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
-
Changed to add link to filecamp document for Alcon
-
Updated to include: Alcon: Various Ophthalmic Knives and Valved Entry Systems
-
First published.