Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
Brand
Computerized Medical Systems Inc
Lot Codes / Batch Numbers
XiO Release 1.5.0 and above
Products Sold
XiO Release 1.5.0 and above
Computerized Medical Systems Inc is recalling XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plan due to In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.
Recommended Action
Per FDA guidance
Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer. The issue was resolved in XiO Release 4.50.00 which has been available since June 2009. A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt. For further questions, please call ( 408) 380-8023
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026