Alerta De Seguridad para Trade Name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. ANVISA registration no. 10345161999. Risk class II. Serial numbers: 401704 and 401809

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.

If you have any questions regarding this field action, please contact Siemens Healthcare Diagnostics SA by phone: (11 3908-2309) If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events ( EA) 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 System of Tecnovigilância / SISTEC access through the link http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp