Device recall
Z-2148-2015: The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic…
FDA device recall · Class II · EKOS Corporation
Key facts
| Recall number (Z-number) | Z-2148-2015 |
|---|---|
| Recall event | 71635 |
| Product | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug… |
| Product code | KRA |
| Recalling firm | EKOS Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2015 |
| 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