FDA-Device2025-11-19Class IIPROCESSING DEFECT
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
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.
Who it affects
All ages
Illnesses reported
None reported
Sold states
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,
Affected count
236 units
Manufactured in
14 Electronics Ave, Danvers, MA, United States
Products
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2026Don't want to check this manually?
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