Field Safety Notice - 1 October to 5 October

List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October

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

Alba Bioscience (Quotient): ALBAClone Anti-Leb

01 October 2018

IVDs, blood transfusion

Model: Z217

MHRA reference: 2018/010/001/601/007

Carl Zeiss

DE/CA08/3.1.58-02

IVDs, cytopathology & histopathology

Model: Cell Observer SD, DirectFRAP, Laser TIRF

MHRA reference: 2018/010/001/228/006

Covidien (Medtronic): Puritan Bennett 980 Ventilator

September 2018

Lung ventilators

MHRA reference: 2018/009/028/228/010

Etac: Rullstol Cross, parking brakes

30 September 2018

Wheelchairs, manual

MHRA reference: 2018/010/001/000/012

GMM General Medical Merate: FMI gear kit

FSCA-001-2018

X Ray, digital acquisition systems

MHRA reference: 2018/010/003/228/012

Heinz Kurz: KURZ-Precise Schneideblock ; 8000110 / 8000110

13 September 2018

Surgical devices, non-powered

MHRA reference: 2018/009/027/081/001

Integrum AB: Axor TC cENTRIC

28 September 2018

Prostheses

MHRA reference: 2018/010/001/000/013

LifeTech Scientific: Cera Plug

30 September 2018

Implants, non active, embolisation products

Model: LT-PLUG-04/LT-PLUG-06

MHRA reference: 2018/010/001/228/021

Medica Medizintechnik (Thera Trainer): THERA- Trainer Balo & Verto

24 July 2018

Diagnostic measurement and monitoring

MHRA reference: 2018/010/003/228/002

Medtronic: MiniMed 640G Insulin Pump

October 2018

Infusion systems

Model: MMT-1711, MMT-1712

MHRA reference: 2018/010/003/228/016

Molnlycke Health Care (Medtronic): Mon-a-Therm

August 2018

Vascular cannula and catheters

MHRA reference: 2018/009/028/228/014

Network Medical Products

08 August 2018

Implants, active, hearing

Model: 74-111-25

MHRA reference: 2018/009/028/601/009

Permobil (TI): Aero R, Aero T, Aero X, Aero Z, TRA, Twist, ZRA, 2GX

3032618-09/06/2018-001-C

Wheelchairs, manual

MHRA reference: 2018/009/021/291/021

Pro Med Instruments (Feinmechanik): DORO LUCENT® Base Unit ; - 1101.021, 1101.031, 1101.026

23 March 2018

Surgical instruments, articulated holding

MHRA reference: 2018/010/004/121/001

Randox Laboratories: Liquid Cardiac Controls

20 September 2018

IVDs, clinical chemistry

Model: CQ5051, CQ5052, CQ5053

MHRA reference: 2018/009/021/601/007

Siemens: Atellica Solution

September 2018

IVDs, clinical chemistry

Model: See additional information

MHRA reference: 2018/010/002/601/014

Siemens: Dimension Lipase/Dimension Vista Lipase

September 2018

IVDs, blood transfusion

Model: SMN# 10460277/ 10461745

MHRA reference: 2018/009/021/601/008

Siemens: RAPIDPoint 500 Blood Gas Analyzer

September 2018

IVDs, extra laboratory testing

MHRA reference: 2018/010/002/601/010

Siemens: Dimension Vista® System

September 2018

IVDs, blood transfusion

MHRA reference: 2018/010/003/228/010

TP Orthodontics: Generation 1 Jasper Vektor

30 September 2018

Dental appliances/instruments

MHRA reference: 2018/009/020/291/015

Welch Allyn: Connex Spot Monitor with Masimo® SpO2

14 September 2018

Monitors, patient

MHRA reference: 2018/009/028/228/011

Published 8 October 2018
Last updated 10 October 2018 + show all updates
  1. Mistaken name has been corrected from TP Orthodontics: Jasper Vektor into TP Orthodontics: Generation 1 Jasper Vektor
  2. First published.