BEUDAMED
    FDA Enforcement Class II Completed

    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    Recall: Z-1490-2026 · Reported March 11, 2026

    Enforcement

    Recall Number
    Z-1490-2026
    Event ID
    98339
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    ESAOTE S.P.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2026
    Initiation Date
    March 14, 2025
    Classification Date
    March 3, 2026
    Address
    Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, N/A, Italy

    Description

    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    Reason

    A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

    Code Info

    UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.

    Distribution

    US: Nationwide distribution in the states of NC and TX.

    Quantity

    5 units