Alerta De Seguridad para Trade name: ELEKTA PLANNING SYSTEM Technical name: 2901010 Software de Planej. of Trat. P / Radiation Therapy ANVISA Registration Number: 80569320003 Class of Risk: III Model Affected: Monaco

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.

According to the company, it is necessary to read and return the knowledge report of the Important User Notifications to Elekta within 30 days. Request collaboration with Elekta representative to implement the solution as soon as possible. The problem does not occur every time the delete function is used in combination with the contour editing tools. Additionally, because of the complexity of the problem, it is not possible to enumerate all the workflows in which it can occur. However, you can avoid triggering the problem by embedding one of these sequences of steps into your overall workflow with the outline: 1. Delete before editing: In newly generated contours, delete any unwanted contours and save before editing (move, rotate, change format) 2. If you need to delete anything after the edits, save and download the data before deleting. This allows the affected code to find all the coordinates of the contour points. 3. Delete the outline and start over. 4. Clean the contour and start again.