Events

Alerta De Seguridad para X-ray system mobile arches in C

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 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.

¿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
  • ID del evento
    I1610-441
  • Número del evento
    2009EBC-0003260
  • Fecha
    2016-10-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=117
  • 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
  • Causa
    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
  • Modelo / Serial
    BRIVO OEC 715, BRIVO OEC 785 and BRIVO OEC 865, specific serials.
  • Descripción del producto
    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...