Z-2572-2011

Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radiation...

Name: Z-2572-2011 Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radiation...
Creator: Computerized Medical Systems Inc
Published: 2008-03-31
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-03-31 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radiation treatment planning using generally accepted contouring... on 2008-03-31. The reason FDA records is "Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked...". 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-2572-2011
Status: Terminated
Initiated: 2008-03-31
Posted: 2011-06-15
Terminated: 2014-04-09
Recalling firm: Elekta Limited
Product: Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. 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: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008. 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.
Quantity in commerce: 307
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, and Venezuela.
Product codes and lots: Focal Release 4.3.1 through 4.34.02

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)