FDA Device recall Z-0664-2025
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 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0664-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-31 |
| 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
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.
Identifiers
| code_info | UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿ |
|---|
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-0664-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.