Home / Recalls / Medical Devices
NeuroLogica Corporation recalls OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Produ
Recalled August 19, 2020 · FDA recall Z-2772-2020 · NeuroLogica
Hazard
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. · FDA Class II
Units
35
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
Description
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.
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.
Manufacturer(s)
NeuroLogica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →