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.
FDA Recall Z-0133-2014 · Posted 2013-11-01
Recalling FirmEKOS Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2013-10-02
Date Terminated2013-11-22
Product Quantityone unit
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.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution in Germany only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.