MICRO-X Rover Mobile X-ray System — Class II medical device recall Z-0665-2025
Ongoing recall by Micro-X Ltd., reported 2024-12-18, distributed nationwide. Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
| Recall number | Z-0665-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, Australia |
| Recall initiated | 2023-11-28 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| UPC / GTIN / UDI-DI | 09357123000037 |
| Serial numbers | MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365, MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395 |
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason for recall
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
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-0665-2025. 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.