Micro-X Rover (REF MXU-RV35)Recalls & reported problems

Summary

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

7 FDA recall records name this device's identifier, 7 still open.

3 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-1670-2025 · 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 ↗

4. 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-1579-2025 · Root cause: Device Design · FDA record ↗

5. Oct 22, 2024Open, Classified

   Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

   Z-0580-2025 · Root cause: Environmental control · FDA record ↗

6. Nov 28, 2023Open, Classified

   Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

   Z-0665-2025 · Root cause: Device Design · FDA record ↗

7. May 31, 2023Open, Classified

   Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.

   Z-0664-2025 · Root cause: Software 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-1669-2025 · Apr 4, 2025 · Open, Classified
  Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system th
• Z-0666-2025 · Oct 23, 2024 · Open, Classified
  MICRO-X Rover Mobile X-ray System, # MXU-RV19
• Z-1786-2022 · Aug 31, 2022 · Open, Classified
  MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19