FDAClass IIDecember 18, 2024

MICRO-X Rover Mobile X-ray System recall

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Why was MICRO-X Rover Mobile X-ray System recalled?

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

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?

MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395

Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Recalling firm
Micro-X Ltd.
Quantity
18
Distribution
US Nationwide Distribution: NJ, CA, PR
Recall date
December 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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