Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions.
FDA Recall Z-1809-2009 · Posted 2009-08-27
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Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-05-08
Date Terminated2011-12-23
Product Quantity1,587 units
Reason for Recall
Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.
Firm Action
An Urgent Medical Device Correction Letter/ Field Safety Letter, dated May 8, 2009, were distributed to all affected users, with a description of the problem and user corrective action steps. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm intends to produce a software fix for the problem. If further clarification is needed, users should contact their Varian Customer Support District or Regional Manager.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution
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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