Micro-X Ltd.: Device Recall

Recall Details

Recall Number

Z-1669-2025

Classification

Class II

Product Type

Device

Recalling Firm

Micro-X Ltd.

Status

Ongoing

Date Initiated

04/04/2025

Location

Tonsley, N/A, Australia

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

13 units

Reason for Recall

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Product Description

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, 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

Distribution Pattern

US: NJ, WA, Puerto Rico OUS: None

Other Recalls by Micro-X Ltd.

• Class II: Risk 04/04/2025
  Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
• Class II: Risk 03/28/2025
  Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
• Class II: Risk 03/28/2025
  Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
• Class II: Risk 10/23/2024
  During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
• Class II: Risk 10/22/2024
  Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

View all recalls by Micro-X Ltd. →