FDA Recall Open, Classified

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

Recall: Z-0666-2025 · Initiated October 23, 2024

Recall

Recall Number
Z-0666-2025
Event Number
95593
Firm
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
FEI Number
3012855798
Product Code
IZL
Status
Open, Classified
Root Cause
Device Design
Initiated
October 23, 2024
Posted
December 12, 2024

Description

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.

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.

Distribution

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

Quantity

23