Field Safety Notice: 9 to 13 November 2020

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 2020.

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

ALCIS: ALBAFLEX dental arch

2 November 2020

Dental appliances / instruments

Model: 2099-AN

MHRA reference: 2020/011/009/487/001

Becton Dickinson: Alaris™ GP and GP Guardrails, Alaris™ neXus GP

10 November 2020

Infusion systems

MHRA reference: 2020/011/006/291/001

Cardinal Health: Protexis Latex Micro Surgical Gloves

October 2020

Gloves, surgical & examination

MHRA reference: 2020/010/023/701/006

GE Healthcare: 2030360-001

GEHC Ref# 30097

ECG

MHRA reference: 2020/011/012/487/004

Kunshan Aoshida Electric Technology: Freedom Chair

2 September 2020

Wheelchairs, powered

Model: A06L

MHRA reference: 2020/004/017/601/007

Microbiologics: KWIK-STIK™ 2or6 Pack 01145 /QC Sets & Panels 5226P

05 October 2020

IVDs, bacteriology

Model: Catalog 01145P Klebsiella pneumoniae derived from NCTC

MHRA reference: 2020/011/005/291/001

Philips: Philips-EPIQ and Affiniti Ultrasound system

27 October 2020

Ultrasound, imaging

Model: EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx Affiniti 30, Affiniti 50 and Affiniti 70
Soft ware version number (if applicable)

Software versions affected worldwide: 1.0.x, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.7.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, 5.0.1.

Software versions affected China only: 1.0.x, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.7.x, 1.8.x, 1.9.x, 2.1.x.

MHRA reference: 2020/011/005/291/005

SD Biosensor: Total 7 products including SARS-CoV-2 Rapid Antigen Test

09 November 2020

IVDs, SARS-CoV-2 PCR Test

MHRA reference: 2020/011/009/601/006

Stereotaxis: Niobe ES

28 October 2020

Surgical navigation system and accessories

Model: 3.2

MHRA reference: 2020/010/013/701/008

Stryker: Mako Integrated Cutting System (MICS)

5 November 2020

Surgical power tools

MHRA reference: 2020/011/004/291/001

Wallac: Screening Center

06 November 2020

IVDs, clinical chemistry

MHRA reference: 2020/010/030/291/002

Welch Allyn: ELI 380 Resting Electrocardiograph

MOD1319

ECG

Model: ELI380-XYYZZ

X=A to Z

Y= A to Z

Z= A to Z or 1 to 9

MHRA reference: 2020/011/012/487/002

Updates to this page

Published 16 November 2020