Events

Alerta De Seguridad para Equipment for Computerized Tomography

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 Ge Medical Systems Israel - Functional Imaging || Ge Medical Systems, Llc. || Ge Healthcare Japan Corporation || Ge Hang Wei Medical Systems Co Ltd. || Ge Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda.

¿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
    I1605-178
  • Número del evento
    2007EBC-0000590
  • Fecha
    2016-05-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 the service procedure describing the replacement of a power supply on the rotation side of the gantry specifies the incorrect torsion for the mounting hardware, due to this error, the three decelerating bolts that adjust the power supply could have an excess of if the torque has been replaced in your system, in the unlikely event that the bolts fail in the scanner's gantry during operation, serious bodily injury could result if the component is fired, which could lead to potentially occurring adverse events about patients.

Device

Equipment for Computerized Tomography

Manufacturer

Ge Medical Systems Israel - Functional Imaging || Ge Medical Systems, Llc. || Ge Healthcare Japan...