Alerta De Seguridad para Clinical Radiotherapy Linear Accelerator with 4DITC - version 10 and 11. Models at risk: Clinac 6EX, Clinac 600C, Clinac IX, Clinac 23EX and Trilogy. Corresponding Anvisa records: 10405410001, 10405410010, 10405410011 and 10405410012.

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.

Sending consecutive ExactTrac signals to the 4D Intgrated Treatment Console may cause unexpected deletion of both the ExactTrac interlocks and the BCCV from the equipment. In the occurrence of the described problem, it is possible to irradiate the patient using a cone different from that specified by the treatment planning, since the BCCV check has not been completed. Varian received no notification of injury to the patient related to the problem. See additional information at http://portal.anvisa.gov.br/wps/wcm/connect/8179950045f00258a0d6a47ffa9843d8/Aviso+Urgente+de+Seguran%C3%A7a.pdf?MOD=AJPERES.