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Health Sciences Authority
Field Safety Notices

Field Safety Notice - Jun 2016

30 June 2016

Audiences

Healthcare professional

Industry member

Product-type

Medical devices

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Table caption

Date of Notification

Title

FSN

30 Jun 2016

TWINFIX QUICK-T KNOT PUSHER SUTURE CUTTERS, Smith & Nephew Inc (HSA 600:41/01-073/16/17_40)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-17_40 FSN [PDF, 123 KB] (opens in new tab)

30 Jun 2016

LEGION HK 11,12,13MM BOLT AND SLEEVE, Smith & Nephew Inc (HSA 600:41/01-073/16/16_36)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-16_36 FSN [PDF, 137 KB] (opens in new tab)

29 Jun 2016

iGuide 2.1.0 and iGuide 2.2.0, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/16/03_37)
Local Contact: Elekta Pte Ltd
Contact no./Email: 62212322

 HSA 6004101-101-16-03_37 FSN [PDF, 39 KB] (opens in new tab)

29 Jun 2016

Rocket® R51551 Thoracentesis Catheter, Rocket Medical PLC (HSA 600:41/01-057/16/03_49)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: info@somnotec.net

 HSA 6004101-057-16-03_49 FSN [PDF, 38 KB] (opens in new tab)

29 Jun 2016

3M PICC/CVC Securement Device + Tegaderm I.V. Advanced Securement Dressing, 3M Health Care (HSA 600:41/01-031/16/01_35)
Local Contact: 3M Technologies (S) Pte Ltd
Contact no./Email: 64508846

 HSA 6004101-031-16-01_35 FSN [PDF, 84 KB] (opens in new tab)

29 Jun 2016

ADVIA Chemistry Theophylline_2 Reagent, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/30_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: 64907374

 HSA 6004101-022-16-30_57 FSN [PDF, 122 KB] (opens in new tab)

29 Jun 2016

Triathlon Modular Handle, Howmedica Osteonics Corp aka Stryker Orthopedics (HSA 600:41/01-014/16/08_33)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com


 HSA 6004101-014-16-08_33 FSN [PDF, 88 KB] (opens in new tab)

29 Jun 2016

Synovis Vascu-Guard Peripheral Vascular Patch, Synovis Surgical Innovations (HSA 600:41/01-001/16/04_45)
Local Contact: Baxter Healthcare(Asia)Pte Ltd
Contact no./Email: 68262616

 HSA 6004101-001-16-04_45 FSN [PDF, 259 KB] (opens in new tab)

28 Jun 2016

AIRVO 2 and myAIRVO 2, Fisher & Paykel Healthcare Limited (HSA 600:41/01-263/16/05_09)
Local Contact: Emergo Singapore Consulting Pte Ltd
Contact no./Email: 68325625

 HSA 6004101-263-16-05_09 FSN [PDF, 47 KB] (opens in new tab)

28 Jun 2016

Allura Xper R8.2, UNIQ R1.0 X-ray Systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/25_18)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-25_18 FSN [PDF, 287 KB] (opens in new tab)

28 Jun 2016

API 3200MD LC/MS/MS system, 3200MD Qtrap LC/MS/MS system, Triple Quad 4500MD LC/MS/MS system and Qtrap LC/MS/MS system, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/03_38)
Local Contact: AB SCIEX Pte Ltd
Contact no./Email: 63043722

 HSA 6004101-255-16-03_38 FSN [PDF, 136 KB] (opens in new tab)

28 Jun 2016

Ceramic Hip Prostheses, Smith & Nephew Orthopaedics AG (HSA 600:41/01-073/16/15_25)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-15_25 FSN [PDF, 83 KB] (opens in new tab)

28 Jun 2016

Nitram DAC MKIII Universal Steriliser, Sirona Dental Systems GmbH (HSA 600:41/01-067/16/01_54)
Local Contact: Fondaco Pte Ltd
Contact no./Email: 63922806


 HSA 6004101-067-16-01_54 FSN [PDF, 397 KB] (opens in new tab)

28 Jun 2016

PHIL (PRECIPITATING HYDROPHOBIC INJECTABLE LIQUID) NON-ADHESIVE LIQUID EMBOLIC SYSTEM, MicroVention Europe, S.A.R.L (HSA 600:41/01-057/16/02_19)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: 68440002

 HSA 6004101-057-16-02_19 FSN [PDF, 149 KB] (opens in new tab)

28 Jun 2016

Femoral Nail A/R Ø 11x280 and T2 SCN Ø9x300, Stryker Trauma GmbH (HSA 600:41/01-014/16/07_17)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com


 HSA 6004101-014-16-07_17 FSN [PDF, 68 KB] (opens in new tab)

27 Jun 2016

PRO-PICC and PRO-LINE Devices, Medcomp (HSA 600:41/01-278/16/02_48)
Local Contact: SingMed Healthcare Systems
Contact no./Email: 65474916


 HSA 6004101-278-16-02_48 FSN [PDF, 1283 KB] (opens in new tab)

27 Jun 2016

Alaris System Infusion PC Unit, CareFusion 303 Inc (HSA 600:41/01-087/16/02_46)
Local Contact: Scanmed Technology (S) Pte Ltd
Contact no./Email: 68723660

 HSA 6004101-087-16-02_46 FSN [PDF, 5662 KB] (opens in new tab)

27 Jun 2016

Philips DuraDiagnost X-Ray System, Phillips Healthcare (Suzhou) Co Ltd (HSA 600:41/01-026/16/24_56)
Local Contact: Phllips Electronics (S) Pte Ltd
Contact no./Email: 62068526

 HSA 6004101-026-16-24_56 FSN [PDF, 140 KB] (opens in new tab)

27 Jun 2016

Alaris System Infusion PC Unit, CareFusion 303 Inc (HSA 600:41/01-003/16/05_46)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 64322048

 HSA 6004101-003-16-05_46 FSN [PDF, 5661 KB] (opens in new tab)

24 Jun 2016

neoBLUE® LED Phototherapy System, Natus Medical Inc (HSA 600:41/01-113/16/01_54)
Local Contact: Equip Medical Pte Ltd
Contact no./Email: 65623008

 HSA 6004101-113-16-01_54 FSN [PDF, 220 KB] (opens in new tab)

24 Jun 2016

XARIO 200 and XARIO 100, Toshiba Medical Systems Corporation (HSA 600:41/01-064/16/03_63)
Local Contact: Toshiba Medical Systems Asia Pte Ltd
Contact no./Email: 62729766

 HSA 6004101-064-16-03_63 FSN [PDF, 226 KB] (opens in new tab)

24 Jun 2016

Cortex Screw Ø 2.7 mm, self-tapping, length 18mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/16/25_52)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 67504213

 HSA 6004101-002-16-25_52 FSN [PDF, 192 KB] (opens in new tab)

23 Jun 2016

BD PhoenixSpec Calibrator Kit, Becton, Dickinson and Company (HSA 600:41/01-003/16/04_23)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 64322048

 HSA 6004101-003-16-04_23 FSN [PDF, 1618 KB] (opens in new tab)

22 Jun 2016

Diapanel, DiaMed GmbH (HSA 600:41/01-027/16/07_20)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262

 HSA 6004101-027-16-07_20 FSN [PDF, 1818 KB] (opens in new tab)

22 Jun 2016

V-PRO® 1, V-PRO® 1 Plus, and V-PRO® maX Low Temperature Sterilization Systems, Steris Corporation (HSA 600:41/01-162/16/01_41)
Local Contact: ITS Science & Medical Pte Ltd
Contact no./Email: info@its-sciencemedical.com

 HSA 6004101-162-16-01_41 FSN [PDF, 209 KB] (opens in new tab)

21 Jun 2016

SOMATOM Definition Flash, SOMATOM Definition Edge and SOMATOM Definition AS, Siemens Healthcare GmbH (HSA 600:41/01-022/16/28_36)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-28_36 FSN [PDF, 156 KB] (opens in new tab)

21 Jun 2016

AutoPlex® System, Stryker Instruments (HSA 600:41/01-014/16/04_35)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com

 HSA 6004101-014-16-04_35 FSN [PDF, 192 KB] (opens in new tab)

21 Jun 2016

Stryker Round Fluted Burs, Stryker Instruments (HSA 600:41/01-014/16/05_49)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com

 HSA 6004101-014-16-05_49 FSN [PDF, 109 KB] (opens in new tab)

21 Jun 2016

Big Bore Oncology, Big Bore Radiology, Philips Medical Systems Inc (HSA 600:41/01-026/16/23_40)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477

 HSA 6004101-026-16-23_40 FSN [PDF, 71 KB] (opens in new tab)

21 Jun 2016

Monolisa HCV Ag-Ab ULTRA V2, DiaMed GmbH (HSA 600:41/01-027/16/06_60)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262

 HSA 6004101-027_16_06_60 FSN [PDF, 168 KB] (opens in new tab)

21 Jun 2016

Access Free T3 Reagent Kit, Beckman Coulter (HSA 600:41/01-052/16/09_59)
Local Contact: Beckman Coulter Singapore PteLtd
Contact no./Email: 63407126

 HSA 6004101-052-16-09_59 FSN [PDF, 37 KB] (opens in new tab)

21 Jun 2016

AllSet+ Gold SSP, One Lambda Inc (HSA 600:41/01-220/16/01_61)
Local Contact: Life Technologies Holding
Contact no./Email: 63629643

 HSA 6004101-220-16-01_61 FSN [PDF, 64 KB] (opens in new tab)

21 Jun 2016

Mandible Distractor, Monoaxial and Proximal Foot Plate, Synthes GmbH (HSA 600:41/01-002/16/24_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135

 HSA 6004101-002-16-24_44 FSN [PDF, 79 KB] (opens in new tab)

20 Jun 2016

Activa® PC, Activa® SC, Activa® RC and Activa® PC+S Devices, Medtronic Inc (HSA 600:41/01-009/16/08_33)
Local Contact: Medtronic International Limited
Contact no./Email: 64365000

 HSA 6004101-009-16-08_33 FSN [PDF, 152 KB] (opens in new tab)

20 Jun 2016

Deep Brain Stimulation Therapy, Medtronic Inc (HSA 600:41/01-009/16/09_37)
Local Contact: Medtronic International Limited
Contact no./Email: 64365000

 HSA 6004101-009-16-09_37 FSN [PDF, 108 KB] (opens in new tab)

17 Jun 2016

Stryker Neurovascular Target Detachable Coils, Stryker Neurovascular (HSA 600:41/01-014/16/03_45)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: iris.lim@stryker.com

 HSA 6004101-014-16-03_45 FSN [PDF, 255 KB] (opens in new tab)

15 Jun 2016

Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/16/05_57)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com

 HSA 6004101-032-16-05_57 FSN [PDF, 1792 KB] (opens in new tab)

15 Jun 2016

Point 4, Kerr Corporation (HSA 600:41/01-168/16/02_19)
Local Contact: KaVo Dental Supply
Contact no./Email: 62961790

 HSA 6004101-168-16-02_19 FSN [PDF, 154 KB] (opens in new tab)

14 Jun 2016

MyCareLink Patient Monitor, Medtronic Inc. (HSA 600:41/01-009/16/07_25)
Local Contact: Medtronic International Ltd.
Contact no./Email: Sherry.ann.panes@medtronic.com

 HSA 6004101-009-16-07_25 FSN [PDF, 201 KB] (opens in new tab)

13 Jun 2016

Babytherm 8004/8010 open care units, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/03_17)
Local Contact: Draeger Medical SEA Pte Ltd
Contact no./Email: ryan.yeo@draeger.com

 HSA 6004101-063-16-03_17 FSN [PDF, 8073 KB] (opens in new tab)

13 Jun 2016

DISCOVERY MR750W 3.0T MRI SYSTEM, GE Medical Systems LLC (HSA 600:41/01-010/16/10_18)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668

 HSA 6004101-010-16-10_18 FSN [PDF, 66 KB] (opens in new tab)

10 Jun 2016

COBAS B 123 SENSOR CARTRIDGE BG/ISE/GLU/LAC, Roche Diagnostics GmbH (HSA 600:41/01-016/16/11_38)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-11_38 FSN [PDF, 740 KB] (opens in new tab)

09 Jun 2016

Dornier Medilas H Holmium Laser System,Dornier Medilas H30 (Medilas H Solvo) holmium: YAG pulsed laser system, Dornier MedTech GmbH (HSA 600:41/01-161/16/01_08)
Local Contact: Dornier MedTech Asia Pte Ltd
Contact no./Email: 65726068

 HSA 6004101-161-16-01_08 FSN [PDF, 3850 KB] (opens in new tab)

09 Jun 2016

Dornier Medilas HRM (Medilas H UroPulse) holmium:YAG pulsed laser system, Dornier MedTech GmbH (HSA 600:41/01-161/16/02_08)
Local Contact: Dornier MedTech Asia Pte Ltd
Contact no./Email: 65726068

 HSA 6004101-161-16-02_08 FSN [PDF, 204 KB] (opens in new tab)

08 Jun 2016

Multiplate® Analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/16/10_24)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

 HSA 6004101-016-16-10_24 FSN [PDF, 83 KB] (opens in new tab)

08 Jun 2016

Dimension® clinical chemistry system,Dimension® Creatinine (CRE2) Flex® reagent cartridge, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/27_34)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com

 HSA 6004101-022-16-27_34 FSN [PDF, 97 KB] (opens in new tab)

08 Jun 2016

Zimmer Natural Nail® Cephalomedullary Nails (ZNN CMN Nails), Zimmer GmbH (HSA 600:41/01-008/16/07_09)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 68547081

 HSA 6004101-008-16-07_09 FSN [PDF, 292 KB] (opens in new tab)

07 Jun 2016

Quantia Digitoxin Reagent, BioKit S.A. (HSA 600:41/01-005/16/07_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 68859103

 HSA 6004101-005-16-07_23 FSN [PDF, 876 KB] (opens in new tab)

06 Jun 2016

Alere TESTPACK + Plus STREP A with OBC, Alere Medical Co., Ltd. (HSA 600:41/01-111/16/02_22)
Local Contact: Unison Collaborative Pte Ltd
Contact no./Email: info@unicoll.com.sg

 HSA 6004101-111-16-02_22 FSN [PDF, 49 KB] (opens in new tab)

03 Jun 2016

Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Medtronic Inc. (HSA 600:41/01-009/16/06_46)
Local Contact: Medtronic International Limited
Contact no./Email: boon.yee.ng@medtronic.com

 HSA 6004101-009-16-06_46 FSN [PDF, 53 KB] (opens in new tab)

03 Jun 2016

PINNACLE® DESTINATION® Guiding Sheath, Terumo Medical Corporation (HSA 600:41/01-028/16/04_56)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603

 HSA 6004101-028-16-04_56 FSN [PDF, 455 KB] (opens in new tab)

02 Jun 2016

Philips Sonalleve MR-HIFU system, Philips Oy (HSA 600:41/01-026/16/21_54)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477

 HSA 6004101-026-16-21_54 FSN [PDF, 33 KB] (opens in new tab)

02 Jun 2016

ALT OSR6X07, Glucose-Stat OSR6X40, Beckman Coulter Inc. (HSA 600:41/01-052/16/08_60)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126

 HSA 6004101-052-16-08_60 FSN [PDF, 111 KB] (opens in new tab)

01 Jun 2016

LEGION HINGE KNEE FEMORAL ASSEMBLY, Smith & Nephew Inc (HSA 600:41/01-073/16/14_52)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: Singapore.surgicalsale@smith-nephew.com

 HSA 6004101-073-16-14_52 FSN [PDF, 110 KB] (opens in new tab)

01 Jun 2016

Alaris™ System PC unit model 8015 withsoftware versions 9.17 and 9.19, CareFusion 303 Inc (HSA 600:41/01-003/16/03_63)
Local Contact: Becton Dickinson Holdings Pte. Ltd.
Contact no./Email: 64322048

 HSA 6004101-003-16-03_63 FSN [PDF, 1342 KB] (opens in new tab)

16 Dec 2015

3.0T 6ch Flex Coil (M0050SS), GE Medical Systems LLC (HSA 600:41/01-010/15/22_36)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668

 HSA 6004101-010-15-22_36 FSN [PDF, 55 KB] (opens in new tab)