Field Safety Notices
Field Safety Notice - Jul 2018
31 July 2018
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 July 2018 | Zimmer® Natural Nail™ System Tibial Nail - Yellow 8.3mm, Zimmer Inc. (HSA 600:41/01-008/18/12_50) | HSA 6004101-008-18-12_50 FSN_Redacted [PDF, 283 KB] (opens in new tab) |
31 July 2018 | Panocell-10, Immucor Inc (HSA 600:41/01-033/18/03_70) | HSA 6004101-033-18-03_70 FSN_Redacted [PDF, 47 KB] (opens in new tab) |
31 July 2018 | IH-QC 5, DiaMed GmbH (HSA 600:41/01-02718/10_57) | HSA 6004101-027-18-10_57_FSN_Redacted [PDF, 459 KB] (opens in new tab) |
30 July 2018 | Abbott ARCHITECT EBV Assay Panel, Abbott GmbH & Co. KG (HSA:600:41/01-005/18/10_69) | HSA 6004101-005-18-10_69 FSN [PDF, 100 KB] (opens in new tab) |
27 July 2018 | Proteus 235, Ion Beam Applications S. A. (HSA 600:41/01-070/18/15_77) | HSA 6004101-070-18-15_77 FSN_Redacted [PDF, 1000 KB] (opens in new tab) |
27 July 2018 | Durex Real Feel Condom, Reckitt Benckiser Healthcare (UK) Ltd (HSA 600:41/01-327/18/01_37) | HSA 6004101-327-18-01_37 FSN_Redacted [PDF, 554 KB] (opens in new tab) |
27 July 2018 | Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit, MAKO Surgical Corp (Stryker) (HSA 600:41/01-070/18/16_18) | HSA 6004101-070-18-16_18 FSN_Redacted [PDF, 185 KB] (opens in new tab) |
27 July 2018 | Artis Q and Artis Pheno Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/18/18_45) | HSA 6004101-022-18-18_45 FSN_Redacted [PDF, 1075 KB] (opens in new tab) |
26 July 2018 | ADVIA Centaur CKMB Calibrator and Master Curve Material (MCM) , and Atellica IM CKMB Calibrator and Master Curve Material (MCM), Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/17_57) | HSA 6004101-022-18-17_57_FSN [PDF, 207 KB] (opens in new tab) |
25 July 2018 | Samsung Digital X-ray System GC80, GC85A, GC70, Samsung Electronics Co Limited (HSA 600:41/01-087/18/01_74) | HSA 6004101-087-18-01_74 FSN_Redacted [PDF, 364 KB] (opens in new tab) |
24 July 2018 | 1 Day ACUVUE® MOIST, Johnson & Johnson Vision Care Inc (HSA 600:41/01-002/18/07_63) | HSA 6004101-002-18-07_63 FSN_Redacted [PDF, 367 KB] (opens in new tab) |
24 July 2018 | Orthopat Reservoirs, Haemonetics Corporation (HSA 600:41/01-070/18/14_38) | HSA 6004101-070-18-14_38 FSN_Redacted [PDF, 523 KB] (opens in new tab) |
23 July 2018 | Gentle Thread PLGA Round Head, 7x20mm and Gentle Thread PLGA Full Thread, 10x30mm, Biomet Orthopaedics (HSA 600:41/01-008/18/11_51) | HSA 6004101-008-18-11_51 FSN_Redacted [PDF, 569 KB] (opens in new tab) |
23 July 2018 | RAPIDPoint® 405/500 Systems and RAPIDLab® 1245/1265 Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-005/18/16_69) | HSA 6004101-022-18-16_69 FSN [PDF, 99 KB] (opens in new tab) |
20 July 2018 | IH-COM FULLVERSION AND IH-COM FOR READER, DiaMed GmbH (HSA 600:41/01-005/18/09_67) | HSA 6004101-027-18-09_67 FSN_Redacted [PDF, 2790 KB] (opens in new tab) |
20 July 2018 | Architect Creatinine Kinase, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/09_61) | HSA 6004101-005-18-09_61 FSN_Redacted [PDF, 320 KB] (opens in new tab) |
19 July 2018 | STA - Néoplastine CI 10 and STA - Néoplastine CI Plus 10, Diagnostica Stago (HSA 600:41/01-137/18/01_59) | HSA 6004101-137-18-01_59 FSN [PDF, 42 KB] (opens in new tab) |
19 July 2018 | ARCHITECT c4000 Processing Module (02P24), ARCHITECT c8000 Processing Module (01G06), ARCHITECT c16000 Processing Module (03L77), Abbott Laboratories (HSA 600:41/01-005/18/08_34) | HSA 6004101-005-18-08_34 FSN [PDF, 370 KB] (opens in new tab) |
18 July 2018 | Philips SureSigns Patient Monitors, VS3 System,VS4 Vital Signs Monitor, and VSV Vital Signs Viewer, Philips Medical Systems (HSA 600:41/01-026/18/21_54) | HSA 6004101-026-18-21_54 FSN_Redacted [PDF, 357 KB] (opens in new tab) |
18 July 2018 | VITROS Chemistry Products Cl-Slides and CREA Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/09_31) | HSA 6004101-303-18-09_31_FSN_Redacted [PDF, 25345 KB] (opens in new tab) |
17 July 2018 | da Vinci Si, Xi and X Surgeon Consoles and da Vinci Si Patient Side Carts, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/13_52) | HSA 6004101-070-18-13_52 FSN_Redacted [PDF, 1392 KB] (opens in new tab) |
17 July 2018 | EZ1 Advanced XL instrument, QIAGEN GmbH (HSA 600:41/01-179/18/01_49) | HSA 6004101-179-18-01_49 FSN_Redacted [PDF, 255 KB] (opens in new tab) |
17 July 2018 | Ortho VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2; Ortho-Clinical ECI Immunodiagnostics Products PSA Reagent Pack/Calibrator; Ortho VITROS Immunodiagnostic Products FSH Reagent Pack; Ortho VITROS Immunodiagnostic Products Prolactin Reagent Pack; Ortho-Clinical VITROS Immunodiagnostic Products TSH Reagent Pack, Ortho Clinical Diagnostics (HSA 600:41/01-303/18/08_75) | HSA 6004101-303-18-08_75 FSN (revised)_Redacted [PDF, 6646 KB] (opens in new tab) |
17 July 2018 | CFX96 Optical Reaction Modules, Life Science Group. Bio-Rad Laboratories, Inc. (HSA 600:41/01-027/18/08_73) | HSA 6004101-027-18-08_73 FSN_Redacted [PDF, 468 KB] (opens in new tab) |
16 July 2018 | Teleflex LMA Unique™, Teleflex Medical (HSA 600:41/01-139/18/03_63) | HSA 6004101-139-18-03_63_FSN_Redacted [PDF, 592 KB] (opens in new tab) |
16 July 2018 | PEG Fully Threaded, Locking 2.5mm x 10mm, Biomet Orthopaedics (HSA 600:41/01-008/18/10_64) | HSA 6004101-008-18-10_64_FSN_Redacted [PDF, 386 KB] (opens in new tab) |
12 July 2018 | Thermo Scientific™ Remel™ Agglutinating Sera Shigella boydii Polyvalent 2 (7 to 11), Remel Europe Ltd (Thermo Fisher Scientific)(HSA 600:41/01-178/18/05_70) | HSA 6004101-178-18-05_70 FSN_Redacted [PDF, 254 KB] (opens in new tab) |
11 July 2018 | Perifix Catheter Connectors, B.Braun Melsungen AG(HSA 600:41/01-012/18/05_51) | HSA 6004101-012-18-05_51 FSN_Redacted [PDF, 1776 KB] (opens in new tab) |
11 July 2018 | JELONET 15CM X 2M CTN 12 (JOAR), Smith & Nephew Medical Limited (HSA 600:41/01-073/18/16_35) | HSA 6004101-073-18-16_35 FSN [PDF, 56 KB] (opens in new tab) |
9 July 2018 | Alinity s System, Abbott GmbH & Co. Kg (HSA 600:41/01-005/18/07_67) | HSA 6004101-005-18-07_67 FSN [PDF, 103 KB] (opens in new tab) |
6 July 2018 | Sorin Group Italia Perceval S Sutureless Heart Valve, Sorin Group Italia S.r.l. (HSA 600:41/01-299/18/01_50) | HSA 6004101-299-18-01_50 FSN_Redacted [PDF, 1072 KB] (opens in new tab) |
5July 2018 | MAYFIELD® Infinity XR2 Radiolucent Base Unit (A2079), Standard; MAYFIELD® Infinity XR2 Low Profile Base Unit (A2079A); MAYFIELD® Infinity XR2 Radiolucent Base Unit, Extended (A2079E) and MAYFIELD® Spine Table Adaptor (A2600R), Integra LifeSciences Corporation (HSA 600:41/01-070/18/12_44) | HSA 6004101-070-18-12_44 FSN_Redacted [PDF, 1392 KB] (opens in new tab) |
4 July 2018 | Atellica Solution System Software V1.13 and Lower, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/15_67) | HSA 6004101-022-18-15_67 FSN [PDF, 134 KB] (opens in new tab) |
3 July 2018 | Guardian™ Connect Mobile App, Medtronic MiniMed (HSA 600:41/01-009/18/11_35) | HSA 6004101-009-18-11_35 FSN_Redacted [PDF, 842 KB] (opens in new tab) |
3 July 2018 | Alinity hq Analyzer, Abbott (HSA 600:41/01-005/18/06_59) | HSA 6004101-005-18-06_59 FSN_Redacted [PDF, 113 KB] (opens in new tab) |
3 July 2018 | GE Healthcare MRI system: 1.5T Signa HDx, 3.0T Signa HDx, GE Medical Systems LLC (HSA 600:41/01-010/18/16_18) | HSA 6004101-010-18-16_18 FSN_Redacted [PDF, 604 KB] (opens in new tab) |
3 July 2018 | ARIES hand held Barcode Scanner, Luminex Corporation (HSA 600:41/01-148/18/01_61) | HSA 6004101-148-18-01_61 FSN_Redacted [PDF, 183 KB] (opens in new tab) |
3 July 2018 | Ring Transjugular Intrahepatic Access Set, Cook Incorporated (HSA 600:41/01-013/18/06_37) | HSA 6004101-013-18-06_37 FSN_Redacted [PDF, 110 KB] (opens in new tab) |
3 July 2018 | Chorion Villus Sampling Needle Sets, William A. Cook Australia Pty. Ltd (HSA 600:41/01-013/18/05_38) | HSA 6004101-013-18-05_38 FSN_Redacted [PDF, 1061 KB] (opens in new tab) |
3 July 2018 | CADD®-Solis VIP Infusion Pumps, Smiths Medical ASD, Inc. (HSA 600:41/01-017/18/03_52) | HSA 6004101-017-18-03_52 FSN_Redacted [PDF, 875 KB] (opens in new tab) |
2 July 2018 | BACT/ALERT® VIRTUO® A, B, & A Unit China, BioMerieux Inc (HSA 600:41/01-146/18/05_34) | HSA 6004101-146-18-05_34 FSN_Redacted [PDF, 266 KB] (opens in new tab) |
2 July 2018 | Proteus 235 – Proton Therapy System , Ion Beam Applications S.A. (HSA 600:41/01-070/18/11_56) | HSA 6004101-070-18-11_56 FSN_Redacted [PDF, 940 KB] (opens in new tab) |
2 July 2018 | M350 OHX, M525 F50 and M525 F40 Microscope Systems, Leica Microsystems (Schweiz) AG(HSA 600:41/01-126/18/03_66) | HSA 6004101-126-18-03_66 FSN_Redacted [PDF, 2835 KB] (opens in new tab) |
2 July 2018 | Wingspan Stent System, Stryker Neurovascular (HSA 600:41/01-070/18/10_45) | HSA 6004101-070-18-10_45 FSN [PDF, 72 KB] (opens in new tab) |
2 July 2018 | Fujifilm 500 Series Duodenoscopes, Fujifilm Corporation (HSA 600:41/01-173/18/01_54) | HSA 6004101-173-18-01_54 FSN_Redacted [PDF, 1238 KB] (opens in new tab) |
6 June 2018 | CORAIL® AMT Neck Trials Surgical Instruments, Depuy (Ireland) (HSA 600:41/01-002/18/06_38) | HSA 6004101-002-18-06_38 FSN (v2)_Redacted [PDF, 1462 KB] (opens in new tab) This FSN is an update to the original FSN published in June 2018. |
30 Apr 2018 | MagNA Pure 24 System, Roche Diagnostics GmbH (HSA 600:41/01-016/18/05_67) | HSA 6004101-016-18-05_67 FSN_ Update [PDF, 340 KB] (opens in new tab) This FSN is an update to the original FSN published in Apr 2018. |
21 Dec 2017 | Hematoxylin II and Horseradish Peroxidase Reagents (Refer FSN for affected Kits' name), Ventana Medical Systems, Inc. (HSA 600:41/01-016/17/20_38) | HSA 6004101-016-17-20_38 FSNv [PDF, 423 KB] (opens in new tab) This FSN is an update to the original FSN published in Dec 2017. |
24 Nov 2016 | IMMULITE/ IMMULITE 1000 PSA / IMMULITE 2000/ IMMULITE 2000 XPi PSA, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/53_24) | HSA 6004101-022-16-53_24 FSN [PDF, 93 KB] (opens in new tab) This updated FSN replaces the original FSN published in Nov 2016. |