Z-1209-2010

XiO Radiation Treatment Planning System, Release 4.51.00

Name: Z-1209-2010 XiO Radiation Treatment Planning System, Release 4.51.00
Creator: Computerized Medical Systems Inc
Published: 2010-02-22
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-02-22 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of XiO Radiation Treatment Planning System, Release 4.51.00 on 2010-02-22. The reason FDA records is "Inconsistent MLC positions, dose, and monitor units". 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-1209-2010
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-03-25
Terminated: 2011-08-24
Recalling firm: Elekta Limited
Product: XiO Radiation Treatment Planning System, Release 4.51.00.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Inconsistent MLC positions, dose, and monitor units
Root cause tag: software
FDA root cause: Software design
Action: Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
Quantity in commerce: Planning system is loaded 25 in locations
Distribution: Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
Product codes and lots: Release 4.51.00

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)