FDA recall Z-0665-2025

Micro-X Ltd. · Class II · device

Product

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Reason for recall

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

Distribution

US Nationwide Distribution: NJ, CA, PR

Key facts

Status
Ongoing
Initiation date
2023-11-28
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-0665-2025