PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 18, 2024 Initiated: May 31, 2023 #Z-0664-2025

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Micro-X Ltd.
Units Affected
5
Distribution
Worldwide and US Nationwide Distribution: NJ, PR, CA
Location
Tonsley

Frequently Asked Questions

What product was recalled?
MICRO-X Rover Mobile X-ray System, # MXU-RV35. Recalled by Micro-X Ltd.. Units affected: 5.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 18, 2024. Severity: Moderate. Recall number: Z-0664-2025.