Field Safety Notices: 18 to 22 October 2021

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

Acumed: Acu-Loc® 2 VDR Plt Std R 70-0357

07 October 2021

Osteosynthesis, bone plates

MHRA reference: 2021/010/015/701/014

BioMérieux: BioFire BCID2 Panel

20 October 2021

IVDs, bacteriology

MHRA reference: 2021/010/019/487/011

BioMérieux: VIDAS® Immuno-Assays

04 November 2021

IVDs, viral microbiology

MHRA reference: 2021/010/001/579/001

Copan Italia: Eswab

October 2021

IVDs, specimen receptacles

MHRA reference: 2021/010/014/701/045

Emergo Consulting (Balt): IVA

13 October 2021

Vascular cannula and catheters

Model: VA3F50, IVA5F45, IVA5F41.45, IVA5F96.45, IVA6F80, EIVA6F80, IVA6F80ST, EIVA6F80ST, IVA6F80ST_MP, EIVA6F80ST_MP, IVA7F41.45, IVA7F96.45 and IVA7F96.90

MHRA reference: 2021/010/021/291/003

Gas Control Equipment: COMBILITE® SERIES

16 September 2021

Regulators for gas cylinders

Model: Pure Oxygen Version

MHRA reference: 2021/010/019/487/013

Hamilton Medical: HAMILTON-C3

05 October 2021

Lung ventilators

Model: 160005

MHRA reference: 2021/010/012/601/500

Integra Lifescience: Accudrain / Hermetic / LimiTorr / MoniTorr

29 September 2021

Cerebrospinal fluid drainage, external

MHRA reference: 2021/010/018/291/001

Integrum: Axor II

06 October 2021

Prostheses

Model: 1288

MHRA reference: 2021/010/018/291/002

Joerns Healthcare: Oxford / HOYER

15 October 2021

Moving & handling

Model: OXF-UP / HOY-UP

MHRA reference: 2021/010/015/601/500

Medtronic: Percept PC BrainSense

October 2021

Implantable neuro stimulators

Model: B35200

MHRA reference: 2021/010/015/579/002

October 2021

Implants, active, cardiac programmers and remote monitoring

Model: 24970A; 24967

MHRA reference: 2021/010/015/579/003

Permobil: TiLite AERO Z

CAPA10090 AERO Zs

Wheelchairs, manual

MHRA reference: 2021/010/018/487/002

Permobil: TiLite ZRA

CAPA10090 ZRAs

Wheelchairs, manual

MHRA reference: 2021/010/004/487/007

Philips: Azurion R2.1.x

October 2021

X Ray, fluoroscopy systems

Model: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228

MHRA reference: 2021/010/019/487/010

Siemens Healthcare: Artis zee / Q / Q.zen

October 2021

X Ray, fluoroscopy systems

MHRA reference: 2021/010/020/601/001

Siemens Healthcare Diagnostics: Aptio Automation & FlexLab Automation

September 2021

IVDs, clinical chemistry

MHRA reference: 2021/010/014/579/016

Siemens Healthcare Diagnostics LASW 21-01: Aptio Automation

October 2021

IVDs, clinical chemistry

Model: SMN 10703038

MHRA reference: 2021/010/015/601/004

Thermo Fisher: Pathodxtra Strep Group D Late

05 October 2021

IVDs, bacteriology

Model: DR0704G

MHRA reference: 2021/010/005/601/006

Thermo Fisher Scientific: OxoidTM Egg Yolk Tellurite Emulsion

15 October 2021

IVDs, bacteriology

Model: SR0054C

MHRA reference: 2021/010/018/601/003

Updates to this page

Published 25 October 2021