Field Safety Notices: 4 to 8 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 July 2022.
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
CU Medical: Defibrillator (AED)
09 June 2022
Defibrillators, Non Implantable
Model: CU-SP1
MHRA reference: 2021/011/001/586/001
Dentsply Sirona: Calibra Esthetic Resin Cement
08 June 2022
Dental Materials
MHRA reference: 2022/007/005/701/125
Depuy: ATTUNE™ Measured Sizing & Rotation Guide Instrument
29 June 2022
Orthopaedic Surgical instruments
Model: 254400525
MHRA reference: 2022/006/030/613/005
GE: Carestation 750 - Carestation 750c
Ref 34125
Anaesthetic Machines & Monitors
MHRA reference: 2022/007/005/613/005
GE: Centricity PACS System
Ref 85463
Picture Archiving And Communication System (PACS)
Model: Software version number: Centricity PACS 7.0 SP0.0.4.7
MHRA reference: 2022/007/001/599/002
GE: Centricity Universal Viewer Zero Footprint client
Ref 85464
Picture Archiving And Communication System (PACS)
MHRA reference: 2022/006/028/599/004
HeartWare: Ventricular Assist System
June 2022
Implantable Ventricular Assist Devices
Model: 1650DE
MHRA reference: 2022/006/030/613/004
LINK: Endo-Model-M & Endo-Model SL (Tibial components)
23 May 2022
Joint Prosthesis, Knee
MHRA reference: 2022/005/023/701/011
Mallinckrodt: INOmax DSIR
22 June 2022
Nitric Oxide Delivery System
MHRA reference: 2022/006/029/701/128
NAL VON MINDEN: Drug-Screen® 7-ACL 200 Test
17 June 2022
IVDs, Clinical Chemistry
MHRA reference: 2022/006/030/701/055
Olympus: TJF-Q170V &TJF-Q190V & TJF-Q290
15 December 2021
Endoscopes, Flexible
MHRA reference: 2022/005/023/613/004
Schiller: DEFIGARD Touch-7
June 2022
Defibrillators, Non Implantable
MHRA reference: 2022/007/001/599/009
ThermoFisher Scientific: Remel
14 March 2022
IVDs, Bacteriology
Model: R4601503
MHRA reference: 2022/003/009/601/501