Field Safety Notices: 29 July to 2 August 2024
List of Field Safety Notices from 29 July to 2 August 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: HeartMate 3 System Controller
July 2024
Heart Ventricle Prosthesis
106524INT, 106531INT, 106531LF2
MHRA reference: 31452267
MHRA reference: 31376846 - Letter
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
19th July 2024
See Section 8
C11137
MHRA reference: 31364293
MHRA reference: 31364293 - Vigilance Response Form
Beckman Coulter : IRISpec CA/CB/CC
19th July 2024
Multiple urine analyte IVD, control
800-7702
MHRA reference: 31372911
MHRA reference: 31372911 - Vigilance Response Form
Beckman Coulter: IRISpec CA/CB/CC
001102
Multiple urine analyte IVD, control
800-7211 (NORTH AMERICA), 800-7702 (INTERNATIONAL)
MHRA reference: 31376942 – Customer letter
MHRA reference: 31376942 – Vigilance Response Form
Beckman Coulter: Access HBc Ab
24th July 2024
See Section 8
Model: 34240
MHRA reference: 31381600
MHRA reference: 31381600
MHRA reference: 31381600 - Vigilance Response Form
Carl Reiner: EasyConnect™ Adapter for 2 to 4 Lumen Jet Catheter
4th July 2024
Adaptor, endoscope element
MHRA reference: 31377372
GE HealthCare: Proteus XR/a
FMI 17144
Stationary basic diagnostic x-ray system, analogue
MHRA reference: 31378512
Laborie: Flowstar
16th July 2024
Model: U2-1
MHRA reference: 31369249
MEGADYNE: See Attachment 3
16th June 2024
Electrosurgical return electrode, reusable
MHRA reference: 31362659
Medevio: Blueflow Venous Stent devices
19th July 2024
FG-02234-004A
MHRA reference: 31377374
Paradigm Spine: HPS 2.0 Rod coupler, S=25N/mm, 27mm
July 2024
Spinal dynamic-stabilization system
MHRA reference: 31376875
Schiller: CARDIOVIT AT-180
23rd July 2024
Electrocardiograph, professional, multichannel
3.920570
MHRA reference: 31366042
THOR Photomedicine: NovoTHOR and NovoTHOR XL
19th April 2024
Phototherapy unit, red light, line-powered
Model: S2188 and S2190
MHRA reference: 30919715