Device recall
Z-3092-2011: Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division…
FDA device recall · Class II · Covidien, PLC
Key facts
| Recall number (Z-number) | Z-3092-2011 |
|---|---|
| Recall event | 59754 |
| Product | Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures. |
| Product code | GEI |
| Recalling firm | Covidien, PLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2011 |
| 510(k) numbers | K011676 |
| FEI number | 1717344 |
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