Tonsley, Australia
Micro-X Ltd. recalls
8 recalls recorded since 2018, most recently on 27 March 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)8
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 March 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1918-2026
- Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Ongoing Class II Medical devices
- Recall started
- 4 April 2025
- Reason
- Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
- Distribution
- US: NJ, WA, Puerto Rico OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1670-2025, Z-1669-2025
- Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator
- 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-ra
Ongoing Class II Medical devices
- Recall started
- 28 March 2025
- Reason
- 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).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1579-2025, Z-1578-2025
- Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generato
- 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 generato
Ongoing Class II Medical devices
- Recall started
- 23 October 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0666-2025
- MICRO-X Rover Mobile X-ray System, # MXU-RV19
Ongoing Class II Medical devices
- Recall started
- 22 October 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0580-2025
- MICRO-X Rover Mobile X-ray System, # MXU-RV35
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0665-2025
- MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Ongoing Class II Medical devices
- Recall started
- 31 May 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0664-2025
- MICRO-X Rover Mobile X-ray System, # MXU-RV35
Ongoing Class II Medical devices
- Recall started
- 31 August 2022
- Reason
- 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 Australia, France, Israel, Japan, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1786-2022
- MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.