Recall archive / FDA device enforcement
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile ... — FDA record Z-1579-2025
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 Mar 28, 2025. 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
- Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
- Reason
- Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- Classification
- Class II
- Recalling firm
- Micro-X Ltd.
- Quantity
- 20 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1579-2025
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 | Serial Number/UDI: MSN0348 (01)09357123000037(11)230123(21)00348; MSN0349 (01)09357123000037(11)230209(21)00349; MSN0351 (01)09357123000037(11)230413(21)00351; MSN0359 (01)09357123000037(11)231130(21)00359; MSN0361 (01)09357123000037(11)230503(21)00361; MSN0365 (01)09357123000037(11)230510(21)00365; MSN0391 (01)09357123000037(11)230929(21)00391; MSN0406 (01)09357123000037(11)240301(21)00406; MSN0416 (01)09357123000037(11)240429(21)00416; MSN0419 (01)09357123000037(11)240628(21)00419; MSN0428 (01)09357123000037(11)240823(21)00428; MSN0429 (01)09357123000037(11)240823(21)00429; MSN0430 (01)09357123000037(11)240824(21)00430; MSN0431 (01)09357123000037(11)240826(21)00431; MSN0432 (01)09357123000037(11)241108(21)00432; MSN0434 (01)09357123000037(11)241115(21)00434; MSN0435 (01)09357123000037(11)241118(21)00435; MSN0436 (01)09357123000037(11)241122(21)00436; MSN0437 (01)09357123000037(11)241125(21)00437; MSN0438 (01)09357123000037(11)250114(21)00438 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
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
- Apr 23, 2025
- Recall initiation date
- Mar 28, 2025
- Center classification date
- Apr 16, 2025
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.