NeuroLogica Corporation: 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 tom

Is my product affected?

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.

• UPC 08806167789220

Check against the official notice below — it lists the full affected range.

What happened

NeuroLogica Corporation has recalled 35 OmniTom Computed Tomography X-ray systems, Model NL5000, with software versions before 05.01.01. The systems have been distributed worldwide including throughout the United States and in Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, and the UK. The recall involves potential issues with the scanner's operational state, specifically related to transport and unintended system shutdowns that could delay patient treatment if proper use instructions are not followed.

The affected systems can be identified by their UDI (08806167789220) and specific serial numbers ranging from 00007 to 00046. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK. Quantity: 35 Lot/code info: UDI: 08806167789220; all NL5000 systems with software version before 05.01.01; Serial Numbers: 00008 00009 00010 00011 00012 00013 00016 00018 00020 00021 00022 00023 00024 00027 00030 00031 00032 00033 00035 00036 00037 00040 00043 00044 00045 00046 00007 00014 00017 00028 00034 00038 00039 00041 00042

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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