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Field Safety Notices: 1 to 5 July 2024

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TypeField safety notice (devices)
Issued9 Jul 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 the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

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

July 2024

Ophthalmic knife, single-use

Model: Refer to FSN

MHRA reference: 33964968 2024/005/003/601/058

bioMérieux: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel 

03 July 2024

Multiple gastrointestinal pathogen nucleic acid IV  

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

MHRA reference: 31017681   

Boston Scientific: Vercise Genus Implantable Pulse Generator System 

03 July 2024

Deep brain electrical stimulation system 

Model: DB-1216 and DB-1232

MHRA reference: 31048718    

Dedalus: MedChart  

21 June 2024

MHRA reference: 31050696 

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: 36849501 2024/006/026/601/050  

HYPHEN BioMed: PT-Phen LRT

14 June 2024

Prothrombin time (PT) IVD, kit, clotting  

MHRA reference: 31101702    

Philips: IntelliVue MX400-550 Patient Monitors  

25 June 2024

Model: 866060, 866062, 866064, 866066  

MHRA reference: 31038119    

werfen: Panocell-10, Ficin-Treated   

25 June 2024

MHRA reference: 31005189    

Zhejiang Innuovo Rehabilitation Devices: Innuovo(Power Wheelchair)

30 April 2024

Model: N5909  

MHRA reference: 30963270

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