Z-0580-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason for Recall
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.
Distribution Pattern
US: TX, PR, MD, CA
Code Information
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391