FDA Enforcement
Class II
Ongoing
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Recall: Z-0580-2025
·
Reported December 4, 2024
Enforcement
- Recall Number
- Z-0580-2025
- Event ID
- 95624
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Micro-X Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2024
- Initiation Date
- October 22, 2024
- Classification Date
- November 27, 2024
- Address
- Unit 14 6 Mab Eastern Promenade, Tonsley, N/A, Australia
Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason
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.
Code Info
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Distribution
US: TX, PR, MD, CA
Quantity
6