BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

    Recall: Z-3211-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3211-2017
    Event ID
    77996
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 4, 2017
    Initiation Date
    August 14, 2017
    Classification Date
    September 22, 2017
    Termination Date
    May 29, 2018
    Address
    5101 Shady Oak Rd S, N/A, Minnetonka, MN, 55343-4100, United States

    Description

    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

    Reason

    incorrect thread on thumbscrews

    Code Info

    Serial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659

    Distribution

    IL, OR, PA

    Quantity

    6 screws