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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

NeuroSync EYE-SYNC Headsets Recalled for Syncing Issues and Lack of Support

Agency Publication Date: July 11, 2025
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Summary

NeuroSync, Inc. is recalling 27 units of its EYE-SYNC eye-tracking system, specifically the X02 model containing Pico Neo 2 headsets. These systems, which are used by healthcare providers to help diagnose concussions (mild traumatic brain injury), are experiencing eye-syncing issues that make the devices inoperable. Because the Pico 2 platform was discontinued and support ended on August 31, 2023, the manufacturer is unable to repair these units.

Risk

The device can become completely inoperable, which prevents medical professionals from being able to record, view, or analyze eye movements needed to identify visual tracking impairments or aid in the diagnosis of concussions.

What You Should Do

  1. This recall involves the NeuroSync EYE-SYNC eye-tracking system (Model X02), which includes a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software in a field case.
  2. Check your device for serial numbers PA7D50NGF4020311G, PA7D50NGF4020191G, or PA7D40NGEA080237G, and lot numbers P-10114-12 or P-10114-13.
  3. Stop using the recalled device immediately as it is inoperable and cannot be repaired.
  4. Contact NeuroSync, Inc. or your medical equipment distributor to arrange for the return, replacement, or correction of the system.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NeuroSync EYE-SYNC containing Pico Neo 2 Headsets
Variants: Pico Neo 2 headset, Android tablet, Proprietary software
Model / REF:
X02
Serial Numbers:
PA7D50NGF4020311G
PA7D50NGF4020191G
PA7D40NGEA080237G
Lot Numbers:
P-10114-13
P-10114-12
UDI:
00868096000300

Software version uniform across all affected devices. Support for platform discontinued as of August 31, 2023.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97014
Status: Active
Manufacturer: NeuroSync, Inc.
Sold By: Medical equipment distributors
Manufactured In: United States
Units Affected: 27 units
Distributed To: New York, Texas, Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.