Events

Alerta De Seguridad para EQUIPMENT FOR ALLURA XPER ANGIOGRAPHY. Anvisa Registry No. 10216710153 and 10216710206. Affected series: 575, 302, 405, 914, 596, 1193, 602, 576, 619, 1687 and 407.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems 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
    1141
  • Fecha
    2012-06-16
  • 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
    When the ceiling monitor suspension falls to its lowest position, there is a possibility of a serious adverse event occurring with the patient or users. The company informed that it will carry out corrective field actions with the affected products in Brazil (FCO72200211). For further information, check http://portal.anvisa.gov.br/wps/wcm/connect/77402d004ba13af7bd1cbfaf8fded4db/Messagem+de+Alerta.pdf?MOD=AJPERES.
  • Causa
    Risk of fall of the ceiling monitor suspension system of the equipment.
  • Acción
    Do not move the suspended ceiling monitor above the patient and do not allow the staff to stand under or near the ceiling monitor. Please forward the information in this alert to anyone who may be affected by the problem.

Device

EQUIPMENT FOR ALLURA XPER ANGIOGRAPHY. Anvisa Registry No. 10216710153 and 10216710206. Affected ...

Manufacturer

Philips Medical Systems Ltda
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA