Field Safety Notices: 21 to 25 October 2024
List of Field Safety Notices from 21 to 25 October 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Navitor™/Navitor Titan™ Transcatheter Heart Valve
October 2024
Transcatheter Heart Valve
Model: NVRO-35, NVRO-29, NVTR-27, NVTR-29, NVRO-27
MHRA reference: 33694126 2024/010/017/601/012
Baxter: 5C4482, R5C4482, R5C4482E, R5C4483, R5C4484
October 2024
Tubing set, peritoneal dialysis
MHRA reference: 33686848 2024/010/022/601/029 – MOH letter
MHRA reference: 33686848 2024/010/022/601/029 – Customer letter
Baxter: HScribe, Vision Express,Q-Stress,XScribe,RScribe
23rd October 2024
Model: HScribe V4.0.0 – V4.34
MHRA reference: 33701600 2024/010/023/601/074
MHRA reference: 33701600 2024/010/023/601/074 - Letter
GE Healthcare: Centricity Universal Viewer Zero Footprint client
FMI85478
Medical Image Management System
MHRA reference: 33684284 2024/010/021/601/071
GS Elektromedizinische Geräte: Battery corpuls cpr (LiPo)
31st July 2024
Secondary Battery
Model: 09120
MHRA reference: 33614772 2024/009/004/601/022
Jenx: Ly-on
19th September 2024
MHRA reference: 33708088
Medtronic: McGrath MAC Video Laryngoscope
September 2024
VIDEO LARYNGOSCOPES
Model: 300-000-000, 301-000-000
MHRA reference: 33624276 2024/007/024/601/087
Olympus: UroPass® Ureteral Access Sheath Set
4th October 2024
Dilator, Catheter
Model: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX
MHRA reference: 32787869 2024/010/001/601/098
Philips: Philips Zenition 50 & Philips Zenition 70
11th October 2024
Interventional Fluoroscopic X-Ray System
Model: 718096 (Zenition 50) and 718133 (Zenition 70)
MHRA reference: 33703245 2024/009/030/601/016
SLE limited: Reusable and Single Use Flow Sensors
22 October 2024
Flow Sensors
MHRA reference: 33708695 2024/009/023/601/081
Storz: see comment
October 2024
MHRA reference: 33686557 2024/010/022/601/021
MHRA reference: 33686557 2024/010/022/601/021 - Covering letter
Terumo: COBE 2991 Cell Processor System
October 2024
Blood Collection Tubing Set
MHRA reference: 33620411 2024/010/018/601/038
Venclose: Venclose EVSRF Catheters
18th October 2024
Refer to comments
MHRA reference: 32980656 2024/009/026/601/068