FDA-Device2019-08-07Class II
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Elekta Inc
Hazard
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.
Sold states
worldwide
Affected count
1396 units
Manufactured in
13723 Riverport Dr Ste 100, N/A, Maryland Heights, MO, United States
Products
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2019Don't want to check this manually?
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