# FDA recall Z-3036-2017

> **NeuroLogica Corporation** · Class II · device recall initiated 2017-05-24.

## Product

Samsung GU60A system-  Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

## Reason for recall

When performing the Stitching function on GU60A system, unintended area is exposed to radiation

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-3036-2017
- **Recalling firm:** NeuroLogica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-24
- **Report date:** 2017-09-06
- **Termination date:** 2018-07-09

- **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-3036-2017

## Citation

> AI Analytics. FDA recall Z-3036-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-3036-2017. Source: US FDA. Licensed CC0.

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