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

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FSNs before this date are on the

BTC Medical Europe Srl: Dispensing kit Clio

27 April 2020

Nuclear medicine

MHRA reference:

GE Healthcare: CARESCAPE Patient Data Module

FMI 36146

Monitors, patient

MHRA reference:

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:

Groupe Sebbin: Mammary Sizers

26 May 2020

Implants, breast

Model: GABXX

MHRA reference:

Lutonix

June 2020

Vascular cannula and catheters

MHRA reference:

June 2020

Implants, active, cardiac programmers and remote monitoring

MHRA reference:

Medtronic Inc: IN.PACT Admiral鈩� and IN.PACT Pacific鈩�

15 June 2020

Vascular cannula and catheters

MHRA reference:

OCON Medical: IUB Ballerine Intrauterine Device

25 May 2020

Implants, non active, contraceptive implants

Model: IUB Ballerine MID

MHRA reference:

PerkinElmer: Vanadis View Plate

11 June 2020

IVDs, immunology

Model: 3224-0010

MHRA reference:

Richard Wolf: TUBE SET FOR TEM

05 June 2020

Surgical equipment, miscellaneous

MHRA reference:

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

May 2020

IVDs, clinical chemistry

MHRA reference:

Verathon Medical: GlideScope庐 Core OneTouch Cable

05 June 2020

Airway devices

Model: 0600-0772

MHRA reference:

Updates to this page

Published 15 June 2020