Field Safety Notices - 08 to 12 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 June 2020

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

BTC Medical Europe Srl: Dispensing kit Clio

27 April 2020

Nuclear medicine

MHRA reference: 2020/005/022/487/003

GE Healthcare: CARESCAPE Patient Data Module

FMI 36146

Monitors, patient

MHRA reference: 2020/006/003/487/008

Groupe SEBBIN: Silicone implants and tissue expanders

27 May 2020

Implants, breast

Model: LS01X, LS02X, LS03X, LS04X, LS05X, LS06, LS07X, LS82X, LS62X, LS89X, LS81X, LS83X

MHRA reference: 2020/006/005/601/007

Groupe Sebbin: Mammary Sizers

26 May 2020

Implants, breast

Model: GABXX

MHRA reference: 2020/006/005/601/008

Lutonix

June 2020

Vascular cannula and catheters

MHRA reference: 2020/006/011/487/007

June 2020

Implants, active, cardiac programmers and remote monitoring

MHRA reference: 2020/003/009/420/004

Medtronic Inc: IN.PACT Admiral™ and IN.PACT Pacific™

15 June 2020

Vascular cannula and catheters

MHRA reference: 2020/006/010/487/004

OCON Medical: IUB Ballerine Intrauterine Device

25 May 2020

Implants, non active, contraceptive implants

Model: IUB Ballerine MID

MHRA reference: 2020/006/001/291/001

PerkinElmer: Vanadis View Plate

11 June 2020

IVDs, immunology

Model: 3224-0010

MHRA reference: 2020/006/011/487/008

Richard Wolf: TUBE SET FOR TEM

05 June 2020

Surgical equipment, miscellaneous

MHRA reference: 2020/006/008/487/003

Siemens: CentraLink(R) Data Management System/Atellica(R) Data Manager

May 2020

IVDs, clinical chemistry

MHRA reference: 2020/006/009/601/001

Verathon Medical: GlideScope® Core OneTouch Cable

05 June 2020

Airway devices

Model: 0600-0772

MHRA reference: 2020/006/001/291/002

Updates to this page

Published 15 June 2020