Events

Alerta De Seguridad para Trade Name: ANGIOGRAPHY EQUIPMENT; Model: AXIOM Artis dFA, AXIOM Artis dFC, registration 10234230096, Class III //// Trade Name: ARTIS ANGIOGRAPHY EQUIPMENT; registry: 10345162023; class III

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; 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
    1857
  • Fecha
    2016-03-18
  • 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 Healthcare advises users of the target devices of this field action to wait until the Siemens engineering team schedules a field visit so that the problem is finally corrected.
  • Causa
    Siemens healthcare informs about the possibility of leakage in the detector's refrigeration system, which may cause fluids to flow into the equipment's structure. failure of the system and even locking can occur due to the loss of the cooling system. however, siemens healthcare notes that this possible hardware failure does not influence the treatment of patients.
  • Acción
    Notification made by Siemens Healthcare Diagnósticos SA in compliance with Resolution RDC 23/2012.

Device

Trade Name: ANGIOGRAPHY EQUIPMENT; Model: AXIOM Artis dFA, AXIOM Artis dFC, registration 10234230...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens AG.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA