BEUDAMED
    FDA Enforcement Class II Ongoing

    ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1

    Recall: Z-0231-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0231-2025
    Event ID
    95459
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ImaCor Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 16, 2024
    Classification Date
    October 25, 2024
    Address
    50 Jericho Tpke Ste 105, N/A, Jericho, NY, 11753-1014, United States

    Description

    ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1

    Reason

    Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.

    Code Info

    UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823

    Distribution

    FL ,GA, NJ, TN

    Quantity

    73 units