FDA Device recall Z-0665-2025
MICRO-X Rover Mobile X-ray System, # MXU-RV35
- FDA Device
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of MICRO-X Rover Mobile X-ray System, # MXU-RV35 by Micro X, citing mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0665-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-28 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Micro X |
| Distribution | US |
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Identifiers
| code_info | MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier).…MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2025%22
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