Field Safety Notices: 29 November to 3 December 2021

List of field safety notices (FSNs) from medical device manufacturers from 29 November to 3 December 2021

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: T15 Stick Fit Hexalobe Drivers

05 November 2021

Orthopaedic Surgical instruments - Insertion/extraction tools

Model: 80-0760

MHRA reference: 2021/011/019/601/003

Chalice Medical: one-way valve

26 November 2021

Infusion & transfusion, heart lung circuits

MHRA reference: 2021/011/023/601/500

Illumina: VeriSeq NIPT Solution v2 Brand

27 October 2021

IVD, genetic testing

Model: 20030577

MHRA reference: 2021/010/027/601/003

Medtronic: Abre Venous Self-expanding Stent System

November 2021

Implants, non active, peripheral vascular stents

Model: Several

MHRA reference: 2021/011/026/487/020

Philips: BV Endura, BV Pulsera, Veradius Unity

November 2021

X Ray, general

MHRA reference: 2021/011/025/487/011

Philips Medical Systems: Allura Xper, UNIQ and CV20 systems

November 2021

X Ray, fluoroscopy systems

Model: 722003, 722005, 722006, 722008, , 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722031, 722033, 722034, 722036, 722038, 722039

MHRA reference: 2021/011/026/487/019

Siemens Healthcare: Sensis Vibe Hemo & Sensis / Sensis Vibe Combo

November 2021

Electrophysiology measurement

MHRA reference: 2021/011/023/601/505

Updates to this page

Published 6 December 2021