Field Safety Notice - 30 April to 04 May 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 30 April to 04 May 2018.


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

Abbott: various

23 April 2018

Implants, active, defibrillators

Cardioverter Defibrillator (Icd)

MHRA reference: 2018/004/020/478/005

Alere Technologies: Alere Afinion ACR Control

24 April 2018

IVDs, clinical chemistry

MHRA reference: 2018/004/020/291/003

Apollo Endosurgery: BIB/Orbera/Orbera365 Intragastric Balloon Systems

April 2018

Implants, non active, gastrointestinal

B-40800, B-50000, B-50012

MHRA reference: 2018/004/030/478/010

Biomet (Zimmer): Phoenix Tibia Nail, 3.5 mm Inserter Connector

02 May 2018

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2018/005/003/478/011

Cytocell: cMYC (MYC) Breakapart

20 April 2018

IVD, genetic testing

MHRA reference: 2018/004/025/701/026

GE Vingmed Ultrasound AS/Healthcare: Vivid 7, Vivid E7, Vivid E9, Vivid E80 / Vivid E90 / Vivid E95


Ultrasound, Imaging

MHRA reference: 2018/004/011/478/001

Intuitive Surgical: da Vinci® Xi™ EndoWrist® Stapler 45 Reload


Staples and staple guns

48645B-03; 48445G-03

MHRA reference: 2018/004/027/701/010

Philips: IntelliVue MX40 Patient Monitor

April 2018

Multi parameter monitor

MHRA reference: 2018/005/003/478/007

Roche Diagnostics: MagNA Pure 24 System

26 April 2018

IVDs, viral microbiology

07290519001 03337138001 03337154001 03313522001

MHRA reference: 2018/004/027/701/006

Thermo Fisher Scientific: Oxoid

19 April 2018

IVDs, bacteriology


MHRA reference: 2018/004/024/601/004

Published 8 May 2018