Field Safety Notices
Field Safety Notice - Mar 2019
31 March 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Mar 2019 | Geistlich Bio-Oss Pen, Geistlich Pharma AG (HSA 600:41/01-335/19/02_50) | HSA 6004101-335-19-02_50_FSN_Redacted [PDF, 2649 KB] (opens in new tab) |
27 Mar 2019 | GE Revolution CT with SmartStep Option (HSA 600:41/01-010/19/08_63) | HSA 6004101-010-19-08_63 FSN_Redacted [PDF, 142 KB] (opens in new tab) |
27 Mar 2019 | COBAS P 501 / 701 POST-ANALYTICAL UNITS, Roche Diagnostics GmbH (HSA 600:41/01-016/19/04_78) | HSA 6004101-016-19-04_78 FSN_Redacted [PDF, 6493 KB] (opens in new tab) |
27 Mar 2019 | Cios Spin, Siemens Healthcare GmbH (HSA 600:41/01-022/19/08_76) | HSA 6004101-022-19-08_76 FSN_Redacted [PDF, 218 KB] (opens in new tab) |
27 Mar 2019 | Draeger VentStar Helix Heated breathing circuit & Set2go, Draegerwerk AG & Co. KGaA (HSA 600:41/01-063/19/02_71) | HSA 6004101-063-19-02_71 FSN_Redacted [PDF, 308 KB] (opens in new tab) |
27 Mar 2019 | Performance Series Sagittal Blade, Stryker Instruments (HSA 600:41/01-014/19/02_56) | HSA 6004101-014-19-02_56 FSN_Redacted [PDF, 158 KB] (opens in new tab) |
26 Mar 2019 | Cios Alpha VA30, Siemens Healthcare GmbH (HSA 600:41/01-022/19/07_64) | HSA 6004101-022-19-07_64 FSN_Redacted [PDF, 239 KB] (opens in new tab) |
26 Mar 2019 | Procell II M (used on cobas e 801 module/analytical unit), Roche Diagnostics GmbH (HSA 600:41/01-016/19/03_34) | HSA 6004101-016-19-03_34 FSN [PDF, 490 KB] (opens in new tab) |
26 Mar 2019 | Ethicon ETHIBOND EXCEL Polyester Suture, Size 2-0, Ethicon, Inc / Ethicon LLC (HSA 600:41/01-002/19/05_79) | HSA 6004101-002-19-05_79 FSN_Redacted [PDF, 158 KB] (opens in new tab) |
25 Mar 2019 | SpiderFX Embolic Protection Devices, eV3 Inc. (HSA 600:41/01-046/19/03_74) | HSA 6004101-046-19-03_74 FSN [PDF, 224 KB] (opens in new tab) |
25 Mar 2019 | Giraffe Bedded Warmer & Panda iRes Warmer, Datex-Ohmeda Inc (HSA 600:41/01-010/19/07_35) | HSA 6004101-010-19-07_35 FSN_Redacted [PDF, 260 KB] (opens in new tab) |
25 Mar 2019 | Cordis Vista Brite Tip® & ADROITTM Guiding Catheters, Cordis Corporation (HSA 600:41/01-307/19/01_38) | HSA 6004101-307-19-01_38 FSN_Redacted [PDF, 219 KB] (opens in new tab) |
22 Mar 2019 | BioFire Diagnostics FilmArray Blood Culture Identification (BCID) Panel, BioFire Diagnostics LLC (HSA 600:41/01-146/19/03_78) | HSA 6004101-146-19-03_78 FSN_Redacted [PDF, 716 KB] (opens in new tab) |
22 Mar 2019 | Cryostats Leica CM1950, Leica CM1860/UV, Leica CM1520, Leica CM3050 S, Leica CM1850UV, Leica CM1850, Leica CM1510 S, Leica CM1100, Leica Biosystems Nussloch GmbH (HSA 600:41/01-126/19/01_61) | HSA 6004101-126-19-01_61 FSN_Redacted [PDF, 8911 KB] (opens in new tab) |
22 Mar 2019 | VITROS XT 7600 Integrated System, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/03_75) | HSA 6004101-303-19-03_75 FSN_Redacted [PDF, 156 KB] (opens in new tab) |
22 Mar 2019 | Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters, Edwards Lifesciences LLC (HSA 600:41/01-060/19/03_54) | HSA 6004101-060-19-03_54 FSN_Redacted [PDF, 145 KB] (opens in new tab) |
22 Mar 2019 | Dejimimi 3 in-the-ear hearing aids, Sivantos GmbH (HSA 600:41/01-337/19/01_62) | HSA 6004101-337-19-01_62 FSN Redacted [PDF, 148 KB] (opens in new tab) |
21 Mar 2019 | Connection lead SP (12V) for Infusomat Space, Infusomat Space P and Perfusor Space, B.Braun Melsungen AG (HSA 600:41/01-012/19/02_68) | HSA 6004101-012-19-02_68 FSN_Redacted [PDF, 2640 KB] (opens in new tab) |
20 Mar 2019 | Innova IGS 6 and Innova IGS 630 Systems, GE Medical Systems SCS (HSA 600:41/01-010/19/06_18) | HSA 6004101-010-19-06_18 FSN_Redacted [PDF, 156 KB] (opens in new tab) |
20 Mar 2019 | Carestream Onsight 3D Extremity System, Carestream Health, Inc. (HSA 600:41/01-012/19/02_68) | HSA 6004101-187-19-01_74 FSN_Redacted [PDF, 89 KB] (opens in new tab) |
20 Mar 2019 | NOxBOXi, Bedfont Scientific Ltd. (HSA 600:41/01-199/19/01_18) | HSA 6004101-199-19-01_18 FSN_Redacted [PDF, 167 KB] (opens in new tab) |
20 Mar 2019 | Coviden Endo Grasp™ Auto Suture™ Grasper; Covidien Endo Clinch™ II Auto Suture™ Grasper, Covidien llc (HSA 600:41/01-046/19/02_46) | HSA 6004101-046-19-02_46 FSN_Redacted [PDF, 367 KB] (opens in new tab) |
19 Mar 2019 | 3T Heater-Cooler Devices, LivaNova Deutschland GmbH (HSA 600:41/01-299/19/01_25) | HSA 6004101-299-19-01_25 FSN_Redacted [PDF, 49 KB] (opens in new tab) |
19 Mar 2019 | EV1000 Clinical Platform, Edwards Lifesciences LLC (HSA 600:41/01-060/19/02_43) | HSA 6004101-060-19-02_43 FSN_Redacted [PDF, 218 KB] (opens in new tab) |
19 Mar 2019 | Johnson & Johnson 1-Day Acuvue Define Brand Contact Lenses with Lacreon (etafilcon A), Johnson & Johnson Vision Inc. (HSA 600:41/01-002/19/03_46) | HSA 6004101-002-19-03_46 FSN_Redacted [PDF, 151 KB] (opens in new tab) |
19 Mar 2019 | 1-DAY ACUVUE® MOIST® for Astigmatism, Johnson & Johnson Vision Inc (HSA 600:41/01-002/19/04_50) | HSA 6004101-002-19-04_50 FSN_Redacted [PDF, 206 KB] (opens in new tab) |
18 Mar 2019 | ACUVUE® OASYS for ASTIGMATISM Brand Contact Lenses, Johnson & Johnson Vision Inc (HSA 600:41/01-002/19/02_63) | HSA 6004101-002-19-02_63 FSN_Redacted [PDF, 345 KB] (opens in new tab) |
18 Mar 2019 | ICU Medical ChemoLock Needlefree Closed System Drug Transfer Device, ICU Medical, Inc (HSA 600:41/01-145/19/02_62) | HSA 6004101-145-19-02_62 FSN_Redacted [PDF, 6665 KB] (opens in new tab) |
18 Mar 2019 | syngo.CT Cardiac Function used in Syngo.via VA20A, VA30A, VB10A, and syngo.CT Cardiac Planning used n syngo.via VB20A, VB30A, Siemens Healthcare GmbH (HSA 600:41/01-022/19/06_50) | HSA 6004101-022-19-06_50 FSN_Redacted [PDF, 2471 KB] (opens in new tab) |
18 Mar 2019 | Digital Linear Accelerators of type ARTISTE™, ONCOR™ and PRIMUS™, Siemens Healthcare GmbH (HSA 600:41/01-022/19/05_77) | HSA 6004101-022-19-05_77 FSN_Redacted [PDF, 1440 KB] (opens in new tab) |
18 Mar 2019 | Alinity s System, Abbott GmbH & Co KG (HSA 600:41/01-005/19/10_73) | HSA 6004101-005-19-10_73 FSN [PDF, 340 KB] (opens in new tab) |
15 Mar 2019 | Philips Azurion R2.0, Philips Medical Systems Nederland BV (HSA 600:41/01-026/19/08_48) | HSA 6004101-026-19-08_48 FSN_Redacted [PDF, 844 KB] (opens in new tab) |
14 Mar 2019 | VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products, Johnson & Johnson International, Ethicon LLC (HSA 600:41/01-002/19/01_51) | HSA 6004101-002-19-01_51 FSN_Redacted [PDF, 311 KB] (opens in new tab) |
14 Mar 2019 | Cios Alpha VA20, Siemens Healthcare GmbH (HSA 600:41/01-022/19/04_71) | HSA 6004101-022-19-04_71 FSN_Redacted [PDF, 787 KB] (opens in new tab) |
14 Mar 2019 | Alinity hq Analyser and Alinity hs Slide Maker Stainer Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/08_49) | HSA 6004101-005-19-08_49 FSN [PDF, 160 KB] (opens in new tab) |
14 Mar 2019 | The Infinity Acute Care System (IACS) amd Standalone Infinity M540 Patient Monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/19/01_76) | HSA 6004101-063-19-01_76 FSN_Redacted [PDF, 155 KB] (opens in new tab) |
14 Mar 2019 | LOGIQ P5 MODEL BT06/BT08 AND LOGIQ A5 BT08 SCANNERS, GE Ultrasound Korea, Ltd (HSA 600:41/01-010/19/05_76) | HSA 6004101-010-19-05_76 FSN_Redacted [PDF, 139 KB] (opens in new tab) |
14 Mar 2019 | Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/19/09_73) | HSA 6004101-005-19-09_73 FSN [PDF, 400 KB] (opens in new tab) |
14 Mar 2019 | Thoratec HeartMate 3 Coring Tool, Thoratec Corporation (HSA 600:41/01-070/19/04_54) | HSA 6004101-070-19-04_54 FSN_Redacted [PDF, 105 KB] (opens in new tab) |
12 Mar 2019 | Alinity s System, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/07_34) | HSA 6004101-005-19-07_34 FSN [PDF, 348 KB] (opens in new tab) |
12 Mar 2019 | Pneumosure Heated Tubeset with RTP, High Flow Tubeset with RTP, and High Flow II Tubeset, Stryker Endoscopy (HSA 600:41/01-014/19/01_77) | HSA 6004101-014-19-01_77 FSN_Redacted [PDF, 273 KB] (opens in new tab) |
12 Mar 2019 | Ortho-Clinical VITROS XT 7600 Integrated System, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/02_70) | HSA 6004101-303-19-02_70 FSN_Redacted [PDF, 186 KB] (opens in new tab) |
11 Mar 2019 | 29901 CareLink Encore™ Programmer Power Supply Model 26907, Medtronic Inc (HSA 600:41/01-009/19/04_43) | HSA 6004101-009-19-04_43 FSN_Redacted [PDF, 711 KB] (opens in new tab) |
11 Mar 2019 | Certofix Quattro, B. Braun Melsungen AG (HSA 600:41/01-012/19/01_35) | HSA 6004101-012-19-01_35 FSN_Redacted [PDF, 2111 KB] (opens in new tab) |
8 Mar 2019 | BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel, BioFire Diagnostics LLC (HSA 600:41/01-146/19/02_70) | HSA 6004101-146-19-02_70 FSN_Redacted [PDF, 817 KB] (opens in new tab) |
8 Mar 2019 | Atellica Solution System Software, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/03_31) | HSA 6004101-022-19-03_31 FSN [PDF, 109 KB] (opens in new tab) |
6Mar 2019 | BioRex CRP Cat No. 1450021, Dialine Diagnostic Systems Pte Ltd (HSA 600:41/01-326/19/01_57) | HSA 6004101-326-19-01_57_FSN [PDF, 93 KB] (opens in new tab) |
5 Mar 2019 | Pall Ultipor 25 Breathing System Filter and Pall Breathing System Filter (for Machine End and Medical Gas Equipment Applications), Pall Medical, A Division of Pall International Sarl (HSA 600:41/01-310/19/01_38) | HSA 6004101-310-19-01_38 FSN_Redacted [PDF, 3593 KB] (opens in new tab) |
5 Mar 2019 | R3 Variable Angle Drill Guide, Smith & Nephew Inc (HSA 600:41/01-073/19/05_66) | HSA 6004101-073-19-05_66 FSN [PDF, 74 KB] (opens in new tab) |
5 Mar 2019 | Albumin BCP (for cobas c 701/702 module), Roche Diagnostics GmbH (HSA 600:41/01-016/19/02_49) | HSA 6004101-016-19-02_49 FSN [PDF, 679 KB] (opens in new tab) |
4 Mar 2019 | MultiDiagnost-Eleva, Philips Medical Systems Nederland BV (HSA 600:41/01-026/19/07_79) | HSA 6004101-026-19-07_79 FSN_Redacted [PDF, 390 KB] (opens in new tab) |
3 Mar 2019 | VITROS® 5600 Integrated System, VITROS® 3600 Immunoassay System, VITROS® XT 7600 Integrated System & VITROS® ECI/ECIQ Immunodiagnostic System, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/01_67) | HSA 6004101-303-19-01_67 FSN_Redacted [PDF, 669 KB] (opens in new tab) |
1 Mar 2019 | Alinity c Processing Module, Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/06_23) | HSA 6004101-005-19-06_23 FSN [PDF, 420 KB] (opens in new tab) |
1 Mar 2019 | da Vinci Xi/X Erbe Footswitch, Intuitive Surgical, Inc. (HSA 600:41/01-070/19/03_38) | HSA 6004101-070-19-03_38 FSN [PDF, 225 KB] (opens in new tab) |
15 Nov 2018 | Carescape R860, Datex-Ohmeda, Inc (HSA 600:41/01-010/18/26_46) | HSA 6004101-010-18-26_46 FSN v2_Redacted [PDF, 198 KB] (opens in new tab) This FSN is an update to the original FSN published in Nov 2018. |
24 July 2018 | RAPIDPoint® 405/500 Systems and RAPIDLab® 1245/1265 Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/16_69) | HSA 6004101-022-18-16_69 FSN [PDF, 95 KB] (opens in new tab) This FSN is an update to the original FSN published in July 2018. |
20 Dec 2017 | Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™, MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™), Boston Scientific Corporation (HSA 600:41/01-007/17/14_43) | HSA 6004101-007-17-14_43 FSN Part 3_Redacted [PDF, 274 KB] (opens in new tab) This FSN is an update to the original FSN published in Dec 2017. |