Company:Computerized Medical Systems Inc.
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above. Recall # Z-2604-2011

REASON
XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on May 20, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
57 units

DISTRIBUTION
Nationwide and Internationally