FDA recall Z-0480-2026

NeuroLogica Corporation · Class II · device

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

Status
Ongoing
Initiation date
2025-10-07
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2026