Safety Alert for Product Name: ACUSON Diagnostic Ultrasound System Technical Name: Ultrasound Apparatus ANVISA Registration Number: 10345162017 Hazard Class: II Model Affected: ACUSON S2000 Serial Numbers Affected: 211771; 211784; 213087; 213596; 213886; 213936; 214179; 214493

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.

Before using the 18L6 HD transducer a test should be performed, which consists of connecting the 18L6HD transducer to the ultrasound system, placing the gel-coated fingertip on the surface of the equipment and sliding the finger across the surface of the transducer. If the finger echo is displayed in triplicate, the test must be repeated. It is also recommended to re-examine all previous breast exams performed with the 18L6 HD transducer with software in the VD10A or VD10C versions to confirm that no triplicate imaging was used as part of the diagnosis. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.