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 - Jul 2016

Date of Notification

Title

FSN

28 Jul 2016

Progressa® Bed (P7500) with P500 Microclimate Management™ Surface, Hill-Rom Inc (HSA 600:41/01-017/16/06_44)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact no./Email: kennethow@idsmed.com

 HSA 6004101-017-16-06_44 FSN707 KB

28 Jul 2016

STERRAD® 100NX™ Sterilizer, Advanced Sterilization Products (HSA 600:41/01-002/16/32_40)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135

 HSA 6004101-002-16-32_40 FSN132 KB

27 Jul 2016

Absorb™ and Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) Systems, Abbott Vascular (HSA 600:41/01-005/16/09_43)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 62700760

 HSA 6004101-005-16-09_43 FSN859 KB

27 Jul 2016

Thermo Scientific Oxoid Columbia Blood Agar Base CM0331 (B,R,S,T,U), Oxoid Limited (HSA 600:41/01-178/16/05_60)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9993

 HSA 6004101-178-16-05_60 FSN219 KB

27 Jul 2016

Ingenuity Core 128 with Software Version 3.5.5, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/16/29_36)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-29_36 FSN133 KB

26 Jul 2016

BD Tritest™ CD3 FITC/CD4 PE/CD45 PerCP, Becton, Dickinson and Company (HSA 600:41/01-003/16/07_58)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 64322048

 HSA 6004101-003-16-07_58 FSN92 KB

26 Jul 2016

VIDAS Estradiol II, BioMerieux SA (HSA 600:41/01-146/16/07_61)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 68016706

 HSA 6004101-146-16-07_61 FSN446 KB

26 Jul 2016

RENASYS™ Transparent Film, Smith & Nephew Inc (HSA 600:41/01-073/16/22_49)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-22_49 FSN271 KB

26 Jul 2016

Xprecia Stride Coagulation Analyzer, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/34_59)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 

 HSA 6004101-022-16-34_59 FSN16 KB

25 Jul 2016

Aptissen HealaFlow, Aptissen SA (HSA 600:41/01-261/16/01_33)
Local Contact: Swissmed Pte Ltd
Contact no./Email: 66356080

 

 HSA 6004101-261-16-01_33 FSN750 KB

25 Jul 2016

Fixture 1002.65A0, Maquet GmbH (HSA 600:41/01-017/16/05_45)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: kennethow@idsmed.com

 

 HSA 6004101-017-16-05_45 FSN1225 KB

22 Jul 2016

OptraPol Cup Refill, Ivoclar Vivadent AG (HSA 600:41/01-067/16/02_19)
Local Contact: Fondaco Pte Ltd
Contact no./Email: 63922806

 HSA 6004101-067-16-02_19 FSN267 KB

21 Jul 2016

NucliSENS easyMAG, bioMérieux SA (HSA 600:41/01-146/16/06_38)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 68016706

 HSA 6004101-146-16-06_38 FSN89 KB

21 Jul 2016

Novus Scientific TIGR® Matrix Surgical Mesh, Novus Scientific AB (HSA 600:41/01-298/16/02_18)
Local Contact: Novus Scientific Pte Ltd
Contact no./Email: 65497871

 HSA 6004101-298-16-02_18 FSN145 KB

20 Jul 2016

Locking Screw Stardrive® Ø 2.4 mm, self-tapping, length 12 mm, TAN (Sterile & Non-Sterile), Synthes GmbH (HSA 600:41/01-002/16/31_09)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135

 HSA 6004101-002-16-31_09 FSN80 KB

20 Jul 2016

Homepump C - Series Silicone Elastomeric Pumps, Halyard Health Inc (HSA 600:41/01-012/16/07_17)
Local Contact: B Braun Singapore Pte Ltd
Contact no./Email: press.sg@bbraun.com

 HSA 6004101-012-16-07_17 FSN115 KB

19 Jul 2016

VITROS Immunodiagnostic Products Estradiol Reagent Pack, Ortho Clinical Diagnostics (HSA 600:41/01-002/16/30_34)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135

 HSA 6004101-002-16-30_34 FSN130 KB

18 Jul 2016

O-arm 1000 and O2 Imaging Systems, Medtronic Navigation Inc (HSA 600:41/01-009/16/13_48)
Local Contact: Medtronic International Limited
Contact no./Email: 64365077

 HSA 6004101-009-16-13_48 FSN1677 KB

HSA 6004101-009-16-13_48 FSN21392 KB

18 Jul 2016

Multidiagnost Eleva, MultiDiagnost Eleva with Flat Detector and UroDiagnost Eleva systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/28_46)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-28_46 FSN435 KB

18 Jul 2016

TrueBeam® Radiotherapy Delivery System with AlignRT®, Varian Medical Systems (HSA 600:41/01-058/16/03_56)
Local Contact: Varian Medical Systems
Contact no./Email: 68870028

 HSA 6004101-058-16-03_56 FSN95 KB

15 Jul 2016

Smith & Nephew TriGen Internal Hex Captured Recon Screw Blue 6.4MM x 65MM, Smith & Nephew Inc. (HSA 600:41/01-073/16/21_52)
Local Contact: Smith & Nephew Pte Limited

Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-21_52 FSN124 KB

15 Jul 2016

Quickie Q7 Rigid Wheelchair, Sunrise Medical(US) LLC (HSA 600:41/01-300/01/01_54)
Local Contact: DNR Wheels Pte Ltd

Contact no./Email: joe@dnrwheels.com

 HSA 6004101-300-16-01_54 FSN6411 KB

15 Jul 2016

Adapter for Colibri, for Electric Pen Drive and Adapter, small, for Colibri (II) and Small Battery Drive (II), Synthes GmbH (HSA 600:41/01-002/16/29_43)
Local Contact: Johnson & Johnson Pte Ltd

Contact no./Email: bsee@its.jnj.com

 HSA 6004101-002-16-29_43 FSN204 KB

14 Jul 2016

RaySearch Laboratories RayStation, RaySearch Laboratories AB (HSA 600:41/01-070/16/16_50)
Local Contact: Transmedic Pte Ltd

Contact no./Email: regulatory@transmedicgroup.com

 HSA 6004101-070-16-16_50 FSN494 KB

14 Jul 2016

Medtronic DBS Pocket Adaptor Models 64001 and 64002, Medtronic Inc (Neuromodulation) (HSA 600:41/01-009/16/12_63)
Local Contact: Medtronic International Ltd

Contact no./Email: 64396849

 HSA 6004101-009-16-12_63 FSN283 KB

14 Jul 2016

Artis Zee Family System, Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/32_51)
Local Contact: Siemens Healthcare Pte Ltd

Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-32_51 FSN1426 KB

14 Jul 2016

Artis systems with 19" Live Display, Siemens Healthcare GmbH (HSA 600:41/01-022/16/31_41)
Local Contact: Siemens Healthcare Pte Ltd

Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-31_41 FSN1283 KB

13 Jul 2016

Perfusor Line, PVC, LL, 150 cm, B Braun Melsungen AG (HSA 600:41/01-012/16/06_40)
Local Contact: B Braun Singapore Pte Ltd

Contact no./Email: 6213 0933

 HSA 6004101-012-16-06_40 FSN40 KB

13 Jul 2016

cobas b 123 Neonatal Bilirubin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/12_31)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-12_31 FSN465 KB

12 Jul 2016

TAPERLOC HIP LATERALISED PC STEM 15.0MM 12/14 TAPER, TAPERLOC HIP LATERALISED PC STEM 17.5MM 12/14 TAPER, Biomet UK Limited (HSA 600:41/01-008/16/08_44)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 68547081

 HSA 6004101-008-16-08_44 FSN3860 KB

12 Jul 2016

NOVOSYN VIOLET 1 (4) 90cm HR40S, B. Braun Surgical SA (HSA 600:41/01-012/16/05_49)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 62130933

 HSA 6004101-012-16-05_49 FSN131 KB

11 Jul 2016

Covidien ValleyLab Laparoscopic Electrodes, Covidien llc (HSA 600:41/01-046/16/06_36)
Local Contact: Covidien Pte Ltd
Contact no./Email: 64396974

 HSA 6004101-046-16-06_36 FSN1330 KB

11 Jul 2016

Reflection Spherical Head Screw 25mm, Smith & Nephew Inc (HSA 600:41/01-073/16/18_33)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-18_33 FSN80 KB

11 Jul 2016

Genesis Trocar Pin, Smith & Nephew Inc (HSA 600:41/01-073/16/19_37)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-19_37 FSN155 KB

11 Jul 2016

DYONICS SMALL SAGITTAL BLADE 9.5x, Smith & Nephew Inc (HSA 600:41/01-073/16/20_35)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-20_35 FSN64 KB

8 Jul 2016

ID-DiaCell I-II-III Asia, DiaMed GmbH (HSA 600:41/01-027/16/08_22)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262

 HSA 6004101-027-16-08_22 FSN1680 KB

8 Jul 2016

ThermoScientific Oxoid GC Agar, CM0367 (B, R, T, Q), Oxoid Limited (HSA 600:41/01-178/16/04_60)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9993

 HSA 6004101-178-16-04_60 FSN293 KB

8 Jul 2016

CELL-DYN Emerald Cleaner, Abbott Laboratories (HSA 600:41/01-005/16/08_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6885 9103

 HSA 6004101-005-16-08_23 FSN70 KB

8 Jul 2016

Temporary Transvenous Pacing Lead System, Medtronic Inc (HSA 600:41/01-009/16/11_45)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5000

 HSA 6004101-009-16-11_45 FSN368 KB

5 Jul 2016

SAFIL QUI+ UNDY 5/0 (1) 45CM DSMP13(M) DDP, B. Braun Surgical SA (HSA 600:41/01-012/16/04_25)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0933

 HSA 6004101-012-16-04_25 FSN917 KB

5 Jul 2016

Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm, Synthes GmbH (HSA 600:41/01-002/16/27_18)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6827 6135

 HSA 6004101-002-16-27_18 FSN151 KB

5 Jul 2016

Heater Cooler 1T, Heater Cooler 3T and FlexTherm devices, SORIN Group Deutschland GmbH (HSA 600:41/01-299/16/01_19)
Local Contact: LivaNova Singapore Pte Ltd
Contact no./Email: 62931033

 HSA 6004101-299-16-01_19 FSN85 KB

4 Jul 2016

MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/04_17)
Local Contact: Elekta Pte Ltd
Contact no./Email: Elekta_Global_PMS@elekta.com

 HSA 6004101-101-16-04_17 FSN53 KB

4 Jul 2016

BD Trucount Absolute Counting Tubes (IVD), Becton Dickinson and Company (HSA 600:41/01-003/16/06_59)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 64322048

 HSA 6004101-003-16-06_59 FSN2190 KB

1 Jul 2016

Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/27_43)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477

 HSA 6004101-026-16-27_43 FSN302 KB

1 Jul 2016

Mueller Hinton + 5 % horse blood agar + 20 mg/l bêta-NAD, bioMérieux SA (HSA 600:41/01-146/16/05_58)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 6801 6706

 HSA 6004101-146-16-05_58 FSN372 KB

1 Jul 2016

NIM® Standard Reinforced EMG Endotracheal Tube, Medtronic Xomed Inc (HSA 600:41/01-009/16/10_51)
Local Contact: Medtronic International Limited
Contact no./Email: 64365077

 HSA 6004101-009-16-10_51 FSN473 KB

1 Jul 2016

Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow, Synthes GmbH(HSA 600:41/01-002/16/26_50)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135

 HSA 6004101-002-16-26_50 FSN297 KB
Healthcare professional, Industry member, Medical devices
Published:

Field Safety Notices

12 Dec 2019