Varian Medical Systems Imaging Laboratory GmbH recalls ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

Recall date

March 21, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0942-2022

FDA classification

Class II

Brand / firm

Varian Medical Systems Imaging Laboratory GmbH

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.

Why it was recalled

Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1