Events

Alerta De Seguridad para X-Ray Equipment JUNO DRF - APOLO DRF

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 Villa Sistemi Medicali S.P.A..

¿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
    I1603-116
  • Número del evento
    2010EBC-0006430
  • Fecha
    2016-03-18
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • 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 an operator was injured at the moment of repositioning a table, when standing behind the patient platform between the left arm of the patient support platform and the sensor support, this situation was presented when entering an area restricted that does not constitute a habitual work position and the delayed activation of the emergency stop, leading to the occurrence of the adverse event on the user.

Device

X-Ray Equipment JUNO DRF - APOLO DRF
  • Modelo / Serial
    JUNO DRF and APOLO DRF
  • Descripción del producto
    It is a universal table for radiological diagnosis, created to meet all needs. It can be used for examinations of the digestive system, skull and skeleton, urography, myelography, vascular and pulmonary exams, and it can also be used, when equipped with a digital camera for angiography.
  • Manufacturer
    Villa Sistemi Medicali S.P.A.

Manufacturer

Villa Sistemi Medicali S.P.A.