Events

Alerta De Seguridad para ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 80015490090 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee biplane, Artis Zeego, Artis Q biplane

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
    2209
  • Fecha
    2017-03-06
  • 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
    Users should notify and instruct their teams to be aware of this problem and if there are any questions regarding the addendum to the operating instructions, the company should be contacted.
  • Causa
    Siemens healthcare diagnostics informs that in the indicated artis systems a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear on the "small" and "micro" (if present) focus, an automatic focus is performed when the pedal is pressed several times. this special system function is not fully written in the currently available operating instructions. if a focus (small / micro) develops a fault, an alternative focus can be selected by pressing the pedal repeatedly. this allows the radiation to be generated again so that clinical treatment or diagnosis can proceed.
  • Acción
    Field Action Code AX058 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will update, correct or supplement the instructions for use.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 800...

Manufacturer

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