Recall Z-0133-2014 ยท KRA Catheter, Continuous Flush
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, includin
| Date | Nov 1, 2013 (initiated Oct 2, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |