|
Date of Notification
|
Title
|
FSN
|
| 31 Oct 2019 |
Emerge Monorail PTCA Dilation Catheter, NC Emerge Monorail PTCA Dilation Catheter, Guidezilla II Guide Extension Catheter and Agent Monorail Paclitaxel-Coated PTCA Balloon Catheter, Boston Scientific Corporation (HSA 600:41/01-007/19/10_82)
Local Contact: Boston Scientific Asia Pacific Pte. Ltd.
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com |
HSA 6004101-007-19-10_82 FSN191 KB |
| 30 Oct 2019 |
Edwards Lifesciences EZ Glide™ Aortic Cannula, Edwards Lifesciences LLC (HSA 600:41/01-060/19/08_86)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 6548 5923
|
HSA 6004101-060-19-08_86 FSN961 KB |
30 Oct 2019
|
Giraffe Incubator, Giraffe Omnibed, Giraffe Incubator Carestation, and Giraffe Omnibed Carestation, Datex-Ohmeda Inc(HSA 600:41/01-010/19/29_85)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-29_85_FSN413 KB |
| 29 Oct 2019 |
Abbott Alinity c, Carbon Dioxide, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/30_73)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-19-30_73 FSN534 KB |
| 25 Oct 2019 |
LemonPrep Tubes and Single Use Cups, Mavidon (HSA 600:41/01-110/19/01_80)
Local Contact: Mandarin Opto-Medic Co Pte Ltd
Contact no./Email: 6747 8777 / manopt@mandarinoptomedic.com
|
HSA 6004101-110-19-01_80 FSN9028 KB |
| 25 Oct 2019 |
ACCU-CHEK® GUIDE BLOOD GLUCOSE METERS, Roche Diabetes Care GmbH (HSA 600:41/01-016/19/25_49)
Local Contact: Roche Diabetes Care Asia Pacific Pte Ltd
Contact no./Email: 6272 9200 / sg.accu-chek@roche.com
|
HSA 6004101-016-19-25_49 FSN2919 KB |
|
25 Oct 2019
|
Torrent Suite Dx Software, Life Technologies Holding Pte ltd. (HSA 600:41/01-220/19/01_75)
Local Contact: Life Technologies Holding Pte ltd.
Contact no./Email: 6362 9574
|
HSA 6004101-220-19-01_75 FSN107 KB |
|
25 Oct 2019
|
TruCal U, DiaSys Diagnostic System GmbH (HSA 600:41/01-032/19/03_75)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
|
HSA 6004101-032-19-03_75 FSN2408 KB |
|
24 Oct 2019
|
Philips Efficia DFM100 Defibrillator/Monitor, Philips Goldway (Shenzhen) Industrial Inc. (HSA 600:41/01-026/19/35_48)
Local Contact: Philips Electronics(Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-19-35_48 FSN1570 KB |
| 24 Oct 2019 |
EVA Dual Chamber Bag - ExactaMix, Baxter Healthcare Corporation (HSA 600:41/01-001/19/05_35)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact no./Email: 6826 2616
|
HSA 6004101-001-19-05_35 FSN750 KB |
| 24 Oct 2019 |
Philips HeartStart XL+Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/19/36_44)
Local Contact: Philips Electronics(Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-19-36_44 FSN540 KB |
|
24 Oct 2019
|
HeartStart XL+Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/19/37_50)
Local Contact: Philips Electronics(Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-19-37_50 FSN216 KB |
| 23 Oct 2019 |
KARL STORZ C-MAC Video Laryngoscope Blades, KARL STORZ SE & Co. KG (HSA 600:41/01-133/19/01_79)
Local Contact: KARL STORZ Endoscopy Singapore Sales Pte Ltd
Contact no./Email: 6922 9150 / sgcustomerservice@karlstorz.com
|
HSA 6004101-133-19-01_79 FSN252 KB |
|
23 Oct 2019
|
Cell Saver ® 5/5+ and Cell Saver® Elite®/Elite®+ 125ml and 225ml bowl sets, Haemonetics Corporation (HSA 600:41/01-070/19/07_71)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regional.pms@transmedicgroup.com
|
HSA 6004101-070-19-07_71 FSN235 KB |
|
23 Oct 2019
|
1 ½” Headed Nail Triathlon Instruments, Howmedica Osteonics Corp (HSA 600:41/01-014/19/06_51)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 6662 5930
|
HSA 6004101-014-19-06_51 FSN130 KB |
|
23 Oct 2019
|
BD PosiFlush SP Syringes 0.9% Sodium Chloride, Becton, Dickinson and Company (HSA 600:41/01-003/19/14_44)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6664 2784 / Customercomplaint@bd.com
|
HSA 6004101-003-19-14_44 FSN57 KB |
|
23 Oct 2019
|
Bard® MaxCore Disposable Biopsy System, Bard Peripheral Vascular Inc (HSA 600:41/01-050/19/05_38)
Local Contact: BARD Singapore Pte Ltd
Contact no./Email: 6664 2784 / complaints.singapore@crbard.com
|
HSA 6004101-050-19-05_38 FSN2434 KB |
|
22 Oct 2019
|
GSS67H Steam Sterilizer, Getinge Sterilization AB (HSA 600:41/01-224/19/15_66)
Local Contact: Getinge Singapore Pte Ltd
Contact no./Email: 6296 1992
|
HSA 6004101-224-19-15_66 FSN1468 KB |
| 22 Oct 2019 |
Allergan XEN45 Glaucoma Treatment System, Allergan (HSA 600:41/01-147/19/02_43)
Local Contact: Allergan Singapore Pte Ltd
Contact no./Email: 6411 5442
|
HSA 6004101-147-19-02_43 FSN6458 KB |
|
22 Oct 2019
|
BIOPHEN™ NORMAL CONTROL PLASMA, HYPHEN Biomed (HSA 600:41/01-032/19/02_89)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
|
HSA 6004101-032-19-02_89 FSN85 KB |
| 21 Oct 2019 |
ThermoScientific™ Oxoid™ Ceftazidime 256 M.I.C.E. strip, MA0120D&F, Oxoid Limited (HSA 600:41/01-178/19/07_57)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
|
HSA 6004101-178-19-07_57 FSN285 KB |
|
21 Oct 2019
|
Vidas 3, Biomerieux S.A. (HSA 600:41/01-146/19/04_23)
Local Contact: Biomerieux Singapore Pte Ltd
|
HSA 6004101-146-19-04_23 FSN526 KB |
|
21 Oct 2019
|
EXACTAMIX Empty EVA Bags, Baxter Healthcare SA (HSA 600:41/01-001/19/04_62)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact no./Email: 6826 2616
|
HSA 6004101-001-19-04_62 FSN2020 KB |
|
21 Oct 2019
|
CLab II Plus Amplifiers used with CardioLab/ComboLab Systems, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/19/28_77)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-28_77 FSN211 KB |
|
21 Oct 2019
|
Boston Scientific Advanix™ Pancreatic Stent, Boston Scientific Corporation (HSA 600:41/01-007/19/09_66)
Local Contact: Boston Scientific Asia Pacific Pte. Ltd.
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
|
HSA 6004101-007-19-09_66 FSN288 KB |
|
21 Oct 2019
|
ECHELON FLEX™ ENDOPATH® 60mm Staplers, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/19/16_35)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 6717
|
HSA 6004101-002-19-16_35 FSN338 KB |
|
17 Oct 2019
|
CARESCAPE Respiratory Modules, GE Healthcare Finland Oy (HSA 600:41/01-010/19/27_18)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
|
HSA 60041-01-010-19-27_18 FSN276 KB |
|
17 Oct 2019
|
SynchroMed™ II Implantable Drug Infusion Pumps, Medtronic Inc. (HSA 600:41/01-009/19/14_46)
Local Contact: Medtronic International Ltd
Contact no./Email: 6439 6932
|
HSA 6004101-009-19-14_46 FSN198 KB |
|
17 Oct 2019
|
GE OEC Fluorostar Compact, GE OEC Fluorostar Series, GE OEC Fluorostar Compact D, GE OEC Medical Systems GmbH (HSA 600:41/01-010/19/26_38)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-26_38 FSN144 KB |
| 15 Oct 2019 |
WECK® Auto® Endo5 Automatic Hem-o-lok Clip Appliers, Teleflex Medical (HSA 600:41/01-139/19/04_68)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3122
|
HSA 6004101-139-19-04_68 FSN309 KB |
| 15 Oct 2019 |
Firefly splashy, James Lecky Design Limited (HSA 600:41/01-351/19/01_88)
Local Contact: Paediatric Seating Solutions Pte Ltd
Contact no./Email: 6908 0036 / Sales@paediatricss.com
|
HSA 6004101-351-19-01_88 FSN1951 KB |
|
15 Oct 2019
|
StealthStation DBS Software, Medtronic Navigation Inc (HSA 600:41/01-009/19/15_37)
Local Contact: Medtronic International Ltd
Contact no./Email: 6439 6932
|
HSA 6004101-009-19-15_37 FSN78 KB |
|
15 Oct 2019
|
VITROS® Chemistry Products 7% BSA and VITROS® Chemistry Products Urine Electrolyte Diluent (UED), Ortho-Clinical Diagnostic (HSA 600:41/01-303/19/09_89)
Local Contact: ORTHO-Clinical Diagnostics Singapore Pte. Ltd
Contact no./Email: 6486 1151
|
HSA 60041-01-303-19-09_89 FSN163 KB |
|
15 Oct 2019
|
Medivators Endo SmartCap Irrigation Tubings, Medivators Inc. (HSA 600:41/01-350/19/01_79)
Local Contact: Cantel Medical Asia/Pacific Pte. Ltd.
Contact no./Email: 6227 9698 / APACregulatory@cantelmedical.com.sg
|
HSA 6004101-350-19-01_79 FSN170 KB |
| 14 Oct 2019 |
HD Concentrates (Acid Concentrate for Bicarbonate Hemodialysis), Fresenius Medical Care Production Sdn Bhd (HSA 600:41/01-062/19/01_82)
Local Contact: Fresenius Medical Care Singapore Pte Ltd
Contact no./Email: 6837 3113
|
HSA 6004101-062-19-01_82 FSN1277 KB |
|
14 Oct 2019
|
Patient Data Manager, Brainlab AG (HSA 600:41/01-047/19/01_87)
Local Contact: BrainLab Limited (Singapore Branch)
Contact no./Email: 6734 1701 / sg.sales@brainlab.com
|
HSA 6004101-047-19-01_87 FSN131 KB |
|
11 Oct 2019
|
Medtronic Programmers and Remote Monitoring Software Apps and a subset of Medtronic Implantable Cardiac Devices, Medtronic Inc (HSA 600:41/01-009/19/13_77)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
|
HSA 6004101-009-19-13_77 FSN149 KB |
|
11 Oct 2019
|
MULTIPLE GOLD CUP ELECTRODES and SNAP ELECTRODE LEADS, GN Otometrics A/S (Natus Medical denmark Aps) (HSA 600:41/01-104/19/03_85)
Local Contact: SurgiPro Pte Ltd
Contact no./Email: 6894 6038
|
HSA 6004101-104-19-03_85 FSN198 KB |
|
11 Oct 2019
|
Catheter connector, Convatec Limited (HSA 600:41/01-044/19/03_50)
Local Contact: Optimal Medical Products Pte Ltd
Contact no./Email: 6253 5247
|
HSA 6004101-044-19-03_50 FSN421 KB |
|
11 Oct 2019
|
HemoSphere Oximetry Smart Cables, Edwards Lifesciences LLC (HSA 600:41/01-060/19/07_68)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 6548 5923
|
HSA 6004101-060-19-07_68 FSN229 KB |
| 10 Oct 2019 |
Arjo Akron Tilt Table Couch, ArjoHuntleigh AB (HSA 600:41/01-065/19/03_44)
Local Contact: Arjo South East Asia Pte Ltd
Contact no./Email: 6202 7366 / singapore@arjo.com
|
HSA 6004101-065-19-03_44 FSN91 KB |
|
10 Oct 2019
|
InteliQ Assayed Multiqual control, Bio-Rad Laboratories (HSA 600:41/01-027/19/11_59)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
|
HSA 6004101-027-19-11_59 FSN210 KB |
|
10 Oct 2019
|
Hepatitis E RNA, Fast-Track Diagnostics S.a.r.l. (HSA 600:41/01-022/19/25_67)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-25_67 FSN2696 KB |
|
10 Oct 2019
|
CRP FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/19/01_73)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629
|
HSA 6004101-032-19-01_73 FSN227 KB |
|
10 Oct 2019
|
PHILIPS DIGITALDIAGNOST RADIOGRAPHY SYSTEM, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/19/34_18)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-19-34_18 FSN3267 KB |
| 09 Oct 2019 |
Tina-quant Soluble Transferrin Receptor (sTFR) assay, Roche Diagnostics GmbH (HSA 600:41/01-016/19/24_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-24_69 FSN453 KB |
|
09 Oct 2019
|
UniCel DxH Slidemaker Stainer (DxH SMS) & UniCel DxH Slidemaker Stainer II (DxH SMS II), Beckman Coulter Inc. (HSA 600:41/01-052/19/05_34)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
|
HSA 6004101-052-19-05_34 FSN180 KB |
|
08 Oct 2019
|
LAG SCREW 3.2 GUIDE PIN SLEEVE, Smith & Nephew Inc (HSA 600:41/01-073/19/10_46)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
|
HSA 6004101-073-19-10_46 FSN230 KB |
|
08 Oct 2019
|
ID Diacell I-II-III, DiaMed GmbH (HSA 600:41/01-027/19/10_34)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
|
HSA 6004101-027-19-10_34 FSN1880 KB |
| 07 Oct 2019 |
NEFA, Randox Laboratories Ltd (HSA 600:41/01-213/19/03_78)
Local Contact: BioMedix Singapore Pte Ltd
Contact no./Email: 6547 8460
|
HSA 6004101-213-19-03_78 FSN79 KB |
|
07 Oct 2019
|
Cardiac Pipettes, Roche Diagnostics GmbH (HSA 600:41/01-016/19/23_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-23_61 FSN372 KB |
|
07 Oct 2019
|
Ventana HE 600 system, Ventana Medical Systems, Inc (Tuscon) (HSA 600:41/01-016/19/22_49)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-22_49 FSN483 KB |
|
07 Oct 2019
|
Cook Guardia Access Nano Embryo Transfer Catheter and Guardia Access Embryo Transfer Catheter, Cook Incorporated (HSA 600:41/01-013/19/10_50)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
|
HSA 6004101-013-19-10_50 FSN66 KB |
|
04 Oct 2019
|
Low Level Output Cable – Interface to Philips Monitor, Datascope Corp (HSA 600:41/01-224/19/14_88)
Local Contact: Getinge South East Asia Pte Ltd
Contact no./Email: 6296 1992
|
HSA 6004101-224-19-14_88 FSN181 KB |
|
04 Oct 2019
|
DTX Safedraw® Kits and Meritrans DTXPlus® Devices, Merit Medical Singapore Pte Ltd (HSA 600:41/01-349/19/01_71)
Local Contact: Merit Medical Singapore Pte Ltd
Contact no./Email: 6753 6311
|
HSA 6004101-349-19-01_71 FSN145 KB |
| 03 Oct 2019 |
StrykeFlow Electrosurgical Probe, Stryker Endoscopy (HSA 600:41/01-014/19/05_82)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 6662 5912 / asean.pms@stryker.com
|
HSA 6004101-014-19-05_82 FSN290 KB |
|
03 Oct 2019
|
MAQUET QUADROX-I SYSTEM VHK AND VKMO ADULT / SMALL ADULT, Maquet Cardiopulmonary GmbH(HSA 600:41/01-224/19/13_85)
Local Contact: Getinge South East Asia Pte Ltd
Contact no./Email: 6296 1992
|
HSA 6004101-224-19-13_85 FSN2461 KB |
|
03 Oct 2019
|
ANALYZER AND ORTHO-CLINICAL ORTHO VISION MAX ANALYZER, ORTHO-CLINICAL DIAGNOSTICS (HSA 600:41/01-303/19/08_73)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151
|
HSA 6004101-303-19-08_73 FSN231 KB |
|
01 Oct 2019
|
Manual Resuscitator, Hsiner Co. Ltd (HSA 600:41/01-149/19/01_86)
Local Contact: I: Emedics Pte Ltd
Contact no./Email: 6747 0166
|
HSA 6004101-149-19-01_86 FSN119 KB |
|
28 Jun 2019
|
Somatom Force, Somatom Definition AS, Somatom Definition Edge, Somatom Definition Flash, Somatom Drive, Somatom Confidence, Somatom, Edge Plus, Siemens Healthcare GmbH (HSA 600:41/01-022/19/13_77)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-13_77 FSN1441 KB
This FSN is an update to the original FSN published in Jun 2019.
|
|
10 Jan 2019
|
Medtronic Dual Chamber Pacemakers, Medtronic Inc (HSA 600:41/01-009/19/01_56)
Local Contact: Medtronic International Limited
Contact No./Email: 6436 5077
|
HSA 6004101-009-19-01_56 FSN1734 KB
This FSN is an update to the original FSN published in Jan 2019.
|
|
07 Sep 2018
|
CentriMag Motor, Thoratec Switzerland GmbH (HSA 600:41/01-005/18/16_51)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6643 2800 / FSN_enquiry@abbott.com
|
HSA 6004101-005-18-16_51 FSN174 KB
This FSN is an update to the original FSN published in Sep 2018.
|