Drug recall
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per…
FDA recall event 66504 · Class II · EKOS Corporation
Key facts
| Event ID | 66504 |
|---|---|
| Recall numbers | Z-0133-2014 |
| Recalling firm | EKOS Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 2, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Nov 22, 2013 |
| City | Bothell |
| State | WA |
| Country | United States |
| FEI number | 3001627457 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: