MICRO-X Rover Mobile X-ray System, # MXU-RV35
This recall is currently active, issued November 27, 2024. It was issued by Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia.
- Recall Initiated
- October 22, 2024
- Posted
- November 27, 2024
- Recall Number
- Z-0580-2025
- Quantity
- 6
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Root Cause
Environmental control
Action Taken
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: support-us@micro-x.com