Z-2596-2011

Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment...

Name: Z-2596-2011 Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment...
Creator: Computerized Medical Systems Inc
Published: 2007-11-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2007-11-30 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring... on 2007-11-30. The reason FDA records is "Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will...". 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-2596-2011
Status: Terminated
Initiated: 2007-11-30
Posted: 2011-06-20
Terminated: 2014-04-10
Recalling firm: Elekta Limited
Product: Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 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: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (col
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.
Quantity in commerce: 233
Distribution: Worldwide Distribution - USA (Nationwide AL, AR, CA, DE, FL, GA, IL, IN, MA, MD, MI, MOP, NE, NY, OH, PA, RI, TX, VA, WA, WI, and WV and the countries of Albania, Argentina, Belgium, Bosnia and Herzegovina, Brazil, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Turkey, United Kingdom, Uruguay, and Venezuela.
Product codes and lots: Focal Release 4.3.0 through 4.34.01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)