Alerta De Seguridad para ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis Q biplane, Artis Q ceiling, Artis Q floor, Artis Q.zen biplane, Artis Q.zen ceiling , Artis Q.zen floor, Artis zeego Serial numbers affected: 161013, 1211250

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

It is possible, in systems with Gigalix X-ray tube of 2 focuses, to acquire the acquisition of images with the great focus after the manual selection of a corresponding organ program. Fluoroscopy is possible in systems with a 3-spot Gigalix X-ray tube with a "small" or "micro" focus that is still intact through the manual selection of a corresponding fluoroscopy program. a large focus is possible.There are standard emergency procedures in place in case of system failures.It is recommended to reinforce these procedures until the update has been done.