Safety Alert for Commercial Name: Three-Dimensional Planning System for Eclipse Radiotherapy Technical Name: ANVISA Registration Number: 10405410007 Hazard Class: III Affected Model: Eclipse Serial Numbers Affected: H48J544

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 problem does not occur when additional changes are made to outline structures. The rescue process is performed correctly after performing the additional steps below. 1) Enable / disable the visibility of the structure; 2) Change the color of the structure; 3) Approve structure; 4) Undo and redo the last operation; or 5) Modify the structure with a tool other than Draw Planar Contour, Brush, Draw Geometrical Shape, or Eraser After you edit a structure, perform any of the five steps above and save. Check and approve structures after completing targeting to avoid using incomplete structures in treatment planning. Ensure that a qualified physician verifies the accuracy and placement of all patient structures (target structure and critical structures) used for treatment planning and to evaluate plans prior to patient treatment. #### UPDATED ON 08/24/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.