MICRO-X Rover Mobile X-ray System, # MXU-RV19

FDA Device Recall #Z-0666-2025 — Class II — October 23, 2024

Recall Summary

Recall Number Z-0666-2025
Classification Class II — Moderate risk
Date Initiated October 23, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Micro-X Ltd.
Location Tonsley
Product Type Devices
Quantity 23

Product Description

MICRO-X Rover Mobile X-ray System, # MXU-RV19

Reason for Recall

During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.

Distribution Pattern

US Nationwide Distribution: TX, CA, OH, ID, WA, AZ

Lot / Code Information

UDI-DI: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.

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-1578-2025 Class II Brand Name: Rover Product Name: Mobile X-ray S... Mar 28, 2025
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.