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Open, Classified

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

FDA Recall Z-0666-2025 · Posted 2024-12-12

Recalling FirmMicro-X Ltd.
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2024-10-23
Product Quantity23

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.

Firm Action

Starting on 10/23/24 Service Bulletin SB002-22 was sent to customers informing them that a field upgrade was released for the installation of an exposure switch holder. Customers were asked to complete and return an acknowledgement response form to [email protected] For further information, contact your local service representative at [email protected], 1-206-249-8764.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211423RoverMicro-X Limited · 2021-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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