Class II — Micro-X Ltd.
| Recalling firm | MICRO-X LTD |
|---|---|
| Registered facility | MICRO-X LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
| Product | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: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 c… |
| Quantity | 5 units |
| Distribution | US: NJ, WA, Puerto Rico OUS: None |
| Initiated | 2025-04-04 |
| Classified | 2025-04-24 |
| Recall number | Z-1670-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Micro-X Ltd. (Z-1670-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96638/
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