Z-1655-2010

Elekta XiO Radiation Treatment Planning System

Name: Z-1655-2010 Elekta XiO Radiation Treatment Planning System
Creator: Computerized Medical Systems Inc
Published: 2010-04-15
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-04-15 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Elekta XiO Radiation Treatment Planning System on 2010-04-15. The reason FDA records is "Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening". 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-1655-2010
Status: Terminated
Initiated: 2010-04-15
Posted: 2010-05-26
Terminated: 2012-06-07
Recalling firm: Elekta Limited
Product: Elekta XiO Radiation Treatment Planning System
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening
Root cause tag: software
FDA root cause: Software design
Action: Elekta issued an undated "Important Safety Notice" to all affected sites via e-mail on 4/20/2010. The notice was also sent to the sites on 4/6/10 and 4/12/10 (for 4 sites) before the firm made the decision to recall. The letter explains the correct functioning of the system, the problem, when and why it occurs, the clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed postcard was enclosed for the customer to return as evidence they received and understood the notice. Sites that do not return the card will be contacted by phone.
Quantity in commerce: The release is being used by 34 customers that also have an Elekta linear accelerator
Distribution: Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
Product codes and lots: 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)