Alerta De Seguridad para CLINAC RADIOTERAPIC LINEAR ACCELERATORS - Registration 10405410001 and HIGH POWER RADIOTHERAPY LINEAR ACCELERATOR CLINAC - Registration 10405410010, Serial Numbers as listed in the appendix. http://en.wikipedia.org/w/index.php?/

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.

Varian's TrueBeam Clinacs and Systems utilize "rigid" physical beam modifying wedges (here referred to simply as "wedges" and excluding the functionality of "dynamic" wedges). These wedges are manufactured in various angles, dimensions and materials, with different configurations of bases for top and bottom fittings and in different configurations for Clinacs with MLC and without MLC. Varian was aware of two recent incidents in which the body of a 30 degree steel upper wedge separated from the wedge base due to the failure of the fastening screws. These incidents did not cause serious injury and in both cases occurred in Clinacs that had been in use for at least 7 (seven) years. In addition, at least one of the wedges had a history of periodic loosening of the fastening and re-tightening screws by the operator. It is likely that, at first, the fault only affects one or two fastening screws, leaving the wedge suspended by the remaining ones, which is a strong indication that others may fail. There are no records of occurrences in Brazil to date. Anvisa follows this field action.