MICRO-X Rover Mobile X-ray System (Micro-X) – Testing Defect (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Brand
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
Lot Codes / Batch Numbers
UDI-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.
Products Sold
UDI-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.
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia is recalling MICRO-X Rover Mobile X-ray System, # MXU-RV19 due to 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 land. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 support-us@micro-x.com For further information, contact your local service representative at support-us@micro-x.com, 1-206-249-8764.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026