Field Safety Notice: 07 to 21 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 07 to 21 June 2019

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

Alere: Alere

24 June 2019

IVDs, clinical chemistry DDS2-403, DDS2-404

MHRA reference: 2019/006/019/601/010

Biomet: DVR Express Disposable Instruments

18 June 2019

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2019/006/018/291/018

Diamed – Bio-Rad: DiaClon Rh-Subgroups + K

11 June 2019

IVDs, blood transfusion Model: 50110//50115

MHRA reference: 2019/006/013/701/018

Elekta:Elekta Unity

June 2019

Radiotherapy

MHRA reference: 2019/006/018/701/017

Intersurgical: 15mm Flextube Single Heated Wire Breathing Systems

19 June 2019

Humidifiers

MHRA reference: 2019/006/012/291/003

Johnson & Johnson: Neutrogena Light Therpay Acne Mask and Refill

19 June 2019

Therapy, adult phototherapy

MHRA reference: 2019/006/020/291/002

Maquet - Getinge: Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps

2249723-05/17/2019-001-C—GB Cardiac assist pumps

MHRA reference: 2019/006/020/487/001

MEDICAL INNOVATION: MID-TUBE

14 June 2019

Feeding systems and tubes

Model: MID136

MHRA reference: 2019/006/019/487/009

Medtronic: Sherpa Active 6F Guide Catheter

June 2019

Vascular cannula and catheters Model: SA6IMAK, SA6RDND1K, SA6RBU35, SA6HSI, SA63DRCSH, SA6AR10, SA6AR20, SA6LCBD, SA63DRC, SA6RBU35SH, SA6AR10SH, SA6RDCK, SA6JL40D, SA6FL40, SA6AR20SH, SA6IMAD, SA6MPHK, SA6HSISH, SA6FL40SH, SA6JR40D, SA6AL10A, SA6AL20A, SA6EBU35A, SA6NOTOSH, SA6SR30, SA6JL40A, SA6IMA, SA6IMASH, SA6PK1W, SA6JR40K, SA6CHAMP05, SA6EBU40A, SA6RCBSHD, SA6RCBD, SA6LCBSHD, SA6CHAMP20K, SA6EBU35D, SA6JCR40, SA6NOTO, SA6AL10D, SA6SR40SH, SA6SR40, SA6CHAMP05SH, SA6AL30A, SA6MP1K, SA6JL50A, SA6JR40A, SA6JL35A, SA6AL75A, SA6MB1D, SA6IMASHJ MHRA reference: 2019/004/015/291/029

Mercian Surgical Supply:900G MALLET

19 June 2019

Surgical devices, non-powered

Model: Mallet with Black PEEK Handle 21.5cm 40mm Diameter 900g - HA5806-21

MHRA reference: 2019/006/026/121/001

Natus Medical: Chartr EP 200

May 2019

Stimulators diagnostic

MHRA reference: 2019/006/017/291/001

RMS: MARLEY/RMS

01 June 2019

Buggies for disabled people

Model: MRL-1 and MRL-2

MHRA reference: 2019/006/018/291/011

Siemens: ARTIS zee and ARTIS Q

27 May 2019

X Ray, fluoroscopy systems

MHRA reference: 2019/006/013/601/009

Thermo Fisher: Oxoid

14 June 2019

IVDs, bacteriology PO0152A

MHRA reference: 2019/006/014/601/010

Zoll: ZOLL AED PRO

12 June 2019

Defibrillators, non-implantable

MHRA reference: 2019/006/019/487/004

Published 24 June 2019