Field Safety Notices: 27 to 31 January 2025

Imported from official source

Alert

Safety Classified by Officially

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.

B. Braun: Sterile Container System, AESCULAP Aicon® Sterile Container System

MHRA reference: 34566597   2025/001/028/601/005

BioMérieux: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

MHRA reference: 34596937   2025/001/030/601/064

Draeger: Infinity Central Station (MS26800) VG3.0 or lower and Edifier speakers (MS34036)

MHRA reference: 34546001   2025/001/024/601/026

Hamilton Medical: Hamilton Medical Ventilators HAMILTON- C2/C3 with Neonatal Option

Neonatal/adult intensive-care ventilator

MHRA reference: 34593334   Customer letter

MHRA reference: 34593334 - FSN   2025/001/031/601/009

Intersurgical: Anaesthesia breathing circuits, reusable

Various Uniflow Coaxial Breathing Systems

MHRA reference:  40199888 2026/007/014/601/090

Intuitive Surgical SAS: Grip Cable Failures on da Vinci X and Xi Reusable Instruments with Jaws

Intuitive Surgical SAS: Pitch Cable Failures on da Vinci X and Xi Tenaculum Forceps and Small Graptor

Robotic surgical retractor, Robotic surgical force

MHRA reference: 34586518   2025/001/002/601/004

Leica Biosystems: Leica CM1950, Cryostat Device

MHRA reference: 34555457   2025/001/027/601/067

Maquet Cardiovascular : Acrobat Product Family

Medtronic: HugoTM Robotic-Assisted Surgery (RAS) Arm Cart Assembly

MHRA reference: 34557945   - Customer ack form

MHRA reference: 34557945   2025/001/027/601/065

Medtronic: Pipeline™ Vantage Embolization Device with Shield™ Technology

MHRA reference: 34594119   2025/001/030/601/020

Merivaara Corporation: MERIVAARA Q-FLOW SURGICAL LIGHT

Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, Q-FLOW MOBILE 

MHRA reference: 34567907   2025/001/028/601/036

MHRA reference: 34567907   - Customer reply form

Interventional Fluoroscopic X-Ray System

MHRA reference: 34541725   2025/001/024/601/053

This is an extract. The publication continues at the source.

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Read the original at the source: https://www.gov.uk/drug-device-alerts/field-safety-notices-27-to-31-january-2025

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October 16, 2026 15:01
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