Alerta De Seguridad para SURGICAL / CLINICAL PLANNING SOFTWARE IPLAN BRAINLAB. Anvisa Registration n ° 80042070008.

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.

Brainlab Ltda reported that if the potentially incorrect format of the object is not detected by the user during the revision of the imported plane, and the object is used in surgery performed with the aid of a navigation system from Brainlab, the information may potentially induce the surgeon to error, ultimately resulting in ineffective treatment, severe injury, or even death of the patient. Refer to the appendix of the enclosed document "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" for detailed instructions on User Corrective Actions. Users should always follow the instructions and warnings as described in the iPlan User Manuals, in particular: "The appearance and visualization may be different between Brainlab applications (eg planning and navigation software) due to to different user interfaces and workflows. Exported data should always be scanned on the target platform before a surgery. " In addition, it is of great importance to read the FIELD SAFETY NOTICE / PRODUCT NOTIFICATION disclosed by the company, which details the failure conditions and the actions required by the user to reduce the risk until the update available from Brainlab.