Recall Z-0841-2013 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco RTP System. Radiation treatment planning.
| Date | Feb 20, 2013 (initiated Feb 11, 2013) |
| Status | Terminated |
| Reason | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. |
| Root cause | Nonconforming Material/Component |
| Action | Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice. |
| Quantity | 13 |
| Distribution | Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc., Jun 24, 2011 |