BEUDAMED
    FDA Enforcement Class II Ongoing

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    Recall: Z-0813-2024 · Reported January 31, 2024

    Enforcement

    Recall Number
    Z-0813-2024
    Event ID
    93598
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B-K Medical A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2024
    Initiation Date
    November 30, 2023
    Classification Date
    January 25, 2024
    Address
    Mileparken 34, N/A, Herlev, N/A, N/A, Denmark

    Description

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    Reason

    An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

    Code Info

    All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.

    Distribution

    US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID, IL, KS, MA, MD, MI, MO, NC, NE, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, and WV.

    Quantity

    N/A