BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250 Radiation therapy system

    Recall: Z-0767-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0767-2016
    Event ID
    72210
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    November 18, 2015
    Classification Date
    February 8, 2016
    Termination Date
    April 3, 2017
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250 Radiation therapy system

    Reason

    The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.

    Code Info

    Manufacturing Lot or Serial Number: S250-0004

    Distribution

    US nationwide distribution including FL, NJ, OK, and MO.

    Quantity

    4