FDA Recall
Open, Classified
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Recall: Z-0664-2025
·
Initiated May 31, 2023
Recall
- Recall Number
- Z-0664-2025
- Event Number
- 95603
- Firm
- Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
- FEI Number
- 3012855798
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- May 31, 2023
- Posted
- December 12, 2024
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.
Action
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.
Distribution
Worldwide and US Nationwide Distribution: NJ, PR, CA
Quantity
5