Device recall
Z-1091-2022: ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System…
FDA device recall · Class II · Neuralynx Inc
Key facts
| Recall number (Z-number) | Z-1091-2022 |
|---|---|
| Recall event | 89843 |
| Product | ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB. |
| Product code | GXY |
| Recalling firm | Neuralynx Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3009391672 |
At a glance
- None 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