Events

Alerta De Seguridad para X-ray computed tomography equipment - CT

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 Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland) Inc || Philips Medical Systems (Cleveland) Inc. || Philips And Neusoft Medical System.

¿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
    I1401-10
  • Número del evento
    2008EBC-0001540
  • Fecha
    2014-01-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=212
  • 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
    It was stated by the manufacturer that during the procedure corresponding to the monitoring of a bolus with a clinical rotation stage of 0.4 seconds, in the references of the aforementioned biomedical equipment that makes use of the software version 3.6.0, opacity may occur taking of the test, which may lead to overuse of unnecessary radiation to the patient.

Device

X-ray computed tomography equipment - CT

Manufacturer

Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland...
  • Source
    NIDFSINVIMA