Events

Alerta De Seguridad para Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Class of risk: III. Allura Xper FD1O / Allura Xper FD1O / 10 Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD1O / Allura Xper FD1O / Allura / Allure Xper FD2O / 1 / Allura Xper FD2O / 1 5 OR Table. List of lots / series: 285/306/308/322/379/565/405/639

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.; Philips Medical Systems Nederland B.V..

¿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
    1970
  • Fecha
    2016-06-23
  • 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
    If you have any questions regarding this action, please contact Philips by phone: 0800 701 7789
  • Causa
    Philips healthcare has discovered, by means of trend analysis, an increase in the error rate of certain low voltage dc ("facc") power supplies used in these products. each system contains multiple faccs, some of which may be subject to a high probability of error. failure of a facc may result in the sudden loss of image acquisition or mechanical motion functionality, depending on which subsystems the facc is feeding. the severity was classified as resulting in severe injury: life threatening or permanent damage or need medical intervention to avoid permanent damage. the probability of occurrence was classified as possible but unlikely. the conclusion of the risk analysis was not acceptable.
  • Acción
    Field action FCO72200371 Sending letter to clients (attached) // FACC replacement affected.

Device

Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Cla...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA