Device recall
Z-2138-2025: Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard…
FDA device recall · Class II · Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Key facts
| Recall number (Z-number) | Z-2138-2025 |
|---|---|
| Recall event | 97091 |
| Product | Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph |
| Product code | GWQ |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180290 |
| FEI number | 3002809369 |
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