BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250, used for proton radiation therapy.

    Recall: Z-0588-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0588-2015
    Event ID
    69778
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 17, 2014
    Initiation Date
    November 10, 2014
    Classification Date
    December 11, 2014
    Termination Date
    March 18, 2015
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250, used for proton radiation therapy.

    Reason

    Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.

    Code Info

    Serial Number: S250-0001

    Distribution

    US Distribution in the state of MO

    Quantity

    1