BEUDAMED
    FDA Enforcement Class II Terminated

    Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

    Recall: Z-1391-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1391-2018
    Event ID
    79628
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NeuroLogica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 25, 2018
    Initiation Date
    January 12, 2018
    Classification Date
    April 17, 2018
    Termination Date
    August 14, 2018
    Address
    14 Electronics Ave, Danvers, MA, 01923-1011, United States

    Description

    Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

    Reason

    While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

    Code Info

    Model Number GMR40. Serial numbers 00001 through 00016.

    Distribution

    US Distribution . Only one consignee was shipped 16 units of the affected device.

    Quantity

    16 units