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Micro-X, Ltd.

Active in EUDAMED
Also registered as Micro-X Limited

Australiafrom SRN EUDAMED SRN AU-MF-000009037

Micro-X, Ltd. is a medical device manufacturer based in Australia, with 7 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II) and 10 FDA recalls as of 13 Nov 2026.

Devices
7
Registrations
EUDAMED
FDA recalls
1010 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 5
  • FDA 510(k) 2
  • EUDAMED 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 7
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN AU-MF-000009037

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

Catalogue7

Newest first, rows 1-7 of 7

  • Micro-X Rover Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Micro-X Rover Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Micro-X Rover Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Micro-X Rover

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Micro-X Rover Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Rover Ref K211423 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rover Ref K201488

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
AU-MF-000009037
EUDAMED status
Active
EUDAMED registered name
Micro-X Ltd
Registered address
A14 - 6 MAB, Eastern Promenade, 5042, Adelaide, Australia
Website
micro-x.com
PRRC contact
Dijana Jerkovic(public in EUDAMED)

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 2
  • 2024 2
  • 2025 4
  • 2026 1

  • 2026

    • 27 Mar 2026 Z-1918-2026 Class II Ongoing X-Ray generator may malfunction resulting in the X-Ray being inoperable. Distribution: US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico. Submission number: K211423

  • 2025

    • 4 Apr 2025 Z-1669-2025 Class II Ongoing Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Distribution: US: NJ, WA, Puerto Rico OUS: None Submission number: K211423
    • 4 Apr 2025 Z-1670-2025 Class II Ongoing Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Distribution: US: NJ, WA, Puerto Rico OUS: None Submission number: K211423
    • 28 Mar 2025 Z-1578-2025 Class II Ongoing Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. Distribution: US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory). Submission number: K211423
    • 28 Mar 2025 Z-1579-2025 Class II Ongoing Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. Distribution: US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory). Submission number: K211423

  • 2024

    • 23 Oct 2024 Z-0666-2025 Class II Ongoing 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. Distribution: US Nationwide Distribution: TX, CA, OH, ID, WA, AZ Submission number: K211423
    • 22 Oct 2024 Z-0580-2025 Class II Ongoing 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. Distribution: US: TX, PR, MD, CA Submission number: K211423

  • 2023

    • 28 Nov 2023 Z-0665-2025 Class II Ongoing Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. Distribution: US Nationwide Distribution: NJ, CA, PR Submission number: K211423
    • 31 May 2023 Z-0664-2025 Class II Ongoing 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. Distribution: Worldwide and US Nationwide Distribution: NJ, PR, CA Submission number: K211423

  • 2022

    • 31 Aug 2022 Z-1786-2022 Class II Ongoing 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 Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of…
      Full distribution text Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.
      Submission number: K211423

Sites1

Frequently asked questions

How many devices does Micro-X, Ltd. have in the registry?

The registry currently lists 7 devices for Micro-X, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Micro-X, Ltd.'s devices?

Among its 7 most recently registered devices, Micro-X, Ltd. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Micro-X, Ltd.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Micro-X, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Micro-X, Ltd.?

FDA recall records list 10 recalls initiated by Micro-X, Ltd., the most recent initiated on 27 Mar 2026. 10 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Micro-X, Ltd. in the registry?

The most recently registered devices listed for Micro-X, Ltd. include Micro-X Rover and Rover.

Generated automatically from registry data and not verified by a human reviewer.