Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Micro-X Ltd. Medical Device Recall: MICRO-X Rover Mobile X-ray System, # MXU-RV35 | SafeCheck