BEUDAMED
    FDA Enforcement Class II Ongoing

    Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

    Recall: Z-0827-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0827-2022
    Event ID
    89758
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mevion Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 6, 2022
    Initiation Date
    February 1, 2022
    Classification Date
    March 25, 2022
    Address
    300 Foster St, N/A, Littleton, MA, 01460-2017, United States

    Description

    Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

    Reason

    Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

    Code Info

    All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.

    Quantity

    39 (36 US, 3 OUS)