Company: Varian Medical Systems
Date of Enforcement Report 2/2/2011
Class ll:

PRODUCT
4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Designed to assist the operator of a radiation device in providing accurate treatment set-ups 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. Model Number H48. Recall # Z-0932-2011
.

REASON
Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on December 14, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4188

DISTRIBUTION
Nationwide and Internationally