Alerta De Seguridad para Trade name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. Technical Name: Ultrasound Device. ANVISA Registry No. 10345161999. Risk class: II (Medium Risk). Model: ACUSON SC2000. Serial numbers: 400294; 401532; 401704; 402705; 402766

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.

Recommendation for users and patients: For the first problem the company recommends that the trackball be assigned to the colored region of interest, to the sample or pulsed or continuous wave Doppler courses, to the M mode courses, to the 2D field of view or to the region RES, especially when the temperature of the transducer reaches 40 ° C. If the problem persists, it is recommended to temporarily increase or decrease the transmission energy or wait for the temperature of the transducer to reach 41 ° C. For the second problem described, the company recommends correcting the case / patient differences in the patient's name at the time of registration. SEE TECNOVIGILANCE ALERTS: 1690; 1933 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