BEUDAMED
    FDA Recall Open, Classified

    EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.

    Recall: Z-0149-2023 · Initiated October 13, 2022

    Recall

    Recall Number
    Z-0149-2023
    Event Number
    90984
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    QEY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 13, 2022
    Posted
    October 28, 2022
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.

    Reason

    Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

    Action

    The recalling firm issued customer letters dated 10/13/2022 via FedEx overnight delivery on 10/13/2022 informing the customer certain serial numbers of the control units were shipped without an instruction for use (IFU) or contained an incorrect IFU. The customer was requested to complete and return the acknowledgment form to indicate receipt of the letter and the EKOS Control Unit 4.0 Instructions for Use (IFU). If the customer is a distributor, they are to follow the attached instructions (complete and return the acknowledgment form and place the provided IFU with their EKOS Control Unit 4.0 Console) and forward the notification to their customers. If the customer is a facility that has sent products to another hospital within their network, they are to follow the same attached instructions and ensure the notification is forwarded to the other hospitals if necessary.

    Distribution

    Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong.

    Quantity

    16 consoles