Safety Alert for Trade name: SOMATOM Computerized Tomography System. Technical name: CT Scanner. . Model: SOMATOM Emotion Registration No .: 10345161972, Risk Class: III; Model: SOMATOM Spirit; Risk Class: III; Registration No: 10345162002 Hazard Class: III. Model: SOMATOM Scope Power, Registration No: 10345161975, Risk Class III :. Model: SOMATOM Perspective, Registration Number: 10345162001, 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.

The problem described will not occur when using a lateral topogram instead of a topograph or pa. Consequently, we recommend the use of topograms in lateral position for all head acquisitions. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link