Field Safety Notices
Field Safety Notice - May 2018
31 May 2018
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 May 2018 | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv® Technology, Zimmer Inc. (HSA 600:41/01-008/18/09_52) | HSA 6004101-008-18-09_52 FSN_Redacted [PDF, 150 KB] (opens in new tab) |
30 May 2018 | SuperDimension™ Navigation System, Covidien llc (HSA 600:41/01-046/18/07_56) | HSA 6004101-046-18-07_56 FSN [PDF, 164 KB] (opens in new tab) |
30 May 2018 | TruClear Sheath 5C, Smith & Nephew Inc (HSA 600:41/01-046/18/06_45) | HSA 6004101-046-18-06_45 FSN_Redacted [PDF, 453 KB] (opens in new tab) |
30 May 2018 | Hoya Pentax Video Endoscopes System, Hoya Corporation (HSA 600:41/01-106/18/02_54) | HSA 6004101-106-18-02_54 FSN_Redacted [PDF, 1266 KB] (opens in new tab) |
28 May 2018 | Gentamicin (GENT) Flex® reagent cartridge, Siemens Healthcare Diagnostic Inc (HSA 600:41/01-022/18/13_31) | HSA 6004101-022-18-13_31 FSN [PDF, 119 KB] (opens in new tab) |
28 May 2018 | Philips Xper Flex Cardio Patient Monitoring System , INVIVO, a division of Philips Medical Systems (HSA 600:41/01-026/18/17_38) | HSA 6004101-026-18-17_38 FSN_Redacted [PDF, 84 KB] (opens in new tab) |
25 May 2018 | M320 Microscope System, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/18/02_52) | HSA 6004101-126-18-02_52 FSN_Redacted [PDF, 1258 KB] (opens in new tab) |
25 May 2018 | VECTRIS™ TRIAL SCREENING LEAD KITS, VECTRIS™ SURESCAN® LEAD KITS, Medtronic, Inc (HSA 600:41/01-009/18/06_71) | HSA 6004101-009-18-06_71 FSN [PDF, 576 KB] (opens in new tab) |
24 May 2018 | LFITTM Anatomic CoCr V40TM Femoral Heads, Howmedica Ostenics Corp (HSA 600:41/01-014/18/06_43) | HSA 6004101-014-18-06_43 FSN [PDF, 1527 KB] (opens in new tab) |
23 May 2018 | ArjoHuntleigh Akron Tilt Table, ArjoHuntleigh AB (HSA 600:41/01-065/18/02_63) | HSA 6004101-065-18-02_63 FSN_Redacted [PDF, 119 KB] (opens in new tab) |
23 May 2018 | PENTAX Duodenoscope ED-3490TK, Hoya Corporation (HSA 600:41/01-106/18/01_68) | HSA 6004101-106-18-01_68 FSN [PDF, 107 KB] (opens in new tab) |
23 May 2018 | Drager Fabius GS Premium Anaesthetic Workstation, Drager Fabius MRI, Drager Fabius Anaesthetic System, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/18/05_46) | HSA 6004101-063-18-05_46 FSN_Redacted [PDF, 4799 KB] (opens in new tab) |
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 [PDF, 501 KB] (opens in new tab) |
21 May 2018 | Biomet® Primary Tibial Plate with Locking Bar, Biomet Orthopaedics (HSA 600:41/01-008/18/08_50) | HSA 6004101-008-18-08_50 FSN_Redacted [PDF, 112 KB] (opens in new tab) |
18 May 2018 | Thermo Scientific™ Remel™ Salmonella paratyphi A-H Stained Suspension, Remel Europe Ltd (HSA 600:41/01-178/18/04_58) | HSA 6004101-178-18-04_58 FSN_Redacted [PDF, 237 KB] (opens in new tab) |
18 May 2018 | Medical Intelligence HexaPOD™ evo RT System, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/18/03_50) | HSA 6004101-101-18-03_50 FSN_Redacted [PDF, 165 KB] (opens in new tab) |
17 May 2018 | Xper Flex Cardio Patient Monitoring System, INVIVO, a division of Philips Medical Systems (HSA 600:41/01-026/18/16_37) | HSA 6004101-026-18-16_37 FSN_Redacted [PDF, 93 KB] (opens in new tab) |
17 May 2018 | Mako RIO System Irrigation Clip, MAKO Surgical Corp. (HSA 600:41/01-070/18/08_51) | HSA 6004101-070-18-08_51 FSN_Redacted [PDF, 196 KB] (opens in new tab) |
17 May 2018 | Arctic Sun 5000 Temperature Management System, Medivance, Inc (HSA 600:41/01-050/18/03_44) | HSA 6004101-050-18-03_44 FSN_Redacted [PDF, 1489 KB] (opens in new tab) |
16 May 2018 | D-RAD SMART PACK 4 HOLE RIGHT STANDARD PLATE, Smith & Nephew, Inc. (HSA 600:41/01-073/18/12_63) | HSA 6004101-073-18-12_63 FSN [PDF, 175 KB] (opens in new tab) |
15 May 2018 | Ortho Vision Analyser & Ortho Vision Max Analyser, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/06_34) | HSA 6004101-303-18-06_34 FSN_Redacted [PDF, 1894 KB] (opens in new tab) |
15 May 2018 | Symbia T and Symbia Intevo, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/18/12_45) | HSA 6004101-022-18-12_45 FSN_Redacted [PDF, 3975 KB] (opens in new tab) |
14 May 2018 | VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/05_61) | HSA 6004101-303-18-05_61 FSN_Redacted [PDF, 1261 KB] (opens in new tab) |
14 May 2018 | Biograph mCT - S/ mCT -X , Biograph mCT Flow, Biograph Horizon, Biograph Truepoint, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/18/11_66) | HSA 6004101-022-18-11_66 FSN_Redacted [PDF, 179 KB] (opens in new tab) |
14 May 2018 | da Vinci® Xi EndoWrist Stapler Release Kit, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/07_68) | HSA 6004101-070-18-07_68 FSN [PDF, 344 KB] (opens in new tab) |
14 May 2018 | Vantage Elan, Canon Medical Systems Corporation (HSA 600:41/01-324/18/01_71) | HSA 6004101-324-18-01_71 FSN_Redacted [PDF, 1349 KB] (opens in new tab) |
11 May 2018 | CLARITI 1 DAY (SOMOFILCON A) 56% ASPHERE SOFT CONTACT LENSES, Coopervision Manufacturing Ltd. (HSA 600:41/01-176/18/01_51) | HSA 6004101-176-18-01_51 FSN_Redacted [PDF, 24 KB] (opens in new tab) |
11 May 2018 | GENESIS II 13MM TIBIAL PUNCH , Smith & Nephew, Inc. (HSA 600:41/01-073/18/11_43) | HSA 6004101-073-18-11_43 FSN [PDF, 192 KB] (opens in new tab) |
10 May 2018 | HARMONIC ACE®+ Shears with Adaptive Tissue Technology, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/05_64) | HSA 6004101-002-18-05_64 FSN_Redacted [PDF, 470 KB] (opens in new tab) |
10 May 2018 | Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc (HSA 600:41/01-027/18/05_23) | HSA 6004101-027-18-05_23 FSN [PDF, 136 KB] (opens in new tab) |
07 May 2018 | Datascope CARDIOSAVE Intra-Aortic Balloon Pump (IABP), Datascope Corp (HSA 600:41/01-081/18/05_62) | HSA 6004101-081-18-05_62 FSN_Redacted [PDF, 569 KB] (opens in new tab) |
07 May 2018 | SAM XT EXTREMITY TOURNIQUET, SAM Medical (HSA 600:41/01-321/18/01_50) | HSA 6004101-321-18-01_50 FSN_Redacted [PDF, 114 KB] (opens in new tab) |
07 May 2018 | HeartWare™ Ventricular Assist Device (HVAD)™ System, HeartWare (HSA 600:41/01-263/18/02_46) | HSA 6004101-263-18-02_46 FSN_Redacted [PDF, 586 KB] (opens in new tab) HSA 6004101-263-18-02_46 FSN update [PDF, 134 KB] (opens in new tab) (This FSN is an update) |
07 May 2018 | Thermo Scientific™ Remel™ Agglutinating Sera, Remel Europe Ltd (HSA 600:41/01-178/18/03_49) | HSA 6004101-178-18-03_49 FSN_Redacted [PDF, 226 KB] (opens in new tab) |
05 May 2018 | Aurinio L 110, L 120, L 150 and L 160, Aurinio OR lights series, Trilux Medical GmbH & Co. KG (HSA 600:41/01-323/18/01_35) | HSA 6004101-323-18-01_35 FSN [PDF, 982 KB] (opens in new tab) |
04 May 2018 | GE Healthcare Revolution EVO & Optima CT660, CT670, CT680, CT540 Scanner System, GE Healthcare Japan Corporation (HSA 600:41/01-010/18/09_51) | HSA 6004101-010-18-09_51 FSN_Redacted [PDF, 587 KB] (opens in new tab) |
04 May 2018 | Prismaflex control units, Gambro Lundia AB (HSA 600:41/01-001/18/02_43) | HSA6004101-001-18-02_43 FSN_Redacted [PDF, 3098 KB] (opens in new tab) |
04 May 2018 | Cascadia Interbody System, K2M Inc (HSA 600:41/01-322/18/01_62) | HSA 6004101-322-18-01_62 FSN_Redacted [PDF, 550 KB] (opens in new tab) |
03 May 2018 | Elecsys Vitamin D Total II, Roche Diagnostics GmbH (HSA 600:41/01-016/18/08_70) | HSA 6004101-016-18-08_70 FSN [PDF, 338 KB] (opens in new tab) |
02 May 2018 | (1) ROCHE DIABETES CARE ACCU-CHEK® AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM AVIVA TEST STRIPS (AVIVA TEST STRIPS); AND (2) ROCHE DIABETES CARE ACCU-CHEK® PERFORMA GLUCOSE MONITORING SYSTEM ACCU-CHEK® PERFORMA TEST STRIPS (PERFORMAN TEST STRIPS); Roche Diabetes Care GmbH (HSA 600:41/01-016/18/07_57) | HSA 6004101-016-18-07_57 FSN_Customer_Redacted [PDF, 201 KB] (opens in new tab) |
02 May 2018 | ACCU-CHEK INFORM II STRIPS, Roche Diabetes Care GmbH (HSA 600:41/01-016/18/06_69) | HSA6004101-016-18-06_69 FSN [PDF, 552 KB] (opens in new tab) |
02 May 2018 | iGuide software 2.2, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/18/01_37) | HSA 6004101-101-18-01_37 FSN [PDF, 250 KB] (opens in new tab) |
02 May 2018 | iGuide 2.2, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/18/02_37) | HSA 6004101-101-18-02_37 FSN [PDF, 34 KB] (opens in new tab) |
17 Jan 2018 | Medfusion® Syringe Pump Model Series 3500 and 4000, Smiths Medical ASD, Inc (HSA 600:41/01-017/18/01_25) | HSA 6004101-017-18-01_25 FSN_Redacted [PDF, 189 KB] (opens in new tab) This updated FSN replaces the original FSN published in January 2018 |
05 Oct 2017 | Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/08_58) | HSA 6004101-027-17-08_58 FSN_updated20180413_Redacted [PDF, 3453 KB] (opens in new tab) This updated FSN replaces the original FSN published in October 2017 |