FDA-Device2024-12-04Class II
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd.
Hazard
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
Sold states
US: TX, PR, MD, CA
Affected count
6
Manufactured in
Unit 14 6 Mab Eastern Promenade, Tonsley, Australia
Products
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2025Don't want to check this manually?
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