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Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile
Recalled April 23, 2025 · FDA recall Z-1579-2025 · Micro-X
Hazard
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. · FDA Class II
Units
20 units
Sold at
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
Description
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Product
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
Manufacturer(s)
Micro-X Ltd.
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →