Computerized Medical Systems Inc 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Computerized Medical Systems Inc
Lot Codes / Batch Numbers
Focal Release 4.3.0 through 4.34.01
Products Sold
Focal Release 4.3.0 through 4.34.01
Computerized Medical Systems Inc is recalling Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 (col
Recommended Action
Per FDA guidance
Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026