Events

Alerta De Seguridad para computerized tomography equipment

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
    I1706-237
  • Número del evento
    2007EBC-0000590 ; 2008EBC-0002241
  • Fecha
    2017-06-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • 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

computerized tomography equipment
  • Modelo / Serial
    CT_RT_16_MKE, DISCOVERY 670 NM/CT, LIGHTSPEED VCT, LIGHTSPEED VCT XT, OPTIMA CT520, OPTIMA CT580, OPTIMA CT660
  • Descripción del producto
    The GENERAL ELECTRIC tomography equipment 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 destined to the diagnosis of the 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 using X-ray technology that are reconstructed in the equipment as three-dimensional models of bodily structures in order to serve as diagnostic tool for diseases, traumas or anomalies, as well as to 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 images of ct (computed tomography) 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.