Z-0133-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2013
- Initiation Date
- October 2, 2013
- Termination Date
- November 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- one unit
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution in Germany only.
Code Information
PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.