FDA recall Z-2114-2025

NeuroSync, Inc. · Class II · device

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).

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-09-19
Report date
2025-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Holliston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2114-2025