Events

Alerta De Seguridad para Equipment for angiography Artis. Model: Artis Zeego. Anvisa Registry n ° 10234230158.

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 Ltda..

¿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
    1452
  • Fecha
    2014-10-24
  • 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 overseas manufacturer performed the problem analysis, evaluating all the inherent risks, which generated corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as a medium risk to health, its severity being critical and its probability of occurrence extremely unlikely. According to the company, this is a possible hardware failure that has no influence on the treatment of patients. The customer will be advised to wait for the Service Team to schedule field corrections and to file the letter with the Operator's Manual. In addition, Siemens advises to inform all personnel of the organization who need to be aware of this problem and act accordingly. According to the company the field action was finalized
  • Causa
    A cable inside the c-arm of affected systems may have been improperly positioned. without an additional measure, there is the possibility of a cable inside the c-arm. the problem will not occur systematically but sporadically over the lifetime of the system.
  • Acción
    Correction in the field / Correction of parts or parts.

Device

Equipment for angiography Artis. Model: Artis Zeego. Anvisa Registry n ° 10234230158.

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA