Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.0.0 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 4.0.0 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 4.0.0 through 4.40.00
Products Sold
XiO Release 4.0.0 through 4.40.00
Computerized Medical Systems Inc is recalling XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment due to XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.
Recommended Action
Per FDA guidance
The firm, CMS, Inc., sent a "XiO Customer Advisory" letter dated April 8, 2008 to all affected customers. The letter describes the product, the problem, and the actions to be taken ( workaround). The letter also states the problem will be resolved in a future release. No release number or date was given. If you have any 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