Z-1644-2012

XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any...

Name: Z-1644-2012 XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any...
Creator: Computerized Medical Systems Inc
Published: 2012-04-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-04-30 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient for whom external beam radiation... on 2012-04-30. The reason FDA records is "XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator". 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-1644-2012
Status: Terminated
Initiated: 2012-04-30
Posted: 2012-05-22
Terminated: 2014-04-01
Recalling firm: Elekta Limited
Product: XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator.
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems, Inc. sent an Important Safety Notice the week of April 30, 2012, by regional support managers via e-mail, fax, or regular mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. North American customers were instructed to go to www.elekta.com, select the SupportPlus Login at the top of the page, enter their portal, select Downloads/Updates to download the latest patches. For Customers outside North America, go to www.elekta.com, select the SOFTWARE button on the left, Treatment Planning Software, then Contact TPS Support tab, Download TPS Software Patches. ............................................................. Customers were also instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. For questions regarding this recall call 408-380-8023.
Quantity in commerce: 1,652 sites received the versions
Distribution: Worldwide Distribution - USA (nationwide) and the country of Canada
Product codes and lots: Versions 4.30.00, 4.31.00, 4.32.00, 4.33.00, 4.33.01, 4.33.02, 4.34.00, 4.34.01, 4.34.02, 4.40.00, 4.40.04, 4.40.05, 4.41.00, 4.41.01, 4.41.02, 4.42.00, 4.43.00, 4.44.01, 4.44.02, 4.44.03, 4.44.04, 4.45.00, 4.46.00, 4.46.01, 4.47.00, 4.50.00, 4.50.01, 4.50.02, 4.50.03, 4.50.04, 4.51.00, 4.51.01, 4.51.02, 4.60.00, 4.60.01, 4.61.00, 4.62.00, 4.62.01, 4.62.02, 4.62.03, 4.62.04, 4.62.05, 4.62.06, 4.63.00, and 4.64.00.

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)