Medical Device Recall: MICRO-X Rover Mobile X-ray System, # MXU-RV35
Micro-X Ltd. · October 22, 2024
Reason for Recall
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.
Distribution
US: TX, PR, MD, CA
States Affected
CA, MD, TX
Quantity Affected
6
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0580-2025
Status: ongoing
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