Company: Computerized Medical Systems Inc.
Date of Enforcement Report 8/24/11
Class ll:

PRODUCT
Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2596-2011

REASON
Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (color, rendering) in Focal can cause the MLC to discard individual leaf edits that do not match the MLC contour. Editing the structure properties in Focal can also cause the collimators to also change under certain circumstances.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 28, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
233 units

DISTRIBUTION
Nationwide and Internationally