Alerta De Seguridad para MOSAIQ Oncology Information System. Anvisa Registry n ° 80569320004.

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.

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic planes using cones. Affected sites will be those satisfying ALL of the three criteria below: 1. Running MOSAIQ Version 2.41 and higher; 2. With at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and 3. Who is dealing with Stereotactic Cones. The problem can be avoided by clicking Cancel in the Create MLC Simple Window window by editing the field dimension in the Create MLC Simple window to return to the correct MLC format for the planned cone before saving or not using the Simple MLC view. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/b84a4980490e7d57a854b905df47c43c/Aviso+de+Seguran%C3%A7a.pdf?MOD=AJPERES