FDA Recall Open, Classified

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

Recall: Z-0580-2025 · Initiated October 22, 2024

Recall

Recall Number
Z-0580-2025
Event Number
95624
Firm
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
FEI Number
3012855798
Product Code
IZL
Status
Open, Classified
Root Cause
Environmental control
Initiated
October 22, 2024
Posted
November 27, 2024

Description

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

Reason

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.

Action

On 10/22/24, Service Bulletin SB007-23-1.0 was emailed to customers restating receiving, storage, and operation conditions and informing customers that extreme humidity environments can adversely affect the equipment. For further information contact your local service representative: phone: 1-206-249-8764 Email: [email protected]

Distribution

US: TX, PR, MD, CA

Quantity

6