BEUDAMED
    FDA Enforcement Class II 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 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0133-2014
    Event ID
    66504
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EKOS Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 13, 2013
    Initiation Date
    October 2, 2013
    Classification Date
    November 1, 2013
    Termination Date
    November 22, 2013
    Address
    11911 N Creek Pkwy S, N/A, Bothell, WA, 98011-8809, United States

    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.

    Code Info

    PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.

    Distribution

    Worldwide Distribution in Germany only.

    Quantity

    one unit