Medical Device Recall: GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
NeuroLogica Corporation · October 7, 2025
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,
States Affected
NATIONWIDE
Quantity Affected
236 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0480-2026
Status: ongoing
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