Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog… — Class II medical device recall Z-1578-2025
Ongoing recall by Micro-X Ltd., reported 2025-04-23, distributed nationwide. Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode
| Recall number | Z-1578-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, Australia |
| Recall initiated | 2025-03-28 |
| Classified | 2025-04-16 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 31 units |
| UPC / GTIN / UDI-DI | 09357123000037, 09357123000051 |
| Model numbers | MXU-RV71 |
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.