Z-2592-2011

Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment...

Name: Z-2592-2011 Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment...
Creator: Computerized Medical Systems Inc
Published: 2010-05-10
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-05-10 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods... on 2010-05-10. The reason FDA records is "Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated 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-2592-2011
Status: Terminated
Initiated: 2010-05-10
Posted: 2011-06-20
Terminated: 2014-04-02
Recalling firm: Elekta Limited
Product: Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above 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: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.
Root cause tag: software
FDA root cause: Software design
Action: Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround.
Quantity in commerce: 308
Distribution: Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkmenistan.
Product codes and lots: Focal Release 4.50.00 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)