Recall – Mismatched values in treatment planning application

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.