Events

Alerta De Seguridad para X-ray system mobile arches in C

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 Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || Ge Oec Medical Systems Gmbh.

¿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
    I1706-243
  • Número del evento
    2009EBC-0003260
  • Fecha
    2017-05-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=86
  • 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

X-ray system mobile arches in C
  • Modelo / Serial
    ELITE, distributed between October 27, 2016 and March 28, 2017
  • Descripción del producto
    X-ray systems or "mobile arcs in C" are general-purpose diagnostic equipment, with mobility around the operating table or examination, based on x-ray technology that allows: obtaining and / or recording of still images (conventional radiography and digital) of internal body structures by exposing a part of the body to a small dose of x-ray radiation; obtaining and / or recording moving images in real time (continuous, pulse or snapshot fluoroscopy) and video lattice of internal structures of the patient as support for diagnostic procedures, surgical procedures and intervention. These equipments are designed for anatomical visual structures converting a x radiation pattern into a visible image through electronic amplification. Clinical applications include, but are not limited to, the following: cholangiography, endoscopy, urology, orthopedics, vascular and cardiac neurology, including the implantation of heart rate management devices, calculus localization, thoracic surgery, gastrointestinal tract investigations, angiography of blood vessels, legs, heart and brain, and can be used for other imaging applications at the discretion of the doctor.
  • Manufacturer
    Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || Ge Oec Medical Systems Gmbh

Manufacturer

Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipament...