BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0038-2026 · Initiated August 29, 2025

    Recall

    Recall Number
    Z-0038-2026
    Event Number
    97505
    Firm
    ImaCor Inc.
    FEI Number
    3006382185
    Product Code
    ITX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 29, 2025
    Posted
    October 3, 2025
    Address
    50 Jericho Tpke, Ste 105, Jericho, NY, 11753-1014

    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.

    Action

    ImaCor, Inc. notified consignees on 08/29/2025 via email. Consignees were instructed to Immediately discontinue use of the affected ClariTEE probes, quarantine all affected units in inventory, confirm receipt of this notice, return all affected units to ImaCor, and complete and return the response form.

    Distribution

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

    Quantity

    45 units