BEUDAMED
    FDA Recall Terminated

    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Recall: Z-1122-2017 · Initiated December 16, 2016

    Recall

    Recall Number
    Z-1122-2017
    Event Number
    76090
    Firm
    Mevion Medical Systems, Inc.
    FEI Number
    3007087027
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 16, 2016
    Posted
    February 2, 2017
    Terminated
    April 13, 2017
    Address
    300 Foster Street, Littleton, MA, 01460-2017

    Description

    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    Reason

    An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

    Action

    Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact [email protected].

    Distribution

    US Nationwide in the states of OK, NJ

    Quantity

    2 units