ACUSON Diagnostic Ultrasound System. Model: ACUSON S2000. Anvisa Registry n ° 10234230192. 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.

The problem occurs when using the CIVCO biopsy connectors in combination with the ACUSON S Family screen orientations. The biopsy needle path may not correspond to the screen orientations and this occurs on the 6C1 HD and 18L6 HD transducers. The potential risk is not to obtain the tissue sample of interest. To avoid this problem, do not use the 6C1 HD and 18L6 HD transducers with the CIVCO biopsy connectors for guided biopsy procedures. For guided procedures with other transducers, follow the instructions given by Siemens in your customer letter, available at: http://portal.anvisa.gov.br/wps/wcm/connect/50122e8049b158f3a2adaada875a0177/Carta+Portugu%C3%AAs+ US016-15-S.pdf? MOD = AJPERES