MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
FDA device recall Z-0665-2025 · posted 2024-12-12 · Open, Classified
Recall details
- Recalling firm
- Micro-X Ltd.
- Reason for recall
- Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
- Action taken
- On 11/28/23 Modification 17 was sent to customers telling them that Control Boards need to be replaced with Control Board PCBA, 12425-04 that will eliminate the issue. For technical assistance contact: support-us@micro-x.com, 1-206-249-8764 Firm asked distributors to do the following: On next visit please confirm that the bulletins were completed and return the documentation.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 18
- Distribution
- US Nationwide Distribution: NJ, CA, PR
- Date initiated
- 2023-11-28
- 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 |