Z-2574-2011

XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any...

Name: Z-2574-2011 XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any...
Creator: Computerized Medical Systems Inc
Published: 2008-05-14
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-05-14 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation... on 2008-05-14. The reason FDA records is "In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight". 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-2574-2011
Status: Terminated
Initiated: 2008-05-14
Posted: 2011-06-15
Terminated: 2014-04-08
Recalling firm: Elekta Limited
Product: XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
Product code: muj
Reason for recall: In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer. The issue was resolved in XiO Release 4.50.00 which has been available since June 2009. A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt. For further questions, please call ( 408) 380-8023
Quantity in commerce: 936
Distribution: Worldwide Distribution -- USA (nationwide) including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
Product codes and lots: XiO Release 1.5.0 and above

Product code muj

K092132Class IIXio Rtp SystemComputerized Medical Systems, Inc. / cleared 2009-09-24

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)