Events

Alerta De Seguridad para BrightView

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 Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine 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
    I1411-491
  • Número del evento
    2008DM-0001422
  • Fecha
    2014-11-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=191
  • 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 it is possible that unscheduled detector and gantry movements may occur, caused by conflicts in the software when performing specific test sequences, leading to possible adverse events on the patients.

Device

BrightView
  • Modelo / Serial
    Brightview with 3/8 "glass, Brightview with 3/8" glass and cephalic flow detector, Brightview X with 3/8 "glass and || Brightview XCT, with software versions 1.2.3 / 2.5.3
  • Descripción del producto
    Clinical diagnosis system by nuclear medicine designed to produce diagnostic images from the detection of radiation that is previously supplied to the patient through a radioactive drug or tracer radioactive with a drug known metabolic pathway.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc. || Philips Nuclear Medicine Inc
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA