Alerta De Seguridad para Commercial Name: Digital Mammography Device Technical Name: Mammography Device ANVISA Registration Number: 10345162027 Hazard Class: III Model Affected: MAMMOMAT Inspiration Serial Numbers Affected: 3063; 3395; 3400; 3630; 3639; 3828; 3833; 4169; 4266; 4274; 4275; 4276; 4451; 4527; 4704; 4708; 4710; 5047; 5078; 6044; 6204; 6356; 6488; 6873

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.

To avoid the problem of inactivating the biopsy functionality, when the error message is displayed, the user is advised not to close the window but cancel the active target first and then close the error message window. After completing these steps, the user can start from the beginning. It is advisable not to use the inversion tool while the scout image is active. In the event of system crash, the Acquisition Workplace must be restarted. ### 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.