EKOS Corporation: Medical Device Recall in 2013 - (Recall #: Z-0133-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 2, 2013

Date Posted: November 13, 2013

Recall Number: Z-0133-2014

Event ID: 66504

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.

Status: Terminated

Product Quantity: one unit

Code Information:

PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.

Distribution Pattern:

Worldwide Distribution in Germany only.

Voluntary or Mandated:

Voluntary: Firm initiated