Recall Z-0133-2014— EKOS Corporation
Class II · Terminated
Class II FDA medical device recall by EKOS Corporation, initiated 2013-10-02, terminated 2013-11-22. It names 2 FDA 510(k) clearances: K111705, K081467. 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.. 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..
- Recalling firm
- EKOS Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-02
- Terminated
- 2013-11-22
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
2 on FDA's record- K111705 — EKOSONIC ENDOVASCULAR SYSTEM
- K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.