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
19th 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)
26th 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)
BALT EXTRUSION SAS: FARGO / CRISTAL BALLOON
26th July 2023
Model: FRG6F115_8MP / CBV18X40/110
MHRA reference: 31845020 2023/009/006/601/008
Belmont Medical Technologies: Belmont Rapid Infuser, RI-2 1000 ml/min,750 ml/min
24th February 2024
Infusion pump, high-flow, warming
Model: 903-00037A and 903-00039A
MHRA reference: 31844932 2023/002/023/601/032
Biocomposites Ltd: GeneX DS 2.5cc and GeneX DS 5cc
29th August 2023
MHRA reference: 31855155 2023/008/029/601/019
Biosense Webster: VARIPULSE Bi-Directional Catheter
26th 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
13th September 2023
Single Chamber Implantable Defibrillator
Model: Model A209 - A219
MHRA reference: 31844620 2023/009/013/601/067
Brandon Medical : Quasar eLite
27th February 2023
Operating light & Operating light system
Model: Various
MHRA reference: 31841136 2023/002/028/601/044
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
23rd July 2024
Embolization implant kit
Model: See attachments
MHRA reference: 31831954 2024/009/009/601/020
Exmoor: Exmoor
20th March 2023
Intranasal splint, non-biodegradable
Model: Nasal Splints
MHRA reference: 31845706 2023/003/028/601/038
Fresenius Medical Care: Stay safe Disinfection Cap
25th September 2023
Vascular catheter protective cap
MHRA reference: 31856516 2023/010/002/601/040
GE Healthcare: Centricity PACS System
6th 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
13th 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)
29th 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
8th 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
13th 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
23rd August 2024
MHRA reference: 31815462 2024/008/027/601/014
Lwenstein Medical: LUISA, TIVAN LS, Life One (LM150TD) series
May 2023
MHRA reference: 31846819 2023/009/004/601/013
Masimo: TC-I Reusable Tip Clip Sensor
June 2023
Model: 1895, 2503, and 4053
MHRA reference: 31841425
Medex: Qitexio 20ml Luer Lock Syringe
28th February 2023
General purpose syringe, single-use
MHRA reference: 31846792 2023/009/005/601/044
Medicina: Medicina ENFit enteral, single use & reusable oral
15th June 2022
Model: LHE01LD, LHE25LD, LHE05, OT005, OT01, OT25, OT05, OTH01, OTH25, OTH05
MHRA reference: 31843630 2023/006/022/601/044
Medline: Hudson RCI AQUAPAK Humidifier Adaptors
FSN 23-08
Hudson RCI AQUAPAK Humidifier Adaptors
Model: < Add model (normal style)>
MHRA reference: 31841420 2023/008/031/601/077
Medtronic: Hugo RAS Arm Cart Assembly Hugo RAS Tower
August 2023
MHRA reference: 31841489 2023/008/029/601/068
Merit Medical: MONARCH Inflation
23rd August 2024
MHRA reference: 31814402 2024/009/004/601/031
Nouvag: Control unit Dispenser DP 30
3rd July 2024
Bedside infusion pump, single-channel