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 Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda.

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
    I1610-441
  • Numéro de l'événement
    2009EBC-0003260
  • Date
    2016-10-25
  • 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=117
  • 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
  • Cause
    The manufacturer reports that if before or during a procedure, the c-arm moves up or down without pressing, it must press the emergency stop button and suspend the use of the equipment, this failure would lead to potential serious adverse events being presented. the patients or users.

Device

X-ray system mobile arches in C
  • Modèle / numéro de série
    BRIVO OEC 715, BRIVO OEC 785 and BRIVO OEC 865, specific serials.
  • Description du dispositif
    X-ray systems or "mobile arcs in C" are general-purpose diagnostic equipment, with mobility around the operation or examination table, based on x-ray technology that allows: obtaining and / or recording of fixed 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 taking video of the patient's internal structures as support for diagnostic, surgical procedures and intervention procedures. These equipments are designed to visualize anatomical structures converting a radiation pattern x 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 implantation of heart rate management devices, calculus localization, thoracic surgery, gastrointestinal tract investigations, vessel angiography of legs, heart and brain, and can be used for other imaging applications at the doctor's discretion.
  • Manufacturer
    GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda

Manufacturer

GE Oec Medical Systems Inc || GE Medical Systems Gmbh || GE Hualun Medical Systems Co., Ltd || GE...