Field Safety Notices: 27 to 31 January 2025
Source: gov.uk (2025-02-04)

List of Field Safety Notices from 27 to 31 January 2025.

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 (https://mhra-gov.filecamp.com/s/o/mCGQ2bkEUkx5oSz6)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

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

27th January 2025

Sterilization Containers

Model: Refer to FSN

MHRA reference: 34566597 (https://mhra-gov.filecamp.com/s/d/FJDzwRjGNL149eiV) 2025/001/xx-xxxx-xxxx

BioMérieux: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

03 February 2025

Model: RFIT-ASY-0116; RFIT-ASY-0104

MHRA reference: 34596937 (https://mhra-gov.filecamp.com/s/d/tWHM2035OZfAMHw1) 2025/001/xx-xxxx-xxxx

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

December 2024

Model: Refer to FSN

MHRA reference: 34546001 (https://mhra-gov.filecamp.com/s/d/s3JkTlB8Qmde5q7s) 2025/001/xx-xxxx-xxxx

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

22 January 2025

Neonatal/adult intensive-care ventilator

Model: Refer to FSN

MHRA reference: 34593334 (https://mhra-gov.filecamp.com/s/d/tIjymLw5lxKnoV4Y) Customer letter

MHRA reference: 34593334 (https://mhra-gov.filecamp.com/s/d/PRrVu0Fwr7utu82E) - FSN 2025/001/xx-xxxx-xxxx

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

ISIFA2024-09-C

Model: Refer to FSN

MHRA reference: 34586558 (https://mhra-gov.filecamp.com/s/d/5KgqahNPgWua7DdZ)

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

ISIFA2024-10-C

Robotic surgical retractor, Robotic surgical force

Model: Refer to FSN

MHRA reference: 34586518 (https://mhra-gov.filecamp.com/s/d/DEHNH43wtks4MBvE) 2025/001/002/601/004

Leica Biosystems: Leica CM1950, Cryostat Device

January 2025

Rev.1

Cryostat microtome IVD

Serial Numbers: Refer to FSN

MHRA reference: 34555457 (https://mhra-gov.filecamp.com/s/d/OClqjv9HA1LfBYCk) 2025/001/xx-xxxx-xxxx

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

January 2025

Medtronic reference: FA1477

Model: MRASC0002

MHRA reference: 34557945 (https://mhra-gov.filecamp.com/s/d/KG31AXeDfPAgTQMn) - Customer ack form

MHRA reference: 34557945 (https://mhra-gov.filecamp.com/s/d/zKphOc1r7Ptfbfh8) 2025/001/xx-xxxx-xxxx

Medtronic: Pipeline™ Vantage Embolization Device with Shield™ Technology

January 2025

Medtronic Reference: FA1466

Bare-metal intracranial vascular stent

Model: Refer to FSN

MHRA reference: 34594119 (https://mhra-gov.filecamp.com/s/d/XesXbEz7ukWUzmtt) 2025/001/xx-xxxx-xxxx

Merivaara Corporation: MERIVAARA Q-FLOW SURGICAL LIGHT

23.01.2025

Operating room light system

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

MHRA reference: 34567907 (https://mhra-gov.filecamp.com/s/d/qJWjbxVYIyZzJfnp) 2025/001/xx-xxxx-xxxx

MHRA reference: 34567907 (https://mhra-gov.filecamp.com/s/d/glt1HosGP9DuePJo) - Customer reply form

Philips: Allura and Azurion systems

13 January 2025

Interventional Fluoroscopic X-Ray System

Model: Refer to FSN

MHRA reference: 34541725 (https://mhra-gov.filecamp.com/s/d/siq46D0t3d9GqiWC) 2025/001/xx-xxxx-xxxx

Sedana Medical: Sedaconda Syringe 1026022

14 January 2025

Anaesthetic Devices

LOT/BN: Refer to FSN

MHRA reference: 34543790 (https://mhra-gov.filecamp.com/s/d/vWqO0L0qtirK7enr)