Field Safety Notices: 23 to 27 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 August

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

Altomed: Damato Ruthenium Plaque Template

01 August 2021

Radiotherapy, afterloading

Model: A7078

MHRA reference: 2021/008/023/601/501

A.M.I: i-Cut ICT5011

20 August 2021

Therapy tissue ablation

MHRA reference: 2021/008/023/291/001

Becton Dickinson: BodyGuard Infusion Pump Systems (Large Volume Infusion Pump Systems)

26 August 2021

Infusion systems

MHRA reference: 2021/008/027/291/002

Cytocell: Del (5q) Deletion Probe

23 August 2021

IVDs, clinical chemistry

Model: LPH024/LPH024-S

MHRA reference: 2021/008/023/601/005

Draeger: Atlan A300/ XL, Atlan A350/ XL

August 2021

Anaesthetic machines & monitors

MHRA reference: 2021/008/025/291/004

GE: CENTRICITY PACS IW WITH UNIVERSAL VIEWER

GEHC ref #85456

Picture archiving and communication system (PACS)

MHRA reference: 2021/008/026/701/042

Getinge: Heater-Cooler Unit

23 August 2021

Heart lung machines

Model: HCU 40 70104.4054; 70105.4917

MHRA reference: 2021/008/025/291/002

Getinge: National UK NRP & Edinburgh NRP Perfusion Pack

23 July 2021

Infusion & transfusion, heart lung circuits

MHRA reference: 2021/007/023/291/002

Iberhospitex: DRENOFAST

09 July 2021

Wound drains

MHRA reference: 2021/008/026/291/010

Liko: OctoStretch with Stretch Leveller, FlexoStretch, Stretch Leveller, LikoStretch 1900, LikoStretch Mod 600 IC

FA 2021-05-002-LUL-003

Hoists and slings

Model: 3156056, 3156057, 3156200, 3156051, 3156065, 3156065B

MHRA reference: 2021/008/026/291/009

Medtronic: DLP Left Heart Vent

August 2021

Infusion & transfusion, heart lung circuits

Model: 12116, 12118

MHRA reference: 2021/008/024/291/015

Paradigm Spine: Siehe Anhang 1: REC 2021-02

06 August 2021

Osteosynthesis, bone screws

MHRA reference: 2021/008/025/579/012

Philips: Infant/Child SMART Pads Cartridges

August 2021

Defibrillators, non implantable

Model: M5072A

MHRA reference: 2021/008/024/291/014

Smiths: Bivona Microlaryngeal Endotracheal Tube

16 August 2021/3012307300-08/09/2021-011-R

Airway devices

Model: 35W025, 25W080, 35W030, 25W085, 35W035, 25W090, 35W040

MHRA reference: 2021/008/025/601/500

Thermo Fisher: Oxoid

18 August 2021

IVDs, bacteriology

Model: SR0047C

MHRA reference: 2021/008/020/601/003

Welch Allyn: ELI280 MLBUR280 BUR280

2021-07-001-MKE-005

Electrophysiology Measurement

MHRA reference: 2021/008/020/487/001

Updates to this page

Published 31 August 2021