FDASeptember 19, 2023device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
neurosync
UPCs
00868096000300
Recall history
No related federal recalls on record for this brand yet.
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