FDA recall Z-1670-2025

Micro-X Ltd. · Class II · device

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

Status
Ongoing
Initiation date
2025-04-04
Report date
2025-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tonsley, N/A, Australia

Primary source

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