Field Safety Notice - 3 to 7 July 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 2017

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

Beckman Coulter: COULTER LH 750 Analyzer; LH 780 Analyzer; LH500 Analyzer; HmX CP Analyzers; HmX AL Analyzers

29 June 2017

IVDs, haematology

MHRA reference: 2017/006/030/601/003

5 July 2017

Ultrasound, Imaging

Model: H7495551000

MHRA reference: 2017/007/005/291/018

Cardiac Pacemaker: EMBLEM™ S-ICDs, EMBLEM™ MRI S-ICDs and SQ-RX™ S-ICDs

30 June 2017

Implants, active, defibrillators

Model: EMBLEM S-ICD (A209, A219), SQ-RX (1010)

MHRA reference: 2017/006/020/291/004

Chalice Medical: Paratherm

23 June 2017

Blood/fluid warming systems

MHRA reference: 2017/002/014/601/009

Cosman Medical: Nitinol TC Reusable Electrodes

June 2017

Therapy tissue ablation

Model: TCN-5-3M, TCN-10-3M, TCN-15-3M, TCN-5, TCN-10, TCN-15, TCN-20, TCNK-5, TCNK-5-C, TCNK-10,TCNK-10-C, TCNK-15, TCNK-15-C, TCNK-20

MHRA reference: 2017/007/005/291/008

Cyberonics: VNS Therapy® AspireSR® and AspireHC® Generator

30 June 2017

Implants, active, stimulators, neuro

Model: VNS Therapy® AspireSR® and AspireHC® Generator; 106, 105

MHRA reference: 2017/006/029/291/004

Depuy Synthes: Impactor for PFNA Blade

21 April 2017

Orthopaedic surgical instruments - impacting tools

Model: Impactor for PFNA Blade; 03.010.410

MHRA reference: 2016/012/012/291/031

Guangzhou Fortunique: SPY-PHI Drape HH2020, HH2000

26 June 2017

Surgical drapes, gowns, masks

MHRA reference: 2017/007/005/291/001

Helica Instruments: Helica

CAR3 TC568

Surgical, diathermy

Model: Helica; Thermal Coagulator

MHRA reference: 2017/007/005/601/003

Horiba Medical: HORIBA ABX

20 June 2017

IVDs, haematology

Model: Yumizen H500 CT

MHRA reference: 2017/007/005/601/009

Mindray: WATO EX-65, WATO EX-55, A5 and A7

June 2017

Anaesthetic machines & monitors

MHRA reference: 2017/007/003/291/036

Novo Nordisk: NovoPen® Echo® and NovoPen® 5

03 July 2017

Insulin injection devices

MHRA reference: 2017/007/003/131/001

One Lambda: AllSet+™ Gold SSP

27 June 2017

IVDs, immunology

MHRA reference: 2017/006/030/291/007

Ossur: Halo Vest/Lil Angel Halo Vest

10 April 2017

Orthoses

Model: 545700L, 545100L, 545800L, 545100K, 545700K 545100S, 545800K 545150K, 545700S 545150L, 545800S 545150S

MHRA reference: 2017/004/011/701/005

R82: Heron

30 June 2017

Bath and aids

Model: 880505-01; 880505-11

MHRA reference: 2017/007/004/291/020

Reha: G-EO System

2017-001

Therapy, standing & walking

Model: G-EO System

MHRA reference: 2017/007/003/291/003

Roche: Elecsys Digoxin

28 June 2017

IVDs, clinical chemistry

MHRA reference: 2017/006/030/701/001

Siemens Healthcare:

29 May 2017

X Ray, fluoroscopy systems

MHRA reference: 2017/006/029/601/011

Siemens: Symbia S, Symbia T, Symbia Intevo

28 June 2017

Nuclear medicine, gamma camera systems & accessories

Model: 10275007, 10275008, 10764804, 8717741

MHRA reference: 2017/005/019/601/013

Stanmore: JTS Grower Drive Unit

4 July 2017

Joint prosthesis, knee

Model: MLE 3

MHRA reference: 2017/007/004/291/019

Published 10 July 2017
Last updated 19 July 2017 + show all updates
  1. Updated link to FSN for Siemens: Symbia S, Symbia T, Symbia Intevo (MHRA Ref: 2017/005/019/601/013)
  2. First published.