FDA-Device2023-07-12Class II
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
NeuroLogica Corporation
Hazard
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.
Affected count
48 units
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2068-2023Don't want to check this manually?
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