Events

Alerta De Seguridad para Technical Name: Equipment For Angiography ANVISA Registration Number: 10234120096 Hazard Class: III Affected Model: AXIOM Artis dFA, AXIOM Artis dFC Serial numbers affected: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 5913; 35936; 35949; 50138

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
    2080
  • Fecha
    2016-12-06
  • 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
    It is possible, in 2-spot Megalix X-ray tube systems, to acquire images with large focus after manual selection of a corresponding organ program. In 3-spot Megalix X-ray systems, fluoroscopy is possible with the "small" or "micro" focus that is still intact through the manual selection of a corresponding fluoroscopy program. In addition, the acquisition of images with the big focus is possible. Standard emergency procedures must be in place in case of system failures. Siemens recommends enforcing these procedures until the upgrade has been made.
  • Causa
    For axiom artis systems with the vb35e software version and megalix x-ray tubes, the semi-automatic focus switch may, in the case of a special type of defect in the "small" and "micro" foci (if present), not work desired when pressing the pedal. the focus defect, which causes the semi-automatic focus switch to fail, becomes more likely as the life of the x-ray tube increases.
  • Acción
    Field Action Code AX052 / 16 / S & AX053 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Technical Name: Equipment For Angiography ANVISA Registration Number: 10234120096 Hazard Class: I...

Manufacturer

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