Recall Z-1209-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, Release 4.51.00.
| Date | Mar 25, 2010 (initiated Feb 22, 2010) |
| Status | Terminated |
| Reason | Inconsistent MLC positions, dose, and monitor units |
| Root cause | Software design |
| Action | Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023. |
| Quantity | Planning system is loaded 25 in locations |
| Distribution | Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |