FDA recall Z-0666-2025

Micro-X Ltd. · Class II · device

Product

MICRO-X Rover Mobile X-ray System, # MXU-RV19

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.

Distribution

US Nationwide Distribution: TX, CA, OH, ID, WA, AZ

Key facts

Status
Ongoing
Initiation date
2024-10-23
Report date
2024-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tonsley, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2025