# FDA recall Z-1691-2019

> **NeuroLogica Corporation** · Class II · device recall initiated 2019-05-06.

## Product

Samsung GM85  Mobile Digital X-ray Imaging System    Product Usage:  The GM85 Digital X-ray imaging System is 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

Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1691-2019
- **Recalling firm:** NeuroLogica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-06
- **Report date:** 2019-06-05
- **Termination date:** 2020-06-10

- **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-1691-2019

## Citation

> AI Analytics. FDA recall Z-1691-2019. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1691-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*