FDA-Device2020-05-06Class II
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
GE Healthcare, LLC
Hazard
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Sold states
US Nationwide Distribution
Affected count
123 in total
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1712-2020Don't want to check this manually?
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