NeuroLogica OmniTom CT Systems Recalled for Operational Shutdown Issues
NeuroLogica is recalling 35 OmniTom CT systems due to potential operational issues that could cause inadvertent shutdowns and delays in patient treatment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential delays in treatment due to operational issues, which fits the criteria for moderate severity without reported injuries or fatalities.
Plain-English summary
NeuroLogica Corporation is recalling 35 OmniTom Computed tomography x-ray systems, Model NL5000. The recall applies to all NL5000 systems with software versions prior to 05.01.01. These devices are intended for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
The recall is due to potential issues related to the operational state of the scanner, specifically regarding transport and inadvertent system shutdowns. If proper use instructions are not followed, there is a possibility of potential delay in patient treatment.
The affected units were distributed worldwide, including the United States, Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, and the UK. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- 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
- NeuroLogica Corporation
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 08806167789220
- all NL5000 systems with software version before 05.01.01
Distribution
Distributed nationwide across the United States.
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