MICRO-X Rover Mobile X-ray System — Class II medical device recall Z-0664-2025
Ongoing recall by Micro-X Ltd., reported 2024-12-18, distributed nationwide. Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to
| Recall number | Z-0664-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, Australia |
| Recall initiated | 2023-05-31 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| UPC / GTIN / UDI-DI | 09357123000037 |
| Serial numbers | 00334, 00348, 00349, 00351 |
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason for recall
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
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-0664-2025. 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.