Field Safety Notices
Field Safety Notice - Aug 2018
31 August 2018
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 Aug 2018 | Philips HeartStart M5072A Infant/Child SMART Pads Cartridge, Philips Medical Systems (HSA 600:41/01-026/18/24_37) | HSA 6004101-026-18-24_37 FSN_Redacted [PDF, 362 KB] (opens in new tab) |
31 Aug 2018 | ARCHITECT ICT Module, Abbott Laboratories (HSA 600:41/01-005/18/12_59) | HSA 6004101-005-18-12_59 FSN [PDF, 278 KB] (opens in new tab) |
31 Aug 2018 | Beckman Coulter Enzymatic Creatinine, Beckman Coulter HDL-Cholestrol, Beckman Coulter Lipase, Beckman Coulter Uric Acid, Beckman Coulter Inc (HSA 600:41/01-052/18/04_73) | HSA 60004101-052-18-04_73 FSN_Redacted [PDF, 150 KB] (opens in new tab) |
31 Aug 2018 | Alinity s System, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/13_31) | HSA 6004101-005-18-13_31 FSN [PDF, 102 KB] (opens in new tab) |
31 Aug 2018 | cobas e 411 analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/18/13_70) | HSA 6004101-016-18-13_70 FSN [PDF, 107 KB] (opens in new tab) |
29 Aug 2018 | Alinity HQ Analyzer, Abbott (HSA 600:41/01-005/18/11_57) | HSA 6004101-005-18-11_57 FSN [PDF, 291 KB] (opens in new tab) |
29 Aug 2018 | VITROS XT 7600 Integrated System, Ortho Clinical Diagnostics (HSA 600:41/01-303/18/11_75) | HSA 6004101-303-18-11_75 FSN [PDF, 187 KB] (opens in new tab) |
28 Aug 2018 | HemosIL ReadiPLasTin, Instrumentation Laboratory Company (HSA 600:41/01-033/18/04_73) | HSA 6004101-033-18-04_73 FSN_Redacted [PDF, 500 KB] (opens in new tab) |
28 Aug 2018 | CoaguChek PT, XS PT, XS PT PST Test, Roche Diagnostics GmbH (HSA 6004101-016-18-12_69) | HSA 6004101-016-18-12_69 FSN [PDF, 584 KB] (opens in new tab) |
27 Aug 2018 | VITEK 2 Antimicrobial Automated Susceptibility Test, bioMerieux (HSA 600:41/01-146/18/06_34) | HSA 6004101-146-18-06_34 FSN_Redacted [PDF, 435 KB] (opens in new tab) |
27 Aug 2018 | D-100 HEMOGLOBIN TESTING SYSTEM, Bio Rad Laboratories, Inc (HSA 600:41/01-027/18/12_67) | HSA 6004101-027-18-12_67 FSN [PDF, 82 KB] (opens in new tab) |
25 Aug 2018 | Medtronic HeartWare™ HVAD™ Controller, HeartWare Inc. (HSA 600:41/01-263/18/03_77) | HSA 6004101-263-18-03_77 FSN_Redacted [PDF, 540 KB] (opens in new tab) |
24 Aug 2018 | Zenith Alpha Thoracic Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013-18-07_76) | HSA 6004101-013-18-07_76 FSN_Redacted [PDF, 197 KB] (opens in new tab) |
24 Aug 2018 | Endologix AFX Endovascular AAA System, Endologix, Inc (HSA 600:41/01-057/18/02_18) | HSA 6004101-057-18-02_18 FSN_Redacted [PDF, 899 KB] (opens in new tab) |
23 Aug 2018 | Invivo Xper Flex Cardio Physiomonitoring System, Invivo, a division of Philips Medical Systems (HSA 600:41/01-026/18/23_74) | HSA 6004101-026-18-23_74 FSN_Redacted [PDF, 84 KB] (opens in new tab) |
23 Aug 2018 | Therakos CELLEX Photopheresis System, Therakos Inc. (HSA 600:41/01-070/18/19_74) | HSA 6004101-070-18-19_74 FSN_Redacted [PDF, 484 KB] (opens in new tab) |
21Aug 2018 | MyLab SevenAlpha, MyLab Seven, MyLab Six Crystaline, MyLab Six, MyLab Gamma, MyLabClass C, MyLab Eight, MyLab60/65/70/75, MyLab70 X Vision and MyLab70 XV-L, Esaote SpA (HSA 600:41/01-288/18/02_38) | HSA 6004101-288-18-02_38 FSN_Redacted [PDF, 97 KB] (opens in new tab) |
21Aug 2018 | VITROS 5600 Integrated System, Ortho-Clinical Diagnostics, Inc. (HSA 600:41/01-303/18/10_70) | HSA 6004101-303-18-10_70 FSN [PDF, 491 KB] (opens in new tab) |
21Aug 2018 | VIROTRIOL HIV-1 Ag, Bio-Rad Laboratories (HSA 600:41/01-027/18/11_49) | HSA 6004101-027-18-11_49 FSN [PDF, 116 KB] (opens in new tab) |
20 Aug 2018 | DxTerity™ Diagnostic Catheter, Medtronic Inc (HSA 600:41/01-009/18/14_38) | HSA 6004101-009-18-14_38 FSN_Redacted [PDF, 677 KB] (opens in new tab) |
16 Aug 2018 | YUKON Polyaxial Screws, K2M, Inc (HSA 600:41/01-070/18/18_66) | HSA 6004101-070-18-18_66 FSN Redacted [PDF, 312 KB] (opens in new tab) |
16 Aug 2018 | Da Vinci S/SI and Da Vinci Monopolar Curved Scissor (MCS), Intuitive Surgical, Inc (HSA 600:41/01-070/18/17_66) | HSA 6004101-070-18-17_66 FSN [PDF, 269 KB] (opens in new tab) |
16 Aug 2018 | Thio Med w/ Dex, Remel Inc (Thermo Fisher Scientific ) (HSA 600:41/01-178/18/06_31) | HSA 6004101-178-18-06_31 FSN_Redacted [PDF, 237 KB] (opens in new tab) |
15 Aug 2018 | Aptio Automation, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/21_75) | HSA 6004101-022-18-21_75 FSN [PDF, 113 KB] (opens in new tab) |
15 Aug 2018 | UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/18/03_23) | HSA 6004101-052-18-03_23 FSN_Redacted [PDF, 138 KB] (opens in new tab) |
14 Aug 2018 | Doro Lucent Headrest System, Pro Med Instruments GmbH (HSA 600:41/01-053/18/01_64) | HSA 6004101-053-18-01_64 FSN_Redacted [PDF, 636 KB] (opens in new tab) |
14 Aug 2018 | Covidien BIS Complete Monitoring System and Covidien BIS View Monitoring System, Covidien LLC (HSA 600:41/01-046/18/10_71) | HSA 6004101-046-18-10_71 FSN_Redacted [PDF, 646 KB] (opens in new tab) |
13 Aug 2018 | 9735345 S7 Install Media Tools Database Version 1.288, 9736041 StealthStation Tools Database Version 1.288, Medtronic Navigation Inc (HSA 600:41/01-009/18/12_46) | HSA 6004101-009-18-12_46 FSN_Redacted [PDF, 108 KB] (opens in new tab) |
13 Aug 2018 | OptiView DAB IHC Detection Kit, ultraView Universal Alkaline, Phosphatase Red Detection Kit, ISH Protease 3, VEMTAMA ISH iView Blue Detection Kit, Ventana Medical Systems, Inc (HSA 600:41/01-016/18/11_73) | HSA 6004101-016-18-11_73 FSN [PDF, 417 KB] (opens in new tab) |
13 Aug 2018 | Medtronic MiniMed Remote Controller, Medtronic MiniMed (HSA 600:41/01-009/18/13_48) | HSA 6004101-009-18-13_48 FSN_Redacted [PDF, 205 KB] (opens in new tab) |
13 Aug 2018 | Hematek Wright Giemsa Stain Pak and Hematek Modified Wright Stain Pak, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/20_49) | HSA 6004101-022-18-20_49 FSN [PDF, 20 KB] (opens in new tab) |
10 Aug 2018 | Power supply units for the sleep therapy devices SOMNObalance, SOMNOsoft 2, prisma SOFT and prism SMART, Löwenstein Medical Technology GmbH + Co. KG (HSA 600:41/01-264/18/01_56) | HSA 6004101-264-18-01_56 FSN_Redacted [PDF, 205 KB] (opens in new tab) |
08 Aug 2018 | Capnostream 20 and Capnostream 20p Bedside Patient Monitors, Covidien LLC (HSA 600:41/01‐046/18/09_54) | HSA 6004104-046-18-09_54 FSN_Redacted [PDF, 1339 KB] (opens in new tab) |
08 Aug 2018 | sterEOS Image Review Workstation, EOS Imaging (HSA 600:41/01-238/18/01_52) | HSA 6004101-238-18-01_52 FSN [PDF, 988 KB] (opens in new tab) |
07 Aug 2018 | Genesis II Non Porous C/R Femoral Size 6 Right, Smith & Nephew, Inc. (HSA 600:41/01-073/18/17_71) | HSA 6004101-073-18-17_71 FSN [PDF, 63 KB] (opens in new tab) |
07 Aug 2018 | Carestation 620/650/650c A1, Carestation 620/650/650c A2, Carestation 30 and 9100c NXT Anesthesia Systems, Datex-Ohmeda (HSA 600:41/01-010/18/17_50) | HSA 6004101-010-18-17_50 FSN_Redacted [PDF, 309 KB] (opens in new tab) |
07 Aug 2018 | Ysio and Ysio Max with Tube stand 3D V, Siemens Healthcare GmbH (HSA 600:41/01-022/18/19_63) | HSA 6004101-022-18-19_63 FSN Redacted [PDF, 1331 KB] (opens in new tab) |
06 Aug 2018 | Elekta Mosaiq, IMPAC Medical Systems, Inc (HSA 600:41/01-101/18/04_35) | HSA 6004101-101-18-04_35 FSN_Redacted [PDF, 1380 KB] (opens in new tab) |
06 Aug 2018 | Stellaris Elite™ Single Port Vitrectomy Cutters in Gauge Sizes 20, 23, and 25, Bausch & Lomb Incorporated (HSA 600:41/01-030/18/01_44) | HSA 6004101-030-18-01_44 FSN Redacted [PDF, 456 KB] (opens in new tab) |
06 Aug 2018 | Juggerknot Long Flex Drill Bit with Sleeve Nitinol Stainless Steel, Biomet Orthopaedics (HSA 600:41/01-008/18/13_18) | HSA 6004101-008-18-13_18 FSN [PDF, 130 KB] (opens in new tab) |
06 Aug 2018 | Philips Allura Xper FD10 X-Ray Imaging System, Philips Allura Xper FD10/10 X-Ray Imaging System, Philips Allura Xper FD20 X-Ray Imaging System, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/22_51) | HSA 6004101-026-18-22_51 FSN_Redacted [PDF, 254 KB] (opens in new tab) |
01 Aug 2018 | CONMED Hall® Small Lithium Battery L3000SM, ConMed Corporation (HSA 600:41/01-302/18/01_46) | HSA 6004101-302-18-01_46 FSN_Redacted [PDF, 110 KB] (opens in new tab) |
06 Dec 2017 | MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7, MAKO Surgical Corp (HSA 600:41/01-070/17/20_64) | HSA 6004101-070-17-20_64 FSN_Redacted [PDF, 105 KB] (opens in new tab) This FSN is an update to the original FSN published in Dec 2017. |