Reported Nov 13, 2013 · Terminated
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per…
EKOS Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EKOS Corporation · 11911 N Creek Pkwy S · Bothell, WA · 98011-8809
Is this the product you have?
- 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.
- Lot codes and dates
- PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.
- Amount recalled
- one unit
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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