BEUDAMED
    FDA Recall Open, Classified

    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)

    Recall: Z-1050-2023 · Initiated December 16, 2022

    Recall

    Recall Number
    Z-1050-2023
    Event Number
    91467
    Firm
    NovaSignal Corp.
    FEI Number
    3013368530
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 16, 2022
    Posted
    February 1, 2023
    Address
    2440 S Sepulveda Blvd, Los Angeles, CA, 90064-1784

    Description

    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)

    Reason

    Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.

    Action

    On 12/16/22, recall notices were emailed to customers. Customers were told they would be contacted by the recalling firm to facilitate the proper disposition of affected devices. If an unexpected reboot occurs, the recalling firm recommends pausing the use of affected devices until unaffected devices arrive. Complete and return the customer response form. Customers with questions can contact Customer Operations at [email protected]

    Distribution

    US Nationwide and Worldwide Distribution: AZ, TX, SC, PA, IL. OUS: CA, SE, NL

    Quantity

    4