Alerta De Seguridad para Linear Accelerators Radiotherapy CLINAC IX, NOVALIS, TRILOGY and UNIQUE. Anvisa Registers: 10405410012, 10405410016, 10405410011 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.

The existence of excessive resistance of the connector in the lines providing the reference voltages to the potentiometers may cause a discrepancy between the actual physical positions and the respective position readings, which in turn leads to incorrect definitions, namely of the size of the field of treatment. As a result, the problem may cause a discrepancy between the actual physical positions and their position readings. Check full information in the company's alert message, available at: xxxx