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Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV19
Recalled December 18, 2024 · FDA recall Z-0666-2025 · Micro-X
Hazard
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. · FDA Class II
Units
23
Sold at
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Description
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
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Manufacturer(s)
Micro-X Ltd.
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →