MICRO-X Rover Mobile X-ray System, # MXU-RV35 — recall Z-0580-2025
U.S. FDA — Device Enforcement · Australia · 2024-10-22 · Class II
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Reported risk: 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.
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