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
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View . FSNs before this date are on the
Agilent: AriaDx Real-Time PCR System
06 June 2022
IVD, genetic testing
Model: K8930AA
MHRA reference:
Arrow International
June 2022
Vascular cannula and catheters
MHRA reference:
CareDx: SSP DR Low
22 June 2022
IVDs, immunology
MHRA reference:
Chiesi: LISAcath
MD-FSCA-CHIESI-2022-001
Feeding systems and tubes
MHRA reference:
Invacare: Action 3NG
10 June 2022
Wheelchairs, manual
MHRA reference:
Leica Biosystems: Leica Biosystems Tissue processor
June 2022
IVDs, cytopathology & histopathology
MHRA reference:
Medtronic: Valiant NavionTM Thoracic Stent Graft System
May 2022
Implants, non active, endoprostheses for aortic aneurysms
Model: All
MHRA reference:
Olympus Corporation: Soltive SuperPulsed Laser Fiber 150 Micron 150碌 BT SU Fiber, 5/Bx
01 June 2022
Therapy, lasers
MHRA reference:
Roche: VENTANA HE 600 System 06917259001
SBN-RDS-Pathology Lab-2022-002
IVDs, cytopathology & histopathology
MHRA reference:
Schwarzer Cardiotek: EP-TRACER
12 May 2022
Monitors, patient
Model: EP-TRACER 38, EP-TRACER 102
MHRA reference:
Siemens Healthineers: Sensis Vibe Combo systems with software VD12A
AX015/22/S
Electrophysiology measurement
MHRA reference:
Siemens Healthineers: ARTIS icono biplane
May 2022
X Ray, fluoroscopy systems
MHRA reference: