Alerta De Seguridad para SISTEMA ADVANTAGESIM MD - Registered at ANVISA under number 80071260089 - versions affected: 7.4 to 7.6 (inclusive).

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 AdvantageSim MD program supports loading multiple images from one scan at a time, and the problem cited may lead to incorrect image labeling. According to the holder of the product registration in Brazil, if incorrectly labeled images are used in RTSS (Radio Therapy Structure Set) system, they are most likely to be rejected by the treatment planning system by radiation. If the RTSS system does not do this rejection, such non-phased data used for treatment planning may be confused with each other, causing errors in radiation treatment planning. The registry holder has announced that it has already initiated field action (IMF 80125 - Field Modification Instruction) for the installation of a new version of AdvantageSim MD 7.7 software, in order to correct the problem. The Technovigilance Unit is following up on this case.