Events

Alerta De Seguridad para Angiography equipment, risk class III: AXIOM ARTIS FC, registration 10234230075, lots / series: 10151, 10279, 10312, 10320, 10379, 10409, 10481, 10501, 10513, 10520, 10526, 10533./// AXIOM ARTIS FA , registration: 10234230093, lots / series: 25062; 25179; 25282; 25329; 25330; 25379; 25418; 25447; 25452. /// Angiography equipment models: AXIOM ARTIS dFA; AXIOM ARTIS dFC, registration 10234230096, batches / series: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 35913; 35936; 35949; 50138./// Angiography equipment Artis models ARTIS ZEE CEILING, ARTIS ZEE FLOOR AND ARTIS ZEEGO, registry 1023420190, lots / series: 135297; 135329; 135758; 135785; 135816; 135825; 135835; 135848; 135869; 135941; 135969; 135980; 135984; 135991; 136056; 136060; 136067; 136068; 136098; 136115; 136119; 136136; 136144; 136199; 136213; 136214; 136215; 136276; 136282; 136283; 136284; 136285; 136288; 136301; 136320; 136355; 136363; 136369; 136373; 136419; 136421; 136424; 136425; 136440; 136443; 136457; 136492; 136580; 136908; 136918; 136926; 136933; 136936; 136944; 136947; 136977; 136995; 137020; 137026; 137033; 137042; 137045; 137074; 137083; 137088; 137089; 137094; 137098; 137099; 137100; 137102; 137105; 137120; 137143; 137158; 137159; 137160; 137161; 137162; 137164; 137182; 137246; 146646; 147531; 147551; 147582; 147600; 147602; 147617; 147619; 147637; 147650; 147706; 147708; 147744; 160143; 160343; 160360; 160415; 160457; 160467; 160836.

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
    1653
  • Fecha
    2015-07-24
  • 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
    The holder informs that the problem involves a failure of the equipment having no influence on the treatment of patients.
  • Causa
    In case the table is near its maximum extension at the end of the head and there is a large amount of liquid on the table surface, the liquid may infiltrate the table through the existing fault and cause contamination of the electronic components. in the event of contamination, table movements may not occur.
  • Acción
    The holding company will do the sealing in the failure of the top cover of the table column. This will ensure protection against ingress of liquids. The company will contact customers to schedule a visit to carry out corrective action.

Device

Angiography equipment, risk class III: AXIOM ARTIS FC, registration 10234230075, lots / series: 1...

Manufacturer

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