Events

Alerta De Seguridad para conventional mobile x-ray systems Practix 160

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 Dmc Gmbh.

¿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
    I1503-110
  • Número del evento
    2008EBC-0003048
  • Fecha
    2015-03-15
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=183
  • 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 states that when the previous systems are disconnected or when the arm of the tube is located in stand by (x-ray generator off), a pulse of radiation (50 kv, 2.5 μgy) can be generated, potentially resulting in the unintentional exposure, this occurs only in systems containing an electronic component in particular in the control board; the component is used only in a small number of systems, leading to the potential occurrence of adverse events on patients or users.

Device

conventional mobile x-ray systems Practix 160
  • Modelo / Serial
    PRACTIX 160
  • Descripción del producto
    This equipment is indicated for the visualization and acquisition of X-ray images for diagnosis.
  • Manufacturer
    Philips Medical Systems Dmc Gmbh

Manufacturer

Philips Medical Systems Dmc Gmbh
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA