Device recall
Z-1951-2012: AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and…
FDA device recall · Class II · Encision, Inc.
Key facts
| Recall number (Z-number) | Z-1951-2012 |
|---|---|
| Recall event | 61529 |
| Product | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling… |
| Product code | GEI |
| Recalling firm | Encision, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2012 |
| 510(k) numbers | K091074 |
| FEI number | 1000117361 |
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