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Micro-X Rover

by Micro-X, Ltd.

Ref MXU-RV35

Micro-X Rover (MXU-RV35) is a device classified as Class IIb in the EU and Class II in the US made by Micro-X, Ltd., registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI 93571230ROVERUE), cleared under FDA 510(k) K211423 on 21 May 2021 and listed in FDA GUDID since 11 Nov 2024 (UDI-DI 09357123000037), active as of 24 Oct 2026. 10 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

10 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211423

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number93571230ROVERUE Basic UDI-DI 09357123000037UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09357123000037 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK211423 Date21 May 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 93571230ROVERUE registered 13 Jul 2026 Active
  • FDA 510(k) K211423 decided 21 May 2021 Active
  • FDA GUDID UDI-DI 09357123000037 listed 11 Nov 2024 Listed

Recalls

10 recalls · 10 ongoing · FDA

    • Ongoing Z-1918-2026 FDA Class II initiated 27 Mar 2026

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

  • 2 recalls, same reason

    • Ongoing Z-1669-2025 FDA Class II initiated 4 Apr 2025
    • Ongoing Z-1670-2025 FDA Class II initiated 4 Apr 2025

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

  • 2 recalls, same reason

    • Ongoing Z-1579-2025 FDA Class II initiated 28 Mar 2025
    • Ongoing Z-1578-2025 FDA Class II initiated 28 Mar 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 FDA Class II initiated 23 Oct 2024

    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 FDA Class II initiated 22 Oct 2024

    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 FDA Class II initiated 28 Nov 2023

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

    • Ongoing Z-0664-2025 FDA Class II initiated 31 May 2023

    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 FDA Class II initiated 31 Aug 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

13 dated events

  1. Recall initiated FDA recalls Z-0665-2025
  2. Recall initiated FDA recalls Z-0580-2025
  3. Recall initiated FDA recalls Z-0666-2025
  4. Listed FDA GUDID 09357123000037
  5. Recall initiated FDA recalls Z-1579-2025
  6. Recall initiated FDA recalls Z-1578-2025
  7. Recall initiated FDA recalls Z-1669-2025
  8. Recall initiated FDA recalls Z-1670-2025
  9. Recall initiated FDA recalls Z-1918-2026
  10. Registered EUDAMED 93571230ROVERUE

3 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Rover EUDAMED
Micro-X GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Device name
Rover Mobile X-ray System
Model / Ref / Catalog
MXU-RV35, Rover
Primary DI / UDI-DI
09357123000037
Basic UDI-DI
93571230ROVERUE
510(k) Number
FDA product code
MQB, IZL
EMDN code
Z11039016 Mobile radiographic units
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680, 892.1720
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MXU-RV35
GUDID
Rover
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Mobile basic diagnostic x-ray system, digital

Cleared under the same submission (K211423)

Similar devices in this category

Other devices filed under MOBILE RADIOGRAPHIC UNITS.

Other devices from Micro-X, Ltd.

  • Micro-X Rover Open recall

    Class II

  • Rover Open recall

    Class II

  • Micro-X Rover Open recall

    Class II

  • Micro-X Rover

    Class II

See all devices from Micro-X, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)