Micro-X Rover
Micro-X Rover (MXU-RV19) is a Class II device made by Micro-X, Ltd., cleared under FDA 510(k) K211423 on 21 May 2021 and listed in FDA GUDID since 18 Jun 2021 (UDI-DI 09357123000013), active as of 23 Oct 2026. 10 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
10 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09357123000013 | Date18 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211423 | Date21 May 2021 | StatusActive |
Official records
- AccessGUDID record 09357123000013
- FDA 510(k) database K211423
Across registries
- FDA 510(k) K211423 decided 21 May 2021 Active
- FDA GUDID UDI-DI 09357123000013 listed 18 Jun 2021 Listed
Recalls
-
- Ongoing Z-1918-2026
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
-
- Ongoing Z-1669-2025
- Ongoing Z-1670-2025
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
-
- Ongoing Z-1579-2025
- Ongoing Z-1578-2025
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
-
- Ongoing Z-0666-2025
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.
-
- Ongoing Z-0580-2025
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.
-
- Ongoing Z-0665-2025
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
-
- Ongoing Z-0664-2025
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.
-
- Ongoing Z-1786-2022
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
Timeline
- Recall initiated FDA recalls Z-1786-2022
- Recall initiated FDA recalls Z-0664-2025
- Recall initiated FDA recalls Z-0665-2025
- Recall initiated FDA recalls Z-0580-2025
- Recall initiated FDA recalls Z-0666-2025
- Recall initiated FDA recalls Z-1579-2025
- Recall initiated FDA recalls Z-1578-2025
- Recall initiated FDA recalls Z-1669-2025
- Recall initiated FDA recalls Z-1670-2025
- Recall initiated FDA recalls Z-1918-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Micro-X
- Generic name
- Mobile basic diagnostic x-ray system, digital
- Model / Ref / Catalog
- Rover, MXU-RV19
- Primary DI / UDI-DI
- 09357123000013
- 510(k) Number
- FDA product code
- MQB, IZL
- GMDN term
- Mobile basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1680, 892.1720
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Mobile basic diagnostic x-ray system, digital.