Z-2114-2025Class II

NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded...

Name: Z-2114-2025 NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded...
Creator: NeuroSync, Inc.
Published: 2023-09-19
License: https://open.fda.gov/license/

NeuroSync, Inc. / initiated 2023-09-19 / Open, Classified / root cause: design

FDA source

NeuroSync, Inc. began a recall of 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... on 2023-09-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2114-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-19
Posted: 2025-07-11
Recalling firm: NeuroSync, Inc.
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).
Product code: QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
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.
Root cause tag: design
FDA root 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).
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2114-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2114-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-23	2025-07-11

Product code QEA

K202927Class IIEye-SyncSyncthink, Inc. / cleared 2021-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)