medical MODERATE Updated 2024-12-04

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

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Recalled Product

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

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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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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