Safety Alert for Trade name: LINEAR DIGITAL ARTISTE ACCELERATOR ###. Technical Name: LINEAR THROTTLE ###. ANVISA registration number: 10234230172 ###. Risk class: III (High Risk) ###. Affected template: Artiste ###. Number of series affected: 10233; 10321

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The consequences that may occur with the use of outdated software are: incorrect designation of the isocenter when using multiple treatment plans with different isocenters based on a single planning TC and when a CBCT is acquired for each isocenter and irrevocable designation of the first 2D image of reference. Recommendation to users and patients: Include the Field Action Letter along with the System Owner's Manual. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link