Events

Alerta De Seguridad para Artistic Angiography Equipment, Model: Artis Zee Biplane and Artis zee floor, register: 10234230190, hazard class III, serial numbers :. Artis Zee Biplane: 154646; Artis zee floor: 136215; 136926; 136933; 136936; 136944; 136947; 136977; 136995; 137020; 137033; 137042; 137045; 137074; 137083; 137088; 137089; 137090; 137094; 137098; 137099; 137100; 137102; 137143; 137158; 137159; 137160; 137161; 137162; 137164; 137182; 137191; 137246; 137281; 137299; 137300; 137306; 137310; 137324; 137346; 137379; 137382; 137387; 137411; 137416; 137426; 137436; 137447.

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
    1638
  • Fecha
    2015-07-13
  • 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
    According to the manufacturer, the Artis system may not move on its own initiative and the movement initiated by the operator. However, when moving, the speed of the system may be higher than usual and cause collision.
  • Causa
    Position sensor failure in the hinged base shaft that is not detected by the system software. the c-arm system can move, unexpectedly, faster than normal.
  • Acción
    The company that owns the registry will update the software. The recommendation, as long as field correction is not performed, is for customers to continue to use the system.

Device

Artistic Angiography Equipment, Model: Artis Zee Biplane and Artis zee floor, register: 102342301...

Manufacturer

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