Z-2594-2011

Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above

Name: Z-2594-2011 Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above
Creator: Computerized Medical Systems Inc
Published: 2009-01-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2009-01-19 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: for use in radiation treatment planning using generally accepted... on 2009-01-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2594-2011
Status: Terminated
Initiated: 2009-01-19
Posted: 2011-06-20
Terminated: 2014-04-10
Recalling firm: Elekta Limited
Product: 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 31
Distribution: 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.
Product codes and lots: Focal Release 4.40.00 and above

Product code MUJ

K013112Class IIFocal SimComputerized Medical Systems, Inc. / cleared 2001-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)