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Micro-X Rover (REF MXU-RV71)Recalls & reported problems

Micro-X Limited · The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas · Class 2

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

7 other recalls cover devices cleared under the same FDA submission (K211423); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 27, 2026Open, Classified

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

    Z-1918-2026 · Root cause: Component design/selection · FDA record ↗

  2. Apr 4, 2025Open, Classified

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

    Z-1669-2025 · Root cause: Device Design · FDA record ↗

  3. Mar 28, 2025Open, Classified

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

    Z-1578-2025 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211423. One submission often covers many models, so check the product and lot details in each record.

  • Z-1670-2025 · Apr 4, 2025 · Open, Classified
    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 incorpor
  • Z-1579-2025 · Mar 28, 2025 · Open, Classified
    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 incorpo
  • Z-0666-2025 · Oct 23, 2024 · Open, Classified
    MICRO-X Rover Mobile X-ray System, # MXU-RV19
  • Z-0580-2025 · Oct 22, 2024 · Open, Classified
    MICRO-X Rover Mobile X-ray System, # MXU-RV35
  • Z-0665-2025 · Nov 28, 2023 · Open, Classified
    MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
  • Z-0664-2025 · May 31, 2023 · Open, Classified
    MICRO-X Rover Mobile X-ray System, # MXU-RV35
  • Z-1786-2022 · Aug 31, 2022 · Open, Classified
    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

Other Solid State X-Ray Imager (Flat Panel/Digital Imager) devices

All Solid State X-Ray Imager (Flat Panel/Digital Imager) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.