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FDA (Device enforcement)Recalled 2024-10-22class ii

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

Hazard

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.

Details from the source

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 Quantity: 6 Lot/code info: UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391

UPC codes

9357123000037

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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