medical Class II Updated 2019-08-07

Elekta Inc recalls Monaco RTP System, software versions 5.10 and 5.11, Radiatio

Recalled Product

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Hazard / Issue

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.

Issued by

FDA

Distribution: worldwide
Lot/Code Info: all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
View official government recall

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