Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Company
- Elekta Inc
- Recall Initiated
- July 3, 2019
- Recall Number
- Z-2091-2019
- Quantity
- 1396 units
- Firm Location
- Maryland Heights, MO
Reason for Recall
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.
Distribution
worldwide
Lot / Code Info
all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
Root Cause
Under Investigation by firm
Action Taken
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.
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