Field Safety Notice - 13 August to 17 August

List of field safety notices (FSNs) from medical device manufacturers from 13 August to 17 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 FSNs

View the latest FSNs

CIVCO Medical Instruments: Endocavity Needle Guide

30 July 2018

Surgical instruments, minimal access

Model: 676-144, 676-150

MHRA reference: 2018/008/016/701/017

Oridion (Medtronic): Capnostream™20 and Capnostream™20p Bedside Patient Monitors

16 August 2018

Monitors, patient

MHRA reference: 2018/008/016/291/024

Peek Vision: Peek Acuity Pro App PV_PAC_001

21 May 2018

Optical, ophthalmic instruments & equipment

MHRA reference: 2018/005/024/291/006

Regen Lab: Cellular Matrix, ArthroVisc40, SkinVisc40

10 July 2018

Implants, non active, injectable joint solutions

Model: ArthroVisc40; ARV-HA40-1, lot 025

MHRA reference: 2018/008/016/701/019

Sheffmed

07 August 2018

Surgical devices, non-powered

Model: Surgical instruments (multiple)

MHRA reference: 2018/008/014/291/017

Siemens: YSIO Systems

02 August 2018

X Ray, digital acquisition systems

MHRA reference: 2018/008/009/601/004

Siemens: Hematek Wright-Giemsa Stain Paks (SMN 10314755) / Hematek Modified Wright’s Stain Paks (SMN 10310965)

August 2018

IVDs, haematology

MHRA reference: 2018/008/010/601/001

Siemens: Patio Automation / StremaLAB Automation

August 2018

IVDs, clinical chemistry

MHRA reference: 2018/008/016/601/003

Siemens Healthineers: AXIOM ARTIS Systems

18 December 2018

X Ray, digital acquisition systems

Model: AXIOM Artis systems with a flat panel detector from a specific production batch

MHRA reference: 2018/001/008/601/005

Vision RT: AlignRT/AlignRT Plus/OSMS

09 August 2018

Radiotherapy planning and verification systems

MHRA reference: 2018/008/010/601/012

Zimmer Biomet: Hiploc Plate

17 August 2018

Osteosynthesis, bone plates

MHRA reference: 2018/008/016/701/021

Intersurgical: Manual Resuscitation Systems

07 June 2017

Resuscitators

MHRA reference: 2017/005/031/291/005

Updates to this page

Published 20 August 2018