Micro-X Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0580-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 22, 2024

Date Posted: December 4, 2024

Recall Number: Z-0580-2025

Event ID: 95624

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.

Status: Ongoing

Product Quantity: 6

Code Information:

UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391

Distribution Pattern:

US: TX, PR, MD, CA

Voluntary or Mandated:

Voluntary: Firm initiated