FDA Device recall Z-0580-2025
MICRO-X Rover Mobile X-ray System, # MXU-RV35
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 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 receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0580-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-22 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Micro X |
| Distribution | CA, MD, PR, TX |
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
Identifiers
| code_info | UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391 |
|---|
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-0580-2025%22
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