BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1050-2023
    Event ID
    91467
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NovaSignal Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    December 16, 2022
    Classification Date
    February 1, 2023
    Address
    2440 S Sepulveda Blvd, N/A, Los Angeles, CA, 90064-1784, United States

    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.

    Code Info

    System (Tablet)UDI-DI/ Serial Numbers: 00850681007443/ 22040001, 00850681007443/ 22040002, 00850681007443/21021223 (00850681007221/ 21090003), 00850681007443/ 22064227 (00850681007221/ 21090004)

    Distribution

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

    Quantity

    4