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NeuroSync, Inc. recalls NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a p
Recalled July 23, 2025 · FDA recall Z-2114-2025 · NeuroSync
Hazard
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. · FDA Class II
Units
27 units
Sold at
United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).
Description
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.
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 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).
Manufacturer(s)
NeuroSync, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →