Recall Z-2577-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
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.
| Date | Jun 16, 2011 (initiated Apr 8, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 75 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |