Device product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Z-0664-2025
Product summary
- Firm
- Micro-X Ltd.
- Event
- Event 95603
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0664-2025
Official wording
Reason: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Code information: UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
Distribution pattern: Worldwide and US Nationwide Distribution: NJ, PR, CA
Derived failure modes
-
Unknown
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.