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

PRODUCT
Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: 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-2599-2011

REASON
Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to snap back to the original positions.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by an Advisory Notice dated February 6, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
760 units

DISTRIBUTION
Nationwide and Internationally