Stepped Tibial Wedge, 5mm Sz 5-6 Lt-Lat/Rt-Mdl, Smith & Nephew Inc (HSA 600:41/01-073/16/03_19)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-03-19 FSN79 KB

27 Jan 2016

Haemonetics MCS+ System, Haemonetics Automated Cell Processor ACP 215, Haemonetics Corporation (HSA 600:41/01-070/16/02_29)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 64776101

 HSA 6004101-070-16-02_29 FSN198 KB

27 Jan 2016

Eclipse™ Treatment Planning System, Varian Medical Systems Inc (HSA 600:41/01-058/16/01_25)
Local Contact: Varian Medical Systems Pacific Inc
Contact no./Email: 68870028

 HSA 6004101-058-16-01_25 FSN242 KB

26 Jan 2016

iChemVELOCITY Urine Chemistry Strips, Iris Diagnostics (HSA 600:41/01-052/16/02_22)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126

 HSA 6004101-052-16-02_22 FSN171 KB

26 Jan 2016

Trilogy 100, Trilogy 200, and Trilogy 202 units with software versions 13.2.04 or 13.2.05 or 14.0.00 or 14.1.01, Respironics Inc (HSA 600:41/01-026/16/04_18)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-04_18 FSN97 KB

26 Jan 2016

ARCHITECT STAT High Sensitive Troponin-I Reagent Kit, Abbott Ireland (Diagnostics Division) (HSA 600:41/01-005/16/01_24)
Local Contact: Abbott Laboratories Singapore Ltd
Contact no./Email: 68859103

 HSA 6004101-005-16-01_24 FSN32 KB

26 Jan 2016

VITROS® 4600 Chemistry System, VITROS® 5600 Chemistry System, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/16/02_23)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276459

 HSA 6004101-002-16-02_23 FSN 1136 KB

HSA 6004101-002-16-02_23 FSN 2117 KB

25 Jan 2016

Leica M525 OH4 / M720 OH5 Surgical Microscopes with 400W Illumination, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/16/01_56)
Local Contact: Leica Microsystems (SEA) Pte Ltd
Contact no./Email: 65505999

 HSA 6004101-126-16-01_56 FSN195 KB

25 Jan 2016

BrightView, BrightView X, BrightView XCT, BrightView XCT Upgrade, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/16/02_48)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-02_48 FSN166 KB

25 Jan 2016

cobas® b 123 POC System, Roche Diagnostics GmbH (HSA 600:41/01-016/16/01_20)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-01_20 FSN574 KB

22 Jan 2016

LCP Distal Tibial Plate & Expert™ A2FN, Synthes GmbH (HSA 600:41/01-002/16/01_55)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135

 HSA 6004101-002-16-01_55 FSN75 KB

22 Jan 2016

HP cosmos Medical treadmill ergometer, h/p/cosmos Sports & Medical GmbH (HSA 600:41/01-039/16/02_54)
Local Contact: United BMEC Pte Ltd
Contact no./Email: 63052525

 HSA 6004101-039-16-02_54 FSN806 KB

21 Jan 2016

Single Lumen Central Venous, Femoral Artery Pressure Monitoring & Radial Artery Pressure Monitoring Catheter Sets, Cook Incorporated (HSA 600:41/01-013/16/01_44)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 62877888

 HSA 6004101-013-16-01_44 FSN157 KB

20 Jan 2016

HF440 devices with fifth pump option, Infomed SA (HSA 600:41/01-070/16/01_52)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com

 HSA 6004101-070-16-01_52 FSN206 KB

19 Jan 2016

Puritan Bennett™ 980 Ventilator System, Covidien llc (HSA 600:41/01-046/16/01_41)
Local Contact: Covidien Private Limited
Contact no./Email: 64396974

 HSA 6004101-046-16-01_41 FSN897 KB

19 Jan 2016

DYONICS RF Broadnose 90 Wand, Smith & Nephew Inc (HSA 600:41/01-073/16/02_50)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-02_50 FSN55 KB

19 Jan 2016

ED-530XT Duodenoscope for Treatment, Fujifilm Corporation (HSA 600:41/01-173/16/01_40)
Local Contact: Fujifilm Asia Pacific Pte Ltd
Contact no./Email: support@fujifilm.com.sg

 HSA 6004101-173-16-01_40 FSN77 KB

18 Jan 2016

BCS/ BCS XP with Dade Innovin, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-022/16/03_61)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-03_61 FSN92 KB

15 Jan 2016

BEAVER 4.0mm Banana Blade, Smith & Nephew Inc (HSA 600:41/01-073/16/01_36)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-01_36 FSN83 KB

14 Jan 2016

ADVIA CENTAUR ENHANCED ESTRADIOL, IMMULITE 1000/IMMULITE 2000 ESTRADIOL [CC 16-03], Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/02_60)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-02_60 FSN104 KB

14 Jan 2016

Multipolar Bipolar Cup, CPT Femoral Stem, Versys Beaded Fullcoat Femoral Stem, Metasul Head, CoCr Head, NexGen Femoral Component, Natural-Knee Flex Femoral Component, Zimmer Unicompartmental Knee Femoral Component and 4 more devices, Zimmer Inc. (HSA 600:41/01-032/16/01_59)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 68547081

 HSA 6004101-008-16-03_35 FSN68 KB

13 Jan 2016

INNOVANCE PFA P2Y, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/16/01_59)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 62213629

 HSA 6004101-032-16-01_59 FSN21 KB

12 Jan 2016

T34 Ambulatory Syringe Pump, Caesarea Medical Electronics Ltd (HSA 600:41/01-287/16/01_33)
Local Contact: Progress Healthcare Pte Ltd
Contact no./Email: 62975955

 HSA 6004101-287-16-01_33 FSN443 KB

12 Jan 2016

Philips IntelliVue Measurement Modules (X1, X2), Philips Medical Systems Boblinger GmbH (HSA 600:41/01-026/16/01_19)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 7445477

 HSA 6004101-026-16-01_19 FSN39 KB

12 Jan 2016

PRN 50-M+ Digital Writer, GSI Group (HSA 600:41/01-010/16/01_29)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668

 HSA 6004101-010-16-01_29 FSN86 KB

11 Jan 2016

Phadia EliA SmDp Well, Phadia AB (HSA 600:41/01-033/16/01_57)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 62984347

 HSA 6004101-033-16-01_57 FSN163 KB

08 Jan 2016

Guide Wire(s) and K-Wire(s) and Intramedullary Pin Metaizeau, Stryker Trauma GmbH (HSA 600:41/01-014/16/01_18)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 65009507

 HSA 6004101-014-16-01_18 FSN196 KB

07 Jan 2016

Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead, Medtronic Inc. (HSA 600:41/01-009/16/01_17)
Local Contact: Medtronic International Limited
Contact no./Email: 64365000

 HSA 6004101-009-16-01_17 FSN4198 KB

06 Jan 2016

Sulcoflex Toric, Rayner Intraocular Lenses Ltd. (HSA 600:41/01-110/16/01_48)
Local Contact: Mandarin Opto-Medic Co Pte Ltd
Contact no./Email: 67478777

 HSA 6004101-110-16-01_48 FSN3169 KB

05 Jan 2016

9131 Defibrillation Electrode, Cardiac Science Corporation (HSA 600:41/01-089/16/01_46)
Local Contact: Progressive Industrial Equipment Co.
Contact no./Email: 62827722

 HSA 6004101-089-16-01_46 FSN510 KB

05 Jan 2016

ADVIA Centaur Systems PSA, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/01_58)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-01_58 FSN84 KB

05 Jan 2016

FRED easy AED, Schiller Medical (HSA 600:41/01-056/16/01_54)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 62730487

 HSA 6004101-056-16-01_54 FSN1391 KB

04 Jan 2016

COULTER® S-CAL® Calibrator Kits, Beckman Coulter Inc (HSA 600:41/01-052/16/01_38)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126

 HSA 6004101-052-16-01_38 FSN112 KB

04 Jan 2016

NexGen Precoat Tibial Plate & NexGen Option Tibial Plate, Zimmer Inc (HSA 600:41/01-008/16/01_45)
Local Contact: Zimmer Pte Ltd
Contact no./Email:6854 7081

 HSA 6004101-008-16-01_45 FSN140 KB

20 Nov 2015

Evita Infinity V500, Babylog VN500 and Evita V300, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/15/03_37)
Local Contact: Draeger Medical SEA Pte Ltd
Contact no./Email: dsa.singapore@draeger.com

 HSA 6004101-063-15-03_37 FSN4216 KB

Healthcare professional, Industry member, Medical devices
Published:

Field Safety Notices

12 Dec 2019