Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. 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 4.3.0 through 4.50.00. 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 4.3.0 through 4.50.00
Products Sold
XiO Release 4.3.0 through 4.50.00
Computerized Medical Systems Inc is recalling XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. Used to create treatmen due to In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.
Recommended Action
Per FDA guidance
Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter dated May 2009, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Computerized Medical Systems, Inc have created "patches" to resolve the problem. A User Notice was sent in March 2011, to all users still using the affected software notifying them of the updated software available to correct the problem. This letter was sent by US Mail but no return receipt was included. 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