RecallRadar

FDA Device recall Z-0666-2025

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

On 2024-12-18 the FDA classified a Class II recall of MICRO-X Rover Mobile X-ray System, # MXU-RV19 by Micro X, citing 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,….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0666-2025
ClassificationClass II
Statusongoing
Initiated2024-10-23
Published2024-12-18
Last updated2026-09-13 11:57 UTC
CompanyMicro X
DistributionUS

Product

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

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.

Identifiers

code_infoUDI-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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0666-2025%22

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