Micro-X Rover (REF MXU-RV19)Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

8 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. Oct 23, 2024Open, Classified

   During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.

   Z-0666-2025 · Root cause: Device Design · FDA record ↗

2. Aug 31, 2022Open, Classified

   Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

   Z-1786-2022 · Root cause: Process control · 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-1918-2026 · Mar 27, 2026 · Open, Classified
  Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
• 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-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-1578-2025 · Mar 28, 2025 · Open, Classified
  Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorpo
• 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-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