IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008. 의 안전성 경고

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's assessment, the severity of the situation is critical if incorrect and unintended positioning occurs for radiation and this is not detected by the user of the product. The possibility of occurrence is remote, as the potential problem occurs only under specific circumstances associated with workflows and specific patient placement scenarios. See Field Safety Notice for additional information. #### UPDATED ON 08/18/2019, the field actions documented by the company are archived in the area. If necessary, the area can reassess the action at any time.