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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97014

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 19, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
NeuroSync, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-2114-2025
Recall number
Z-2114-2025
Initiated
September 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
NeuroSync, Inc.
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

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

Distribution pattern

United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).