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

Reason: 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.

Code information: OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66; SN: 91 (01)00884838099203(21)91; SN: 104 (01)00884838099258(21)104, (2) Model: 722222 SN: UDI: 165 (01)00884838099210(21)165 183 (01)00884838099210(21)183 189 (01)00884838099210(21)189 182 (01)00884838099210(21)182 185 (01)00884838099210(21)185 159 (01)00884838099210(21)159 184 (01)00884838099210(21)184 190 (01)00884838099210(21)190 174 (01)00884838099210(21)174 177 (01)00884838099210(21)177 (3)Model: 722280 20 (01)00884838103276(21)20

Distribution pattern: 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.