# FDA recall Z-0480-2026

> **NeuroLogica Corporation** · Class II · device recall initiated 2025-10-07.

## Product

GM85 Digital Mobile X-ray imaging System;  Model Number: GM85;

## Reason for recall

The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.

## Distribution

Domestic: US Nationwide Distribution.  International: Australia, Belgium, Canada, Chile, China Mainland, Czech Republic, Denmark, Ecuador, Finland, France, Germany, GHANA, Hungary, India, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab Emir., Vietnam,

## Key facts

- **Recall number:** Z-0480-2026
- **Recalling firm:** NeuroLogica Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-07
- **Report date:** 2025-11-19

- **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-0480-2026

## Citation

> AI Analytics. FDA recall Z-0480-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0480-2026. Source: US FDA. Licensed CC0.

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