Field Safety Notices: 14 to 18 September 2026
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Type | Field safety notice (devices) |
|---|---|
| Issued | 23 Sept 2026 |
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: Amplatzer Amulet Left Atrial Appendage Occluder
September 2026
Cardiac defect occluder
Model: 9-ACP2-007-016, 9-ACP2-007-018, 9-ACP2-007-020, 9-ACP2-007-022, 9-ACP2-010-025, 9-ACP2-010-028, 9-ACP2-010-031, 9-ACP2-010-034
MHRA reference: 40786527 2026/009/010/601/054
Abiomed: Automated Impella Controller (AIC)
01 August 2026
Intracardiac circulatory assist axial-pump catheter
Model: 0042-0040; 0042-0010; 0042-0000
MHRA reference: 40838299 2026/008/018/601/067
bioMérieux: EMAG
21 September 2026
MHRA reference: 40870441 2026/009/021/601/065
Biomet: Avantage
17 September 2026
Orthopedic Prosthetics Instruments, Reusable - Other
MHRA reference: 40846082 2026/009/017/601/105 Distributor Letter
MHRA reference: 40846082 2026/009/017/601/105 HCP Letter
Cook: Williams Cystoscopic Injection Needle
15 September 2026
General-purpose endoscopic needle, single-use
Model: 090001-S26
MHRA reference: 40833994 2026/009/016/601/075
GE Healthcare: Signa Artist - Signa Artist Evo
Ref 67959
Full-body MRI system, superconducting magnet
MHRA reference: 40820852 2026/009/015/601/082
Hologic: APTIMA DBS EXTRACTION BUFFER
17 July 2026
Model: ASY-12006
MHRA reference: 40837295 2026/009/016/601/074
Intelerad: IntelePACS
09 September 2026
Radiological PACS software
MHRA reference: 40833327 2026/009/017/601/004
Percussionaire: IPV 1
Date17 August 2026
MHRA reference: 40843859 2026/009/017/601/075 Customer Letter
MHRA reference: 40843859 2026/009/017/601/075 Distributor Letter
Philips: Spectral CT 728333 Spectral CT China 728340 Spectral CT 7600 728342 Spectral CT Plus China 728344 Spectral CT Verida 728345 Spectral CT Verida L4L 728346
4 September 2026
Full-body CT system
MHRA reference: 40699134 2026/008/020/601/032
Serosep: EntericBio Viral Panel 3
14 September 2026
Multiple gastrointestinal pathogen nucleic acid
MHRA reference: 40824074 2026/007/003/601/095