Company: Accuray, Inc.
Date of Enforcement Report 1/28/2009
Class:ll

PRODUCT
Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-0629-2009

REASON
System may use random incorrect data to calculate dose. Resulting dose calculation can exceed 100% of correct dose

RECALLING FIRM/MANUFACTURER
Accuray, Inc., Sunnyvale, CA, by letter dated November 14, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4 units

DISTRIBUTION
Nationwide