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Routine Notice Added Final

Field Safety Notices List

MHRA Drug & Device Alerts

Published March 31st, 2026

Detected April 1st, 2026

Summary

MHRA published its weekly list of Field Safety Notices (FSNs) covering 23-27 March 2026, listing 14 medical device safety notices from manufacturers. Devices affected include cochlear implant batteries, MRI systems, intraocular lenses, mammography systems, surgical staplers, ventilators, and X-ray imaging systems from manufacturers including Advanced Bionics, Canon Medical Systems, Philips, Hologic, and Intuitive Surgical. MHRA publishes these FSNs for information only—healthcare providers who receive notices directly from manufacturers must act on them.

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What changed

MHRA published its weekly Field Safety Notices list for 23-27 March 2026, compiling 14 medical device safety notices from manufacturers. Devices covered include cochlear implant batteries (Advanced Bionics), MRI systems (Canon Medical Systems), intraocular lenses (Cristalens), mammography systems (Hologic), surgical staplers (Intuitive Surgical), safety needles (Jiangsu Micsafe Medical Technology), tissue expanders (MENTOR), ventilators and imaging systems (Philips/Philips Respironics), and infant positioning devices (MyWam). MHRA reference numbers are provided for each FSN, with full details available via Filecamp links.

Healthcare providers should monitor for any FSNs received directly from manufacturers and take appropriate action as required. Questions about specific FSNs should be directed to the issuing manufacturer. This is a routine informational publication—MHRA explicitly states it publishes these notices for information only. No specific compliance deadline or penalties are associated with this notice itself.

What to do next

Review any Field Safety Notices received directly from manufacturers
Take appropriate action on received FSNs as required by the manufacturer
Direct questions about specific FSNs to the issuing manufacturer

Source document (simplified)

Field Safety Notices: 23-27 March 2026

List of field Safety Notices for 23-27 March 2026

From: Medicines and Healthcare products Regulatory Agency Published 31 March 2026 Message type: Field safety notice Issued: 31 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 the 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

Advanced Bionics: M Zn Air Battery Pak

23 March 2026

Cochlear implant/auditory brainstem implant batter

MHRA reference: 38958648 2026/003/025/601/149

Canon Medical Systems: Vantage Galan and Vantage Titan

16 March 2026

Full-body MRI system, superconducting magnet

Model: MRT-3020 and MRT-3010

MHRA reference: 38929487 2026/001/030/601/159

Cristalens: Lens, Intraocular Lens

13 March 2026

Model: ARTIS PL E / ARTIS Symbiose

MHRA reference: 38950598 2026/003/025/601/090

Heraeus: PALAMIX uno / PALAMIX duo

20 March 2026

Model: 66057893; 66057897

MHRA reference: 38975280 2026/003/016/601/066

Hologic: 3Dimensions and Selenia® Dimensions

25 March 2026

X-ray System, Diagnostic, Mammographic, Stationary

MHRA reference: 38968793 2026/003/026/601/068

Intuitive Surgical: 8mm SureForm 30 Gray Reload

Ref ISIFA2026-02-R

Surgical staple, non-bioabsorbable

Model: 48230M-05 and 48230M-06

MHRA reference: 38958239 2026/003/025/601/123

Jiangsu Micsafe Medical Technology: Safety Needle

20 March 2026

Model: 25G x 5/8”(0.5 x 16mm)

MHRA reference: 38899973 2026/003/023/601/005

MENTOR: CPX 4 Tissue Expanders

03 March 2026

Skin-port tissue expander

MHRA reference: 38906522 2026/002/025/601/043

MyWam: GRIZZLY

02 February 2026

MHRA reference: 38923982 2026/003/023/601/035

Philips: Vue PACS v12

06 February 2026

MHRA reference: 38906039 2026/003/005/601/059

Philips: Trilogy Evo; Trilogy Evo O2; Trilogy EV300

09 February 2026

Portable Electric Ventilator

MHRA reference: 38927948 2026/002/011/601/010

Philips: Azurion, Allura Xper, Allura Centron, Allura CV20

26 February 2026

Stationary angiographic x-ray system, digital

Model: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722229, 722230, 722231, 722232, 722233, 722234, 722235, 722236, 722280, 722281, 722282, 722400

MHRA reference: 38906391 2026/003/003/601/073