Field Safety Notices: 31 May to 4 June 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 31 May to 4 June 2021.

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

Abbott: NeuroTherm NT2000iX Radiofrequency (RF) Generator

26 May 2021

Therapy tissue ablation

Model: RFG-NT-2000

MHRA reference: 2021/005/027/487/005

B.Braun Medical: Caresite Extension Set

26 May 2021

Infusion & transfusion, administration sets

MHRA reference: 2021/005/027/601/001

BioMérieux: Sabouraud 2 agar (SAB2-T)

27 May 2021/FSCA 5201

IVDs, bacteriology

MHRA reference: 2021/005/027/487/006

BioMérieux: VIDAS Anti-HBs Total II

03 June 2021/FSCA 5202

IVDs, viral microbiology

MHRA reference: 2021/006/002/487/026

Brainlab: ExacTrac Dynamic

29 April 2021

Radiotherapy planning and verification

Model: 20910-01

MHRA reference: 2020/009/024/487/008

ConMed: Buffalo Filter LaparoVue Visibility System

24 May 2021

Endoscopes, rigid

MHRA reference: 2021/005/006/701/027

Hill-Rom: Affinity 4 Birthing Bed

MOD 1331

Beds and accessories

Model: Frames (P3700B, P3700C, P3700D, & P3700E)

MHRA reference: 2021/005/027/487/021

Integra LifeSciences: Codman Bactiseal EVD Catheter Set

08 October 2020

Cerebrospinal fluid drainage, external

Model: 821750; 821749

MHRA reference: 2021/006/002/487/023

iQ HealthTech: iQemo chemotherapy prescribing system

02 May 2021

Drug dosage calculator

MHRA reference: 2021/002/023/401/011

ITP Innovative Tomography Product: Interventional Needle KIM/KIR, Biopsy Needle BIM

20 April 2021

Surgical instruments, minimal access

MHRA reference: 2021/005/025/487/021

Össur: Miami J Select

May 2021

Orthoses

MHRA reference: 2021/005/027/487/007

Randox Laboratories: NEFA (Non-esterified fatty acid)

10 May 2021/REC 527

IVDs, clinical chemistry

MHRA reference: 2021/005/026/601/003

Randox Laboratories: RX Imola

21 April 2021/REC513

IVDs, clinical chemistry

Model: RX4900 & RX4900R

MHRA reference: 2021/005/024/601/504

Roche Diagnostics: Cobas 6500

May 2021

IVDs, clinical chemistry

MHRA reference: 2021/005/027/487/022

Therapy Equipment: Diamond High Suction Controller

24 May 2021

Surgical equipment, miscellaneous

Model: 7701, 7705, 7852

MHRA reference: 2021/006/002/487/021

Tyromotion: Lexo

25 May 2021

Therapy, standing & walking

MHRA reference: 2021/005/018/601/003

Updates to this page

Published 7 June 2021