Recall Z-2567-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.3.1 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 15, 2011 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re |
| Root cause | Software design |
| Action | Computerized Medical Systems, Inc. sent a "XiO CUSTOMER ADVISORY" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to "Yes" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00. Questions should be directed to the manufacturer's representative at 408-830-8023. |
| Quantity | 784 |
| Distribution | Worldwide Distribution-- USA (nationwide) including Puerto Rico and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, E |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |