The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2068-2023·Announced 2023-07-12

OmniTom CT imaging device recalled for wheel loosening and battery contamination

NeuroLogica is recalling OmniTom CT imaging devices due to wheels that may loosen and battery boards that may be contaminated, both of which could prevent the device from operating properly and delay patient imaging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a medical imaging device with functional defects that could delay patient treatment. No illnesses or injuries have been reported, meeting the criterion for high-severity risk-of-harm product.

Plain-English summary

NeuroLogica Corporation is recalling OmniTom and OmniTom Elite X-ray computed tomography (CT) devices, Model NL5000, used for imaging head and neck anatomy. Approximately 48 units have been distributed worldwide, including throughout the United States and internationally to Australia, Canada, the Bahamas, India, Italy, Korea, Portugal, Saudi Arabia, Scotland, and Thailand.

The recall addresses two defects that could prevent proper device operation. The wheels on the device may loosen over time with normal use, potentially making the device immovable and preventing imaging procedures. Additionally, the batteries that power the device contain contaminated circuit boards, which may prevent the device from powering on. Either defect could result in inability to operate the device and delay patient treatment.

Specific devices are identified by their serial numbers, which are provided in the FDA recall notice. Healthcare facilities and imaging centers using the OmniTom or OmniTom Elite should verify whether their devices are affected and contact NeuroLogica Corporation for remediation options.

The recalled product

Product
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
Manufacturer
NeuroLogica Corporation
Category
Medical Device — Diagnostic imaging
Hazard
Affected units
48

Distribution

Distributed nationwide across the United States.

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