BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2091-2019 · Initiated July 3, 2019

    Recall

    Recall Number
    Z-2091-2019
    Event Number
    83273
    Firm
    Elekta Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 3, 2019
    Address
    13723 Riverport Dr, Ste 100, Maryland Heights, MO, 63043-4819

    Description

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

    Reason

    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.

    Action

    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.

    Distribution

    worldwide

    Quantity

    1396 units