Field Safety Notices: 18 to 22 July 2022

List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 July 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

Abbott: Assurity, Endurity

July 2022

Implants, Active, Pacemakers

MHRA reference: 2022/007/021/596/003

Ambu: VivaSight 2 DLT

30 May 2022

Airway Devices

MHRA reference: 2022/005/030/701/003

B Braun Medical: Space

19 July 2022

Infusion Systems

MHRA reference: 2022/007/019/601/501

Beaver‐Visitec International: CustomEyes

28 June 2022

Phacoemulsification / Vitrectomy Systems

MHRA reference: 2022/007/012/291/018

Cook Medical: Roadrunner PC Wire Guide

2022FA0002

Vascular Cannula/Catheter Accessories

MHRA reference: 2022/007/020/596/001

GE Healthcare: Centricity High Acuity (CHA) C.C and Anesthesia

Ref 38010

Monitors, Patient

MHRA reference: 2022/007/015/596/007

Intuitive: Generator E-100 374848-09

July 2022

Surgical, Diathermy

MHRA reference: 2022/007/014/701/053

Leica Biosystems: X-TRA Slides

27 June 2022

IVDs, Cytopathology & Histopathology

Model: 3800209

MHRA reference: 2022/007/014/590/003

Medtronic: EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

July 2022

Implants, Non Active, Peripheral Vascular Stents

MHRA reference: 2022/007/020/596/013

Philips: V60 Ventilator V60 Plus Ventilator V680 Ventilator

30 June 2022

Lung Ventilators

MHRA reference: 2022/007/019/291/001

Roche: Refer to FSN

July 2022

IVDs, Clinical Chemistry

MHRA reference: 2022/007/008/701/083

Stryker: TRITANIUM BPLATE TRIATHLON

June 2022

Joint Prosthesis, Knee

MHRA reference: 2022/004/021/291/001

Updates to this page

Published 25 July 2022