Recall Z-0664-2025 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35
| Date | Dec 12, 2024 (initiated May 31, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 5 |
| Distribution | Worldwide and US Nationwide Distribution: NJ, PR, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |