Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog… — Class II medical device recall Z-1669-2025
Ongoing recall by Micro-X Ltd., reported 2025-04-30, distributed in NJ, PR, WA. Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
| Recall number | Z-1669-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-X Ltd., Tonsley, N/A, Australia |
| Recall initiated | 2025-04-04 |
| Classified | 2025-04-24 |
| Reported by FDA | 2025-04-30 |
| Distributed | NJ, PR, WA |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 09357123000051 |
| Serial numbers | 334, 352, 364, 382, 383, 384, 385, 386, 387, 388, 389, 390, 395 |
| Model numbers | MXU-RV35, MXU-RV71 |
Product
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 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 internal fastening mechanism within generator of mobile x-Ray to fail.
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-1669-2025. 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.