Events

Alerta De Seguridad para Digital X-ray system

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 Agfa Healthcare N.V..

¿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
    I1602-46
  • Número del evento
    2011EBC-0007060
  • Fecha
    2016-02-04
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=158
  • 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 affirms that the referenced equipment could represent loss of motorized movement needing to make the commutation to the manual movement, leading to possible delays in the attention of the patients.

Device

Digital X-ray system
  • Modelo / Serial
    DX-D100
  • Descripción del producto
    It allows to capture and process a wide range of studies with greater productivity thanks to the image quality, in an agile way it is passed to direct radiology, ideal for the study of external and internal patients, small hospitals and radiological imaging centers, emergency room, orthopedic centers and clinics private, as well as medical consultations allow to reduce the doses applied to the patient, thanks to cesium iodide technology, and does so for DR as for CR based on water technology is easily installed in limited spaces requires minimal training, provides a wide range of images in a short time
  • Manufacturer
    Agfa Healthcare N.V.

Manufacturer

Agfa Healthcare N.V.