Events

Alerta De Seguridad para X-ray diagnostic equipment

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 Medical Systems Monterrey, México S.A. De C.V. || Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc || B.M. Tech Worldwide Co., Ltd..

¿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
    I1804-269
  • Número del evento
    2008EBC-0002088
  • Fecha
    2018-04-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=49
  • 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

Device

X-ray diagnostic equipment
  • Modelo / Serial
    DPX-NT, DPX Bravo, DPX Duo, DPX-MD, Prodigy and Prodigy Advance
  • Descripción del producto
    X-ray diagnostic equipment designed to measure the calcium content of the bone, examination called bone density or dual-energy x-ray absorptiometry or the bone densitometer is designed to calculate bone mineral density and body composition (lean or adipose tissue mass) ) of patients when their doctors indicate it.Obtain estimation of bone mineral density in several anatomic places (spine, femur, whole body and forearm. Obtaining an estimate of the risk of relative fracture based on the value of the t-score of the patient using Defracture risk categories defined by the World Health Organization (WHO). Fractures that appear in the instructions for use in the operation manual.
  • Manufacturer
    Ge Medical Systems Monterrey, México S.A. De C.V. || Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc || B.M. Tech Worldwide Co., Ltd.

Manufacturer

Ge Medical Systems Monterrey, México S.A. De C.V. || Ge Medical Systems Ultrasound & Primary Care...