Data / Medical devices / Australia / Micro-X Ltd

Micro-X Ltd: FDA-registered device maker in Tonsley South Australia, Australia, 2 510(k) clearances

Name: Micro-X Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Micro-X Ltd is registered with the FDA (registration 3012855798) in Tonsley South Australia, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2021. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012855798
Address: A14 6 MAB Eastern Promenade, Tonsley South Australia, Australia, 5042
Owner or operator: MICRO-X LTD (10057299)
Roles: Contract manufacturer, Manufacturer
First device listed: March 16, 2018
Registered through: 2026
Brand names listed: Rover

Devices it lists

Device	Product code	Class	Role	Source
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 21, 2021	K211423	Rover	IZL	Substantially Equivalent	Micro-X Limited	accessdata.fda.gov
July 17, 2020	K201488	Rover	IZL	Substantially Equivalent	Micro-X , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 27, 2026	98644	Class II	Ongoing	Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71	X-Ray generator may malfunction resulting in the X-Ray being inoperable.	accessdata.fda.gov
April 4, 2025	96638	Class II	Ongoing	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 that incorporates a self-contained X-ray g	Potential for internal fastening mechanism within generator of mobile x-Ray to fail.	accessdata.fda.gov
March 28, 2025	96518	Class II	Ongoing	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 incorporates a self-contained X-ray generator,	Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.	accessdata.fda.gov
October 23, 2024	95593	Class II	Ongoing	MICRO-X Rover Mobile X-ray System, # MXU-RV19	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 t	accessdata.fda.gov
October 22, 2024	95624	Class II	Ongoing	MICRO-X Rover Mobile X-ray System, # MXU-RV35	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 beha	accessdata.fda.gov
November 28, 2023	95617	Class II	Ongoing	MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71	Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.	accessdata.fda.gov
May 31, 2023	95603	Class II	Ongoing	MICRO-X Rover Mobile X-ray System, # MXU-RV35	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.	accessdata.fda.gov
August 31, 2022	90839	Class II	Ongoing	MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19	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	accessdata.fda.gov

Compare with other makers

Updated April 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.