Field Safety Notices: 13 to 17 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021

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

ConvaTec: AQUACEL Ag Dressing and AQUACEL AG+ EXTRA

May 2021

Wound management

MHRA reference: 2021/009/014/291/001

Cook Medical: Inferior Vena Cava (IVC) Filter

15 September 2021

Implants, non active, vena cava filters

MHRA reference: 2021/009/015/487/009

Elekta: Digital Linear Accelerator

August 2021

Radiotherapy

Model: Linac

MHRA reference: 2021/009/015/487/008

Elekta: Monaco

September 2021

Radiotherapy planning and verification systems

MHRA reference: 2021/009/010/291/003

Getinge: Cardiosave Intra-Aortic Balloon Pumps

10 September 2021

Cardiac assist pumps

Model: 0998-XX-0800-XX

MHRA reference: 2021/009/014/291/004

Henry Schein: IV Sets/Accessories

25 May 2021

Infusion & transfusion, administration sets

MHRA reference: 2021/009/015/701/010

Limacorporate: Discovery Elbow - Humeral condyle kit

06 September 2021

Joint prosthesis, elbow

Model: 114991 - 114700

MHRA reference: 2021/009/013/701/026

Microbiologics: Helix Elite SARS-CoV-2 Process Control (Swab)

09 September 2021

IVDs, SARS-CoV-2 PCR Test

Model: HE0063S

MHRA reference: 2021/008/025/701/059

Microbiologics: Helix Elite SARS-CoV-2 Process Control (Pellet)

09 September 2021

IVDs, SARS-CoV-2 PCR Test

Model: HE0062S

MHRA reference: 2021/008/025/701/062

Philips: EPIQ & Affiniti Ultrasound systems

September 2021

Ultrasound, imaging

Model: EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi, Affiniti 30, Affiniti 50, Affiniti 70

MHRA reference: 2021/009/010/291/002

Roche: ONLINE TDM parameters

August 2021

IVDs, SARS-CoV-2 PCR Test

Model: VANC3, GENT2, PHNY2, THEO2, PHNO2

MHRA reference: 2020/011/017/487/002

Updates to this page

Published 20 September 2021