Alerta De Seguridad para Ultrasound Diagnostic System. Models at risk: SSA-660A, SSA-790A, SSA-680A, SSA-780A. Anvisa Registry n ° 10295030071.

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.

Under certain conditions, the surface temperature of the transducers may increase when used in 2D + PW mode or 2D + CDI (Power, ADF) + PW mode and depending on the transducer the time for this temperature increase varies as follows: - PST-65AT (approximately 20 seconds); PVT-745BTF / H, PVT-674BT (approximately 3 minutes); PVT-661VT (about 5 minutes); - Other transducers (15 minutes or more). #### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.