Recall archive / FDA device enforcement
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71 — FDA record Z-0665-2025
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 Nov 28, 2023. 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; 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.
- Classification
- Class II
- Recalling firm
- Micro-X Ltd.
- Quantity
- 18
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0665-2025
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 | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution: NJ, CA, PR
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 18, 2024
- Recall initiation date
- Nov 28, 2023
- Center classification date
- Dec 12, 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.