NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a p
FDA device recall Z-2114-2025 · posted 2025-07-11 · Open, Classified
Recall details
- Recalling firm
- NeuroSync, Inc.
- Reason for recall
- Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
- Action taken
- NeuroSync notified affected customers beginning on 09/19/2024 via direct email and telephone calls. Customers were instructed to discontinue use of the affected Pico 2 device, return or decommission the unit, and transition to the new replacement system provided (Pico 3 platform).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- QEA
- Quantity affected
- 27 units
- Distribution
- United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).
- Date initiated
- 2023-09-19
- Date posted
- 2025-07-11
- Location
- Holliston, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EYE-SYNC (K202927) | Syncthink, Inc. | 2021-10-02 |