Holliston, MA, United States
NeuroSync, Inc. recalls
1 recall recorded since 2018, most recently on 19 September 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 September 2023
- Reason
- 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).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2114-2025
- 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 h
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.