Micro-X Ltd.: Device Recall
Recall #Z-0666-2025 · 10/23/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0666-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Micro-X Ltd.
- Status
- Ongoing
- Date Initiated
- 10/23/2024
- Location
- Tonsley, Australia
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Reason for Recall
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.
Product Description
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Distribution Pattern
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Other Recalls by Micro-X Ltd.
- Class II: Risk 04/04/2025
- Class II: Risk 04/04/2025
- Class II: Risk 03/28/2025
- Class II: Risk 03/28/2025
- Class II: Risk 10/22/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.