Device recall
Z-2396-2019: AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth…
FDA device recall · Class II · Ad-Tech Medical Instrument Corporation
Key facts
| Recall number (Z-number) | Z-2396-2019 |
|---|---|
| Recall event | 82719 |
| Product | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring… |
| Product code | GZL |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2022 |
| 510(k) numbers | K163355 |
| FEI number | 2183456 |
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