Field Safety Notices: 7 to 11 April 2025
List of Field Safety Notices from 7 to 11 April 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 . FSNs before this date are on the
Beckman Coulter: DxC 500i Clinical Analyzer
28 March 2025
See Section 8
MHRA reference: 听听 2025/004/008/601/120
Farla Medical Ltd: Instramed
3 April 2025
MHRA reference: 听听 2025/004/008/601/023
Fresenius Kabi AG: COMPOSTOP FLEX 2F PLT PROC. LEUKO RED.
2 April 2025
MHRA reference: 听听 2025/003/025/601/050听
Galt Medical Corp: Guidewire Introducer Needle & Guidewire
1649395-03-28-2025-001-R
Vascular Catheter Introduction Needle
MHRA reference: 听听 2025/004/009/601/076
MHRA reference: 听听 2025/004/009/601/076
GE Medical Systems Ultrasound and Primary Care Diagnostics: Venue Go, Venue Fit
FMI 78101
Ultrasound system, imaging, general-purpose
MHRA reference: 听听 2025/004/008/601/113
IBA Dosimetry GmbH: myQA iON
24 March 2025
MHRA reference: 听听 2025/004/007/601/081
Intervascular SAS: HEMAPATCH WOVEN
April 2025
Graft, vascular, synthetic
Model: HEW100/100P (1); HEW25/100P (1) ; HEW25/50P (1) ; HEW50/50P (1) ; HEW75/75P (1)
MHRA reference: 听
Intuitive Surgical: Ion Endoluminal System
ISIFA2025-05-C
Surgical planning/navigation-enhancement system
Model: 380748
MHRA reference: 听听 2025/004/009/601/027
iSTAR Medical SA: MINIject S
Glaucoma supraciliary implant
MHRA reference: 听 2024/009/006/601/052
Maquet Cardiovascular, LLC: VASOVIEW HEMOPRO 2
March 2025
Model: VH-4000, VH-4001
MHRA reference: 听听 2025/004/008/601/151
Roche Diabetes Care Gmbh: Accu-Chek Spirit 3.15 ml cartridge system
SB_RDC_2024_05
PORTABLE MICRO INFUSION INSTRUMENTS 鈥� CONSUMABLES
MHRA reference: 听听 2025/004/008/601/144 鈥� Healthcare Professionals
MHRA reference: 听 听2025/004/008/601/144 鈥� Retailer/ Distributer
MHRA reference: 听听 2025/004/008/601/144 - Accu-Chek Spirit 3.15 ml cartridge Users
SCHILLER AG: FRED easyport
1 April 2025
Non-rechargeable professional semi-automated exter
Model: 3.940050
MHRA reference: 听 2025/003/028/601/033听听听
Welch Allyn: Refer to section 8 鈥淐omments鈥�
4 April 2025
Refer to section 8 鈥淐omments鈥�
MHRA reference: 听听听 2025/004/004/601/045