Alerta De Seguridad para Commercial Name: CT Scanning System / Ingenuity CT. Technical name: CT Scanner / Computerized Tomography Scanner. ANVISA registration number: 10216710191. Class of risk: III - High Risk. Affected Models: Brilliance CT 6-Slice / Brilliance CT 64-Slice / Brilliance iCT / Brilliance iCT / Brilliance iCT / Brilliance CT 16-Slice / Ingenuity CT / Ingenuity Flex. Series Affected: See below

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 Radiologist or physician should be aware of the fact that if they do not recognize the CT number deviation and the image artifacts resemble the patient's history, in the most severe cases, this problem can lead to misdiagnosis. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link