Class 2 Device Recall NeuroSync

• Date Initiated by Firm: September 19, 2023
• Date Posted: July 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2114-2025
• Recall Event ID: 97014
• 510(K)Number: K202927
• Product Classification: Brain injury adjunctive interpretive oculomotor assessment aid - Product Code QEA
• 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).
• Code Information: 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
• Recalling Firm/ Manufacturer: NeuroSync, Inc.; 118 Washington St Ste 14; Holliston MA 01746-1373
• For Additional Information Contact: Gary Gregory; +1-508-3978555
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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).
• Quantity in Commerce: 27 units
• Distribution: United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QEA