Device recall
Z-1216-2019: Neuro Omega System, incorporating HaGuide software. For neurological and…
FDA device recall · Class I · Alpha Omega Engineering
Key facts
| Recall number (Z-number) | Z-1216-2019 |
|---|---|
| Recall event | 82540 |
| Product | Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue. |
| Product code | GZL |
| Recalling firm | Alpha Omega Engineering |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 3, 2020 |
| 510(k) numbers | K123796, K171581 |
| FEI number | 3001610756 |
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