FDAOctober 23, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

micro xmicro

UPCs

09357123000013

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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