Field Safety Notices: 19 to 23 August 2024
List of Field Safety Notices from 19 to 23 August 2024.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Getinge: Custom Tubing Set - See Annex I
15 August 2024
Tubing set, heart-lung bypass
Model: See Annex I
MHRA reference: 31543898 2024/008/019/601/004
Fisher & Paykel Healthcare: Airvo 3 NIV
August 2024
Professional high-flow respiratory unit, humidify
Model: PT311XX
First manufacturing date: 17 March 2021; Last manufacturing date: 14 March 2024
Software version: 1.5.1 or earlier
MHRA reference: 31529707 2024/008/015/601/035
ThermoFisher Scientific: Cholesterol
05.06.2024
Total cholesterol lipid IVD, kit, enzyme spectroph
Catalog Number: 981813
Lot Number: WB28, WA26
MHRA reference: 31554738 – Letter 2024/006/006/601/020
MHRA reference: 31554738 – Distributor response form
MHRA reference: 31554738 – Response form
Siemens: Atellica IM and ADVIA Centaur Erythropoietin (EPO)
25 January 2024
Model: Refer to FSN
MHRA reference: 31566323 2024/001/025/601/052
MHRA reference: 31566323 – Response letter
Siemens: Sensis, Sensis Vibe Hemo, Sensis Vibe Combo
November 2022
Cardiac catheterization laboratory computer
Serial number: Sensis/Sensis Vibe systems with software version VD12A
MHRA reference: 31566604 2023/010/027/601/011
Siemens: Cios Alpha VA30, Cios Spin VA30, Cios Flow VA30
September 2023
Portable general-purpose fluoroscopic x-ray system
Serial number: Cios systems with software version VA30A
MHRA reference: 31566552 2023/009/012/601/061
Medtronic: Vanta™ Implantable Neurostimulator (INS)
August 2024
Vanta with AdaptiveStim Technology
Model: 977006
MHRA reference: 31566524 2024/008/020/601/021
Medtronic: McGrath MAC Video Laryngoscope
July 2024
VIDEO LARYNGOSCOPES
Model: 300-000-000, 301-000-000
MHRA reference: 31554799 – Letter 2024/007/024/601/087
MHRA reference: 31554799 – Customer Acknowledgement form
Drive DeVilbiss Healthcare Ltd: SAMSOFT 175 and Mini SAMSOFT 150
06 August 2024
Samsoft
Model: SAMSOFT 175 (SN < 90760371) and any serial No. starting with the letter D and Mini SAMSOFT 150 (SN < 90760431)
MHRA reference: 31566414 2024/008/020/601/060
Siemens: Atellica CI, Atellica IM and ADVIA Centaur CA 19-9
July 2024
Model: Refer to FSN
MHRA reference: 31560996 2024/007/031/601/074
MHRA reference: 31560996 – Customer letter
Siemens: Atellica CH Analyzer, Atellica CI Analyzer
13 March 2024
Atellica CH Iron3 - Iron IVD, kit, spectrophotometry
Model: Refer to FSN
MHRA reference: 31565659 2024/003/018/601/016
MHRA reference: 31565659 – Customer letter
Medtronic: NIM Contact™ and NIM™ Standard EMG Reinforced Endotracheal Tubes
July 2024
EMG TUBE REINFORCED
Model: Refer to FSN
MHRA reference: 31563916 2022/005/017/613/002
Abbott: Alinity m System
19 March 2024
List Numbers: 08N53-002
MHRA reference: 31562491 2024/003/021/601/058
Siemens: IMMULITE 2000 Analyzer and IMMULITE 2000 XPi Analyzer
April 2024
Thyroglobulin antibody IVD, kit, chemiluminescent
Model: Refer to FSN
MHRA reference: 31562470 2024/004/026/601/067
Medtronic: NIM Vital™ Nerve Monitoring System
June 2024
Nerve-locating system
Model: NIM4CM01: NIM Vital™ Console NIM4CPB1: NIM Vital™ Patient Interface 4 Channel
MHRA reference: 31562099 2024/006/028/601/021
Medtronic: Ascenda™ Intrathecal catheters
May 2024
Design update to Ascenda™ Intrathecal catheters
Model: 8780, 8781, and 8784
MHRA reference: 31561682 2024/005/013/601/004
Siemens: ACUSON Juniper and ACUSON Maple Ultrasound systems
07 August 2024
General-purpose ultrasound imaging system
Model: 11335791
MHRA reference: 31561592 2024/008/020/601/024
Boston Scientific: ISLEEVE™ Expandable Introducer Set
20 February 2024
Vascular Catheter Introduction Set
Model: H74939349140
MHRA reference: 31560930 2024/002/020/601/033
Leonhard Lang GmbH: GS Corpuls defibrillation electrodes
08 July 2024
Defibrillation electrodes
Model: REF 04324.3 corPatch easy; REF 05120.1 corPatch easy pre-connected; REF 05120.3 corPatch easy pedriatic
MHRA reference: 31554930 2024/007/017/601/031
Siemens: Atellica® UAS 800 Urine Sediment Analyzer, Atellica® 1500 Automated Urinalysis System
January 2024
Urine analyser IVD, laboratory, automated
Model: All versions up to and including v4.0.400
MHRA reference: 31554888 2024/001/031/601/043
MHRA reference: 31554888 – Customer letter
Medtronic: StealthStation™ S8 App
April 2024
Stereotactic surgery system, multi-purpose
Model: 9735762
Version number: 1.0.1, 1.0.2, 1.0.3, 1.1.0 and 1.2.0.
MHRA reference: 31554817 2024/004/017/601/022
Abbott: Alinity hq Analyzer
14 June 2024
Haematological cell analyser IVD, automated
Model: 09P68-01
Software version 5.6 and below
MHRA reference: 31564847 2024/006/018/601/023
Alcon: DAILIES TOTAL1®, TOTAL30®
15 August 2024
Soft contact lens
Model: Attachment 1
MHRA reference: 31583112 2024/008/012/601/038
MHRA reference: 31583112 – Customer letter
Siemens: ADVIA® 1800, ADVIA® 2400 and ADVIA® Chemistry XPT Systems
August 2024
Microalbumin IVD, kit, nephelometry/turbidimetry
Model: Refer to FSN
MHRA reference: 31584267 2024/008/021/601/054
MHRA reference: 31584267 – Customer letter
Change Healthcare Canada Company: Change Healthcare Cardiology Hemo & Hemodynamics
August 2024
Cardiac Catheterization laboratory computer
Model: 13.0.3,13.1.2,13.1.2 HF1,13.2,14.1.1,14.2,14.3.2,15.0.1
MHRA reference: 31589755 2024/008/021/601/148
Siemens: Atellica® CH and Atellica® CI Analyzers
August 2024
Microalbumin IVD, kit, nephelometry/turbidimetry
Model: Refer to FSN
MHRA reference: 31584413 2024/008/021/601/054
MHRA reference: 31584413 – Customer letter
Mindray: BeneHeart C Series Automated External Defibrillator
14 June 2024
Automated External Defibrillator
Model: Refer to Appendix 1
MHRA reference: 31596514 2024/006/011/601/028