Recall Z-2408-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
| Date | Jun 3, 2011 (initiated Sep 10, 2010) |
| Status | Terminated |
| Reason | When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate. |
| Root cause | Software design |
| Action | Elekta / Computerized Medical Systems Inc began mailing an Important Safety Notice to all affected customers in September 2010. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised not to mix treatment plan information from multiple planning systems. Customers were asked to return the postcard as proof of receipt and their understanding of the Safety Notice. For questions regarding this recall call 408-830-8000. |
| Quantity | 1377 |
| Distribution | Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Sal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |