Device recall
Z-0864-2016: EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three…
FDA device recall · Class II · EKOS Corporation
Key facts
| Recall number (Z-number) | Z-0864-2016 |
|---|---|
| Recall event | 73195 |
| Product | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use… |
| Product code | KRA |
| Recalling firm | EKOS Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2016 |
| 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