MICRO-X Rover Mobile X-ray System (Micro-X) – Operation Requirements (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Brand
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
Lot Codes / Batch Numbers
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Products Sold
UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia is recalling MICRO-X Rover Mobile X-ray System, # MXU-RV35 due to 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 cond. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MD, TX, PR
Page updated: Jan 10, 2026