Events

Alerta De Seguridad para single-photon emission computerized tomograph Spect E.CAM /SYMBIA

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 Siemens Medical Solutions Usa, Inc. || Siemens A.G. || Orbotech Medical Denmark.

¿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
    I1603-126
  • Número del evento
    2008EBC-0001900
  • Fecha
    2016-03-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 incidents that occurred during collimator change operations that led to the injury of the user, and found that although the user manual is effective, it seems that additional instructions such as visual aids could help to make the change procedure of the collimator more secure , which could potentially reduce the presentation of adverse events on users.

Device

single-photon emission computerized tomograph Spect E.CAM /SYMBIA
  • Modelo / Serial
  • Descripción del producto
    Image acquisition system that allows detecting or visualizing the distribution of radionuclide absorption in the body or organ, making use of the following techniques: planar tomography, whole-body tomography, topographic imaging and imaging for isotopic conenergies up to 588kev. Detector heads easily rotate in numerous positions to offer general-purpose studies, cardiology, oncology and neurology.
  • Manufacturer
    Siemens Medical Solutions Usa, Inc. || Siemens A.G. || Orbotech Medical Denmark

Manufacturer

Siemens Medical Solutions Usa, Inc. || Siemens A.G. || Orbotech Medical Denmark
  • Source
    NIDFSINVIMA