FDAJuly 15, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
neurologica
UPCs
08806167789220
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGM85 Digital Mobile X-ray imaging System; Model Number: GM85;2025-10-07
- FDAGM60A. Digital Diagnostic Mobile X-Ray System.2024-07-08
- FDASamsung Digital Diagnostic Mobile X-ray System, Model GM85.2023-12-28
- FDAOmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL50002023-06-06
- FDASamsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System2023-03-08
- FDAWS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.2019-07-25
- FDAHS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.122019-07-25
- FDASamsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications2019-05-06
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