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

Recall date

October 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0480-2026

FDA classification

Class II

Brand / firm

NeuroLogica Corporation

Sold / distributed

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 Ara…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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