Company: Accuray, Inc
Date of Enforcement Report 10/1/2008
Class:ll

PRODUCT
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher, Recall # Z-2056-2008

REASON
Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.

RECALLING FIRM/MANUFACTURER
Accuray, Inc., Sunnyvale, CA, by letter on April 16, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
109 units

DISTRIBUTION
Nationwide and Internationally