Recall Z-0665-2025 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
| Date | Dec 12, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 18 |
| Distribution | US Nationwide Distribution: NJ, CA, PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |