Alerta De Seguridad para TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips Healthcare.

¿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
  • Fecha
    2012-02-01
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: tumorloc in brilliance ct big bore, extended brilliance workspace (ebw), gemini gxl 16, gemini tf 16, gemini tf 64, gemini tf big bore medical device manufacturer, philips healthcare, has issued a field safety notice on their tumorloc software application in brilliance ct big bore, extended brilliance workspace (ebw), gemini gxl 16, gemini tf 16, gemini tf 64, and gemini tf big bore systems. according to the manufacturer, tumorloc will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. in tumorloc, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the organ list. this occurs when using the save button, exit button or sendtolaser button. philips further explained that there may be a risk of unintended radiation to healthy tissue and failure to deliver radiation to target lesion. however, this is highly unlikely to occur because tumorloc does not have the capability to create treatment plans that include dose information. as confirmed by the local supplier, the affected product has been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH