Recall Z-2114-2025 ยท QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
NeuroSync, Inc.
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 support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to reco
| Date | Jul 11, 2025 (initiated Sep 19, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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). |
| Quantity | 27 units |
| Distribution | United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202927 | EYE-SYNC Syncthink, Inc., Oct 2, 2021 |