Device recall
Z-0626-2019: Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-0626-2019 |
|---|---|
| Recall event | 81595 |
| Product | Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. |
| Product code | NEY |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K163105 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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