MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA device recall Z-0664-2025 · posted 2024-12-12 · Open, Classified
Recall details
- Recalling firm
- Micro-X Ltd.
- 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.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 5
- Distribution
- Worldwide and US Nationwide Distribution: NJ, PR, CA
- Date initiated
- 2023-05-31
- Date posted
- 2024-12-12
- Location
- Tonsley, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rover (K211423) | Micro-X Limited | 2021-05-21 |