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Open, Classified

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 record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).

FDA Recall Z-2114-2025 · Posted 2025-07-11

Recalling FirmNeuroSync, Inc.
Recall StatusOpen, Classified
Product CodeQEA
Date Initiated2023-09-19
Product Quantity27 units

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.

Firm 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).

Root Cause

Device Design

Distribution Pattern

United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202927EYE-SYNCSyncthink, Inc. · 2021-10-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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