MICRO-X Rover Mobile X-ray System — Class II medical device recall Z-0666-2025
Ongoing recall by Micro-X Ltd., reported 2024-12-18, distributed nationwide. During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped
| Recall number | Z-0666-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, Australia |
| Recall initiated | 2024-10-23 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 23 |
| UPC / GTIN / UDI-DI | 09357123000013 |
| Serial numbers | 234, 237, 262, 266, 269, 271, 274, 290, 292, 307, 310, 311, 312, 320, 321, 322, 323, 327, 329, 330, 331, 332, 333 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0666-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.