Field Safety Notices
Field Safety Notice - Sep 2018
30 September 2018
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
28 Sep 2018 | Medtronic FlexCath Advance Steerable Sheath, Medtronic CryoCath LP (HSA 600:41/01-009/18/16_46) | HSA 6004101-009-18-16_46 FSN_Redacted [PDF, 138 KB] (opens in new tab) |
28 Sep 2018 | HydroSet Injectable HA Bone Substitute, Stryker Leibinger GmbH & Co. KG (HSA 600:41/01-014/18/07_68) | HSA 6004101-014-18-07_68 FSN_Redacted [PDF, 109 KB] (opens in new tab) |
28 Sep 2018 | 25GA Vitrectomy Cutter, Johnson & Johnson Surgical Vision Inc. (HSA 600:41/01-018/18/01_18) | HSA 6004101-018-18-01_18 FSN_Redacted [PDF, 113 KB] (opens in new tab) |
27 Sep 2018 | buddy™ Disposable Set, Belmont Instrument Corporation (HSA 600:41/01-070/18/20_63) | HSA 6004101-070-18-20_63 FSN_Redacted [PDF, 249 KB] (opens in new tab) |
27 Sep 2018 | ATELLICA® IM 1300 ANALYZER, ATELLICA® IM 1600 ANALYZER, ATELLICA® CH 930 ANALYZER, ATELLICA® SAMPLE HANDLER PRIME, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/18/24_57) | HSA 6004101-022-18-24_57 FSN [PDF, 108 KB] (opens in new tab) |
27 Sep 2018 | INTRAFIX SAFESET LL, B.Braun Melsungen AG (HSA 600:41/01-012/18/07_50) | HSA 6004101-012-18-07_50 FSN_Redacted [PDF, 1229 KB] (opens in new tab) |
26 Sep 2018 | CrystaIClear Plus; RUSCH CARE CrystaIClear (PVC) Tracheostomy Cannula (no Cuff) ‐ Set; RUSCH CrystaIClear (PVC) Tracheostomy Cannula (Cuffed); RUSCH CrystalClear (PVC) Tracheostomy Cannula (no Cuff), Teleflex Medical Europe (HSA 600:41/01-139/18/04_51) | HSA 6004101-139-18-04_51 FSN_Redacted [PDF, 506 KB] (opens in new tab) |
26 Sep 2018 | Xper Flex Cardio Patient Monitoring System, Invivo (a division of Philips Medical Systems), (HSA 600:41/01-026/18/25_63) | HSA 6004101-026-18-25_63 FSN_Redacted [PDF, 138 KB] (opens in new tab) |
26 Sep 2018 | LOGIQ E10 Ultrasound Systems combined with TEE probes, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC (HSA 600:41/01-010/18/22_50) | HSA 6004101-010-18-22_50 FSN_Redacted [PDF, 283 KB] (opens in new tab) |
26 Sep 2018 | Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP), Datascope Corp (HSA 600:41/01-017/18/05_35) | HSA 6004101-017-18-05_35 FSN_Redacted [PDF, 416 KB] (opens in new tab) |
25 Sep 2018 | Roche Diagnostics Elecsys® FT4 III, Roche Diagnostics GmbH (HSA 600:41/01-016/18/15_73) | HSA 6004101-016-18-15_73 FSN [PDF, 355 KB] (opens in new tab) |
23 Sep 2018 | StageOne Hip Cement Spacer Mold, Biomet Orthopaedics (HSA 600:41/01-008/18/14_48) | HSA 6004101-008-18-14_48 FSN_Redacted [PDF, 98 KB] (opens in new tab) |
22 Sep 2018 | ConvaTec Feeding Tubes; ConvaTec Ryles tubes; ConvaTec Mülly Suction Catheter Set; Convatec / Nelaton and Female PVC intermittent Catheters, Convatec Limited (HSA 600:41/01-044/18/01_18) | HSA 6004101-044-18-01_18 FSN_Redacted [PDF, 876 KB] (opens in new tab) |
20 Sep 2018 | B20/B20i/B40/B40i (Bx0), and B105/B125 (B1x5) Patient Monitors, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/18/21_77) | HSA 6004101-010-18-21_77 FSN_Redacted [PDF, 136 KB] (opens in new tab) |
20 Sep 2018 | ABX Difftrol, Horiba ABX SAS (HSA 600:41/01-137/18/02_69) | HSA 6004101-137-18-02_69 FSN_Redacted [PDF, 142 KB] (opens in new tab) |
19 Sep 2018 | Acid Concentrate for Bicarbonate Haemodialysis, Fresenius Medical Care Production Sdn Bhd (HSA 600:41/01-062/18/02_74) | HSA 6004101-062-18-02_74 FSN _Redacted [PDF, 1865 KB] (opens in new tab) |
19 Sep 2018 | ALINITY I PROCESSING MODULE, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/18_67) | HSA 6004101-005-18-18_67 FSN_Redacted [PDF, 199 KB] (opens in new tab) |
18 Sep 2018 | Ghiatas® Beaded Breast Localization Wire, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/18/05_71) | HSA 6004101-050-18-05_71 FSN_Redacted [PDF, 1826 KB] (opens in new tab) |
18 Sep 2018 | Dash 3000/4000/5000, Solar 8000M/i, and Solar 9500 Patient Monitors, GE Medical Systems Information Technologies, Inc (HSA 600:41/01-010/18/20_38) | HSA 6004101-010-18-20_38 FSN_Redacted [PDF, 355 KB] (opens in new tab) |
17 Sep 2018 | System DRX Ascend/Q-Rad System, Carestream Health, Inc. (HSA 600:41/01-187/18/01_64) | HSA 6004101-187-18-01_64 FSN_Redacted [PDF, 220 KB] (opens in new tab) |
17 Sep 2018 | COOPERSURGICAL SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER™, CooperSurgical Inc (HSA 600:41/01-017/18/04_62) | HSA 6004101-017-18-04_62 FSN_Redacted [PDF, 2554 KB] (opens in new tab) |
17 Sep 2018 | CooperSurgical 5mm Elastic Stays, Blunt End, CooperSurgical Inc. (HSA 600:41/01-145/18/01_48) | HSA 6004101-145-18-01_48 FSN_Redacted [PDF, 2722 KB] (opens in new tab) |
17 Sep 2018 | Terumo® Advanced Perfusion System 1, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/18/06_51) | HSA 6004101-028-18-06_51 FSN [PDF, 157 KB] (opens in new tab) |
14 Sep 2018 | Gambro AK 98 Dialysis Machine, Gambro Lundia AB (HSA 600:41/01-001/18/04_46) | HSA 6004101-001-18-04_46 FSN_Redacted [PDF, 322 KB] (opens in new tab) |
14 Sep 2018 | Aptio Automation System, Inpeco SA (HSA 600:41/01-022/18/23_61) | HSA 6004101-022-18-23_61 FSN_Redacted [PDF, 134 KB] (opens in new tab) |
13 Sep 2018 | CARESCAPE B450 and B850 monitors, GE Healthcare Finland Oy (HSA 600:41/01-010/18/19_56) | HSA 6004101-010-18-19_56 FSN_Redacted [PDF, 670 KB] (opens in new tab) |
13 Sep 2018 | B. Braun SpaceCover Comfort & B Braun SpaceCover Standard, B Braun Melsungen AG (HSA 600:41/01-012/18/06_64) | HSA 6004101-012-18-06_64 FSN [PDF, 72 KB] (opens in new tab) |
11 Sep 2018 | ARCHITECT Alere NT-proBNP for ARCHITECT Controls 2R10-10, Axis-Shield Diagnostics Ltd (HSA 600:41/01-005/18/17_70) | HSA 6004101-005-18-17_70 FSN_Redacted [PDF, 109 KB] (opens in new tab) |
10 Sep 2018 | Centricity Universal Viewer, GE Healthcare (HSA 600:41/01-010/18/18_35) | HSA 6004101-010-18-18_35 FSN_Redacted [PDF, 285 KB] (opens in new tab) |
10 Sep 2018 | ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 pacemakers and VISIONIST and VALITUDE CRT-Ps, Boston Scientific Corporation (HSA 600:41/01-007/18/05_62) | HSA 6004101-007-18-05_62 FSN_Redacted [PDF, 225 KB] (opens in new tab) |
10 Sep 2018 | ADVIA Chemistry Creatinine Kinase (CK_L) Assay, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/18/22_59) | HSA 6004101-022-18-22_59 FSN [PDF, 123 KB] (opens in new tab) |
7 Sep 2018 | CentriMag Motor, Thoratec Switzerland GmbH (HSA 600:41/01-005/18/16_51) | HSA 6004101-005-18-16_51 FSN_Redacted [PDF, 575 KB] (opens in new tab) |
7 Sep 2018 | Accu-Chek® Inform II system, cobas h 232 POC system, CoaguChek® Pro II system, CoaguChek® XS Plus / XS Pro system, Roche Diagnostics GmbH (HSA 600:41/01-016/18/14_34) | HSA 6004101-016-18-14_34 FSN_Redacted [PDF, 610 KB] (opens in new tab) |
7 Sep 2018 | FilmArray Blood Culture Identification (BCID) Panel, BioFire Diagnostic, LLC (HSA 600:41/01-146/18/07_31) | HSA 6004101-146-18-07_31 FSN_Redacted [PDF, 478 KB] (opens in new tab) |
7 Sep 2018 | O-Arm 1000 Imaging System, Medtronic Navigation Inc (HSA 600:41/01-009/18/15_52) | HSA 6004101-009-18-15_52 FSN_Redacted [PDF, 909 KB] (opens in new tab) |
7 Sep 2018 | Abbott Alinity c Creatine Kinase, Abbott Alinity c Creatine Kinase (HSA 600:41/01-005/18/15_57) | HSA 6004101-005-18-15_57 FSN_Redacted [PDF, 291 KB] (opens in new tab) |
7 Sep 2018 | GibcoTM MEM Non-Essential Amino Solution (100X); GibcoTM GlutaMAXTM Supplement; GibcoTM Sodium Pyruvate (100mM); GibcoTM DPBS, calcium, magnesium, Life Technologies Corporation (HSA 600:41/01-220/18/02_67) | HSA 6004101-220-18-02_67 FSN_Redacted [PDF, 336 KB] (opens in new tab) |
7 Sep 2018 | MyLab Six and MyLab Gamma, Esaote SpA (HSA 600:41/01-263/18/04_52) | HSA 6004101-263-18-04_52 FSN_Redacted [PDF, 97 KB] (opens in new tab) |
6 Sep 2018 | Alinity ci‐series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/14_23) | HSA 6004101-005-18-14_23 FSN [PDF, 392 KB] (opens in new tab) |
6 Sep 2018 | ABL90 FLEX (393-090) analyzers, Radiometer Medical Aps (HSA 600:41/01-219/18/01_75) | HSA 6004101-219-18-01_75 FSN [PDF, 38 KB] (opens in new tab) |
5 Sep 2018 | VirtuoSaph® Plus Endoscopic Vessel Harvesting System, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/18/05_77) | HSA 6004101-028-18-05_77 FSN [PDF, 293 KB] (opens in new tab) |
5 Sep 2018 | Terumo® Advanced Perfusion System 1, Terumo Cardiovascular Systems Corp (HSA 600:41/01-028/18/04_50) | HSA 6004101-028-18-04_50 FSN [PDF, 323 KB] (opens in new tab) |
5 Sep 2018 | MEDUMAT Transport with and without CO2 measurement (WM 28300 and WM 28400) incl. Akku-Pack or Akku-Pack PLUS rechargeable battery packs; Akku-Pack rechargeable battery pack (WM 28384); Akku-Pack PLUS rechargeable battery pack (WM 28385), WEINMANN Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-056/18/04_44) | HSA 6004101-056-18-04_44 FSN_Redacted [PDF, 162 KB] (opens in new tab) |
4 Sep 2018 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/12_34) | HSA 6004101-303-18-12_34 FSN_Redacted [PDF, 370 KB] (opens in new tab) |
4 Sep 2018 | CyPass® Micro-Stent, Alcon Laboratories, Inc. (HSA 600:41/01-135/18/01_35) | HSA 6004101-135-18-01_35 FSN_Redacted [PDF, 633 KB] (opens in new tab) |
28 Aug 2018 | CoaguChek PT, XS PT, XS PT PST Test, Roche Diagnostics GmbH (HSA 600:41/01-016/18/12_69) | HSA 6004101-016-18-12_69 FSN v [PDF, 663 KB] (opens in new tab) This updated FSN replaces the original FSN published in Aug 2018. |
26 Jun 2018 | CARESCAPE B650 Monitor, GE Healthcare Finland Oy (HSA 600:41/01-010/18/14_56) | HSA 6004101-010-18-14_56 FSN_v2_Redacted [PDF, 669 KB] (opens in new tab) This FSN is an update to the original FSN published in June 2018. |
21 May 2018 | Cobas m 511 integrated hematology analyser, Roche Diagnostics GmbH (HSA 600:41/01-016/18/09_59) | HSA 6004101-016-18-09_59 FSN_version [PDF, 796 KB] (opens in new tab) This FSN is an update to the original FSN published in May 2018. |
10 Nov 2017 | Covidien Puritan Bennett 980 Series Ventilator, Covidien IIc (HSA 600:41/01-046/17/09_37) | HSA 6004101-046-17-09_37 FSN Part 2_Redacted [PDF, 149 KB] (opens in new tab) This FSN is an update to the original FSN published in Nov 2017. |
30 Jun 2016 | Philips M1783A/M5526A Sync Cables & 989803195641 ECG Out Cables, Philips Medical Systems (HSA 600:41/01-026/16/26_41) | HSA 6004101-026-16-26_41 FSN_Update_Redacted [PDF, 84 KB] (opens in new tab) This FSN is an update. |