X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY. Anvisa Registry No. 10216710193. Affected units: EP16E100069, EP16E110084, EP16E110014, EP16E110044, EP16E110083, EP16E110012, EP16E110021, EP16E110008, EP16E110070, EP16EB110003, EP16EB110004, EP16EB110005 and EP16EB110006.