Alerta De Seguridad para HIGH ENERGY RADIOTHERAPIC LINEAR ACCELERATOR CLINAC. Models: 21EX, 23EX, 2100C, 2100C / D, 2300C / D, iX, CX, NOVALIS, Tx, TRILOGY, TRILOGY TX. Anvisa Registry: 10405410010, 10405410016, 10405410017, 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.

The action recommended by the manufacturer is palliative and the company informed that a software fix is ​​being developed, but has not determined the deadline for its completion. See details of the field action in the Varian alert message, available at http://portal.anvisa.gov.br/wps/wcm/connect/09468c004510a13a938db7c2afb947e8/Messagem+de+Alerta.pdf?MOD=AJPERES #### Update (10/16/2014): The company reported that the field correction is planned for October 2015. #### Updated 10/25/2017, the company submitted a monitoring report informing the recommendation in the notice of security check of the dosimetry symmetry of the equipment with an extra security system called Yield Interlock, registration 10405410032.