Rover

• • 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

1. 31 Aug 2022 Recall initiated FDA recalls Z-1786-2022
2. 31 May 2023 Recall initiated FDA recalls Z-0664-2025
3. 28 Nov 2023 Recall initiated FDA recalls Z-0665-2025
4. 22 Oct 2024 Recall initiated FDA recalls Z-0580-2025
5. 23 Oct 2024 Recall initiated FDA recalls Z-0666-2025
6. 28 Mar 2025 Recall initiated FDA recalls Z-1579-2025
7. 28 Mar 2025 Recall initiated FDA recalls Z-1578-2025
8. 4 Apr 2025 Recall initiated FDA recalls Z-1669-2025
9. 4 Apr 2025 Recall initiated FDA recalls Z-1670-2025
10. 27 Mar 2026 Recall initiated FDA recalls Z-1918-2026

1 earlier event are in the sections above.

510(k) Number

K211423 ↗

FDA product code

IZL

Device class

Class II

Regulation

21 CFR Part 892.1720

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

• VMX MOBILE X-RAY SYSTEM by GE MEDICAL SYSTEMS, INC.
• MINXRAY, MODEL HF120/60H POWERPLUS by Minxray, Inc.
• MINXRAY, MODEL HF100H+ by Minxray, Inc.
• ACU-RAY HF SERIES PORTABLE X-RAY UNIT by Sterne Equipment Co., Ltd.
• Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
• AMX Navigate Mobile X-Ray System by GE Medical Systems, LLC
• PRACTIX CONVENIO by Philips Medical Systems North America, Inc.
• MOBILEDIAGNOST WDR by Sedecal., Sa.
• iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System by FIRST SOURCE INC.
• X-RAY STAND, PORTABLE by General X-Ray, Inc.

• Micro-X Rover Open recall

  Class II

  FDA 510(k) K211423 Active Cleared 21 May 2021 GUDID on market

• Rover

  Class II

  FDA 510(k) K201488 Active Cleared 17 Jul 2020

• Micro-X Rover Open recall

  Class II

  CE/MDR FDA 510(k) K211423 Active Cleared 21 May 2021 +1authorizations

• Micro-X Rover Open recall

  Class II

  FDA 510(k) K211423 Active Cleared 21 May 2021 GUDID on market

See all devices from Micro-X, Ltd. →