BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips eL18-4 Transducer.

    Recall: Z-2052-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2052-2025
    Event ID
    96994
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2025
    Initiation Date
    May 28, 2025
    Classification Date
    July 2, 2025
    Address
    1 Echo Dr, Reedsville, PA, 17084-8603, United States

    Description

    Philips eL18-4 Transducer.

    Reason

    Ultrasound transducer devices were refurbished beyond their useful life.

    Code Info

    Model No.989605456291, 989605431531; UDI: (01)00884838070813(21)B2JXFM, (01)00884838070813(21)B25L9M, (01)00884838070813(21)B25LJ0, (01)00884838070813(21)B25LY7, (01)00884838070806(21)B29W04; Serial No. B2JXFM, B25L9M, B28MJZ, B25LJ0, B25LY7, B29W04.

    Distribution

    Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.

    Quantity

    5,230 units