Recall archive / FDA device enforcement
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rov... — FDA record Z-1669-2025
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 Apr 4, 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-RV71, 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 internal fastening mechanism within generator of mobile x-Ray to fail.
- Classification
- Class II
- Recalling firm
- Micro-X Ltd.
- Quantity
- 13 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1669-2025
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-DI) 352 (01)09357123000051(11)230823(21)00352 334 (01)09357123000051(11)220921(21)00334 389 (01)09357123000051(11)230814(21)00383 383 (01)09357123000051(11)230814(21)00383 384 (01)09357123000051(11)230816(21)00384 382 (01)09357123000051(11)230809(21)00382 386 (01)09357123000051(11)230908(21)00386 385 (01)09357123000051(11)230906(21)00385 387 (01)09357123000051(11)230914(21)00387 388 (01)09357123000051(11)230916(21)00388 364 01)09357123000051(11)230705(21)00364 390 (01)09357123000051(11)231013(21)00390 395 (01)09357123000051(11)231106(21)00395 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: NJ, WA, Puerto Rico OUS: None
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
- Apr 30, 2025
- Recall initiation date
- Apr 4, 2025
- Center classification date
- Apr 24, 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.