BEUDAMED
    FDA Enforcement Class II Ongoing

    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

    Recall: Z-2406-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2406-2021
    Event ID
    88451
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    July 26, 2021
    Classification Date
    September 2, 2021
    Address
    1450 Beale St Ste 205, N/A, Saint Charles, MO, 63303, United States

    Description

    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

    Reason

    If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

    Code Info

    Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10

    Distribution

    Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom

    Quantity

    N/A