BEUDAMED
    FDA Recall Open, Classified

    Philips eL18-4 EMT Transducer.

    Recall: Z-2053-2025 · Initiated May 28, 2025

    Recall

    Recall Number
    Z-2053-2025
    Event Number
    96994
    Firm
    Philips Ultrasound, Inc
    FEI Number
    2518586
    Product Code
    ITX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 28, 2025
    Posted
    July 2, 2025
    Address
    1 Echo Dr, Reedsville, PA, 17084-8603

    Description

    Philips eL18-4 EMT Transducer.

    Reason

    Ultrasound transducer devices were refurbished beyond their useful life.

    Action

    An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.

    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