FDA Enforcement
Class II
Ongoing
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Recall: Z-0664-2025
·
Reported December 18, 2024
Enforcement
- Recall Number
- Z-0664-2025
- Event ID
- 95603
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Micro-X Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2024
- Initiation Date
- May 31, 2023
- Classification Date
- December 12, 2024
- Address
- Unit 14 6 Mab Eastern Promenade, Tonsley, N/A, Australia
Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35
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 Info
UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
Distribution
Worldwide and US Nationwide Distribution: NJ, PR, CA
Quantity
5