Events

Alerta De Seguridad para Image Suite Software

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 Orex Computed Radiography Ltd || Carestream Health Ltd || Rayco (Shanghai) Medical Products Company Limited.

¿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
    I1607-273
  • Número del evento
    2012DM-0008595
  • Fecha
    2016-07-01
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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 reports that it has detected the possibility that the superimposed text of the i / d and a / p values corresponding to the identification of laterality and position of the image, are shown inverted in the images of computerized tomography and magnetic resonance that are received in the image image software. , leading to confusions of medical personnel and potentially adverse events on patients when erroneous readings of the obtained images are made.

Device

Image Suite Software

Manufacturer

Orex Computed Radiography Ltd || Carestream Health Ltd || Rayco (Shanghai) Medical Products Compa...
  • Source
    NIDFSINVIMA