Field Safety Notices: 28 October to 1 November 2024

List of Field Safety Notices from 28 October to 1 November 2024

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

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View . FSNs before this date are on the

Abiomed: Impella heart pump

2 April 2024

Intracardiac Circulatory Assist Axial Pump Cath.

Model: all models of Impella heart pumps

MHRA reference: ÌýÌý 2024/002/025/601/001Ìý

Arjo: IndiGo Intuitive Drive Assistance

September 2024

Accessory for basic electric hospital beds

Model: INDI-XXX

MHRA reference: ÌýÌýÌýÌý 2023/012/013/601/033

Becton, Dickinson and Company: See comments box

6 November 2024

See comments box

MHRA reference: ÌýÌýÌýÌý 2024/010/031/601/058ÌýÌý

Bordier Affinity Products: As described in the FSN-240829UK � Attached

29 August 2024

MHRA reference: ÌýÌý 2024/010/028/601/045Ìý

Cartiva Inc (Stryker): Cartiva Synthetic Cartilage Implant (SCI) 6mm, 8mm

31 October 2024

MHRA reference: 2024/011/015/601/048

Dutch Ophthalmic Research Center (DORC): Silicone Oil

September 2024

Vitreous humour replacement medium, intraoperative

MHRA reference: ÌýÌý 2024/010/015/601/033Ìý

Getinge: Universal Remote Control

21 October 2024

Medical device remote control keypad

Model: 100925A0

MHRA reference: ÌýÌýÌý 2024/010/025/601/079 - Customer letter

MHRA reference: ÌýÌýÌý 2024/010/025/601/079 - Reply formÌýÌý

HYALTECH: Visthesia 1.5%

10 October 2024

Ophthalmic Viscosurgical Devices

MHRA reference: ÌýÌýÌý 2024/010/024/601/003

SIEMENS Healthineers: Atellica CH β2-Microglobulin (B2M)

October 2024

See section 8

MHRA reference: ÌýÌý 2024/010/029/601/126Ìý

Smiths Medical: Tracheal Tube Reusable Introducer and Guides

4 November 2024

Endotracheal tube introducer/guide, reusable

Model: See FSN

MHRA reference: ÌýÌýÌý 2024/010/030/601/028Ìý

TAEWOONG Medical : Niti-S Tracheobronchial Uncovered Stent

14 March 2024

Bare-metal tracheal/bronchial stent, sterile

Model: BRxxxxW

MHRA reference: ÌýÌý 2024/003/014/601/001

Updates to this page

Published 5 November 2024
Last updated 8 May 2025 show all updates
  1. Added 'ARTIVA Inc: Cartiva Synthetic Cartilage Implant (SCI) 6mm, 8mm'

  2. First published.