Company: Micro-X Ltd.
Date of Enforcement Report: 9/23/2022
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
VOLUME OF PRODUCT IN COMMERCE
Worldwide distribution – U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.