FDAFDA · Food and drugs·Recall number Z-0580-2025
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Published December 4, 2024 · Recall initiated: October 22, 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
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro-X Ltd.
- Distributor
- US: TX, PR, MD, CA
- Lot
- UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.