BEUDAMED
    FDA Recall Terminated

    MEVION S250i

    Recall: Z-0705-2019 · Initiated October 1, 2018

    Recall

    Recall Number
    Z-0705-2019
    Event Number
    81751
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    October 1, 2018
    Terminated
    April 10, 2020
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    MEVION S250i

    Reason

    Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

    Action

    On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee.

    Distribution

    DC

    Quantity

    1 unit