Alerta De Seguridad para Angiography Equipment ALLURA XPER. Register Anvisa n ° 10216710153. Products under risk in Brazil: models with codes 722003,722005, 722006, 722008, 722014, 722015, 722019, 722020 with software version 7.2.X.

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.; Philips Medical Systems Nederlands B. V..

¿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
    1522
  • Fecha
    2015-03-06
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    This is an electronic defect in the intermittent alarm of the product, which in certain circumstances may lead to a situation in which the five-minute sound signal from the fluoroscopy does not sound. Through customer complaints and internal testing, Philips Healthcare has discovered an intermittent electronic defect in the product. According to the company, the problem does not create a dangerous situation, however the beep is an available tool to help avoid the excessive incidence of radiation in the patient. See Security Notice published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/f4260380478c61258259ebfe096a5d32/Aviso+de+Seguran%C3%A7a+-+FCO72200270.pdf?MOD=AJPERES
  • Causa
    Five minute product alarm does not sound intermittently.
  • Acción
    Philips will perform a software update to fix the alarm problem (installation of the new version R7.2.8). Until software correction is performed, the user must observe the real-time dosing information and accumulated fluoroscopy time reported by the system - the failure condition is restored when a new patient case is initiated, or when the system is restarted.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA