BEUDAMED
    FDA Enforcement Class II Ongoing

    Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

    Recall: Z-1918-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1918-2026
    Event ID
    98644
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Micro-X Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2026
    Initiation Date
    March 27, 2026
    Classification Date
    April 22, 2026
    Address
    Unit 14 6 Mab Eastern Promenade, N/A, Tonsley, N/A, N/A, Australia

    Description

    Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

    Reason

    X-Ray generator may malfunction resulting in the X-Ray being inoperable.

    Code Info

    Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462

    Distribution

    US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.

    Quantity

    32 units