Field Safety Notices
Field Safety Notice - Mar 2019
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 March 2019
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
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. |