Field Safety Notices
Field Safety Notice - Jun 2019
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 June 2019
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
28 Jun 2019 | Philips Ingenuity CT system, Philips Ingenuity TF PET/CT Imaging System, Philips Brilliance Computed Tomography X-Ray System, Philips IQon Spectral CT System, Philips Vereos PET/CT System, Philips Medical Systems(Cleveland), Inc (HSA 600:41/01-026/19/20_50) | HSA 6004101-026-19-20_50 FSN [PDF, 998 KB] |
28 Jun 2019 | DATASCOPE INTRA-AORTIC BALLOON PUMPS (IABP), Datascope Corp. (HSA 600:41/01-224/19/07_80) | HSA 6004101-224-19-07_80 FSN [PDF, 650 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, 1632 KB] |
27 Jun 2019 | MiniMed™ Paradigm™ Series Insulin Pumps, Medtronic MiniMed (HSA 600:41/01-009/19/10_44) | HSA 6004101-009-19-10_44 FSN [PDF, 176 KB] |
27 Jun 2019 | Philips DigitalDiagnost Radiography System, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/19/19_48) | HSA 6004101-026-19-19_48 FSN [PDF, 179 KB] |
26 Jun 2019 | Hitachi Clinix II, Hitachi, Ltd (HSA 600:41/01-054/19/01_44) | HSA 6004101-054-19-01_44 FSN [PDF, 95 KB] |
24 Jun 2019 | Occlutech Figulla Flex II ASD, Occlutech Holding AG (HSA 600:41/01-057/19/01_76) | HSA 6004101-057-19-01_76 FSN [PDF, 6755 KB] |
24 Jun 2019 | Sekisui Automated Coagulation Analyzer CP3000, Sekisui Medical Co. Ltd. (HSA 600:41/01-005/19/26_57) | HSA 6004101-005-19-26_57 FSN [PDF, 697 KB] |
20 Jun 2019 | Single-Use Suction Valve, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/03_76) | HSA 6004101-004-19-03_76 FSN [PDF, 1469 KB] |
20 Jun 2019 | GE Revolution CT, GE Medical Systems, LLC (HSA 600:41/01-010/19/18_71) | HSA 6004101-010-19-18_71 FSN [PDF, 114 KB] |
19 Jun 2019 | BD Vacutainer® Plastic Lithium Heparin Tubes, Becton, Dickinson and Company (HSA 600:41/01-003/19/06_70) | HSA 6004101-003-19-06_70 FSN [PDF, 148 KB] |
19 Jun 2019 | Ultra-Drive Irrigation Tubing Assembly, Biomet Orthopedics (HSA 600:41/01-008/19/04_51) | HSA 6004101-008-19-04_51 FSN [PDF, 366 KB] |
18 Jun 2019 | BD Connecta Plus 3-Stopcock, Becton Dickinson Infusion Therapy AB (HSA 600:41/01-003/19/05_54) | HSA 6004101-003-19-05_54 FSN [PDF, 122 KB] |
18 Jun 2019 | Carefusion Alaris System, CareFusion 303 Inc (HSA 600:41/01-003/19/04_77) | HSA 6004101-003-19-04_77 FSN [PDF, 233 KB] |
17 Jun 2019 | Defibrillation electrodes for adults for the Weinmann MEDUCORE Standard2 Monitor/Defibrillator, WEINMANN Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-301/19/02_64) | HSA 6004101-301-19-02_64 FSN [PDF, 601 KB] |
14 Jun 2019 | ECG trunk cables and leadwires, GE Healthcare Finland Oy (HSA 600:41/01-010/19/17_79) | HSA 6004101-010-19-17_79 FSN [PDF, 293 KB] |
14 Jun 2019 | cobas® 6800/8800 Systems Processing Transfer Head, Roche Diagnostics GmbH (HSA 600:41/01‐016/19/11_23) | HSA 6004101-016-19-11_23 FSN [PDF, 472 KB] |
13 Jun 2019 | Alinity ci-series system control module, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/25_59) | HSA 6004101-005-19-25_59 FSN [PDF, 304 KB] |
12 Jun 2019 | Philips Vereos PET/CT System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/19/18_37) | HSA 6004101-026-19-18_37 FSN [PDF, 503 KB] |
12 Jun 2019 | ARCHITECT Ceruloplasmin, Alinity c Ceruloplasmin Reagent Kit, Sentinel CH (HSA 600:41/01-005/19/24_67) | HSA 6004101-005-19-24_67 FSN [PDF, 1583 KB] |
11 Jun 2019 | Centricity Universal Viewer with Centricity PACS foundation 6.0 SP9 or higher used in combination with Centricity PACS 6.0 SP9 or higher, GE Healthcare (HSA 600:41/01-010/19/16_35) | HSA 6004101-010-19-16_35 FSN [PDF, 141 KB] |
11 Jun 2019 | BrightView SPECT, BrightView X, BrightView XCT Handcontroller, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/19/17_38) | HSA 6004101-026-19-17_38 FSN [PDF, 372 KB] |
10 Jun 2019 | EQUISTREAM®, EQUISTREAM® XK, AND GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETERS, Bard Access Systems Inc (HSA 600:41/01-050/19/03_66) | HSA 6004101-050-19-03_66 FSN [PDF, 529 KB] |
07 Jun 2019 | UNI-GRAFT K DV (12 MM/15 CM), Aesculap AG (HSA 600:41/01‐012/19/03_54) | HSA 6004101-012-19-03_54 FSN [PDF, 1941 KB] |
06 Jun 2019 | Artis zee and Artis Q Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/12_62) | |
06 Jun 2019 | Randox Human Assayed Multi-Sera-Level 2, Randox Laboratories Ltd (HSA 600:41/01-213/19/01_34) | HSA 6004101-213-19-01_34 FSN [PDF, 1667 KB] |
06 Jun 2019 | Alinity i BNP Calibrators, Alinity i BNP Controls, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/23_23) | HSA 6004101-005-19-23_23 FSN [PDF, 375 KB] |
06 Jun 2019 | Weinmann MEDUCORE Standard2 Monitor/Defibrillator, Weinmann Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-301/19/01_48) | HSA 6004101-301-19-01_48 FSN [PDF, 111 KB] |
06 Jun 2019 | Sensation Plus 7.5 Fr. 40cc Intra-Aortic Balloon Catheter with Accessories, Datascope Corp. (HSA 600:41/01-224/19/06_35) | HSA 6004101-224-19-06_35 FSN [PDF, 491 KB] |
06 Jun 2019 | Spectra Optia Apheresis System, Terumo BCT (HSA 600:41/01-155/19/01_37) | HSA 6004101-155-19-01_37 FSN [PDF, 121 KB] |
03 Jun 2019 | Elecsys Syphilis (200 test/kit), Roche Diagnostics GmbH (HSA 600:41/01-016/19/10_75) | HSA 6004101-016-19-10_75 FSN [PDF, 339 KB] |
03 Jun 2019 | BD Microtainer Tubes, Becton Dickinson, Caribe Ltd. (HSA 600:41/01-003/19/03_73) | HSA 6004101-003-19-03_73 FSN [PDF, 129 KB] |
02 Apr 2019 | Bilirubin direct Gen 2, cobas c701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/05_69) | HSA 6004101-016-19-05_69 FSN [PDF, 129 KB] This FSN is an update to the original FSN published in Apr 2019. |