Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. 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 4.3.1 through 4.34.02. 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 4.3.1 through 4.34.02
Products Sold
Focal Release 4.3.1 through 4.34.02
Computerized Medical Systems Inc is recalling Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radiati due to Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open norm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as
Recommended Action
Per FDA guidance
Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008. The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403) 830-8023.
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