Device recall
Z-0479-2014: Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar…
FDA device recall · Class II · Aesculap, Inc.
Key facts
| Recall number (Z-number) | Z-0479-2014 |
|---|---|
| Recall event | 66533 |
| Product | Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. |
| Product code | GEI |
| Recalling firm | Aesculap, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2014 |
| 510(k) numbers | K952524 |
| FEI number | 2916714 |
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