Reported Dec 4, 2024 · Ongoing

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

Micro-X Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Micro-X Ltd. · Unit 14 6 Mab Eastern Promenade · Tonsley · N/A

Is this the product you have?

  • MICRO-X Rover Mobile X-ray System, # MXU-RV35
Lot codes and dates
  • UDI-DI9357123000037
  • Serial Numbers
    • 348
    • 349
    • 361
    • 351
    • 365
    • 391
Amount recalled
6

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

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