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Field Safety Notices: 1 to 5 July 2024

List of Field Safety Notices from 1 to 5 July 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

View . FSNs before this date are on the

Alcon: Various Ophthalmic Knives and Valved Entry Systems – UPDATED FSN

July 2024

Ophthalmic knife, single-use

Model: Refer to FSN

MHRA reference: 2024/005/003/601/058

bioMérieux: BIOFIRE FILMARRAY Gastrointestinal (GI) PanelÌý

03 July 2024

Multiple gastrointestinal pathogen nucleic acid IVÌýÌý

Model: RFIT-ASY-0116 (GI, 30-pack) ; RFIT-ASY-0104 (GI, 6-pack)Ìý

MHRA reference: ÌýÌýÌý

Boston Scientific: Vercise Genus Implantable Pulse Generator SystemÌý

03 July 2024

Deep brain electrical stimulation systemÌý

Model: DB-1216 and DB-1232

MHRA reference: ÌýÌýÌýÌý

Dedalus: MedChart Ìý

21 June 2024

MHRA reference: Ìý

Gyrus ACMI, Inc. (Olympus Surgical Technologies America): Olympus Everest Bipolar Cutting Forceps

Date: 1st July 2024

Description: Electrode, Electrosurgical, Active, Foot-controlle

Model: EG3005, EG3006-020

MHRA reference: MHRA reference: 2024/006/026/601/050 Ìý

HYPHEN BioMed: PT-Phen LRT

14 June 2024

Prothrombin time (PT) IVD, kit, clottingÌýÌý

MHRA reference: ÌýÌýÌýÌý

Philips: IntelliVue MX400-550 Patient MonitorsÌýÌý

25 June 2024

Model: 866060, 866062, 866064, 866066ÌýÌý

MHRA reference: ÌýÌýÌýÌý

werfen: Panocell-10, Ficin-TreatedÌýÌýÌý

25 June 2024

MHRA reference: ÌýÌýÌýÌý

Zhejiang Innuovo Rehabilitation Devices: Innuovo(Power Wheelchair)

30 April 2024

Model: N5909 Ìý

MHRA reference:

Updates to this page

Published 12 July 2024
Last updated 19 November 2024 Show all updates
  1. Changed to add link to filecamp document for Alcon

  2. Updated to include: Alcon: Various Ophthalmic Knives and Valved Entry Systems

  3. First published.