FDA recall Z-0942-2022

Varian Medical Systems Imaging Laboratory GmbH · Class II · device

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status: Completed
Initiation date: 2022-03-21
Report date: 2022-04-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Baden, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2022