Safety Alert for ELEKTA PLANNING SYSTEM. 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.

Examples of desktop files are provided with system versions 3.10.00 or later. The user can access these files in the Treatment Table Library of the product and use them as a template, editing the treatment parameters as needed. However, the sample files and their default values ​​were not created for clinical use and the Monaco system was designed based on the assumption that the user would normally rename the file after entering actual treatment values. When table parameter sample files are edited, the (electron) densities changed and "Save is selected, those files will be updated with those new, user-defined densities. Subsequently, when a software update is loaded, under conditions described above, the table densities modified in these files will be overwritten with a default value of 1,000, which may lead to an incorrect radiation dose release for the patient - the delivered dose will have an electron density value of 1,000 instead of the value programmed for treatment. In this case, there is a possibility of serious injury to the patient.