MHRA publishes Field Safety Notices for 14 to 18 September 2026
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The UK MHRA has listed medical device Field Safety Notices issued between 14 and 18 September 2026. The excerpt does not identify the specific devices involved.
The MHRA has published its weekly list of field safety notices (FSNs) for 14 to 18 September 2026. The list was published on 23 September 2026. An FSN is a notice a manufacturer sends to the people who use its medical devices. The MHRA says it publishes the list "for information only". The source does not say what the problem is with any device, and it does not say whether any patient was harmed.
The list names these manufacturers and products. Abbott: Amplatzer Amulet Left Atrial Appendage Occluder (September 2026; models 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). Abiomed: Automated Impella Controller (AIC) (01 August 2026; models 0042-0040, 0042-0010, 0042-0000). bioMérieux: EMAG (21 September 2026). Biomet: Avantage (17 September 2026). Cook: Williams Cystoscopic Injection Needle (15 September 2026; model 090001-S26). GE Healthcare: Signa Artist and Signa Artist Evo (Ref 67959). Hologic: APTIMA DBS EXTRACTION BUFFER (17 July 2026; model ASY-12006). Intelerad: IntelePACS (09 September 2026).
The list also names: Percussionaire: IPV 1 (17 August 2026). Philips: Spectral CT 728333, Spectral CT China 728340, Spectral CT 7600 728342, Spectral CT Plus China 728344, Spectral CT Verida 728345 and Spectral CT Verida L4L 728346 (4 September 2026). Serosep: EntericBio Viral Panel 3 (14 September 2026). The source gives an MHRA reference for each entry. It does not say where the devices were sold. It does not give a consumer action such as a return or refund.
What you can do: The source says that anyone who receives an FSN from a manufacturer must always act on it. If you have a question about a particular FSN, the source says to contact the manufacturer. If you feel unwell, contact your doctor or NHS 111.
What you can doAI-generated
- ✓Talk to your doctor if you use an Abbott Amplatzer Amulet Left Atrial Appendage Occluder device. The MHRA issued a field safety notice for multiple models between 9-ACP2-007-016 and 9-ACP2-010-034 in September 2026. Your doctor has the details about what the problem is and whether you need follow-up care.
- ✓Ask your GP or hospital which specific Philips Spectral CT scanner model was used for your recent scan. The MHRA listed six Spectral CT models with field safety notices issued on 4 September 2026. They need to tell you if your imaging was affected.
- ✓Check the MHRA website for the full field safety notice details on any device you use. The weekly list names the manufacturer, device, and model but not the actual safety issue. The complete notice explains what went wrong and what action you should take.
- ✓Read the paperwork that came with any Abiomed Impella Controller if you have one implanted. Three models of the Automated Impella Controller were flagged on 1 August 2026. You need to know what the manufacturer says about your specific device and model number.
Always consult a healthcare professional for personal medical advice.
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