BEUDAMED
    FDA Enforcement Class II Ongoing

    ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

    Recall: Z-0038-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0038-2026
    Event ID
    97505
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ImaCor Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 15, 2025
    Initiation Date
    August 29, 2025
    Classification Date
    October 3, 2025
    Address
    50 Jericho Tpke Ste 105, Jericho, NY, 11753-1014, United States

    Description

    ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

    Reason

    Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

    Code Info

    Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

    Distribution

    US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.

    Quantity

    45 units