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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66504
Product Type Devices
Status Ongoing
Recalling Firm EKOS Corporation
City Bothell
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution in Germany only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. PT3B-783. PT3B represents the model number. Adding 783 creates the serial number. Class II 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. one unit Z-0133-2014