Events

Alerte De Sécurité sur Equipment for Computerized Tomography

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 Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems 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
  • ID de l'événement
    I1805-302
  • Numéro de l'événement
    2017EBC-0000590-R1
  • Date
    2018-05-21
  • 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=46
  • 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

Equipment for Computerized Tomography
  • Modèle / numéro de série
    OPTIMA CT660 and REVOLUTION EVO.
  • Description du dispositif
    The equipment for GENERAL ELECTRIC tomography is designed to: obtain, process and offer images of different planes osections of the body taken at different angles and planes by X-ray technology that are reconstructed in the equipment as three-dimensional models of body structures for the diagnosis of whole body and of selected parts of the body in patients of all ages. Obtain, process and offer images of different planes or sections of the body taken at different angles and planes by means of X-ray technology that are reconstructed in the equipment as three-dimensional structures of the body in order to serve as a diagnostic tool for diseases, traumas or anomalies, as well as plan, guide and supervise the treatment. The system can be used as a diagnostic imaging support in minimally invasive procedures, such as biopsies and ablation of tumors and pathologies. The system can acquire anatomical CT (computed tomography) images that are useful in clinical terms for simulation and treatment planning.
  • Manufacturer
    Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd.

Manufacturer

Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hangwei Medical Systems Co Ltd.