Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2024