BEUDAMED
    FDA Recall Terminated

    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    Recall: Z-0133-2014 · Initiated October 2, 2013

    Recall

    Recall Number
    Z-0133-2014
    Event Number
    66504
    Firm
    EKOS Corporation
    FEI Number
    3001627457
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 2, 2013
    Posted
    November 1, 2013
    Terminated
    November 22, 2013
    Address
    11911 N Creek Pkwy S, Bothell, WA, 98011-8809

    Description

    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    Reason

    The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.

    Action

    EKOS notified their customer by email on October 2, 2013, about the recall. EKOS has requested the customer to return of EkoSonic Control Unit PT3B-783, so that it can be replaced. CORRECTIVE ACTION: This single affected unit will be reworked with the correct power entry module and released into finished goods as a refurbished control unit. EKOS did not distributed any affected devices in the US. For any questions, please call EKOS Corporation at 425-415-3100.

    Distribution

    Worldwide Distribution in Germany only.

    Quantity

    one unit