U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Catheter, continuous flush - Product Code KRA
원인
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.
조치
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.
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.