ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
FDA Recall Z-0942-2022 · Posted None
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Recalling FirmVarian Medical Systems Imaging Laboratory GmbH
Recall StatusCompleted
Product CodeIYE
Date Initiated2022-03-21
Product Quantity14
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
Firm Action
On 3/21/22, Varian Medical Systems issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the recall, Varian asked consignees to take the following actions:
Please retain a copy of this document along with your most current product labeling.
Advise the appropriate personnel working in your radiotherapy department of the content of this letter.
This document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com.
Please complete the attached Return Response form provided. Kindly return the completed form to [email protected].
Root Cause
Software Design Change
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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