Field Safety Notices
Field Safety Notice - Oct 2019
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 October 2019
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
Table caption
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) | HSA 6004101-007-19-10_82 FSN [PDF, 192 KB] |
30 Oct 2019 | Edwards Lifesciences EZ Glide™ Aortic Cannula, Edwards Lifesciences LLC (HSA 600:41/01-060/19/08_86) | HSA 6004101-060-19-08_86 FSN [PDF, 961 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) | HSA 6004101-010-19-29_85_FSN [PDF, 414 KB] |
29 Oct 2019 | Abbott Alinity c, Carbon Dioxide, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/30_73) | HSA 6004101-005-19-30_73 FSN [PDF, 535 KB] |
25 Oct 2019 | LemonPrep Tubes and Single Use Cups, Mavidon (HSA 600:41/01-110/19/01_80) | HSA 6004101-110-19-01_80 FSN [PDF, 9029 KB] |
25 Oct 2019 | ACCU-CHEK® GUIDE BLOOD GLUCOSE METERS, Roche Diabetes Care GmbH (HSA 600:41/01-016/19/25_49) | HSA 6004101-016-19-25_49 FSN [PDF, 2919 KB] |
25 Oct 2019 | Torrent Suite Dx Software, Life Technologies Holding Pte ltd. (HSA 600:41/01-220/19/01_75) | HSA 6004101-220-19-01_75 FSN [PDF, 108 KB] |
25 Oct 2019 | TruCal U, DiaSys Diagnostic System GmbH (HSA 600:41/01-032/19/03_75) | HSA 6004101-032-19-03_75 FSN [PDF, 2409 KB] |
24 Oct 2019 | Philips Efficia DFM100 Defibrillator/Monitor, Philips Goldway (Shenzhen) Industrial Inc. (HSA 600:41/01-026/19/35_48) | HSA 6004101-026-19-35_48 FSN [PDF, 1571 KB] |
24 Oct 2019 | EVA Dual Chamber Bag - ExactaMix, Baxter Healthcare Corporation (HSA 600:41/01-001/19/05_35) | HSA 6004101-001-19-05_35 FSN [PDF, 751 KB] |
24 Oct 2019 | Philips HeartStart XL+Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/19/36_44) | HSA 6004101-026-19-36_44 FSN [PDF, 540 KB] |
24 Oct 2019 | HeartStart XL+Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/19/37_50) | HSA 6004101-026-19-37_50 FSN [PDF, 216 KB] |
23 Oct 2019 | KARL STORZ C-MAC Video Laryngoscope Blades, KARL STORZ SE & Co. KG (HSA 600:41/01-133/19/01_79) | HSA 6004101-133-19-01_79 FSN [PDF, 253 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) | HSA 6004101-070-19-07_71 FSN [PDF, 236 KB] |
23 Oct 2019 | 1 ½” Headed Nail Triathlon Instruments, Howmedica Osteonics Corp (HSA 600:41/01-014/19/06_51) | HSA 6004101-014-19-06_51 FSN [PDF, 131 KB] |
23 Oct 2019 | BD PosiFlush SP Syringes 0.9% Sodium Chloride, Becton, Dickinson and Company (HSA 600:41/01-003/19/14_44) | HSA 6004101-003-19-14_44 FSN [PDF, 58 KB] |
23 Oct 2019 | Bard® MaxCore Disposable Biopsy System, Bard Peripheral Vascular Inc (HSA 600:41/01-050/19/05_38) | HSA 6004101-050-19-05_38 FSN [PDF, 2434 KB] |
22 Oct 2019 | GSS67H Steam Sterilizer, Getinge Sterilization AB (HSA 600:41/01-224/19/15_66) | HSA 6004101-224-19-15_66 FSN [PDF, 1469 KB] |
22 Oct 2019 | Allergan XEN45 Glaucoma Treatment System, Allergan (HSA 600:41/01-147/19/02_43) | HSA 6004101-147-19-02_43 FSN [PDF, 6458 KB] |
22 Oct 2019 | BIOPHEN™ NORMAL CONTROL PLASMA, HYPHEN Biomed (HSA 600:41/01-032/19/02_89) | HSA 6004101-032-19-02_89 FSN [PDF, 85 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) | HSA 6004101-178-19-07_57 FSN [PDF, 285 KB] |
21 Oct 2019 | Vidas 3, Biomerieux S.A. (HSA 600:41/01-146/19/04_23) | HSA 6004101-146-19-04_23 FSN [PDF, 527 KB] |
21 Oct 2019 | EXACTAMIX Empty EVA Bags, Baxter Healthcare SA (HSA 600:41/01-001/19/04_62) | HSA 6004101-001-19-04_62 FSN [PDF, 2021 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) | HSA 6004101-010-19-28_77 FSN [PDF, 211 KB] |
21 Oct 2019 | Boston Scientific Advanix™ Pancreatic Stent, Boston Scientific Corporation (HSA 600:41/01-007/19/09_66) | HSA 6004101-007-19-09_66 FSN [PDF, 288 KB] |
21 Oct 2019 | ECHELON FLEX™ ENDOPATH® 60mm Staplers, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/19/16_35) | HSA 6004101-002-19-16_35 FSN [PDF, 339 KB] |
17 Oct 2019 | CARESCAPE Respiratory Modules, GE Healthcare Finland Oy (HSA 600:41/01-010/19/27_18) | HSA 60041-01-010-19-27_18 FSN [PDF, 277 KB] |
17 Oct 2019 | SynchroMed™ II Implantable Drug Infusion Pumps, Medtronic Inc. (HSA 600:41/01-009/19/14_46) | HSA 6004101-009-19-14_46 FSN [PDF, 199 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) | HSA 6004101-010-19-26_38 FSN [PDF, 145 KB] |
15 Oct 2019 | WECK® Auto® Endo5 Automatic Hem-o-lok Clip Appliers, Teleflex Medical (HSA 600:41/01-139/19/04_68) | HSA 6004101-139-19-04_68 FSN [PDF, 310 KB] |
15 Oct 2019 | Firefly splashy, James Lecky Design Limited (HSA 600:41/01-351/19/01_88) | HSA 6004101-351-19-01_88 FSN [PDF, 1951 KB] |
15 Oct 2019 | StealthStation DBS Software, Medtronic Navigation Inc (HSA 600:41/01-009/19/15_37) | HSA 6004101-009-19-15_37 FSN [PDF, 78 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) | HSA 60041-01-303-19-09_89 FSN [PDF, 164 KB] |
15 Oct 2019 | Medivators Endo SmartCap Irrigation Tubings, Medivators Inc. (HSA 600:41/01-350/19/01_79) | HSA 6004101-350-19-01_79 FSN [PDF, 170 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) | HSA 6004101-062-19-01_82 FSN [PDF, 1278 KB] |
14 Oct 2019 | Patient Data Manager, Brainlab AG (HSA 600:41/01-047/19/01_87) | HSA 6004101-047-19-01_87 FSN [PDF, 131 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) | HSA 6004101-009-19-13_77 FSN [PDF, 149 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) | HSA 6004101-104-19-03_85 FSN [PDF, 198 KB] |
11 Oct 2019 | Catheter connector, Convatec Limited (HSA 600:41/01-044/19/03_50) | HSA 6004101-044-19-03_50 FSN [PDF, 421 KB] |
11 Oct 2019 | HemoSphere Oximetry Smart Cables, Edwards Lifesciences LLC (HSA 600:41/01-060/19/07_68) | HSA 6004101-060-19-07_68 FSN [PDF, 229 KB] |
10 Oct 2019 | Arjo Akron Tilt Table Couch, ArjoHuntleigh AB (HSA 600:41/01-065/19/03_44) | HSA 6004101-065-19-03_44 FSN [PDF, 92 KB] |
10 Oct 2019 | InteliQ Assayed Multiqual control, Bio-Rad Laboratories (HSA 600:41/01-027/19/11_59) | HSA 6004101-027-19-11_59 FSN [PDF, 210 KB] |
10 Oct 2019 | Hepatitis E RNA, Fast-Track Diagnostics S.a.r.l. (HSA 600:41/01-022/19/25_67) | HSA 6004101-022-19-25_67 FSN [PDF, 2696 KB] |
10 Oct 2019 | CRP FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/19/01_73) | HSA 6004101-032-19-01_73 FSN [PDF, 227 KB] |
10 Oct 2019 | PHILIPS DIGITALDIAGNOST RADIOGRAPHY SYSTEM, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/19/34_18) | HSA 6004101-026-19-34_18 FSN [PDF, 3267 KB] |
09 Oct 2019 | Tina-quant Soluble Transferrin Receptor (sTFR) assay, Roche Diagnostics GmbH (HSA 600:41/01-016/19/24_69) | HSA 6004101-016-19-24_69 FSN [PDF, 453 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) | HSA 6004101-052-19-05_34 FSN [PDF, 180 KB] |
08 Oct 2019 | LAG SCREW 3.2 GUIDE PIN SLEEVE, Smith & Nephew Inc (HSA 600:41/01-073/19/10_46) | HSA 6004101-073-19-10_46 FSN [PDF, 231 KB] |
08 Oct 2019 | ID Diacell I-II-III, DiaMed GmbH (HSA 600:41/01-027/19/10_34) | HSA 6004101-027-19-10_34 FSN [PDF, 1880 KB] |
07 Oct 2019 | NEFA, Randox Laboratories Ltd (HSA 600:41/01-213/19/03_78) | HSA 6004101-213-19-03_78 FSN [PDF, 80 KB] |
07 Oct 2019 | Cardiac Pipettes, Roche Diagnostics GmbH (HSA 600:41/01-016/19/23_61) | HSA 6004101-016-19-23_61 FSN [PDF, 372 KB] |
07 Oct 2019 | Ventana HE 600 system, Ventana Medical Systems, Inc (Tuscon) (HSA 600:41/01-016/19/22_49) | HSA 6004101-016-19-22_49 FSN [PDF, 483 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) | HSA 6004101-013-19-10_50 FSN [PDF, 66 KB] |
04 Oct 2019 | Low Level Output Cable – Interface to Philips Monitor, Datascope Corp (HSA 600:41/01-224/19/14_88) | HSA 6004101-224-19-14_88 FSN [PDF, 181 KB] |
04 Oct 2019 | DTX Safedraw® Kits and Meritrans DTXPlus® Devices, Merit Medical Singapore Pte Ltd (HSA 600:41/01-349/19/01_71) | HSA 6004101-349-19-01_71 FSN [PDF, 146 KB] |
03 Oct 2019 | StrykeFlow Electrosurgical Probe, Stryker Endoscopy (HSA 600:41/01-014/19/05_82) | HSA 6004101-014-19-05_82 FSN [PDF, 290 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) | HSA 6004101-224-19-13_85 FSN [PDF, 2462 KB] |
03 Oct 2019 | ANALYZER AND ORTHO-CLINICAL ORTHO VISION MAX ANALYZER, ORTHO-CLINICAL DIAGNOSTICS (HSA 600:41/01-303/19/08_73) | HSA 6004101-303-19-08_73 FSN [PDF, 231 KB] |
01 Oct 2019 | Manual Resuscitator, Hsiner Co. Ltd (HSA 600:41/01-149/19/01_86) | HSA 6004101-149-19-01_86 FSN [PDF, 120 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) | HSA 6004101-022-19-13_77 FSN [PDF, 1441 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) | HSA 6004101-009-19-01_56 FSN [PDF, 1734 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) | HSA 6004101-005-18-16_51 FSN [PDF, 175 KB] This FSN is an update to the original FSN published in Sep 2018. |