Events

Alerta De Seguridad para ultrasound 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 Philips Medical Systems || Philips Ultrasound Inc..

¿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
    I1603-129
  • Número del evento
    2008DM-0001665
  • Fecha
    2016-03-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 safety fasteners from the control panel to the base of the referenced medical devices may loosen over time, which could subsequently lead to detachment from the assembly of the ultrasound system, leading to potential adverse events on patients or patients. users.

Device

ultrasound equipment
  • Modelo / Serial
    EPIQ 5 and EPIQ 7
  • Descripción del producto
    Designed to obtain, treat and analyze internal body images of the patient's body such as muscles, organs, their shape, structures and possible pathologies or injuries through the emission of ultrasound waves and the formation of images from the information contained in the echoes received for diagnostic purposes.
  • Manufacturer
    Philips Medical Systems || Philips Ultrasound Inc.

Manufacturer

Philips Medical Systems || Philips Ultrasound Inc.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA