BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1391-2018 · Initiated January 12, 2018

    Recall

    Recall Number
    Z-1391-2018
    Event Number
    79628
    Firm
    NeuroLogica Corporation
    FEI Number
    3004938766
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 12, 2018
    Terminated
    August 14, 2018
    Address
    14 Electronics Ave, Danvers, MA, 01923-1011

    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.

    Action

    A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503.

    Distribution

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

    Quantity

    16 units