Events

Alerta De Seguridad para file system and transfer of medical images

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 Fujifilm Corporation || Fujifilm Techno Products 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
    I1611-502
  • Número del evento
    2009DM-0004506
  • Fecha
    2016-11-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=115
  • 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 during the sending of an fcr image to a pacs from another manufacturer, that the images of a patient were assigned to a different patient, leading to potentially adverse events occurring on the patients.

Device

file system and transfer of medical images
  • Modelo / Serial
    SYNAPSE, software version 4.0, 4.1, 4.2 and 4.3
  • Descripción del producto
    Software and hardware for the storage, transfer and processing of diagnostic images from different imaging equipment such as resonance imaging, tomographs, X-ray equipment, ultrasound, and nuclear medicine equipment, in order to allow diagnosis by the treating physicians and the departments of Medical diagnostic.
  • Manufacturer
    Fujifilm Corporation || Fujifilm Techno Products Co, Ltd

Manufacturer

Fujifilm Corporation || Fujifilm Techno Products Co, Ltd