Z-2604-2011

XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above

Name: Z-2604-2011 XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
Creator: Computerized Medical Systems Inc
Published: 2010-05-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-05-19 / 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 on 2010-05-19. The reason FDA records is "XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds...". 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-2604-2011
Status: Terminated
Initiated: 2010-05-19
Posted: 2011-06-20
Terminated: 2014-04-02
Recalling firm: Elekta Limited
Product: XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.
Root cause tag: software
FDA root cause: Software design
Action: A Safety Notice, dated 5/20/10, was sent to Elekta / Computerized Medical Systems Inc clients in May 2010. The notice indicates the problem, the clinical impact. The notice states a future XiO Release will resolve the issue. A return postcard is included with the mailing to verify consignee received the notice. For sites not returning the postcard by 5/28/10, the recalling firm will contact them via phone or email to confirm receipt of the notice. The notice also informed the consignees they would be contacted when a solution was available.
Quantity in commerce: 57
Distribution: Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil, Canada, Colombia, France, India, Ireland, Israel, Italy, Malaysia, Netherlands, Philippines, Poland, Spain, and United Kingdom.
Product codes and lots: XiO Release 4.50.00 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)