FDA-Device2024-12-18Class II

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

Micro-X Ltd.
Hazard

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

Sold states
US Nationwide Distribution: NJ, CA, PR
Affected count
18
Manufactured in
Unit 14 6 Mab Eastern Promenade, Tonsley, Australia
Products
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0665-2025

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