Events

Alerta De Seguridad para Digital diagnostic 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 Samsung Electronics 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
    I1402-54
  • Número del evento
    2012EBC-0009015
  • Fecha
    2014-02-06
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=210
  • 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 is reported by the manufacturer that despite performing the normal operation of the unit and after releasing the remote control switch, an uncontrolled movement of the x-ray tube head is presented which is moved to its maximum limit and the "code of error 4308 ", leading to the potential occurrence of adverse events on the patient bear the operator.

Device

Digital diagnostic x-ray system
  • Modelo / Serial
    XGEO GC80, GC80V80
  • Descripción del producto
    It has been designed to capture digital images by x-rays of various parts of the body, including the head, chest, spine, abdomen, joints, hands, feet and other organs. It has not been designed to perform mammograms.
  • Manufacturer
    Samsung Electronics Co., Ltd

Manufacturer

Samsung Electronics Co., Ltd