Field Safety Notices: 16 to 20 September 2024
List of Field Safety Notices from 16 to 20 September 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 . FSNs before this date are on the
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: 聽聽 2024/008/027/601/009
Ziehm Imaging: Several Ziehm device types and OEM products
27 May 2024
VARIOUS DIAGNOSTIC AND INTEROPERATIVE BIOIMAGING
MHRA reference: 聽聽 2024/009/013/601/066
Getinge: Leg holder
04 April 2024
Leg procedure positioner
Model: 1003.80A0
MHRA reference: - FSN聽聽 2024/004/009/601/015
MHRA reference: - Reply form
Swemac Innovation AB: Motec Wrist Radius Hemi Prosthesis
13.09.2024
Updated FSN
Model: All batches/lots
MHRA reference: 聽聽 2024/005/006/601/075
Bruker Daltonics: UMIC Colistin
11.July.2024
Model: 240410COL, 240418COL, 240506COL
MHRA reference: 聽聽 2024/077/012/601/014
Serres Oy: Pre-gelled bag 2000 ml
23 August 2023
Model: 57567-0, LOT. 1109986
MHRA reference: 聽聽 2023/009/006/601/032
Exmoor Plastics Ltd: Exmoor Plastics Nasal Splints
06 April 2023
Nasal splints
Model: Refer to FSN
MHRA reference: 聽聽 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: 聽聽 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: 聽聽 2024/009/016/601/016
Royal College of Obstetricians & Gynaecologists (RCOG): Tommy鈥檚 Pathway: Clinical Decision Support Tool Version: 1.8.7
13.09.2024
MHRA reference: 聽聽 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: 聽聽 2024/009/011/601/074
Olympus: Thunderbeat Type 鈥� 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: 聽聽 2024/008/020/601/020
Olympus: Thunderbeat Type 鈥� S 鈥� 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 鈥� Refer to FSN for additional LOT numbers
MHRA reference: 聽聽 2024/008/020/601/020