MICRO-X Rover Mobile X-ray System, # MXU-RV19
Published December 18, 2024 · Recall initiated: October 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro-X Ltd.
- Distributor
- US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
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