Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV19

Recall date

October 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0666-2025

FDA classification

Class II

Brand / firm

Micro-X Ltd.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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