BEUDAMED
    FDA Enforcement Class II Ongoing

    NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2

    Recall: Z-2217-2024 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2217-2024
    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 Traditional Ultrasound , REF: NSC-TCDNG2

    Reason

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

    Code Info

    UDI: 00850681007405/Serial Numbers: 21092746 21122802 21122803 21092748 21092749 21122804 21123066 23063826 22074381 23063828 22033706 22064206 22074380 21092747 22113115 23063825 21122805 21082646 23063856 23104174 21123068 22103022 22064204 22064205 21123067 22074378 22074379 23033578

    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

    28 systems