Events

Alerte De Sécurité sur magnetic resonance equipment

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Philips Medical Systems Nederland B.V. || Philips Healthcare ( Suzhou) Co., Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    2018EBC-0017485
  • Date
    2018-04-17
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données

Device

magnetic resonance equipment
  • Modèle / numéro de série
    T5, T10-NT, ACSNT, Intera 0.5T / 1.0T / 1.5T, Achieva 1.5T, Multiva 1.5T
  • Description du dispositif
    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
    Philips Medical Systems Nederland B.V. || Philips Healthcare ( Suzhou) Co., Ltd.

Manufacturer

Philips Medical Systems Nederland B.V. || Philips Healthcare ( Suzhou) Co., Ltd.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NIDFSINVIMA