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.
This recall has been terminated (originally issued June 16, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- April 8, 2008
- Posted
- June 16, 2011
- Terminated
- April 8, 2014
- Recall Number
- Z-2577-2011
- Quantity
- 75
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.
Lot / Code Info
XiO Release 4.0.0 through 4.40.00
Root Cause
Software design
Action Taken
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.