Events

Alerta De Seguridad para Equipment for Computerized Tomography

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, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd..

¿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
    I1805-302
  • Número del evento
    2017EBC-0000590-R1
  • Fecha
    2018-05-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=46
  • 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

Device

Equipment for Computerized Tomography
  • Modelo / Serial
    OPTIMA CT660 and REVOLUTION EVO.
  • Descripción del producto
    The equipment for GENERAL ELECTRIC tomography is designed to: obtain, process and offer images of different planes osections of the body taken at different angles and planes by X-ray technology that are reconstructed in the equipment as three-dimensional models of body structures for the diagnosis of whole body and of selected parts of the body in patients of all ages. Obtain, process and offer images of different planes or sections of the body taken at different angles and planes by means of X-ray technology that are reconstructed in the equipment as three-dimensional structures of the body in order to serve as a diagnostic tool for diseases, traumas or anomalies, as well as plan, guide and supervise the treatment. The system can be used as a diagnostic imaging support in minimally invasive procedures, such as biopsies and ablation of tumors and pathologies. The system can acquire anatomical CT (computed tomography) images that are useful in clinical terms for simulation and treatment planning.
  • Manufacturer
    Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd.

Manufacturer

Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd.