Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
Worldwide distribution: US (nationwide) including the following states: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, Wisconsin. And the following Countries of: Australia, Azerbaijan, Chile, Croatia, Czechoslovakia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea South, Lebanon, Mexico, Netherlands, Norway, Pakistan, Poland, Russian Federate, Senegal, Spain, South Africa, Sweden, Switzerland, Taiwan, and Uruguay.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1801-2020