# FDA recall Z-2068-2023

> **NeuroLogica Corporation** · Class II · device recall initiated 2023-06-06.

## 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

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.

## Key facts

- **Recall number:** Z-2068-2023
- **Recalling firm:** NeuroLogica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-06
- **Report date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2068-2023

## Citation

> AI Analytics. FDA recall Z-2068-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2068-2023. Source: US FDA. Licensed CC0.

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