Alerta De Seguridad para Radiation Treatment Planning System / FOCAL Model. Anvisa Registration No. 80569320008. Version 4.80.00 of the FOCAL model.

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 a CT phantom is scanned and the images are transferred to the Focal, you can sample the densities using the Image Statistics tool in Focal. In the case where the thickness of the CT slice is not equal to the spacing of the CT slice, the Image Statistics tool will report an incorrect HU. If you base your CT-to-ED file on this incorrect density information, this will result in errors in the calculation of the dose. The magnitude of the error in the dose calculation will depend on the magnitude of the HU error. The problem occurs when the CT Slice Spacing is not equal to the CT Slice Thickness, and the Image Statistics tool information is used to populate the CT-to-ED file. According to the company's risk assessment, Focal will assign an incorrect density that will lead to errors in the dose, which can result in adverse consequences without serious health. Check information in the Important Notice to the User, available at http://portal.anvisa.gov.br/wps/connect/57699e8046ec7179a7c6b741cdd33a01/Amanda+Importante+to+Usu%C3%A3rio+-+FOCAL+7.pdf?MOD = AJPERES.