BEUDAMED
    FDA Enforcement Class II Terminated

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    Recall: Z-2325-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2325-2016
    Event ID
    74691
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B-K Medical A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    June 28, 2016
    Classification Date
    August 3, 2016
    Termination Date
    August 29, 2016
    Address
    Mileparken 34, Herlev, N/A, Denmark

    Description

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    Reason

    In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.

    Code Info

    Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

    Distribution

    Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

    Quantity

    6