Field Safety Notices: 22 to 26 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 February 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

Acutronic: fabian HFO and fabian +nCPAP evolution

18 February 2021

Lung Ventilators

Model: fabian HFO:111001, 111001.01, 112001, 113001

MHRA reference: 2021/002/024/291/008

Baxter: Prismaflex Control Unit

09 February 2021

Dialysis, haemofilters

Model: 107493. • 113082, • 113874, • 114489, • 114870 • 955052, • G5010007, • G5064801, • G5006203

MHRA reference: 2021/002/008/487/006

BD: Venflon Pro Safety I.V. Cannula

01 March 2021

Vascular Cannula And Catheters

Model: Venflon Pro Safety I.V. Cannula

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

Brainlab: ExacTrac Dynamic

10 February 2021

Radiotherapy Planning and Verification Systems

Model: 20910-06

MHRA reference: 2021/002/024/291/007

DiaMed: DiaClon anti-N and DiaClon anti-M/N

24 February 2021

IVDs, Haematology

Model: 007111 and 006011

MHRA reference: 2021/002/025/601/002

Immucor: MatchIt! DNA Software

17 February 2021

IVDs, Immunology

Model: V1.2 and V1.3

MHRA reference: 2021/002/023/601/005

Leica: BOND Ready-To-Use Primary Antibody CD19 (BT51E)

18 February 2021

IVDs, Clinical Chemistry

Model: Novocastra liquid mouse monoclonal antibody CD19

MHRA reference: 2021/002/018/601/004

Likamed: SELEXA ; SELEXA / keine

Beds and accessories

Model: SELEXA ; SELEXA / keine

MHRA reference: 2021/002/019/487/001

Philips: HeartStart FR2+ AED, HeartStart FRx AED, HS1 (Onsite) AED, HS1 (Home) AED

23 February 2021

Defibrillators, Non Implantable

Model: FR2+: M3840A, M3841A, M3860A, M3861A, 861364, 861365, 861372, 861373, 861374, 861375, 861458, 861459. FRx : 861304, 861305

MHRA reference: 2021/002/025/291/001

RaySearch: Radiation Therapy Treatment Planning System

19 February 2021

Radiotherapy Planning And Verification Systems

Model: RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs

MHRA reference: 2021/002/024/291/006

Stryker: LIFEPAK® CR2 DEFIBRILLATOR

26 February 2021

Defibrillators, Non Implantable

Model: CR2-2-000XXX

MHRA reference: 2021/002/018/487/001

Updates to this page

Published 1 March 2021