Recall Z-1579-2025— Micro-X Ltd.

Name: FDA recall Z-1579-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-28

Class II · Ongoing

Class II FDA medical device recall by Micro-X Ltd., initiated 2025-03-28. It names one FDA 510(k) clearance: K211423. 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. Reason: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode..

Recalling firm: Micro-X Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-03-28
Firm location: Tonsley, Australia

510(k) clearances named in this recall

1 on FDA's record

K211423 — RoverMicro-X Limited·cleared 2021-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

Data sourced from openFDA. This site is unofficial and independent of the FDA.