Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
Brand
Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland
Lot Codes / Batch Numbers
DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127, 00856100006165
Products Sold
DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165
Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland is recalling ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 due to Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong locatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location
Recommended Action
Per FDA guidance
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 returnresponse@varian.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026