Device 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.
Z-0133-2014
Product summary
- Firm
- EKOS Corporation
- Event
- Event 66504
- Status
- Terminated
- Classification
- Class II
- Quantity
- one unit
- Official record key
device-enforcement:Z-0133-2014
Official wording
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 information: PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.
Distribution pattern: Worldwide Distribution in Germany only.
Derived failure modes
-
Unknown
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.