NeuroSync, Inc. recalls NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 h…

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).

• FDA enforcement recordOfficial FDA database entry for Z-2114-2025
• FDA 510(k) clearance · K202927The device's official FDA premarket clearance record
• FDA device classification · QEAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.1455The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find NeuroSync, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.