Safety Alert for BRAINSCAN Radiosurgery System, Anvisa registration no. 80042070001, Versions 5.2, 5.21, 5.3 and 5.31 manufactured by BrainLab GmbH, Germany and marketed in Brazil by Brainlab Ltda.

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.

Imaging devices, such as CT scanners and MRI scanners, usually rely on their own reference system. The stereotactic localization process in BrainSCAN calibrates the imported image set into a standard localizer-specific reference system. BrainSCAN uses the first localized image set defined as Reference Set (except if the user has set it differently). Any additional image set must be additionally registered with the Reference Set using the image merge function. This procedure ensures that all treatment information is based on a single reference system. In the event that a set of additional images without proper recording (no localization or fusion) is selected in the active window during the printing of the Treatment Parameters, the correctness of the isocenter coordinates may be affected in the printing of the Treatment Parameters, remaining correct, however, the cursors printed by BrainSCAN on the Laser-aided patient positioning overlays or the file exported to the BrainLab Exac Trac system or the Novalis Body system. It is therefore essential that any image datasets imported from BrainScan be recorded in the initial localized data set by image merging or relocation in order to ensure that all sets of images refer to a single reference system. If you need further clarification, please contact your BrainLAB Support Representative.