Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2168
  • Date
    2017-02-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    The company has identified in mammomat inspiration systems with vb30 software version and with biopsy functionality that there is a potential for potential error that blocks the biopsy functionality, leaving it unavailable in situations where there is a compression force decrease or when there is use of the tool. inversion while the scout image is active during the targeting phase.
  • Action
    Field Action Code XP040 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will letter to the client.

Device

Commercial Name: Digital Mammography Device Technical Name: Mammography Device ANVISA Registratio...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA