MICRO-X Rover Mobile X-ray System, # MXU-RV35
This recall is currently active, issued December 12, 2024. It was issued by Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia.
- Recall Initiated
- May 31, 2023
- Posted
- December 12, 2024
- Recall Number
- Z-0664-2025
- Quantity
- 5
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide and US Nationwide Distribution: NJ, PR, CA
Lot / Code Info
UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
Root Cause
Software design
Action Taken
The firm will notify consignees using a service bulletin that was already posted. Additionally, the firm will implement a firmware update to extend the timer (4 ms to 10 ms minimum) to ensure even short exposures achieve the necessary image quality for diagnostic use.