Events

Alerta De Seguridad para Mammography System

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 Siemens A.G. || Siemens Shanghai Medical Equipment Ltd. || Siemens Healthcare 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
    I1702-61
  • Número del evento
    2008EBC-0002281
  • Fecha
    2017-02-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 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 has identified that the referenced devices enabled with the biopsy functionality can block such a function, when the inversion tool is used simultaneously with the image scanogram (image of the explorer), leading to the occurrence of equipment blockages and possible adverse events on the patients.

Device

Mammography System
  • Modelo / Serial
  • Descripción del producto
    This equipment is a universal mammography workstation for SCREENING and diagnosis in patients. Its intended use is to detect suspicious lesions in soft tissue for which special technical performance is required. It has the following clinical applications: mammography review, mammography diagnostic test, mammography magnification images, mammography with special compression plates and mammography biopsy-stereotactic.
  • Manufacturer
    Siemens A.G. || Siemens Shanghai Medical Equipment Ltd. || Siemens Healthcare Gmbh

Manufacturer

Siemens A.G. || Siemens Shanghai Medical Equipment Ltd. || Siemens Healthcare Gmbh
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA