Events

Alerta De Seguridad para Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Affected Model: Artis zeego, Artis zee biplane, Artis zee ceiling, Artis zee floor, Artis zee Multi-purpose Serial Numbers affected: 147551; 147708; 136918; 136933; 136947; 137020; 137026; 137042; 137045; 137074; 137105; 137164; 137379; 137411; 137658; 160457;

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
    2081
  • 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 for Megalix X-ray tube systems to perform focussed acquisition of images 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. Consider reinforcing these procedures until the upgrade has been made.
  • Causa
    For artis systems with software versions vc21c and vd11 and megalix cat + x-ray tubes, the semi-automatic focus switch may, in cases of defects in the "small" and "micro" foci (if present), not work as intended when pressing the pedal. this type of focus defect, which causes the failure of the semiautomatic focus switch, becomes more likely as the life of the x-ray tube increases. as a matter of clarity, systems with the vc21b software version do not are affected.
  • Acción
    Field Action Code AX050 / 16 / S & AX051 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registrati...

Manufacturer

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