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