Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Des...
FDA Device Recall #Z-1578-2025 — Class II — March 28, 2025
Recall Summary
| Recall Number | Z-1578-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 28, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Micro-X Ltd. |
| Location | Tonsley |
| Product Type | Devices |
| Quantity | 31 units |
Product Description
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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 for Recall
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Distribution Pattern
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
Lot / Code Information
Serial Number/UDI: MSN0334 (01)09357123000051(11)220921(21)00334; MSN0350 (01)09357123000037(11)230328(21)00350 ; MSN0352 (01)09357123000051(11)230823(21)00352; MSN0364 01)09357123000051(11)230705(21)00364; MSN0382 (01)09357123000051(11)230809(21)00382; MSN0383 (01)09357123000051(11)230814(21)00383; MSN0384 (01)09357123000051(11)230816(21)00384; MSN0385 (01)09357123000051(11)230906(21)00385; MSN0386 (01)09357123000051(11)230908(21)00386; MSN0387 (01)09357123000051(11)230914(21)00387; MSN0388 (01)09357123000051(11)230916(21)00388; MSN0389 (01)09357123000051(11)230918(21)00389; MSN0390 (01)09357123000051(11)231013(21)00390; MSN0395 (01)09357123000051(11)231106(21)00395; MSN0397 (01)09357123000051(11)231118(21)00397; MSN0399 (01)09357123000051(11)240122(21)00399; MSN0400 (01)09357123000051(11)240207(21)00400; MSN0401 (01)09357123000051(11)240131(21)00401; MSN0402 01)09357123000051(11)240202(21)00402; MSN0403 (01)09357123000051(11)240205(21)00403; MSN0405 (01)09357123000051(11)240206(21)00405; MSN0408 (01)09357123000051(11)240308(21)00408; MSN0409 (01)09357123000051(11)240312(21)00409; MSN0410 (01)09357123000051(11)240318(21)00410; MSN0411 (01)09357123000051(11)240319(21)00411; MSN0422 (01)09357123000051(11)240724(21)00422; MSN0423 (01)09357123000051(11)240808(21)00423; MSN0424 (01)09357123000051(11)240809(21)00424; MSN0425 (01)09357123000051(11)240812(21)00425; MSN0426 (01)09357123000051(11)240812(21)00426; MSN0427 (01)09357123000051(11)240812(21)00427;
Other Recalls from Micro-X Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1670-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray S... | Apr 4, 2025 |
| Z-1669-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray S... | Apr 4, 2025 |
| Z-1579-2025 | Class II | Brand Name: Rover Product Name: Mobile X-ray S... | Mar 28, 2025 |
| Z-0666-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | Oct 23, 2024 |
| Z-0580-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Oct 22, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.