Company:Varian Medical Systems, Inc.
Date of Enforcement Report 5/18/2011
Class ll:

PRODUCT
The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall #Z-2119-2011

REASON
A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17 units

DISTRIBUTION
Nationwide and Internationally