FDA Device recall Z-2114-2025
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets
- FDA Device
- Class II
- ongoing
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class II recall of NeuroSync EYE-SYNC containing Pico Neo 2 Headsets by Neurosync, citing 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 servi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2114-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-19 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Neurosync |
| Distribution | US |
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
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.
Identifiers
| code_info | Model No X02. UDI-DI: 00868096000300. Serial Numbers: PA7D50NGF4020311G (Lot P-10114-13), PA7D50NGF4020191G (Lot P-1011…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2114-2025%22
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