Recall Z-0666-2025— Micro-X Ltd.
Class II · Ongoing
Class II FDA medical device recall by Micro-X Ltd., initiated 2024-10-23. It names one FDA 510(k) clearance: K211423. 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..
- Recalling firm
- Micro-X Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-23
- Firm location
- Tonsley, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MICRO-X Rover Mobile X-ray System, # MXU-RV19
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.