Recall Z-2114-2025— NeuroSync, Inc.

Name: FDA recall Z-2114-2025
Creator: U.S. Food and Drug Administration
Published: 2023-09-19

Class II · Ongoing

Class II FDA medical device recall by NeuroSync, Inc., initiated 2023-09-19. It names one FDA 510(k) clearance: K202927. 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 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).. 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 longer in production or serviceable as of August 31, 2023..

Recalling firm: NeuroSync, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-19
Firm location: Holliston, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K202927 — EYE-SYNCSyncthink, Inc.·cleared 2021-10-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.