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
Miltenyi Biotec B.V. & Co. KG: LIFE 21 apheresis unit
30.08.2024
Apheresis System
330-000-621, 330-000-622
MHRA reference: 31738772 2024/008/030/601/071
JRI Orthopaedics Ltd: AVANTEON Stem Inserter
24 July 2024
Orthopaedic implant inserter/extractor, reusable
Catalogue: 007006
LOT: 106255
MHRA reference: 31738843 2024/007/019/601/020
Waldemar Link GmbH: Universal Handle, Stainless Steel, straight
02.09.2024
Surgical instrument handle, non-torque-limiting
Model: 130-394/01
MHRA reference: 31750110 2024/009/002/601/071
MHRA reference: 31750110 - Reply form
Fresenius Medical Care: multiFiltratePRO Machine
19.08.2024
Mandatory Software Update
Haemodialysis system, institutional/home-use
Model: M205001
Software version: Software versions 6.02 and 5.02
MHRA reference: 31755107 2024/005/020/601/024
GE Healthcare: Centricity High Acuity Anesthesia
03.09.2024
Patient health record information system
Model: Software version 5.8 and above
MHRA reference: 31754166 2024/006/028/601/045
Becton Dickinson: Guidewire 70cm x 1mm (0.038)
02 August 2024
Cardiac/peripheral vascular guidewire, single-use
Model: Refer to FSN
MHRA reference: 31752646 2024/007/030/601/057
Stryker: iBur Distal Bend Cutting Accessories
July 2024
Precision Round, Distal Bend
Model: Appendix A in the attached Field Safety Notice
MHRA reference: 31762188 2024/007/031/601/083
Smiths Medical: CADD Medication Cassette Reservoir
05 September 2024
Model: Refer to FSN
MHRA reference: 31747982 2024/009/002/601/020
Schiller Medical: DEFIGARD Touch7 monitor and defibrillator
June 2024
Monitor Defibrillator
Model: All DEFIGARD Touch7 devices
MHRA reference: 31740373 2024/006/028/601/011
Olympus: High Flow Insufflation Unit
21st March 2023
Laparoscopic insufflators
Model: UHI-4
MHRA reference: 31672021 2024/003/018/601/076
JRI Orthopaedics Ltd: Furlong Evolution Trial Necks
29 May 2024
Femoral Stem Prosthesis Trial
Model: Refer to FSN
MHRA reference: 31779920 2024/005/028/601/065
GE Healthcare: Aisys CS2 , Avance CS2 , Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900, and Aespire 7100 anesthesia devices equipped with the Auxiliary Common Gas Outlet (ACGO)
30 August 2024
Anaesthesia system
Model: Refer to FSN
MHRA reference: 31779707 2024/008/002/601/040
Intersurgical Ltd: IPPB Flextube breathing system
04.09.2024
Ventilator breathing circuit, single-use
Model: 1415000, 1415002, 1416000
MHRA reference: 31775757 2024/009/004/601/080
Hologic, Inc.: Selenia Dimensions / 3Dimensions
26 August 2024
X-ray system, Diagnostic, Mammographic, Stationary
Model: Refer to FSN
MHRA reference: 31765694
Bohus BioTech AB: Minivisc Plus
29 August 2024
Eye Lubricant
Model: MPFX16100 and MPFX17100
MHRA reference: 31738826 2024/008/030/601/022
Agfa NV: DR 800
06.08.2024
Digital Radiography X-ray System DR 800
Model: 6010/200
MHRA reference: 31732211 - Completion date: (15 October 2024)
Agfa NV: DR 800
06.08.2024
Digital Radiography X-ray System DR 800
Model: 6010/200
MHRA reference: 31732211 - Completion date: (15 April 2025)
Randox Laboratories Ltd: Randox HbA1c Calibrator Set
04th September 2024
Glycated Haemoglobin (HbA1c) IVD, calibrator
Model: 623672, 637478
MHRA reference: 31795803
Kinova Inc.: Kinova Jaco assistive robotic arm
26.08.2024
Assistive dynamic arm support system
Model: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001
MHRA reference: 31801360 2024/008/012/601/041
Becton Dickinson: BD FACSDuet Sample Preparation Systems
13 August 2024
AUTOSAMPLERS
Model: Refer to FSN
MHRA reference: 31795715 2024/008/007/601/066
Boston Scientific: AVVIGO+ Multi-Modality Guidance System
05 September 2024
Ultrasound System, Imaging, Cardiovascular
Model: Refer to FSN
MHRA reference: 31795673 2024/009/005/601/077