Field Safety Notice - Aug 2019

30 Aug 2019 

Philips S7-3t & S8-3t Transesophageal (TEE) Transducers, Philips Ultrasound, Inc (HSA 600:41/01-026/19/27_86)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477

HSA 6004101-026-19-27_86 FSN [PDF, 165 KB]

29 Aug 2019

Alaris™ EtCOz Module (Model 8300), CareFusion 303 Inc (HSA 600:41/01-003/19/11_46)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6664 2784 / Customercomplaint@bd.com

HSA 6004101-003-19-11_46 FSN [PDF, 2776 KB]

29 Aug 2019

8 G x 10 CM JamshidiTM Crown Bone Marrow Biopsy/Aspiration Needle with MAC, CareFusion (HSA 600:41/01-003/19/12_18)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6664 2784 / Customercomplaint@bd.com

HSA 6004101-003-19-12_18 FSN [PDF, 186 KB]

28 Aug 2019

Beckman Coulter Enzymatic Creatinine; Triglycerides; Uric Acid; Direct Bilirubin; Total Bilirubin, Beckman Coulter (HSA 600:41/01-052/19/04_78)
Local Contact: Beckman Coulter Singapore
Contact no./Email: 6340 7126

HSA 6004101-052-19-04_78 FSN [PDF, 76 KB]

28 Aug 2019 

Ultrasonic Diagnostic Apparatus WS80A and HS70SA, Samsung Medison Co., Ltd (HSA 600:41/01-346/19/01_80)
Local Contact: Quest Asia Technologies Pte Ltd
Contact no./Email: 6746 2628 / CS@QuestAsia.sg

HSA 6004101-346-19-01_80 FSN [PDF, 338 KB]

28 Aug 2019

Coopersurgical Transwarmer Warming Infant Transport Mattress, Coopersurgical Inc (HSA 600:41/01-063/19/04_50)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com

HSA 6004101-063-19-04_50 FSN [PDF, 790 KB]

27 Aug 2019

Lyphocheck Specialty Immunoassay Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/19/06_73)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262

HSA 6004101-027-19-06_73 FSN [PDF, 131 KB]

26 Aug 2019 

Principelle IF Honey Based Lonogen Formulation Ointment, Principelle BV (HSA 600:41/01-343/19/01_46)
Local Contact: Recura Pte Ltd

HSA 6004101-343-19-01_46 FSN [PDF, 1391 KB]

26 Aug 2019

CHOC II AGAR and COLUMBIA CNA WITH SHEEP BLOOD AGAR/ CHOC II, Thermo Scientific Microbiology Sdn. Bhd. (HSA 600:41/01-178/19/04_31)
Local Contact: THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com

HSA 6004101-178-19-04_31 FSN [PDF, 1289 KB]

26 Aug 2019

LivaNova Stockert SCP Centrifugal Pump System, LivaNova Deutschland GmbH (HSA 600:41/01-299/19/02_50)
Local Contact: LivaNova Singapore Pte Ltd
Contact no./Email: 6293 1033

HSA 6004101-299-19-02_50 FSN [PDF, 842 KB]

26 Aug 2019

NobelParallel CC NP 3.75x10mm, Nobel Biocare AB (HSA 600:41/01-168/19/04_87)
Local Contact: Kavo Dental Supply
Contact no./Email: 6311 9812

HSA 6004101-168-19-04_87 FSN [PDF, 83 KB]

23 Aug 2019

CentriMag Motor, Thoratec Switzerland GmbH (HSA 600:41/01-339/19/04_63)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000

HSA 6004101-339-19-04_63 FSN [PDF, 75 KB]

23 Aug 2019

ThermoScientificTM OxoidTM Meropenem 32 M.I.C.E. strip, Oxoid Limited (HSA 600:41/01-178/19/05_75)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com

HSA 6004101-178-19-05_75 FSN [PDF, 401 KB]

22 Aug 2019

EMBLEM™ S-ICDS, EMBLEM MRI S-ICDS, Boston Scientific Corporation (HSA 600:41/01-007/19/07_44)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com

HSA 6004101-007-19-07_44 FSN [PDF, 365 KB]

22 Aug 2019

Atellica UAS 800 Analyzer and Atellica 1500 Automated Urinalysis System, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/22_70)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com

HSA 6004101-022-19-22_70 FSN [PDF, 113 KB]

21 Aug 2019

Mobi-C Implant, LDR Medical (HSA 600:41/01-008/19/06_85)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com

HSA 6004101-008-19-06_85 FSN [PDF, 257 KB]

21 Aug 2019

Triathlon Femoral Distal Augment, Howmedica Osteonics Corporation (HSA 600:41/01‐014/19/03_86)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 6662 5930

HSA 6004101-014-19-03_86 FSN [PDF, 132 KB]

19 Aug 2019

Palacos LV+G, Palacos MV+G, Palacos R+G, Heraeus Medical GmbH (HSA 600:41/01-344/19/01_64)
Local Contact: Indola Pharma Link Singapore Pte Ltd
Contact no./Email: 6636 9007 / indola@singnet.com.sg

HSA 6004101-344-19-01_64 FSN [PDF, 6377 KB]

19 Aug 2019

Blanketrol III Hyper-hypothermia System, Gentherm Medical LLC (HSA 600:41/01-021/19/03_76)
Local Contact: Thermal International (S) Pte Ltd
Contact no./Email: 6225 2911 / sales@thermal.com.sg

HSA 6004101-021-19-03_76 FSN [PDF, 5703 KB]

16 Aug 2019

Atellica CH 930 Analyzer, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/20_67)
Local Contact: Siemens Healthcare Pte. Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com

HSA 6004101-022-19-20_67 FSN [PDF, 300 KB]

16 Aug 2019

Siemens ATELLICA® IM 1300 ANALYZER, ATELLICA® IM 1600 ANALYZER, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/21_57)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com

HSA 6004101-022-19-21_57 FSN [PDF, 128 KB]

16 Aug 2019

Tina-quant Soluble Transferrin Receptor (sTFR) assay, Roche Diagnostics GmbH (HSA 600:41/01-016/19/18_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

HSA 6004101-016-19-18_59 FSN [PDF, 416 KB]

16 Aug 2019

Ru-106 Eye Applicator CCB, Eckert & Ziegler BEBIG GmbH (HSA 600:41/01-070/19/06_71)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regional.pms@transmedicgroup.com

HSA 6004101-070-19-06_71 FSN [PDF, 1299 KB]

15 Aug 2019 

Monnal T40, T50, T60, T75, Air Liquide Medical Systems S.A. (HSA 600:41/01-338/19/03_35)
Local Contact: Nyprax Pharma Pte Ltd
Contact no./Email: 6348 0481 / nypraxreg@singnet.com.sg 

HSA 6004101-338-19-03_35 FSN [PDF, 167 KB]

15 Aug 2019 

Rocket KCH Fetal Bladder Drain, Rocket Medical PLC (HSA 600:41/01-287/19/01_79)
Local Contact: Progress Healthcare Pte Ltd
Contact no./Email: 6297 5955 / sales@progress.com.sg

HSA 6004101-287_19_01_79 FSN [PDF, 233 KB]

15 Aug 2019

TRILLY PED.AF FULL COATED STE (EU6582 CONVENIENCE KIT TRILLY), Eurosets S.R.L (HSA 600:41/01-218/19/01_80)
Local Contact: Perfusion Services & Supplies Pte Ltd
Contact no./Email: 6398 0630 / admin@perfusionsvcs.com

HSA 6004101-218-19-01_80 FSN [PDF, 352 KB]

15 Aug 2019

Concerto / Basic Shower Trolley, ArjoHuntleigh AB (HSA 600:41/01-065/19/02_66)
Local Contact: Arjo South East Asia Pte. Ltd.
Contact no./Email: 6202 7366 / singapore@arjo.com

HSA 6004101-065-19-02_66 FSN [PDF, 354 KB]

14 Aug 2019 

EASYRET, Quantel Medical (HSA 600:41/01-261/19/02_74)
Local Contact: Swissmed Pte Ltd
Contact no./Email: 6635 6080 / info@swissmed.asia 

HSA 6004101-261-19-02_74 FSN [PDF, 151 KB]

14 Aug 2019

Atellica IM anti-CCP IgG (aCCP) Assay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/19_78)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com

HSA 6004101-022-19-19_78 FSN [PDF, 113 KB]

14 Aug 2019

Boston Scientific ZOOM Latitude Programming System, Boston Scientific Corporation (HSA 600:41/01-007/19/06_64)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_ Query@bsci.com

HSA 6004101-007-19-06_64 FSN [PDF, 230 KB]

14 Aug 2019

Philips Efficia DFM 100, Philips Goldway (Shenzhen) Industrial Inc. (HSA 600:41/01-026/19/26_48)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477

HSA 6004101-026-19-26_48 FSN [PDF, 2860 KB]

13 Aug 2019

Titanium Abutments, Nobel Biocare AB (HSA 600:41/01-168/19/03_52)
Local Contact: Kavo Dental Supply
Contact no./Email: 6311 9842

HSA 6004101-168-19-03_52 FSN [PDF, 52 KB]

13 Aug 2019

Proteus XR/a Fixed RAD systems, GE Hualan Medical Systems Co. Ltd. (HSA 600:41/01-010/19/22_63)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com

HSA 6004101-010-19-22_63 FSN [PDF, 96 KB]

08 Aug 2019

Hemospray Endoscopic Hemostat, Wilson-Cook Medical, Inc. (HSA 600:41/01-013/19/09_62)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com

HSA 6004101-013-19-09_62 FSN [PDF, 564 KB]

08 Aug 2019

AssayTip/AssayCup tray, Roche Diagnostics GmbH (HSA 600:41/01-016/19/17_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

HSA 6004101-016-19-17_69 FSN [PDF, 495 KB]

07 Aug 2019 

ClosureRFG™ Radiofrequency Generator RFG3, Medtronic, Inc (HSA 600:41/01-046/19/09_43)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6489 6849

HSA 6004101-046-19-09_43 FSN [PDF, 2100 KB]

07 Aug 2019

Blanketrol II hyper-hypothermia system (230V), Gentherm Medical LLC (HSA 600:41/01-021/19/02_52)
Local Contact: Thermal International (S) Pte Ltd
Contact no./Email: 6225 2911 / sales@thermal.com.sg

HSA 6004101-021-19-02_52 FSN [PDF, 4788 KB]

06 Aug 2019

Edwards Lifesciences TruWave Disposable Pressure Transducer, Edwards Lifesciences LLC (HSA 600:41/01-060/19/05_48)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 68836836

HSA 6004101-060-19-05_48 FSN [PDF, 179 KB]

06 Aug 2019 

Medtronic Micra™ Delivery System, Medtronic Inc (HSA 600:41/01-009/19/11_56)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077

HSA 6004101-009-19-11_56 FSN [PDF, 194 KB]

06 Aug 2019

Ortho-Clinical Biovue® System ABD Confirmation Cassette, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/06_75)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151

HSA 6004101-303-19-06_75 FSN [PDF, 151 KB]

05 Aug 2019

Air Liquide Monnal T60, Air Liquide Medical Systems S.A. (HSA 600:41/01-338/19/02_76)
Local Contact: Nyprax Pharma Pte Ltd
Contact no./Email: 6348 0481 / nypraxreg@singnet.com.sg

HSA 6004101-338-19-02_76 FSN [PDF, 116 KB]

02 Aug 2019 

Norm-O-Temp hyperthermia system, Gentherm Medical LLC (HSA 600:41/01-021/19/01_51)
Local Contact: Thermal International (S) Pte Ltd
Contact no./Email: 6225 2911 / sales@thermal.com.sg

HSA 6004101-021-19-01_51 FSN [PDF, 2374 KB]

01 Aug 2019

ONLINE TDM Vancomycin Gen. 3, Roche Diagnostics GmbH (HSA 600:41/01-016/19/16_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com

HSA 6004101-016-19-16_34 FSN [PDF, 144 KB]

01 Aug 2019

DYONICS 4.5 mm Full Radius Curved Concave Blade, Smith & Nephew Inc (HSA 600:41/01-073/19/09_51)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com

HSA 6004101-073-19-09_51 FSN [PDF, 82 KB]