BEUDAMED
    FDA Enforcement Class II Terminated

    Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated

    Recall: Z-2248-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2248-2017
    Event ID
    77261
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Communications
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    April 21, 2017
    Classification Date
    June 5, 2017
    Termination Date
    September 20, 2017
    Address
    1410 Lakeside Pkwy Ste 100, N/A, Flower Mound, TX, 75028-4026, United States

    Description

    Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated

    Reason

    The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.

    Code Info

    Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615

    Distribution

    Worldwide Distribution - US and Canada

    Quantity

    57 units