MICRO-X Rover Mobile X-ray System, # MXU-RV19
Reported: December 18, 2024 Initiated: October 23, 2024 #Z-0666-2025
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.
Details
- Recalling Firm
- Micro-X Ltd.
- Units Affected
- 23
- Distribution
- US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
- Location
- Tonsley
Frequently Asked Questions
What product was recalled? ▼
MICRO-X Rover Mobile X-ray System, # MXU-RV19. Recalled by Micro-X Ltd.. Units affected: 23.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2024. Severity: Moderate. Recall number: Z-0666-2025.
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