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

Recall date

July 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2091-2019

FDA classification

Class II

Brand / firm

Elekta Inc

Sold / distributed

worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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