Field Safety Notices: 6 to 10 December 2021

List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 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 FSNs since November 2014.

FSNs before this date are on the National Archives website

Convatec: Avelle Negative Pressure Wound Therapy Pump

25 November 2021

Active wound management

MHRA reference: 2021/011/015/291/015

Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e

23 November 2021

Anaesthetic machines & monitors

Model: Isoflurane 6682280 & 6886621, Desflurane 6682287 & 6886631, Sevoflurane 6682285, 6886611, 6682282 & 6887135.

MHRA reference: 2021/012/006/487/003

Invacare: AVIVA RX

30 November 2021

Wheelchairs, powered

MHRA reference: 2021/011/030/701/055

Medline International: Soft suction liner

03 December 2021

Surgical equipment, miscellaneous

MHRA reference: 2021/012/008/487/004

Medtronic: HawkOne Directional Atherectomy System

December 2021/ FA1203

Vascular cannula/catheter accessories

MHRA reference: 2021/012/008/487/007

Medtronic: LigaSure Blunt Tip Laparoscopic Sealer/Divider

December 2021/ FA1215

Surgical, diathermy

Model: Nano-coated LF1837

MHRA reference: 2021/012/008/487/005

Philips Medical: Philips Azurion biplanes, monoplanes with a floor mounted configuration and PolyG2 monoplanes with Software R2.2

November 2021

X Ray, fluoroscopy systems

Model: 722221, 722228, 722225, 722068, 722226, 722078, 722224

MHRA reference: 2021/012/006/487/002

Philips: Zenition 50, Zenition 70 & Veradius Unity

December 2021

X Ray, fluoroscopy systems

Model: Wireless Foot switch 3P: 459801238191

Wireless Foot switch 3P: 459801238231

MHRA reference: 2021/012/008/487/006

QIAGEN: QIAcube Connect MDx

18 November 2021

IVD, genetic testing

MHRA reference: 2021/012/006/487/004

Randox Health: Drugs of Abuse Array

2 November 2021

IVDs, blood transfusion

MHRA reference: 2021/011/023/601/502

Schiller Medical: DEFIGARD Touch-7 (Update to FSN 10 to 14 Feb 2021)

November 2021

Defibrillators, non implantable

MHRA reference: 2021/012/008/487/003

Siemens Healthcare: Atellica CH 930 Analyzer

November 2021

IVDs, clinical chemistry

Model: SMN 11067000

MHRA reference: 2021/011/026/601/002

Updates to this page

Published 13 December 2021