Field Safety Notices: 20 to 24 June 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 June 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
Agilent: AriaDx Real-Time PCR System
06 June 2022
IVD, genetic testing
Model: K8930AA
MHRA reference: 2022/006/006/601/508
Arrow International
June 2022
Vascular cannula and catheters
MHRA reference: 2022/006/021/596/003
CareDx: SSP DR Low
22 June 2022
IVDs, immunology
MHRA reference: 2022/006/024/595/001
Chiesi: LISAcath
MD-FSCA-CHIESI-2022-001
Feeding systems and tubes
MHRA reference: 2022/005/027/601/504
Invacare: Action 3NG
10 June 2022
Wheelchairs, manual
MHRA reference: 2022/006/010/701/029
Leica Biosystems: Leica Biosystems Tissue processor
June 2022
IVDs, cytopathology & histopathology
MHRA reference: 2022/006/008/593/005
Medtronic: Valiant NavionTM Thoracic Stent Graft System
May 2022
Implants, non active, endoprostheses for aortic aneurysms
Model: All
MHRA reference: 2021/002/018/291/009
Olympus Corporation: Soltive SuperPulsed Laser Fiber 150 Micron 150µ BT SU Fiber, 5/Bx
01 June 2022
Therapy, lasers
MHRA reference: 2022/005/012/596/001
Roche: VENTANA HE 600 System 06917259001
SBN-RDS-Pathology Lab-2022-002
IVDs, cytopathology & histopathology
MHRA reference: 2022/006/008/701/044
Schwarzer Cardiotek: EP-TRACER
12 May 2022
Monitors, patient
Model: EP-TRACER 38, EP-TRACER 102
MHRA reference:2022/005/006/701/046
Siemens Healthineers: Sensis Vibe Combo systems with software VD12A
AX015/22/S
Electrophysiology measurement
MHRA reference: 2022/006/013/601/502
Siemens Healthineers: ARTIS icono biplane
May 2022
X Ray, fluoroscopy systems
MHRA reference: 2022/005/020/601/004