Events

Alerta De Seguridad para angiograph

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 GE Medical Systems Scs (Gems Scs) || GE Hualun Medical Systems Co., Ltd || XPRO Sistemas 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
    I1410-424
  • Número del evento
    2009EBC-0003319
  • Fecha
    2014-10-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=193
  • 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 reports that it has detected unintentional movements of the image intensifier driven by the anti-collision sensor, leading to the potential occurrence of adverse events on the patient.

Device

angiograph
  • Modelo / Serial
    ANGIX
  • Descripción del producto
    These devices are designed to visualize internal anatomical structures of the patient by converting the pattern of X-ray radiation into a visible image through electronic amplification and radiological visualization of the heart, blood vessels or lymphatic system during or after injection of contrast medium. They are indicated for use in procedures such as diagnosis and intervention of vascular angiography for the generation of fluoroscopic images of human anatomy, rotation exploration, cardiology and others.
  • Manufacturer
    GE Medical Systems Scs (Gems Scs) || GE Hualun Medical Systems Co., Ltd || XPRO Sistemas Ltda

Manufacturer

GE Medical Systems Scs (Gems Scs) || GE Hualun Medical Systems Co., Ltd || XPRO Sistemas Ltda