Safety Alert for Exactrac Location System - Technical Name: Sistema Estereotaxico - Registro 80042070004 - Risk Class III (High Risk) - Versions 6.0.0 to 6.0.5. the Exactrac Software are Potentially Affected

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 company recommends that the user be aware of the following guidelines: "As often required, always ensure that the correct DRRs of the current patient are displayed in ExacTrac and that a precise fusion with the X-ray images for patient placement is possible. If incorrect DRRs are displayed, quit and restart the ExacTrac software. To minimize the likelihood of this problem occurring in the affected ExacTrac versions: - Reduce to the maximum the number of contours exported to ExacTrac (export to ExacTrac only the contours required for positioning). - Avoid exporting large contours to the ExacTrac, such as table top models. -After each (re) initialization of the ExacTrac application on any workstation, always load first a phantom plane that does not contain outlines. Generate DRRs from that phantom once by selecting the Define DRR Settings tab before loading other patient treatment plans. General reminder: Continue to follow the instructions and warnings described in the User's Guide. In the context of this notification, specifically take into account the relevant safety observations for X-ray correction and verification: - Image overlay functions should be used to verify the accuracy of the fusion in both image views, especially if the images contain a series of similar structures such as the vertebrae. - Do not perform patient treatment unless accurate imaging is possible. - Large correction displacements (eg, greater than 10 mm) may indicate an incorrect automatic melting. In these cases, check the offset offset a second time. - Image overlay functions should be used to verify the accuracy of the fusion in both image views, especially if the images contain a series of similar structures such as the vertebrae. - Do not perform patient treatment unless accurate imaging is possible. - Large correction displacements (eg, greater than 10 mm) may indicate an incorrect automatic melting. In these cases, check the offset offset a second time. "