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Field Safety Notices: 16 to 20 September 2024

Medicines Healthcare Products Regulatory Agency

September 23
10:30 2024

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

Philips: Azurion, Allura Xper, Integris and MultiDiagnost Eleva

22 August 2024

Interventional Fluoroscopic X-Ray System

Model: Refer to FSN

Serial numbers: See Units Affected List for C&R 2023-IGT-BST-006

MHRA reference: 31896827 2024/008/027/601/009

Ziehm Imaging: Several Ziehm device types and OEM products

27 May 2024

VARIOUS DIAGNOSTIC AND INTEROPERATIVE BIOIMAGING

MHRA reference: 31896162 2024/009/013/601/066

Getinge: Leg holder

04 April 2024

Leg procedure positioner

Model: 1003.80A0

MHRA reference: 31895217 - FSN 2024/004/009/601/015

MHRA reference: 31895217 - Reply form

Swemac Innovation AB: Motec Wrist Radius Hemi Prosthesis

13.09.2024

Updated FSN

Model: All batches/lots

MHRA reference: 31909312 2024/005/006/601/075

Bruker Daltonics: UMIC Colistin

11.July.2024

Model: 240410COL, 240418COL, 240506COL

MHRA reference: 31895212 2024/077/012/601/014

Serres Oy: Pre-gelled bag 2000 ml

23 August 2023

Model: 57567-0, LOT. 1109986

MHRA reference: 31879748 2023/009/006/601/032

Exmoor Plastics Ltd: Exmoor Plastics Nasal Splints

06 April 2023

Nasal splints

Model: Refer to FSN

MHRA reference: 31866862 2023/003/028/601/038

Abbott: Alinity m System, Alinity m HR HPV AMP Kit & Alinity m STI AMP Kit

11 September 2024

Model: Refer to FSN

MHRA reference: 31945167 2024/009/016/601/026

illumina: NovaSeq 6000Dx Instrument including DRAGEN Server, Illumina DRAGEN Server for NextSeq 550Dx

17 September 2024

Nucleic acid sequence analyser IVD, NGS

Model: 20068232

MHRA reference: 31945051 2024/009/016/601/016

Royal College of Obstetricians & Gynaecologists (RCOG): Tommys Pathway: Clinical Decision Support Tool Version: 1.8.7

13.09.2024

MHRA reference: 32397983 2024/009/009/601/079

Semeda: ALFA-Flex, BETA-Flex

16.07.2024

Orthosis ankle/foot. Foot abduction splints

Model: Refer to FSN

MHRA reference: 32352074 2024/009/011/601/074

Olympus: Thunderbeat Type S

26 September 2023

Soft-tissue ultrasonic surgical system holder/tip

Model: TB-0535FCS for Thunderbeat Type S, 35 cm and TB-0545FCS for Thunderbeat Type S, 45 cm

MHRA reference: 32400906 2024/008/020/601/020

Olympus: Thunderbeat Type S Updated FSN

16 January 2024

Soft-tissue ultrasonic surgical system holder/tip

Model: TB-0535FCS for Thunderbeat Type S, 35 cm and TB-0545FCS for Thunderbeat Type S, 45 cm Refer to FSN for additional LOT numbers

MHRA reference: 32426598 2024/008/020/601/020

Updates to this page

Published 23 September 2024

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