# FDA recall Z-1670-2025

> **Micro-X Ltd.** · Class II · device recall initiated 2025-04-04.

## 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 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.

## Distribution

US: NJ, WA,  Puerto Rico  OUS: None

## Key facts

- **Recall number:** Z-1670-2025
- **Recalling firm:** Micro-X Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-04
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tonsley, N/A, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1670-2025

## Citation

> AI Analytics. FDA recall Z-1670-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1670-2025. Source: US FDA. Licensed CC0.

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