MICRO-X Rover Mobile X-ray System recalled over fire hazard

Recall date

October 22, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35

Recall number

Z-0580-2025

FDA classification

Class II

Brand / firm

Micro-X Ltd.

Sold / distributed

US: TX, PR, MD, CA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MICRO-X Rover Mobile X-ray System, # MXU-RV35