Alerta De Seguridad para XIO RTP system. Models at risk: version 5.51 and higher. Anvisa Registry n ° 80569320003.

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.

When fixed filters are defined in Source File Maintenance, the user sets the maximum allowed field size for each filter. The maximum field size is being ignored by the software when both fixed filters and MLCs are present in a beam. The result is incorrect calculation and dose administration outside the physical filter extension. The dose distribution calculated by XiO does not correspond to the dose administered to the patient in regions exceeding the physical size of the filter. • Varian and Siemens linear accelerators avoid administration. • Elekta linear accelerators with motorized filters avoid administration. • Elekta linear accelerators with fixed filters do not prevent administration. Check additional information in the Alert Message released by Elekta.