MHRA Field Safety Notices - February 23-27, 2026
Summary
The MHRA has published a list of five Field Safety Notices (FSNs) issued between February 23-27, 2026, for medical devices. These notices are for informational purposes, and recipients are advised to contact the manufacturer with any questions.
What changed
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a compilation of five Field Safety Notices (FSNs) related to medical devices that were issued between February 23 and February 27, 2026. The notices cover a range of devices including an intracardiac circulatory assist device, an in-vitro diagnostic kit, a medical image management system, a surgical navigation system, and a bath lift. Each FSN includes a unique MHRA reference number and details about the affected product models.
Healthcare providers and manufacturers receiving these FSNs are instructed to act upon them. The MHRA provides these notices for informational purposes only and advises that any specific questions regarding the content or required actions should be directed to the respective manufacturers. While no specific compliance deadline is stated for this informational notice, the overarching instruction is to always act on an FSN received from a manufacturer, implying immediate attention is required upon receipt of an individual FSN.
What to do next
- Review the listed Field Safety Notices for potential impact on devices in use.
- Contact the respective manufacturers for any questions or clarification regarding specific FSNs.
- Ensure internal procedures are in place to act upon all received FSNs.
Source document (simplified)
Field Safety Notices: 23-27 February 2026
List of Field Safety Notices from 23-27 February 2026.
From: Medicines and Healthcare products Regulatory Agency Published 3 March 2026 Message type: Field safety notice Issued: 3 March 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
Abiomed: Automated Impella Controller (AIC)
2025-FSN-000110 Update
Intracardiac circulatory assist axial-pump cath
Model: 0042-0040; 0042-0010; 0042-0000
MHRA reference: 38336479 2025/010/010/601/082
Diagnostica Stago: Br STA - Liatest Free Protein S 2ml and 6ml
27 January 2026
Protein S IVD, kit, nephelometry/turbidimetry
MHRA reference: 38609056 2026/001/023/601/017
GE HealthCare: Centricity Universal Viewer
Ref 85491
Medical Image Management System
MHRA reference: 38668494 2026/002/027/601/103
IMACTIS: CT-Navigation System
Ref 27001
Robot, surgical, navigation unit
MHRA reference: 38594015 2026/002/020/601/102
Mangar: Archimedes bath lift
12 January 2026
MHRA reference: 38425004 2025/012/011/601/066
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Published 3 March 2026 Contents
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