Events

Alerta De Seguridad para RX PCR Scanner ELEVA. Anvisa Registry: 10216719006.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems 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
    957
  • Fecha
    2009-03-11
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The cited problem can occur every time the following events occur simultaneously: a patient is selected in the patient list, the examination tab is pressed and a query to the database is running at the same time in the background. According to Philips Medical System Ltda (holder of product registration in Brazil), the equipment will be updated with a software version that will correct this error. The company has not yet released the timeline for correcting the error. The ANVISA Technovigilance Unit is monitoring this case.
  • Causa
    The equipment may perform an incorrect selection of patients, which may cause confusion of data belonging to different patients.
  • Acción
    The recommended action for product users is that, before saving the images, check the patient selection list if the correct patient is selected.

Device

RX PCR Scanner ELEVA. Anvisa Registry: 10216719006.

Manufacturer

Philips Medical Systems Ltda.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA