BEUDAMED
    FDA Enforcement Class III Ongoing

    Philips X3-1 Ultrasound Transducer

    Recall: Z-1627-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1627-2026
    Event ID
    97643
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2026
    Initiation Date
    September 5, 2025
    Classification Date
    March 24, 2026
    Address
    1 Echo Dr, Reedsville, PA, 17084-8603, United States

    Description

    Philips X3-1 Ultrasound Transducer

    Reason

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

    Code Info

    Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.

    Distribution

    US Nationwide distribution.

    Quantity

    17 units