Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. 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 4.3.1 through 4.40.00. 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 4.3.1 through 4.40.00. All lot or serial numbers.
Products Sold
XiO Release 4.3.1 through 4.40.00. All lot or serial numbers.
Computerized Medical Systems Inc is recalling XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatme due to XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly whe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re
Recommended Action
Per FDA guidance
Computerized Medical Systems, Inc. sent a "XiO CUSTOMER ADVISORY" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to "Yes" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00. Questions should be directed to the manufacturer's representative at 408-830-8023.
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