Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia MICRO-X Rover Mobile X-ray System, # MXU-RV35 Recall
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: 00334, 00348, 00349, 00351, 00361.¿
Products Sold
UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia is recalling MICRO-X Rover Mobile X-ray System, # MXU-RV35 due to Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to var. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Recommended Action
Per FDA guidance
The firm will notify consignees using a service bulletin that was already posted. Additionally, the firm will implement a firmware update to extend the timer (4 ms to 10 ms minimum) to ensure even short exposures achieve the necessary image quality for diagnostic use.
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 noticePage updated: Jan 10, 2026