Commercial name: Ultrasound Diagnostic System ACUSON //. Technical Name: Ultrasound Apparatus //. ANVISA Registration No. 10345162017 //. Risk class: II (Medium Risk) //. Serial numbers: 202134; 210786; 211085; 210658; 211397; 211277; 211523; 212172; 211080; 212118 의 안전성 경고

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 to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - Do not perform measurements using the Doppler tracing tool in a full-screen display format - do not reposition the region of interest of the Virtual Touch IQ from the original (default) location. SEE TECNOVIGILANCE ALERTS: 1649; 1650; 1673 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) 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