Field Safety Notices: 13 to 17 January 2025
List of Field Safety Notices from 13 to 17 January 2025.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Baxter: Braun Pro 6000
26 June 2024
Infrared patient thermometer, ear
Model: Refer to FSN
MHRA reference: 34454081 2024/006/026/601/029
Baxter: Control-A-Flo Solution Administration Set with Needle Y-site
14th January 2025
FLOW REGULATOR SET
Model: Refer to FSN
MHRA reference: 34440212 2025/001/014/601/029
Illumina: NovaSeq 6000Dx Instrument including DRAGEN Server and Illumina DRAGEN Server for NextSeq 550Dx
16 January 2025
Nucleic acid sequence analyser IVD, NGS
Model: Refer to FSN
MHRA reference: 34465698 2025/001/015/601/035
Kirwan: Disposable Bipolar Pencil 25GA Straight
19th November 2024
Model: Refer to FSN
MHRA reference: 34429079 2024/011/019/601/046
Loewenstein Medical: Elisa 300, Elisa 500, Elisa 600, Elisa 800VIT
07.01.2025
Critical Care Ventilator
Software update
Model: Refer to FSN
MHRA reference: 34440538 BfArM xxxxx/24
Medline: Electrosurgical Electrode - UPDATED FSN
09 January 2025
FSN 24-02
Update to FSN issued in April 2024 – MHRA ref 29296734
Additional lot numbers are impacted by this new recall
Model: see Annex 1
MHRA reference: 34402496 2024/004/018/601/041
Medtronic: Percept™ PC Implantable Neurostimulator (INS) Model B35200 Unable to be Interrogated – UPDATED FSN
January 2025
Software Update
Medtronic Reference: FA1231
Model: Refer to FSN
MHRA reference: 34458244 2022/004/001/291/004
Medtronic: Percept™ PC Model B35200 Implantable Neurostimulator (INS) – UPDATED FSN
January 2025
INS Failure After Cardioversion - Software Update
Medtronic Reference: FA1206
Model: Refer to FSN
MHRA reference: 34458194 2021/010/015/579/002
Philips: Azurion and Allura Xper series – Follow up FSN
15 November 2024
Interventional Fluoroscopic X-Ray System
Follow up to FSN issued in June 2023 - MHRA ref. 5303178
Model: Refer to FSN
MHRA reference: 34417413 2023/006/008/601/030
Philips: Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5
01 October 2024
Magnetic Resonance Imaging (MRI) unit
Model: Refer to FSN
MHRA reference: 34453566 2024/004/026/601/037
Philips: Tack Endovascular System
January 2025
Multiple peripheral artery stent, bare metal
Model: Refer to FSN
MHRA reference: 34425077 2025/001/013/601/032
Vygon: LIFECATH PICC+MST DOUBLE 4.5FG B10
10.01.2025
Catheters, Central Venous, Peripherally Inserted
Batch/LOT: 101024GT
MHRA reference: 34424440 2025/001/013/601/053
Zimmer Biomet: Optipac® Vacuum mixing system
16 January 2025
Orthopaedic cement, antimicrobial
Model: Refer to FSN Attachment 2 - Affected Product List
MHRA reference: 34467376 2025/001/016/601/099