BEUDAMED
    FDA Enforcement Class II Terminated

    MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

    Recall: Z-2746-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2746-2018
    Event ID
    80615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 22, 2018
    Initiation Date
    June 29, 2018
    Classification Date
    August 10, 2018
    Termination Date
    October 2, 2018
    Address
    300 Foster St, Littleton, MA, 01460-2017, United States

    Description

    MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

    Reason

    QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.

    Code Info

    S250-0001 through S250-0006 and S250i-0007

    Distribution

    US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.

    Quantity

    7