BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0827-2022 · Initiated February 1, 2022

    Recall

    Recall Number
    Z-0827-2022
    Event Number
    89758
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    LHN
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    February 1, 2022
    Address
    300 Foster St, Littleton, MA, 01460-2017

    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.

    Action

    Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers. Customers are instructed to complete and return the acknowledgement receipt. Please contact Mevion Customer service ([email protected]) with any questions or concerns.

    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)