# FDA recall Z-1391-2018

> **NeuroLogica Corporation** · Class II · device recall initiated 2018-01-12.

## Product

Solid state x-ray imager (flat panel/digital imager)      Solid state x-ray imager (flat panel/digital imager)  Medical

## Reason for recall

While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

## Distribution

US Distribution . Only one consignee was shipped 16 units of the affected device.

## Key facts

- **Recall number:** Z-1391-2018
- **Recalling firm:** NeuroLogica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-04-25
- **Termination date:** 2018-08-14

- **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-1391-2018

## Citation

> AI Analytics. FDA recall Z-1391-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1391-2018. Source: US FDA. Licensed CC0.

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