Alerta De Seguridad para IPLAN Planning Software and BRAINSCAN Software. Antivirus Registration No. 80042070008. Affected models: iPLAN RT Image (versions prior to Version 4.1.2), iPLAN RT and BrainSCAN (discontinued).

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.

Except for TC or standardized SUV (Standard Absorption Value) PET, Brainlab software only supports image sequences that contain a uniform calibration of pixel values ​​assigned by the image acquisition device (scanner) for all images, for all slices of the sequence. If such unsupported image sequence is used with Brainlab software, Brainlab software will apply the same pixel value calibration contained in the center image crop of the image sequence to all cuts. If multiple pixel value calibrations are contained in the other cuts of the unsupported sequence, those pixel values ​​will be configured with the same uniform calibration during loading: in a PET image sequence these uniformly calibrated pixels may have a different activity value, and will be displayed with different brightness and color compared to cropping images displayed by the scanner using varying calibrations. If it occurs during the use of an unsupported image sequence, this effect may be misleading to the customer during treatment planning, resulting, for example, in the incorrect definition of volumes of interest in the planning software. Objects created for these volumes of interest may differ in location or dimension relative to the actual and desired definition of the structure. If this is not detected by the user during treatment planning, target volumes may be erroneously defined for an irradiation schedule.