FDA Medical Device Recalls (openFDA)
EKOS Corporation: 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.
- Recall number
- Z-0133-2014
- Recalling firm
- EKOS Corporation
- 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.
- Status
- Terminated
- Initiated
- 2013-10-02
- Posted
- 2013-11-01
- Terminated
- 2013-11-22
- 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.
- Root cause
- Mixed-up of materials/components
- Action
- EKOS notified their customer by email on October 2, 2013, about the recall. EKOS has requested the customer to return of EkoSonic Control Unit PT3B-783, so that it can be replaced. CORRECTIVE ACTION: This single affected unit will be reworked with the correct power entry module and released into finished goods as a refurbished control unit. EKOS did not distributed any affected devices in the US. For any questions, please call EKOS Corporation at 425-415-3100.
- Quantity
- one unit
- Distribution
- Worldwide Distribution in Germany only.
- Lot, serial or model codes
- PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.
- 510(k) numbers
- ["K081467","K111705"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3001627457
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28