Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. 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.
FDA Recall Z-2594-2011 · Posted 2011-06-20
Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2009-01-19
Date Terminated2014-04-10
Product Quantity31
Reason for Recall
Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.
Firm Action
Elekta CMS Software sent an "ADVISORY NOTICE" dated January 19, 2009 to its affected customers. The notice identified the product, the problem, and the acton to be taken. Customers were informed that the workaround method available is to (use the image fusion feature already in Focal to relign the scans). The firm states that this issue is resolved in Focal version 4.62.00, which was released in March 2011.
If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singapore, Spain, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.