medical Class II Updated 2024-12-04

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: TX, MD, CA
Lot/Code Info: UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
View official government recall

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