Device recall
Z-2114-2025: NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico…
FDA device recall · Class II · NeuroSync, Inc.
Key facts
| Recall number (Z-number) | Z-2114-2025 |
|---|---|
| Recall event | 97014 |
| Product | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in… |
| Product code | QEA |
| Recalling firm | NeuroSync, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K202927 |
| FEI number | 3014133165 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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