20
Apr
2022

Recall – Mismatched values in treatment planning application

,
0

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

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