Safety Alert for Commercial Name: iPlan Surgical / Clinical Planning Software, Brainlab and Brainscan Brand Technical Name: Surgical / Clinical Planning Software ANVISA Registration Number: 80042070008 Hazard Class: III

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.

As a temporary solution to reduce the dose deviation described to less than 2% using the Pencil Beam algorithm in iPlan RT 4.5.x, Brainlab recommends modification of the machine profile according to the instructions outlined in the Product Notification Appendix. Perform appropriate pre-treatment quality control on all Brainlab treatment planning systems as recommended by Brainlab. Independent dose calculation using third-party quality control software or dose measurements on a phantom is an appropriate way to judge the accuracy of the dose calculation. For details, refer to the Brainlab Technical Reference - Principles of Physics Reference Manual. Treatment Verification and Review (Retroactive) To determine the level of impact of the problem described above in a given treatment plan, review the results of your pre-treatment quality control. Even if no quality control procedure has been performed prior to the patient's treatment, this can be done retroactively at any time. For details, refer to the Brainlab Technical Reference - Principles of Physics Reference Manual.