Alerta De Seguridad para magnetic resonance equipment

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 Systems Nederland B.V. || Philips Healthcare ( Suzhou) 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
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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


  • Modelo / Serial
    T5, T10-NT, ACSNT, Intera 0.5T / 1.0T / 1.5T, Achieva 1.5T, Multiva 1.5T
  • Descripción del producto
    The intended use of PHILIPS MRI medical electromedical systems is class IIa diagnostic equipment. The systems can generate transverse and spectroscopic images in any orientation of the internal structure of the head, body or extremities. Magnetic resonance images represent the spatial distribution of protons or other nuclei with spin. The appearance of the images is determined by different physical properties of tissue and anatomy, and the technique of acquisition by applied MRI. The image acquisition process can be synchronized with the patient's breathing or with the cardiac cycle. The systems can use combinations of images to generate physical parameters and related derived images. The images, the spectra, and the measurements of physical parameters, after being interpreted by the medical specialist, provide information that can facilitate the diagnosis and planning of the therapy. The accuracy of certain physical parameters depends on the system and the acquisition parameters, and must be regulated and validated by the clinical user. For some studies, the use of contrast media may be essential. During an MRI exam, energy is transferred to the patient in the form of radio frequency waves, changing magnetic fields and acoustic noise. The PHILIPS magnetic resonance systems do not emit radiation-ionizing agents. Non-invasive diagnostic equipment
  • Manufacturer