BEUDAMED
    FDA Enforcement Class III Ongoing

    Philips OMNI II TEE Ultrasound Transducer

    Recall: Z-1623-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1623-2026
    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 OMNI II TEE Ultrasound Transducer

    Reason

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

    Code Info

    Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.

    Distribution

    US Nationwide distribution.

    Quantity

    2 units