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).
This recall is currently active, issued July 11, 2025. It was issued by Neurosync, Inc..
- Company
- Neurosync, Inc.
- Recall Initiated
- September 19, 2023
- Posted
- July 11, 2025
- Recall Number
- Z-2114-2025
- Quantity
- 27 units
- Firm Location
- Holliston, MA
- Official Source
- View on FDA website ↗
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).
Lot / Code Info
Model No X02. UDI-DI: 00868096000300. Serial Numbers: PA7D50NGF4020311G (Lot P-10114-13), PA7D50NGF4020191G (Lot P-10114-13), PA7D40NGEA080237G (Lot P-10114-12) Software Revisions: Software version uniform across all affected devices
Root Cause
Device Design
Action Taken
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).