Recall archive / FDA device enforcement
MICRO-X Rover Mobile X-ray System, # MXU-RV35 — FDA record Z-0580-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Micro-X Ltd.
- Quantity
- 6
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0580-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: TX, PR, MD, CA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 4, 2024
- Recall initiation date
- Oct 22, 2024
- Center classification date
- Nov 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.