Recall Z-2091-2019 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
| Date | Jul 3, 2019 |
| Status | Open, Classified |
| Reason | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly. |
| Root cause | Under Investigation by firm |
| Action | Elekta began distribution of their Important Field Safety Notice to all affected customers from 07/03/2019 by email. The notice informs users of the specific product and version numbers affected by the issue, and any work-arounds that can be used to avoid the issue. The problem will be resolved in a future Monaco software release. |
| Quantity | 1396 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151233 | Monaco Impac Medical Systems, Inc., Jul 7, 2015 |