Alerta De Seguridad para Linear accelerator elekta. Anvisa Registration n ° 80569320007. Models under risk: Digital accelerator Precise, Synergy Platform, Synergy S, Infinity, Axesse.

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.

Some digital accelerators have increased the settings of automatic screening of the electron applicator in the field to values ​​greater than the factory defaults. The increase in auto-tracking values ​​against factory defaults is against the company's recommendations and may cause the system to not operate in accordance with IEC standards, particularly with regard to the IEC 60601-2-1 safety standard - the Increased auto-tracking values ​​over factory defaults will result in an increase in radiation leakage from the electron applicator in the patient plane as well as around the applicator, which may cause the leakage values ​​to exceed the limits specified in safety standard IEC 60601-2-1. See also the Company Safety Notice at: http://portal.anvisa.gov.br/wps/wcm/connect/0e2b5b8041bb1969933dd79d63c1a945/Aviso_de_Seguranca.pdf?MOD=AJPERES