FDA recall Z-0664-2025

Product

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.

Distribution

Worldwide and US Nationwide Distribution: NJ, PR, CA

Key facts

Status

Ongoing

Initiation date

2023-05-31

Report date

2024-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonsley, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0664-2025