Company:Varian Medical Systems Oncology Systems.
Date of Enforcement Report 10/21/2009
Class:ll
PRODUCT
Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009
REASON
Software Issue/Mistreatment Potential — Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered..
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on July 17, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 units
DISTRIBUTION
TX
