BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-1670-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1670-2025
    Event ID
    96638
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Micro-X Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 30, 2025
    Initiation Date
    April 4, 2025
    Classification Date
    April 24, 2025
    Address
    Unit 14 6 Mab Eastern Promenade, N/A, Tonsley, N/A, N/A, Australia

    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

    Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

    Code Info

    Serial Number/UDI-DI - 349 (01)09357123000037(11)230209(21)00349 348 (01)09357123000037(11)230123(21)00348 350 (01)09357123000037(11)230328(21)00350. 351 (01)09357123000037(11)230413(21)00351 361 (01)09357123000037(11)230503(21)00361

    Distribution

    US: NJ, WA, Puerto Rico OUS: None

    Quantity

    5 units