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Recall Observatory FDA recall evidence

Device product

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

Z-0580-2025

October 22, 2024

Class II

Product summary

Firm
Micro-X Ltd.
Event
Event 95624
Status
Ongoing
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-0580-2025

Official wording

Reason: 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.

Code information: UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391

Distribution pattern: US: TX, PR, MD, CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.