Safety Alert for RADIOTERAPIC LINEAR ACCELERATORS CLINAC, CX, iX, UNIQUE and TRILOGY. Anvisa registry involved in this field action: 10405410017, 10405410012, 10405410010, 10405410001, 10405410011, 10405410016 and 10405410020

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.

According to Varian Medical Systems Brazil, this problem is not related to TrueBeam devices, occurring only in Clinac®, Trilogy®, Trilogy Tx ™, Novalis Tx ™ and Unique accelerators. The company developed a technical solution that provides rules for the gantry and rotation of Clinac®, Trilogy®, Trilogy Tx ™, Novalis Tx ™ and Unique treatment tables. In physical mode, an additional screen is provided that allows the physicist to set zone limits. In clinical mode, the remote movements of the treatment table and the position of the gantry will be checked and rotation of the gantry outside the defined zone will be prohibited. Zone rules apply to the following types of movement: Remote Auto GoTo, Remote Setup, and Remote Manual Move. Actions recommended to users: • DO NOT USE GANTRY MOVEMENTS IN THE MANUAL MODE IF THE PATIENT IS FOUND IN THE TREATMENT CUP; • Observe all movement of the equipment, directly or from the outside of the treatment room, using closed circuit monitors; • When remote automatic movements are used, users should perform pre-treatment simulation inside the dome to check for potential collisions. • Always follow all warnings in the Clinac instructions for use.