Reported Jul 23, 2025 · Ongoing
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a…
NeuroSync, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuroSync, Inc. · 118 Washington St Ste 14 · Holliston, MA · 01746-1373
Is this the product you have?
- 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 codes and dates
- Model No X02
- UDI-DI00868096000300
- Serial Numbers
PA7D50NGF4020311G (Lot P-10114-13)PA7D50NGF4020191G (Lot P-10114-13)PA7D40NGEA080237G (Lot
- P-10114-12) Software RevisionsSoftware version uniform across all affected devices
- Amount recalled
- 27 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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