BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 16, 2024

    Recall

    Recall Number
    Z-0231-2025
    Event Number
    95459
    Firm
    ImaCor Inc.
    FEI Number
    3006382185
    Product Code
    ITX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 16, 2024
    Posted
    October 25, 2024
    Address
    50 Jericho Tpke, Ste 105, Jericho, NY, 11753-1014

    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.

    Action

    ImaCor issued Inventory Correction for ImaCor ClariTEE Probe (CLT-010 and CLT-010-1) letter on 9/16/24. Letter states reason for recall, health risk and action to take: 1. Identify the Affected Devices o Please check your inventory for ClariTEE probes with lot numbers 20250509 and 20250823. Inform ImaCor of the number of applicable probes currently in inventory. 2. Prepare the Products for Return o Package the affected products securely to prevent damage during shipment. 3. Shipping Instructions o Please ship the affected products via FedEx using FedEx Account Number 665380920 to cover the shipping cost. Ship to: ImaCor Inc, 50 Jericho Turnpike, Suite 105, Jericho, NY 11753. Destination phone number is (516) 393-0970. o Attach a copy of this letter inside the package for reference. 4. Replacement Devices o Once we receive the returned devices, we will ship replacement probes to your facility. Replacement probes are expected to be available on or about October 15, 2024. Please return all affected devices by October 7. If you have any questions or need assistance, please contact Jenn Kujawski at [email protected]. Our team is ready to assist you with any inquiries and can provide additional details if needed.

    Distribution

    FL ,GA, NJ, TN

    Quantity

    73 units