Events

Alerta De Seguridad para radiosurgery equipment Elekta

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 Elekta Instrument AB.

¿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
    I1410-412
  • Número del evento
    2009EBC-0005038
  • Fecha
    2014-10-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=194
  • 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 the coordinate system to be aligned with the adapter frame of the previous systems may experience a movement of the lens up to 0.5mm from the intended position, since the block flanges may cause the frame to be poorly closed preventing the coordinate frame from it is fixed properly, causing a small mechanical mismatch between the decoded system and the frame adapter in the z direction, which can lead to possible adverse events on the patients.

Device

radiosurgery equipment Elekta
  • Modelo / Serial
    LEKSELL GAMMA KNIFE, serials FV001 up to FV376
  • Descripción del producto
    Radiosurgery system for the use in stereotactic radiation of intracranial structures. Surgery is continued by providing a prescribed dose in the form of one or more shots of ionizing radiation directed at the target site. During radiation there are no moving parts inside the unit and therefore, safety, stability and precision are inherent characteristics
  • Manufacturer
    Elekta Instrument AB

Manufacturer

Elekta Instrument AB
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NIDFSINVIMA