BEUDAMED
    FDA Enforcement Class II Ongoing

    NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

    Recall: Z-2216-2024 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2216-2024
    Event ID
    94673
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NovaSignal Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 3, 2024
    Initiation Date
    May 6, 2024
    Classification Date
    June 27, 2024
    Address
    2440 S Sepulveda Blvd, Los Angeles, CA, 90064-1784, United States

    Description

    NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

    Reason

    Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

    Code Info

    UDI-DI: 00850681007399 (US devices), 00850681007481(Canadian devices)/Serial Numbers: 22123240 22033466 22023447 21041633 21122796 22043986 23053678 23033627 22123241 21102756 21102757 21091951 21122798 21041632 22064209 23033624 23033625 22064212 22064207 22064210 21081932 22064208 21041631 21051651 22113121 21102759 21081931 21081933 21122801 21091952 23063852 22113120 22113122 23053679 22113119 23053681 21102760 21122799 22103019 22113113 23063830 23023429 23023421 23063829 22123270

    Distribution

    Worldwide - US Nationwide distribution in the states of MA, TX, NY, MN, AZ, AL, CO, CA, OH, MO, FL, TN, NJ, GA, OK, KY, WA and the country of Canada.

    Quantity

    45 systems