FDA-Device2024-12-18Class II
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Micro-X Ltd.
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.
Sold states
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Affected count
23
Manufactured in
Unit 14 6 Mab Eastern Promenade, Tonsley, Australia
Products
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2025Don't want to check this manually?
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