Field Safety Notices: 31 July to 4 August 2023

List of field safety notices (FSNs) from medical device manufacturers from 31 July to 4 August 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

Abbott: Trifecta Valve, Trifecta Valve w. Glide Technology

31 July 2023

Aortic Heart Valve Bioprosthesis

Model: TF-19A, TF-21A, TF23A, TF25A, TF-27A, TF-29A, TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, and TFGT-29A

MHRA reference: 5437718

Abbott: HeartMate Touch Communication System

August 2023

Multiple active implantable device programmer

Model: HMT1150

MHRA reference: 5442038

bioMérieux: EBV R-GENE (Ref. 69-002B) - BK Virus R-GENE (Ref. 69-013B)

01 August 2023

MHRA reference: 5437365

Canon: Vantage Galan,Vantage Centurian,Vantage Titan

27 July 2023

Full-body MRI system, superconducting magnet

Model: MRT-3010, MRT-3020

MHRA reference: 5437298

Getinge: APERLAN PY AGENT A, APERLAN PY AGENT B

04 August 2023

Disinfectant, medical device

Model: APERLAN PY AGENT A, APERLAN PY AGENT B

MHRA reference: 6924181

ICU Medical: Volumetric infusion pump & infusion sets

02 August 2023

MHRA reference: 5437735

14 July 2023

Acetabular shell

Model: 183-610/05

MHRA reference: 5395267

Medtronic: Activa Clinician Programmer Application

August 2023

Multiple active implantable device programmer

Model: A610

MHRA reference: 5442065

Siemens Healthineers: Symbia Pro.specta

CAN 001-2023

SPECT/CT Diagnostic Imaging System

Model: 11364752, 11364753

MHRA reference: 5457782

Teleflex: Endotracheal Tubes

May 2023

Basic endotracheal tube, single-use

MHRA reference: 5437203

Updates to this page

Published 7 August 2023