Field Safety Notices: 14 to 18 September 2026

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.

Abbott: Amplatzer Amulet Left Atrial Appendage 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)

Intracardiac circulatory assist axial-pump catheter

MHRA reference: 40838299 2026/008/018/601/067

MHRA reference: 40870441 2026/009/021/601/065

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

General-purpose endoscopic needle, single-use

MHRA reference: 40833994 2026/009/016/601/075

GE Healthcare: Signa Artist - Signa Artist Evo

Full-body MRI system, superconducting magnet

MHRA reference: 40820852 2026/009/015/601/082

MHRA reference: 40837295 2026/009/016/601/074

MHRA reference: 40833327 2026/009/017/601/004

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

MHRA reference: 40699134 2026/008/020/601/032

Multiple gastrointestinal pathogen nucleic acid