The Recall Desk
ModerateFDA (Devices)·Z-2114-2025·Announced 2025-07-23

NeuroSync EYE-SYNC headsets are inoperable and cannot be repaired

NeuroSync EYE-SYNC systems containing Pico Neo 2 headsets are being recalled because eye syncing issues render the device inoperable and it cannot be repaired. 27 units are affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall where the device simply does not operate, with no incorrect result or patient hazard stated in the source.

Plain-English summary

NeuroSync EYE-SYNC systems containing Pico Neo 2 Headsets are being recalled. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet and proprietary software in a portable field case. The system records, measures and analyses eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury. The action covers 27 units, model X02, UDI-DI 00868096000300.

The stated reason is eye syncing issues causing the device to be inoperable, and that it is 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. The FDA classified the action as Class II.

Distribution was nationwide in the United States, in New York, Texas and Georgia.

Facilities should identify affected units using the model number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

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 analyz
Manufacturer
NeuroSync, Inc.
Category
Medical Device — Eye tracking system
Hazard
  • device-inoperable
  • unsupported-platform
  • no-repair-available
  • class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • PA7D50NGF4020191G (Lot P-10114-13)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category