Field Safety Notices: 1 to 5 November 2021
List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 November 2021
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 the latest FSNs
View a list of FSNs published since January 2020
FSNs before this date are on the National Archives website
CareDx: SCORE 6
29 October 2021
IVDs, immunology
MHRA reference: 2021/011/001/579/013
Getinge: Customized tubing sets
28 October 2021
Infusion & transfusion, heart lung circuits
MHRA reference: 2021/011/001/579/014
Intelerad: IntelePACS
01 November 2021
Picture archiving and communication system (PACS)
Model: Enhanced Viewer
MHRA reference: 2021/011/001/601/001
Matrix Diagnostics: GHB Urine Cassette Test
26 October 2021
IVDs, extra laboratory testing
Model: MD1700
MHRA reference: 2021/010/026/601/002
Moog: FreeGo Pump
26 October 2021
Feeding systems and tubes
Model: 5400
MHRA reference: 2021/011/002/579/009
Owens and Minor: Sterling Zero Nitrile Powder-Free Exam Glove
14 October 2021
Gloves, surgical & examination
MHRA reference: 2021/010/021/291/002
Pajunk: SPROTTE NRFit
25 October 2021
Injection devices
Model: 051163-29A
MHRA reference: 2021/010/025/601/500
Philips: Philips Allura Xper and Azurion systems
October 2021
X Ray, fluoroscopy systems
Model: 722001, 722002, 722003, 722005, 722006, 722008, 722010
MHRA reference: 2021/011/003/579/008
Siemens Healthineers: ARTIS icono / pheno
October 2021
X Ray, fluoroscopy systems
Model: Cardio/Angio System
MHRA reference: 2021/010/011/601/002
Trinity Biotech: Bartels ELISA Legionella Urinary Antigen
21 October 2021
IVDs, bacteriology
MHRA reference: 2021/011/003/579/011