Class 2 Device Recall EKOS EkoSonic Control Unit

• Date Initiated by Firm: October 02, 2013
• Date Posted: November 01, 2013
• Recall Status: Terminated on November 22, 2013
• Recall Number: Z-0133-2014
• Recall Event ID: 66504
• 510(K)Number: K081467 K111705
• Product Classification: Catheter, continuous flush - Product Code KRA
• Product: 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.
• Code Information: PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.
• FEI Number: 3001627457
• Recalling Firm/ Manufacturer: EKOS Corporation; 11911 N Creek Pkwy S; Bothell WA 98011-8809
• For Additional Information Contact: Jocelyn Kersten; 425-415-3132
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Mixed-up of materials/components
• 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.
• Quantity in Commerce: one unit
• Distribution: Worldwide Distribution in Germany only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KRA; 510(K)s with Product Code = KRA