BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250i

    Recall: Z-0705-2019 · Reported January 16, 2019

    Enforcement

    Recall Number
    Z-0705-2019
    Event ID
    81751
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 16, 2019
    Initiation Date
    October 1, 2018
    Classification Date
    January 9, 2019
    Termination Date
    April 10, 2020
    Address
    300 Foster St, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250i

    Reason

    Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

    Code Info

    DI: (01)00864366000124 Serial Number: S250i-0007

    Distribution

    DC

    Quantity

    1 unit