Alerta De Seguridad para Vivid E90, Vivid E90, Vivid E90, Vivid E90 Vivid E90, Vivid E90, Vivid E90, Vivid E90, Vivid E90, Vivid E90 with software version 201, revision 54.0 and 61.0

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 following actions are recommended: 1. After selecting a patient in the DICOM worklist, be sure to review and confirm that patient demographics shown on the ultrasound scanner screen during the examination are of the intended patient. 2. In scenarios where the incorrect and / or actual patient already exists in the patient file, a 'Patient Match' dialog box will be displayed to inform you of inconsistent patient information. Be sure to properly analyze patient demographics. 3. To reduce the likelihood of a problem occurring, reduce the DICOM worklist search size by: a) Setting 'maximum results' to 75 in the Worklist Data Flow Setup dialog box (available when you select Configuration | DICOM Worklist * Properties) and / or b) * Configuring the DICOM worklist server to automatically delete 'scheduled procedure steps' that were performed on the ultrasonic scanner . If this option is not available on your DICOM worklist server, be sure to manually clear all scheduled 'procedural steps' that were run on the DICOM worklist on a regular basis (for example, every day). * The actual instructions on how to perform this step depend on which DICOM worklist server is used in your department. Consult your IT department to learn how to perform the step.