Field Safety Notices
Field Safety Notice - Oct 2019
31 October 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) |
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] (opens in new tab) 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] (opens in new tab) 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] (opens in new tab) This FSN is an update to the original FSN published in Sep 2018. |