Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog… — Class II medical device recall Z-1670-2025

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-1670-2025`
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	5 units
UPC / GTIN / UDI-DI	`09357123000037`
Model numbers	`MXU-RV35`

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.

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-1670-2025. 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.