Medicines Healthcare Products Regulatory Agency
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
Abbott: Afinion 2
19 May 2023
MHRA reference: 31845652 2023/009/004/601/050
Agfa HealthCare NV: Enterprise Imaging XERO Viewer
September 2024
MHRA reference: 31859890 2024/009/009/601/019
Agilent: Please see comments (section 8)
26 June 2023
MLH2 antigen IVD; MSH6 antigen IVD; PMS2 IVD
Model: GA08561-2, GA08661-2, GA08761-2
MHRA reference: 31848393 2023/007/004/601/015
MHRA reference: 31848393 2023/007/004/601/015 (Acknowledgement)
Biosense Webster: VARIPULSE Bi-Directional Catheter
26 April 2024
Cardiac irreversible electroporation system catheter
MHRA reference: 31867911 2024/005/007/601/069
Boston Scientific: EMBLEM S-ICD and EMBLEM MRI S-ICD
13 September 2023
Single Chamber Implantable Defibrillator
Model: Model A209 - A219
MHRA reference: 31844620 2023/009/013/601/067
CODAN ARGUS: ARGUS 717V
September 2024
General purpose infusion pump
MHRA reference: 31808419 2024/008/026/601/016
MHRA reference: 31808419 2024/008/026/601/016 (Customer reply form)
Emboflu: SQUID / SQUIDPERI
23 July 2024
Embolization implant kit
Model: See attachments
MHRA reference: 31831954 2024/009/009/601/020
GE Healthcare: Centricity PACS System
6 September 2024
Picture archiving and communication system
MHRA reference: 31814656 2024/009/006/601/054
GE HealthCare: Centricity PACS; Centricity Universal Viewer
October 2023
MHRA reference: 31841514 2023/010/002/601/061
Getinge: MAQUET ACROBAT-i Vacuum Stabilizer System
13 September 2023
ACROBAT-i Vacuum Stabilizer System
Model: OM-10000Z
MHRA reference: 31841801 2023/009/019/601/046
Getinge: MEERA operating table (see 8. Comments)
29 August 2024
Universal operating table, electrohydraulic
Model: 720001B0; 720001B2; 720001F0; 720001F2; 710001B0; 710001B2; 700001B0; 700001F0
MHRA reference: 31876559 2024/009/011/601/067 (Customer letter)
MHRA reference: 31876559 2024/009/011/601/067 (Reply form)
Illumina: NextSeq 550Dx / MiSeq Dx / NovaSeq 6000Dx
8 May 2024
Nucleic acid sequence analyser IVD, NGS
MHRA reference: 31814691 2024/005/006/601/079
Implantcast: IFU / OPT: MUTARS RS stems and extension pieces
13 May 2024
Model: 09300015, MURSSTxx, 67300025, 67300125, 67611220, 67611220N, 67622514, 67621512, 67622012, 67622515
MHRA reference: 31831899 2024/005/016/601/010
JRI Orthopaedics Limited: Evolution Rasps
23 August 2024
MHRA reference: 31815462 2024/008/027/601/014
Merit Medical: MONARCH Inflation
23 August 2024
MHRA reference: 31814402 2024/009/004/601/031
Oxylitre Holdings Limited: Standard Pressure Regulators
August 2023
Non-fixed medical gas cylinder regulator
Model: R16 Series
MHRA reference: 31840218 2023/008/031/601/035
Permobil: Smartdrive MX2+with Pushtracker E2/E3
5 May 2023
Wheelchair electric-motor-driven propulsion system
Model: MX2+
MHRA reference: 31845530 2023/005/008/601/045
Philips: Evolution Upgrade 3.0T, Ingenia 1.5T, Ingenia 3.0T
23 August 2024
Magnetic Resonance Imaging (MRI) unit
Model: 781260, 781270, 781358, 781359, 782101, 782103, 782105, 782106, 782107, 782108, 782109, 782110, 782112, 782113, 782115, 782117, 782118, 782119, 782120, 782129, 782133, 782136, 782140, 782143, 782150, 782151
MHRA reference: 31855156 2024/009/002/601/046
Reison Medical: Tube Holder
CC-23-014
Model: 10-611
MHRA reference: 318413742023/009/004/601/022
Siemens Healthcare: Atellica DCA Analyzer and ACR Reagent Kit
March 2023
See general comments - GMDN 56680 and GMDN 62751
MHRA reference: 31842976 2023/003/016/601/002
MHRA reference: 31842976 2023/003/016/601/002 (letter)
Siemens Healthineers: Atellica DCA Analyzer and ACR Reagent Kit
March 2023
See general comments
MHRA reference: 31854788 2023/003/016/601/002
SLE Ltd: SLE6000 Infant Ventilator
24 June 2024
SLE6000 ventilator
Model: SLE6000
MHRA reference: 31844091 2024/006/014/601/058
Smiths Medical: Portex Blue Line Siliconised PVC Tracheotomy Tube
9 September 2024
Tracheostomy tube, non-reinforced, non-customized
Model: See FSN
MHRA reference: 31842702 2024/004/011/601/037
Terumo: Spectra Optia Apheresis System
June 2024
MHRA reference: 31833460 2024/006/006/601/049
Tosoh Europe: AIA-PACK MULTI ANALYTE CONTROL
5 September 2023
MHRA reference: 31842892 2023/009/001/601/029
Vygon: DOLPHIN inflation device
5 September 2023
Catheter-balloon inflator, single-use
MHRA reference: 31859864 2023/009/007/601/049