Field Safety Notice - 20 to 24 August

List of field safety notices (FSNs) from medical device manufacturers from 20 August to 24 August

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 FSN

View the latest FSNs

Beekley: S-SPOT, TomoSPOT, O-SPOT

9021987-2018-00001

Mammography

Model: 777, 777S, 782, 782S, 783, 783S, 784, 784S, 785, 785S, 791, 791S

MHRA reference: 2018/006/025/601/002

Biocartis: Idylla™ Instrument

20 August 2018

IVD, genetic testing

MHRA reference: 2018/008/021/701/007

Cook Medical: Zenith Branch Endovascular Graft-Iliac Bifurcation

12 February 2018

Implants, non active, surgical vascular grafts & patches

MHRA reference: 2018/005/031/291/002

Cook Medical: Zenith Alpha™ Thoracic Endovascular Graft

21 August 2018

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2018/008/021/291/003

Idoman Teoranta: Thermablate EAS

18 July 2018

Therapy tissue ablation

MHRA reference: 2018/007/026/228/003

Leica: HistoCore Spectra CV

August 2018

IVDs, cytopathology & histopathology

Model: HistoCore Spectra CV

MHRA reference: 2018/008/022/291/022

Natus: EMU40

25 June 2018

Monitors, patient

MHRA reference: 2018/008/021/291/002

Ortho-Clinical: VITROS 5600 Integrated System

August 2018

IVDs, clinical chemistry

MHRA reference: 2018/008/016/601/006

Roche/Ventana: FLO-LOK III Dispenser

21 August 2018

IVDs, cytopathology & histopathology

MHRA reference: 2018/008/009/291/020

Smith & Nephew: GENESIS II C/R Femoral Component SZ 6 Right

01 August 2018

Joint prosthesis, knee

MHRA reference: 2018/008/006/701/022

Varian: TrueBeam® & EDGE™ Radiotherapy Delivery Systems

21 August 2018

Radiotherapy

Model: H19

MHRA reference: 2018/008/023/291/001

Zimmer Biomet: Affixus® Hip Fracture Nail

22 August 2018

Osteosynthesis, nails intramedullary

MHRA reference: 2018/008/022/701/017

Zimmer Biomet: Vitality® Shear-off Set Screw

23 August 2018

Osteosynthesis, bone screws

MHRA reference: 2018/008/023/701/006

Updates to this page

Published 28 August 2018