Field Safety Notices: 17 to 21 March 2025
List of Field Safety Notices for 17 to 21 March 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
Arthrex INC: OATS® 2.0 Single-Use Set, 12 mm
R545
Orthopaedic osteotome
Model: ABS-8981-12S
MHRA reference: 35005107 2024/011/008/601/055
Beckman Coulter: DxC 500i Clinical Analyzer
7th March 2025
See section 8
MHRA reference: 35005098 2025/003/014/601/032
MHRA reference: 35005098 2025/003/014/601/032 – Vigilance response form
Beckman Coulter: DxC 500i Clinical Analyzer
13th March 2025
See Section 8
MHRA reference: 35028594 2025/003/018/601/085
MHRA reference: 35028594 2025/003/018/601/085 – Vigilance response form
Caesarea Medical Electronics Limited: BodyGuardTM MultiPurpose Infusion Pump System
11th September 2024
Ambulatory non-insulin infusion pump, electronic
MHRA reference: 34870431 2025/002/026/601/022
Canon Medical Systems Corporation: Vantage Orian, Vantage Elan, Vantage Titan
14th March 2025
Full-body MRI system, superconducting magnet
Model: MRT-1550, MRT-2020, MRT-1504, MRT-2004
MHRA reference: 35014991 2025/003/014/601/090
Covidien llc: Hugo™ RAS Arm Cart Assembly
March 2025
MHRA reference: 35046359 2025/001/027/601/065
GE Healthcare: Please see section 8 Comments
FMI 85480
MHRA reference: 35040388 2025/003/019/601/023
GE Medical Systems LLC : Revolution CT and Revolution Apex series
FMI 25504
Full-body CT system
MHRA reference: 35025644 2025/003/014/601/077
ICU Medical Inc: ProPort™ Plastic Implantable Ports
27th February 2025
Spinal port/catheter
Model: See FSN
MHRA reference: 35018979 2025/002/024/601/026
Medtronic Limited: Evolut PRO+, Evolut FX, Evolut FX+ Systems
March 2025
Transcatheter Aortic Valve
Model: EVPROPLUS-23, EVPROPLUS-26, EVPROPLUS-29, EVPROPLUS-34, EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, EVFXPLUS-23, EVFXPLUS-26, EVFXPLUS-29, EVFXPLUS-34
MHRA reference: 35044823 2025/003/019/601/037
PendraCare International B.V: CLIMBER
FSCA 25-001
Vascular Guide Catheter
Model: EBU 3.5
MHRA reference: 35042141 2025/002/025/601/045 - Letter
PFM medical: Kölner Drainage; Redon Bottle
30th March 2023
Manual wound suction syst; Closed-wound drainage
MHRA reference: 35005209 2023/004/011/601/007
Philips Medical Systems: Philips Allura and Azurion
13th January 2025
Interventional Fluoroscopic X-Ray System
Model: 722031722003722010722026722005
MHRA reference: 35026809 2025/001/015/601/013
Radiometer Medical ApS : ABL90 FLEX and ABL90 FLEX PLUS Analyzer
11th March 2025
See section 8
Model: 393-090, 393-092
MHRA reference: 35056560 - Letter
Siemens Healthcare Diagnostics Inc: Atellica CH Revised C-Reactive Protein (RCRP)
March 2025
See comments
Model: N/A
MHRA reference: 35042868 2025/003/013/601/080
Thoratec Corporation: HeartMate 3 Mobile Power Unit (MPU)
March 2025
Heart Ventricle Prosthesis
Model: 107758, 107758UK, L107758
MHRA reference: 35006306 2025/003/013/601/040
Thoratec Corporation: HeartMate 3 Mobile Power Unit (MPU)
March 2025
Heart Ventricle Prosthesis
Model: 107758, 107758UK, L107758
MHRA reference: 35006368 2025/003/013/601/040 - Letter
Wright Medical Technology Inc: TENDON SPACER (SWANSON/HUNTER) 24CM X 3MM FLEXSPAN
RA2024-3843283
MHRA reference: 35006173 2025/001/021/601/030