mhra
MHRA publishes field safety notices covering medical devices and diagnostics
MHRA’s listing covers cardiac support devices, imaging systems, software and laboratory products, but contains conflicting dates for the reporting period.
What Changed
The Medicines and Healthcare products Regulatory Agency (MHRA) published a listing of manufacturer field safety notices (FSNs) on 10 November 2026. Its title identifies the period as 2–6 November 2026, while the introductory description says 2–6 October 2026, leaving the reporting week uncertain.
The listing spans circulatory support systems, imaging equipment, surgical accessories, software and laboratory products. MHRA states that it publishes these notices for information only.
Who Is Affected
The announcement is relevant to healthcare organisations, clinical teams and laboratories using the named products. Entries include the Abiomed Automated Impella Controller, Datascope Cardiosave Intra-Aortic Balloon Pumps, Hologic 3Dimensions and Selenia Dimensions Systems, and Philips Lumify Diagnostic Ultrasound System.
Software entries include the Dexcom G7 iOS CGM App and Intelerad InteleShare. Laboratory products include INOVA Diagnostics Aptiva CTD Essential Reagent and the Myogenes Clozapine Test. Inclusion in the listing does not, by itself, establish that every unit of a named product is affected in the same way.
Regulatory and Technical Implications
MHRA says recipients must always act on a manufacturer FSN. However, the listing does not describe individual failure modes, patient risks, affected batches or corrective instructions. It therefore does not establish a common stop-use instruction or recall status across the products.
Some entries provide model identifiers that help distinguish products. The Abiomed controller entry names models 0042-0040, 0042-0010 and 0042-0000. The Intuitive Surgical SP Monopolar Curved Scissors Tip Cover entry identifies model 430035-13.
Manufacturer Actions
The announcement does not introduce a new general action timetable for manufacturers. MHRA directs questions about a particular FSN to the relevant manufacturer.
Product-specific action for notice recipients depends on the individual manufacturer notice. MHRA references can help identify the relevant entry: the Dexcom application is listed under reference 41397874 and Intelerad InteleShare under reference 41396114.
Confirmed Dates
The page records a publication date of 10 November 2026 and a separate “Issued” date of 2 November 2026. The disagreement between the months in the title and introductory description remains unresolved.
Individual notice dates extend across different periods. Abiomed is dated 20 October 2026, Intelerad 3 November 2026 and Olympus POLYLOOP 30 September 2026. The Hologic and Philips entries specify only November 2026. These dates do not constitute a shared implementation deadline.
Official Source
MHRA’s GOV.UK announcement is titled “Field Safety Notices from 02 to 06 November2026.”
Https://www.gov.uk/drug-device-alerts/field-safety-notices-from-02-to-06-november2026
Source and related services
Field Safety Notices from 02 to 06 November2026. ↗Source date: 10/11/2026
This news provides general information and does not replace device-specific legal or conformity assessment advice.