Device recall
Z-0133-2014: The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power…
FDA device recall · Class II · EKOS Corporation
Key facts
| Recall number (Z-number) | Z-0133-2014 |
|---|---|
| Recall event | 66504 |
| 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… |
| Product code | KRA |
| Recalling firm | EKOS Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 22, 2013 |
| 510(k) numbers | K081467, K111705 |
| FEI number | 3001627457 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database