FDA-Device2022-10-05Class II
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Micro-X Ltd.
Hazard
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
Sold states
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.
Affected count
42 units
Manufactured in
A14 6 MAB Eastern Promenade, N/A, Tonsley, N/A, Australia
Products
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2022Don't want to check this manually?
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