Recall Z-2574-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
| Date | Jun 15, 2011 (initiated May 14, 2008) |
| Status | Terminated |
| Reason | In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight. |
| Root cause | Software design |
| Action | Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer. The issue was resolved in XiO Release 4.50.00 which has been available since June 2009. A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt. For further questions, please call ( 408) 380-8023 |
| Quantity | 936 |
| Distribution | Worldwide Distribution -- USA (nationwide) including Puerto Rico, and 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |