Company: Accuray Inc.
Date of Enforcement Report 2/9/2011
Class ll:

PRODUCT
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended 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-1008-2011.

REASON
If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.

RECALLING FIRM/MANUFACTURER
Accuray Inc, Sunnyvale, CA, by letter dated December 29, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
71

DISTRIBUTION
Nationwide and Internationally