FDA-Device2022-04-20Class II
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Varian Medical Systems Imaging Laboratory GmbH
Hazard
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Sold states
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.
Affected count
14
Manufactured in
Tafernstrasse 7, DATTWIL, Baden, N/A, Switzerland
Products
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2022Don't want to check this manually?
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