# FDA recall Z-2114-2025

> **NeuroSync, Inc.** · Class II · device recall initiated 2023-09-19.

## 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).

## 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).

## Key facts

- **Recall number:** Z-2114-2025
- **Recalling firm:** NeuroSync, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-19
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Holliston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2114-2025

## Citation

> AI Analytics. FDA recall Z-2114-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2114-2025. Source: US FDA. Licensed CC0.

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