Device recall
Z-0535-2022: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or…
FDA device recall · Class II · DIXI MEDICAL USA
Key facts
| Recall number (Z-number) | Z-0535-2022 |
|---|---|
| Recall event | 89306 |
| Product | The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5… |
| Product code | GZL |
| Recalling firm | DIXI MEDICAL USA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2023 |
| 510(k) numbers | K170959 |
| FEI number | 3014527920 |
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