Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. 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 4.34.00 through 4.50.00. 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 4.34.00 through 4.50.00
Products Sold
Focal Release 4.34.00 through 4.50.00
Computerized Medical Systems Inc is recalling Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For use in radia due to Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.
Recommended Action
Per FDA guidance
Computerized Medical System sent a CUSTOMER ADVISORY dated June 12, 2009, to all affected users. This advisory identified the product, the problem, and the action needed to be taken by the customer. There were no patients mistreated as a result of this issue 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