Events

Alerte De Sécurité sur X-ray system mobile arches in C

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 Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || Ge Oec Medical Systems Gmbh.

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
    I1706-243
  • Numéro de l'événement
    2009EBC-0003260
  • Date
    2017-05-22
  • 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=86
  • 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

X-ray system mobile arches in C
  • Modèle / numéro de série
    ELITE, distributed between October 27, 2016 and March 28, 2017
  • Description du dispositif
    X-ray systems or "mobile arcs in C" are general-purpose diagnostic equipment, with mobility around the operating table or examination, based on x-ray technology that allows: obtaining and / or recording of still images (conventional radiography and digital) of internal body structures by exposing a part of the body to a small dose of x-ray radiation; obtaining and / or recording moving images in real time (continuous, pulse or snapshot fluoroscopy) and video lattice of internal structures of the patient as support for diagnostic procedures, surgical procedures and intervention. These equipments are designed for anatomical visual structures converting a x radiation pattern into a visible image through electronic amplification. Clinical applications include, but are not limited to, the following: cholangiography, endoscopy, urology, orthopedics, vascular and cardiac neurology, including the implantation of heart rate management devices, calculus localization, thoracic surgery, gastrointestinal tract investigations, angiography of blood vessels, legs, heart and brain, and can be used for other imaging applications at the discretion of the doctor.
  • Manufacturer
    Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipamentos || Medico-Hospitalares Ltda || Ge Oec Medical Systems Gmbh

Manufacturer

Ge Oec Medical Systems Inc || Ge Healthcare Do Brasil Comércio E Servicos Para Equipament...