Alerta De Seguridad para Ingenuity CT / Brilliance CT / Ingenuity Flex / MX8000 Dual v. EXP. Model: Brilliance CT (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP - Registro Anvisa nº 10216710191, 10216710209 e 10216710142

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.

There is a risk of serious injury to the patient and Technician / Operator as a result of table movement. For the patient: • There is a possibility of withdrawal or movement of invasive medical devices, such as IV, tracheostomy and tracheostomy drapes. To the Technician / Operator: • There is a possibility of crushing point in the subframe; and • A possibility of locking between the table and the Gantry if the Technician / Operator remains between them to move the patient ahead