FDA recall Z-0580-2025

Product

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

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.

Distribution

US: TX, PR, MD, CA

Key facts

Status

Ongoing

Initiation date

2024-10-22

Report date

2024-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonsley, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2025