Device product
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Z-2091-2019
Product summary
- Firm
- Elekta Inc
- Event
- Event 83273
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1396 units
- Official record key
device-enforcement:Z-2091-2019
Official wording
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.
Code information: all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
Distribution pattern: worldwide
Derived failure modes
-
Unknown
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.