Micro-X Ltd.: Device Recall

Recall Details

Recall Number

Z-0580-2025

Classification

Class II

Product Type

Device

Recalling Firm

Micro-X Ltd.

Status

Ongoing

Date Initiated

10/22/2024

Location

Tonsley, Australia

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6

Reason for Recall

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.

Product Description

MICRO-X Rover Mobile X-ray System, # MXU-RV35

Distribution Pattern

US: TX, PR, MD, CA

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 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.

View all recalls by Micro-X Ltd. →