FDA recall Z-1579-2025

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 early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

Distribution

US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).

Key facts

Status
Ongoing
Initiation date
2025-03-28
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tonsley, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1579-2025