BEUDAMED
    FDA Enforcement Class II Ongoing

    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

    Recall: Z-0136-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0136-2025
    Event ID
    95431
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B-K Medical A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    September 4, 2024
    Classification Date
    October 18, 2024
    Address
    Mileparken 34, N/A, Herlev, N/A, N/A, Denmark

    Description

    bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

    Reason

    The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

    Code Info

    All serial numbers, GTIN 05704916000264.

    Distribution

    Worldwide - US Nationwide - There was also government/military distribution and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

    Quantity

    1648 devices