Company: Varian Medical Systems Imaging Laboratory GmbH
Date of Enforcement Report: 4/20/2022
Class II
PRODUCT
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Recall Number:
Z-0942-2022
REASON
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Imaging Laboratory GmbH on 3/21/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
14
DISTRIBUTION
U.S. Nationwide and International