FDA-Device2025-04-23Class II
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury d
Micro-X Ltd.
Hazard
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Sold states
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
Affected count
20 units
Manufactured in
Unit 14 6 Mab Eastern Promenade, Tonsley, Australia
Products
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1579-2025Don't want to check this manually?
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