Company:Varian Medical Systems Oncology Systems
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
Varis, Aria Radiation Oncology – Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, 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. Recall # Z-1809-2009p>

REASON
Potential mistreatment– due to software issues, retired plans may be used and treated repeatedly.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 8, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,587 units

DISTRIBUTION
Nationwide and Internationally