Events

Alerta De Seguridad para cardiovascular X-ray systems

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited.

¿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
    I1610-409
  • Número del evento
    2008EBC-0002432
  • Fecha
    2016-10-04
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer informs that the generator's breathing valve could be in the wrong position resulting in a failure of the ht tank, which would cause an interruption of the operation during the procedure, leading to potential adverse events on the patients.

Device

cardiovascular X-ray systems
  • Modelo / Serial
    ALLURA FC and INTUIS, references 723003, 723001 and 723005, specific serials.
  • Descripción del producto
    Monoplane or biplane systems used for diagnostic and interventional cardiovascular procedures, which have a stand with a C-suspended arm and digital image acquisition technology. Indicated for the diagnosis of cardiovascular diseases. It can also be used for diagnosis in surgical procedures and treatment for the placement of stents, demarcated implants in people of all ages.
  • Manufacturer
    Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited

Manufacturer

Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA