Events

Alerta De Seguridad para ARTIS EQUIPMENT FOR ANGIOGRAPHY, Registration 10234230190 - Serial Numbers: 121125

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; Siemens AG.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1680
  • Fecha
    2015-08-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Siemens Ltda informs that in the described situation, the Artis system does not move alone, the movement continues being initiated by the operator. However, when this movement occurs, the system may unexpectedly have a higher than usual speed, potentially resulting in a collision. The company informs that the only equipment affected in Brazil is not yet installed.
  • Causa
    Siemens healthcare has identified a possible position sensor failure on the rotating base shaft that is not being detected by the system software. after activating operator movement, the c-arm system may move unexpectedly faster than normal.
  • Acción
    The company informs that this problem will be solved with the software update through the modification AX037 / 15 / S (Patch 2). After installing this update, the possible speed of the Artis system will be limited to the allowed level. More information in the Customer Letter

Device

ARTIS EQUIPMENT FOR ANGIOGRAPHY, Registration 10234230190 - Serial Numbers: 121125

Manufacturer

Siemens Ltda.; Siemens AG
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA