FDAClass IIDecember 4, 2024

MICRO-X Rover Mobile X-ray System recall

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

Why was MICRO-X Rover Mobile X-ray System 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Recalling firm
Micro-X Ltd.
Quantity
6
Distribution
US: TX, PR, MD, CA
Recall date
December 4, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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