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-1579-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1579-2025
    Event ID
    96518
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Micro-X Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 23, 2025
    Initiation Date
    March 28, 2025
    Classification Date
    April 16, 2025
    Address
    Unit 14 6 Mab Eastern Promenade, Tonsley, 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 early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

    Code Info

    Serial Number/UDI: MSN0348 (01)09357123000037(11)230123(21)00348; MSN0349 (01)09357123000037(11)230209(21)00349; MSN0351 (01)09357123000037(11)230413(21)00351; MSN0359 (01)09357123000037(11)231130(21)00359; MSN0361 (01)09357123000037(11)230503(21)00361; MSN0365 (01)09357123000037(11)230510(21)00365; MSN0391 (01)09357123000037(11)230929(21)00391; MSN0406 (01)09357123000037(11)240301(21)00406; MSN0416 (01)09357123000037(11)240429(21)00416; MSN0419 (01)09357123000037(11)240628(21)00419; MSN0428 (01)09357123000037(11)240823(21)00428; MSN0429 (01)09357123000037(11)240823(21)00429; MSN0430 (01)09357123000037(11)240824(21)00430; MSN0431 (01)09357123000037(11)240826(21)00431; MSN0432 (01)09357123000037(11)241108(21)00432; MSN0434 (01)09357123000037(11)241115(21)00434; MSN0435 (01)09357123000037(11)241118(21)00435; MSN0436 (01)09357123000037(11)241122(21)00436; MSN0437 (01)09357123000037(11)241125(21)00437; MSN0438 (01)09357123000037(11)250114(21)00438

    Distribution

    US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).

    Quantity

    20 units