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NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Recalled November 19, 2025 · FDA recall Z-0480-2026 · NeuroLogica
Hazard
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. · FDA Class II
Units
236 units
Sold at
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,
Description
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.
Product
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Manufacturer(s)
NeuroLogica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →