Field Safety Notice: 08-12 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 08 to 12 April 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

Cellnovo Group

28 March 2019 This company has gone into administration. The group has discontinued all manufacturing and commercial activities.

Please refer to the letter sent to customers and the press release: https://www.cellnovo.com/press-releases MHRA reference: 2019/004/005/223/002

A.R.C. Laser: Wolf with a wavelength of 445nm

29 March 2019

Therapy, lasers MHRA reference: 2019/004/008/291/005

Abbott: Alinity i Processing Module

05 April 2019

IVDs, clinical chemistry

MHRA reference: 2019/004/009/701/024

Apollo Healthcare Technologies: Pandora Profiling Bed

05 April 2019

Beds and accessories APH031 MHRA reference: 2019/004/008/291/001

Biomet (Zimmer): T7 Driver AO

10 April 2019

Orthopaedic Surgical instruments - Insertion/extraction tools MHRA reference: 2019/004/010/291/016

Boston Scientific: Auriga™ XL 4007 & Auriga™ 30 Laser System

09 April 2019

Therapy, lasers

M0068FS4007G0 – Auriga XL 4007 General System

MHRA reference: 2019/004/009/291/019

Dornier: Dornier Standard Diode and Nd:YAG Lightguides

05 April 2019

Therapy, lasers

MHRA reference: 2019/004/005/291/024

EKOS Corp: EKOS Control System 4.0 - Connector interface cabl

27 March 2019 Ultrasound, imaging MHRA reference: 2019/004/005/291/018

Fannin: Blood agar No 2 + Horse Blood & Staph/ Strep Selective Agar Mofified

03 April 2019 IVDs, bacteriology MHRA reference: 2019/004/005/601/004

Fresenius: CompoStop® Systems

20 March 2019

Storage & collection devices

MHRA reference: 2019/003/021/601/014

GE: Precision 500D

FMI 10927

X Ray, fluoroscopy systems

MHRA reference: 2019/004/009/291/015

Integra LifeSciences: Joint Prosthesis, Toe

08 April 2019

Joint prosthesis, toe MGT-890-10MT; MGT-890-20MT; MGT-890-30MT MHRA reference: 2019/003/029/487/003

JRI Orthopaedics: ACE Trial Cup

08 April 2019

Joint prosthesis, hip 051-44-00 & 051-50-00 MHRA reference: 2019/004/008/291/006

Leonhard Lang (Schiller) Customer: Schiller Defibrillation Electrode

11 April 2019

Defibrillators, non-implantable

0-21-0003, 0-21-0020, 2.155061, 2.155065, 2.155063, 0-21-0037,

MHRA reference: 2019/004/011/701/019

Leonhard Lang (Schiller) Distributor: Schiller Defibrillation Electrode

11 April 2019

Defibrillators, non-implantable

0-21-0003, 0-21-0020, 2.155061, 2.155065, 2.155063, 0-21-0037,

MHRA reference: 2019/004/011/701/019

Molnlycke Health Care: Neurosurgical procedure kits

04 April 2019

Surgical devices, non-powered

MHRA reference: 2019/004/005/291/023

Olympus Surgical Technologies America: Diego Elite Shaver Blade

11 April 2019

Surgical power tools MHRA reference: 2019/004/009/291/017

Ortho-Clinical: VITROS Chemistry Products CK Slides

April 2019

IVDs, clinical chemistry MHRA reference: 2019/004/010/601/012

Philips: MobileDiagnost wDR

08 March 2019

X ray, mobiles

Model: 712001,712002, 712004, 712005

MHRA reference: 2019/004/003/291/001

Philips: IntelliVue MX40 Patient Monitor

22 March 2019

Monitors, patient MHRA reference: 2019/004/011/291/024

Rifton: TRAM / E PACER QUICK RELEASE BUCKLES

007 – FSCA Moving & handling TRAM - K310 & K320 / E PACER -K660 MHRA reference: 2019/004/008/291/011

Teleflex: Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery

10 April 2019

Airway devices MHRA reference: 2019/004/010/291/024

Therakos (Mallinckrodt): Apheresis

09 August 2018

Photopheresis kit Cellex Photopheresis System

MHRA reference: 2018/009/014/291/002

Thermo Fisher: Oxoid

05 April 2019

IVDs, bacteriology

Model: MA0122

MHRA reference: 2019/004/008/601/008

Published 15 April 2019