MICRO-X Rover Mobile X-ray System — Class II medical device recall Z-0580-2025
Ongoing recall by Micro-X Ltd., reported 2024-12-04, distributed in CA, MD, PR, TX. Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees
| Recall number | Z-0580-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, Australia |
| Recall initiated | 2024-10-22 |
| Classified | 2024-11-27 |
| Reported by FDA | 2024-12-04 |
| Distributed | CA, MD, PR, TX |
| Quantity | 6 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 09357123000037 |
| Serial numbers | 348, 349, 351, 361, 365, 391 |
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0580-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.