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).
Recall
- Recall Number
- Z-2114-2025
- Event Number
- 97014
- Firm
- NeuroSync, Inc.
- FEI Number
- 3014133165
- Product Code
- QEA
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- September 19, 2023
- Posted
- July 11, 2025
- Address
- 118 Washington St, Ste 14, Holliston, MA, 01746-1373
Description
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).
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.
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).
United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).
27 units