Company: NeuroLogica Corporation
Date of Enforcement Report: 8/19/2020
Class II

PRODUCT

OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 – Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

Recall Number: Z-2772-2020

REASON

There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.

RECALLING FIRM/MANUFACTURER

NeuroLogica Corporation on 7/15/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

35

DISTRIBUTION

U.S. Nationwide and International