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Recall Observatory FDA recall evidence

Device product

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

Z-0666-2025

October 23, 2024

Class II

Product summary

Firm
Micro-X Ltd.
Event
Event 95593
Status
Ongoing
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-0666-2025

Official wording

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.

Code information: UDI-DI: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.