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Elekta Inc recalls Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Recalled August 7, 2019 · FDA recall Z-2091-2019 · Elekta
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. · FDA Class II
Units
1396 units
Sold at
worldwide
Description
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.
Product
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Manufacturer(s)
Elekta Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →