Field Safety Notice - 02 to 06 April 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 April 2018

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

Arcoma: 0180 Intuition / 0072 Precision

16 March 2018

X Ray, digital acquisition systems

Model: 0180 / 0072

MHRA reference: 2018/003/029/701/016

Arjo: Entroy

4 April 2018

Hoists and slings

Model: GAB1000-01 and GAB1000-11

MHRA reference: 2018/003/012/601/006

Balt Extrusion: ECLIPSE 2L and COPERNIC2L

03 January 2017

Vascular cannula and catheters

MHRA reference: 2017/010/012/291/032

Buhlmann Laboratories: IBDoc, component: CalApp Reader (software)

12 March 2018

IVDs, clinical chemistry

MHRA reference: 2018/003/027/291/014

Becton Dickinson: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes

09 April 2018

IVDs, specimen receptacles

MHRA reference: 2018/004/005/291/012

Depuy Synthes GmbH: Epoca Revision Set

26 March 2018

Orthopaedic surgical instruments - Insertion/extraction tools

Model: 03.401.072 & 03.401.077

MHRA reference: 2018/003/028/291/008

DIDACTIC S.A.S.: Infusion sets

31 January 2018

Infusion & transfusion, administration sets

MHRA reference: 2017/012/013/000/003

Ethicon: 5mm ENDOPATH® XCEL™ Bladeless Trocars with Optiview Technology

5mm ENDOPATH® XCEL™ Trocars - VOLUNTARY RECALL

Surgical instruments, minimal access

MHRA reference: 2018/003/023/478/029

Ethicon: 5mm ENDOPATH® XCEL™ Trocars with Optiview Technology

26 March 2018

Surgical Instruments, Minimal Access

MHRA reference: 2018/004/005/291/008

GE Healthcare: Lunar Prodigy

April 2018

Bone Densitometer System

MHRA reference: 2018/004/004/291/018

LivaNova: PLATINIUM VR

16 March 2018

Implants, active, defibrillators

Model: VR 1240, DR 1540, CRT-D 1741, SonR CRT-D 1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844

MHRA reference: 2018/003/019/291/005

Phadia AB: EliA Intrinsic Factor Well

FSN2018-02

IVDs, immunology

Model: 14-5668-01

MHRA reference: 2018/003/028/601/008

Richard Wolf GmbH: TUBE SET FOR TEM

26 March 2018

Suction equipment

Model: 4170.801

MHRA reference: 2018/003/029/701/003

Rocket Medical: R55990-ISO-6

28 March 2018

Cerebrospinal fluid drainage, external

MHRA reference: 2018/004/003/601 /004

Siemens Healthcare Diagnostics: Dimension / Dimension VISTA

March 2018

IVDs, clinical chemistry

MHRA reference: 2018/003/029/601/003

Siemens Medical Solutions (Siemens Healthineers): Acuson SC2000 Ultrasound System

April 2018

Ultrasound, imaging

10433816

MHRA reference: 2018/004/003/601/009

Published 9 April 2018