FDAClass IIDecember 18, 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?

Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.

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: 00334, 00348, 00349, 00351, 00361.¿

Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Recalling firm
Micro-X Ltd.
Quantity
5
Distribution
Worldwide and US Nationwide Distribution: NJ, PR, CA
Recall date
December 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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