Events

Alerta De Seguridad para X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY BRILLIANCE CT 64 (ANVISA Registry: 10216710191) and INGENUITY CT (Registro ANVISA: 10216710209). Software version 3.5.1.

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
    1129
  • Fecha
    2012-05-02
  • 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
    For additional information, refer to the Safety Notice issued by Philips (available at http://migre.me/8Weax) or contact the company through the call center - Tel .: 0800 701 7789.
  • Causa
    When a tilted scan is planned, the scan addition changes from the user-defined (non-continuous) values ​​to a continuous scan. the problem affects software version 3.5.1 of the products mentioned.
  • Acción
    The health facilities that have the equipment mentioned in this alert should verify the existence of affected products in their inventories, observing the software version that is installed in the equipment - if it is version 3.5.1, it is affected equipment. When using the equipment, check the addition of the sweep after adjusting the planned slope (in sweep) and, if it is CONTINUOUS instead of NOT CONTINUOUS, it must be changed to NOT CONTINUOUS to complete the sweep.

Device

X-RAY SYSTEM FOR COMPUTERIZED TOMOGRAPHY BRILLIANCE CT 64 (ANVISA Registry: 10216710191) and INGE...

Manufacturer

PHILIPS MEDICAL SYSTEMS LTDA
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA