Field Safety Notices: 30 August to 3 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 30 August to 3 September 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

Balt: SILK VISTA

12 April 2021

Intracranial flow diverters / stents

Model: All

MHRA reference: 2021/008/027/291/001

Botiss: Cerabone Plus

30 July 2021

Implants, dental

MHRA reference: 2021/008/025/579/011

Edan: Central Monitoring System

11 August 2021

Monitors, Patient

Model: MFM-CMS

MHRA reference: 2021/008/027/291/004

Elekta: MOSAIQ

August 2021

Radiotherapy

MHRA reference: 2021/008/031/291/004

EndoTools: Endomina v2

19 April 2021

Endoscopes, flexible

Model: IA-EM8616610505-00

MHRA reference: 2021/008/024/601/501

GE Healthcare: CENTRICITY PACS IW WITH UNIVERSAL VIEWER

GEHC Ref#85456

Picture archiving and communication system (PACS)

MHRA reference: 2021/008/026/291/011

Gore: CARDIOFORM Septal Occluder

September 2021

Implants, non-active, cardiac appendage and septal defect occluders / plugs

MHRA reference: 2021/008/030/701/024

Philips: CombiDiagnost R90

August 2021

X Ray, fluoroscopy systems

Model: 709030

MHRA reference: 2021/008/031/291/001

Philips: Ingenia 1.5T, 1.5T S, 1.5T Evolution, Ingenia 3.0T, 3.0T CX, Achieva 3.0T, Ingenia Elition S & X

FCO78100530

Magnetic resonance, equipment & accessories

Model: 781341, 781342, 781315, 781271, 781277, 781357, 781358

MHRA reference: 2021/008/027/291/014

Qiagen: QIAstat-Dx Respiratory SARS-CoV-2 Panel

23 August 2021

IVDs, SARS-CoV-2 PCR test

MHRA reference: 2021/008/025/291/003

Roche: Cobas EGFR Mutation Test v2

SBN-RDS-ML-2021-011

IVD, genetic testing

MHRA reference: 2021/008/027/291/013

Stryker: Cartilage Substitute

25 August 2021

Cartilage substitute

MHRA reference: 2021/008/027/291/003

ThermoFisher Scientific: B·R·A·H·M·S Solution 2 KRYPTOR GOLD

11 June 2021

IVD, genetic testing

MHRA reference: 2021/006/010/487/001

Zimmer Biomet: Various Spinal Implants

30 August 2021

Spinal implants

MHRA reference: 2021/008/031/291/003

Updates to this page

Published 6 September 2021