Z-2582-2011

XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any...

Name: Z-2582-2011 XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any...
Creator: Computerized Medical Systems Inc
Published: 2010-11-16
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-11-16 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation... on 2010-11-16. The reason FDA records is "XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values...". 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-2582-2011
Status: Terminated
Initiated: 2010-11-16
Posted: 2011-06-17
Terminated: 2014-04-03
Recalling firm: Elekta Limited
Product: XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescribed.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati
Root cause tag: software
FDA root cause: Other
Action: Elekta CMS Software drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was distributed to all affected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be available in July 2011.
Quantity in commerce: 556
Distribution: Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam
Product codes and lots: Release 4.50 and higher

Product code MUJ

K102216Class IIXio Rtp SystemComputerized Medical Systems, Inc. / cleared 2010-10-01

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)