Events

Alerta De Seguridad para Computerized Tomography Equipment

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 And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland) Inc || Philips Healthcare (Suzhou) Co., Ltd || Philips Medical Systems (Cleveland) Inc..

¿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
    I1605-194
  • Número del evento
    2008EBC-0001540
  • Fecha
    2016-05-05
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 the manufacturer reports that the referenced devices present the following series of drawbacks: 1) cardiac mri - irregular appearance of the contrast in vessels.2) losing annotations on image in cct.3) artifact halo.4) unable to fit z locations in the pre-scan and ct scanner of 4d.5) wrong z annotations in the planned box for coronary / sagittal inspection (see aclient information chart) .6) unintentional change of acquisition time in the scanner rule.7) bolo tracker not it is activated as expected.8) system does not respond when paused.9) unplanned results during multiphase pulmonary series could cause a system collision.10) communication errors between the computer host and the gantry.11) artifact mill of wind with a zone width of 0.67mm. if these situations occur, they could lead to potential adverse events on patients or delays in care.

Device

Computerized Tomography Equipment

Manufacturer

Philips And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee D...
  • Source
    NIDFSINVIMA