Oncentra Brachy Planning, Record no. 80569320017, Annex I: Products Affected 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 statement, the magnitude of the error of calculation of the dose depends on the transformation of the registry and may range from 0 to 100% of the correct dose value. We have identified two clinical scenarios in which the problem may impact patient care: 1. Multi-modal imaging prior to the first fraction, in which the secondary data sets are used in contour definition and dose assessment. 2. Pre-treatment image examinations and plan adjustment based on contour definition and dose evaluation in the secondary data set (pretreatment). The isodose line function, which is commonly used for dose assessments in conjunction with the dose assessment functions mentioned above, is not affected by this problem. The company also reports that the problem was discovered during the introduction of a new treatment protocol at a client center on March 18, 2015. The client perceived the problem directly when comparing the DVH values ​​with the isodose lines during the evaluation plan. ##### Update of the field action: UPDATED ON 11/03/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.