Field Safety Notices: 26 to 30 June 2023

List of Field Safety Notices (FSNs) from 26 to 30 June 2023

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

Acumed: 70.0mm Tension Band Kit

22 June 2023

Model: TB-1570K-S, 30-0095K-S

MHRA reference: 5332199

BD: Magic3 Go/Hydrosil Go Intermittent Silicone Catheter

03 May 2023

Single administration urethral drainage catheter

MHRA reference: 5216505

Boston Scientific: IntellaNav StablePoint Ablation Catheter

24 March 2023

Catheter, Cardiac Ablation

MHRA reference: 5132942

BVI: CryoTreQ

21 March 2023

Ophthalmic cryosurgical system, mechanical

MHRA reference: 5324211

Flexicare: BriteBlade Pro

12 June 2023

Laryngoscope Blade, Single Use

MHRA reference: 5327028

Getinge: Rotaflow II drive (flex); Rotaflow II drive (compact)

21 June 2023

Heart-lung bypass System

Model: 701074622

MHRA reference: 5331928

Hamilton Medical: HAMILTON-C1/HAMILTON-T1/HAMILTON-C2/HAMILTON-C3

22 May 2023

MHRA reference: 5241929 2023/005/025/601/043

Integra: Codman Cranial Access Kit without drugs

22 June 2023

Craniotomy Kit

MHRA reference: 5331908 2023/006/023/601/059

Johnson & Johnson Vision: VERITAS Advanced Infusion & Fluidics Packs

14 June 2023

Ultrasonic Surgical System Tubing set

Model: VRT-AI & VRT-AF

MHRA reference: 5332289 2023/006/012/601/044

LifeVac: LifeVac

28 April 2023

Airway Emergency Clearance/ Suction Plunger

MHRA reference: 5216503 2023/005/003/601/013

Medical Measurement Systems: Flowstar

23 February 2023

physiological monitoring. reusable urine flow meter

Model: U2-1

MHRA reference: 5182895

Optergo: Optical Ergonomic Solutions

12 May 2023

MHRA reference: 5241967

Philips: Ingenia Elition, MR 7700

05 June 2023

Magnetic Resonance Imaging (MRI) unit

Model: 781358, 782107, 782119, 782136, 781357, 782106, 782137, 782118, 782132, 782144, 782120, 782130, 782150, 782151

MHRA reference: 5331930

Philips: Patient Information Center iX

26 April 2023

Model: 866389,866390

MHRA reference: 5326968

Philips: IntelliVue MX40 Patient Monitor

FSCA 2023-CC-HPM-014

Model: 865350, 865351, 867146, 865352

MHRA reference: 5323701

QuidelOrtho: Quidel Triage Cardiac Panel

25 May 2023

MHRA reference: 5338144

Randox: LIQUID URINE CONTROL LEVEL 2

28 June 2023

Multiple urine analyte IVD, control

MHRA reference: 5337733

Siemens Healthineers: ARTIS pheno/icono

June 2023

Stationary angiographic x-ray system, digital

MHRA reference: 5332221

ThermoFisher Scientific: EliA GliadinDP IgG Well

Ref: QA2023-03

Gliadin antibody IVD, kit, fluorescent immunoassay

Model: 14-5539-01

MHRA reference: 5228918

UFSK-International OSYS: UFSK-OSYS

27 April 2023

Treatment Chair

Model: 500 XLE

MHRA reference: 5323076

Vela Diagnostics: Sentosa SQ HIV Genotyping Reagents (4x16)

27 June 2023

HIV1 genotyping IVD, kit, nucleic acid technique

MHRA reference: 5332538

Updates to this page

Published 5 July 2023