Field Safety Notices: 20 to 24 June 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 June 2022

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Agilent: AriaDx Real-Time PCR System

06 June 2022

IVD, genetic testing

Model: K8930AA

MHRA reference: 2022/006/006/601/508

Arrow International

June 2022

Vascular cannula and catheters

MHRA reference: 2022/006/021/596/003

CareDx: SSP DR Low

22 June 2022

IVDs, immunology

MHRA reference: 2022/006/024/595/001

Chiesi: LISAcath

MD-FSCA-CHIESI-2022-001

Feeding systems and tubes

MHRA reference: 2022/005/027/601/504

Invacare: Action 3NG

10 June 2022

Wheelchairs, manual

MHRA reference: 2022/006/010/701/029

Leica Biosystems: Leica Biosystems Tissue processor

June 2022

IVDs, cytopathology & histopathology

MHRA reference: 2022/006/008/593/005

Medtronic: Valiant NavionTM Thoracic Stent Graft System

May 2022

Implants, non active, endoprostheses for aortic aneurysms

Model: All

MHRA reference: 2021/002/018/291/009

Olympus Corporation: Soltive SuperPulsed Laser Fiber 150 Micron 150µ BT SU Fiber, 5/Bx

01 June 2022

Therapy, lasers

MHRA reference: 2022/005/012/596/001

Roche: VENTANA HE 600 System 06917259001

SBN-RDS-Pathology Lab-2022-002

IVDs, cytopathology & histopathology

MHRA reference: 2022/006/008/701/044

Schwarzer Cardiotek: EP-TRACER

12 May 2022

Monitors, patient

Model: EP-TRACER 38, EP-TRACER 102

MHRA reference:2022/005/006/701/046

Siemens Healthineers: Sensis Vibe Combo systems with software VD12A

AX015/22/S

Electrophysiology measurement

MHRA reference: 2022/006/013/601/502

Siemens Healthineers: ARTIS icono biplane

May 2022

X Ray, fluoroscopy systems

MHRA reference: 2022/005/020/601/004

Updates to this page

Published 27 June 2022