Company: Varian Medical Systems, Inc
Date of Enforcement Report 4/27/2011
Class ll:

PRODUCT
Varian Medical Systems, Varis Vision – RT Chart version 7.3.10. For radiation therapy. Model number H83. Recall # Z-1957-2011

REASON
An issue with the Varis Vision software where treatment can occur without the dynamic Multileaf Collimator component and may deliver a higher than expected dose of radiation..

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on February 7, 2011. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
421 units

DISTRIBUTION
Nationwide and Internationally