# FDA recall Z-2772-2020

> **NeuroLogica Corporation** · Class II · device recall initiated 2020-07-15.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2772-2020
- **Recalling firm:** NeuroLogica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-15
- **Report date:** 2020-08-19
- **Termination date:** 2021-07-13

- **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-2772-2020

## Citation

> AI Analytics. FDA recall Z-2772-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2772-2020. Source: US FDA. Licensed CC0.

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