Elekta Inc Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Brand
Elekta Inc
Lot Codes / Batch Numbers
all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
Products Sold
all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
Elekta Inc is recalling Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System due to 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 we. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026