NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a p
Summary
The FDA issued a Class II for NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico by NeuroSync, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-2114-2025
Action Date
2025-07-23
Status
Ongoing
Category
device
Product Description
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).
Lot/Code Info: 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
Quantity Affected: 27 units
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).
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-19
Company
Holliston, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 109 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NeuroSync, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NeuroSync, Inc. have FDA actions?
This is the only FDA action we have on record for NeuroSync, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2114-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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