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