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 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
LINK: MobileLink Acetabular Cup System
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