Alerta De Seguridad para Angiography Equipment ALLURA Philips. ANVISA records n ° 10216710153 and 10216710206. Models under risk: Allura Xper FD10 Ceiling / Allura Xper FD10 Floor / Allura Xper FD10 Ceiling / Allura Xper FD10 Floor / Allura Xper FD10 Allura Xper FD20 / 10; Allura Xper FD20 / 20; Allura Xper FD10 / 10 OR Table; Allura Xper FD20 / 10 OR Table; Allura Xper FD20 / 20 OR Table.

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 System 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
    1525
  • Fecha
    2015-03-11
  • 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
    If the Pedal is frequently used on an anti-fatigue mat, on an uneven surface or on the pedestal, your pedals may tilt. This can lead to an intermittent or continuous impossibility of obtaining fluoroscopic images or exposures in real time. Before starting a procedure, the user must check if the foot switch has any inclined pedals. If any inclined pedal is identified, the procedure must be interrupted and local service should be called. The inclined pedal can lead to an intermittent or continuous impossibility of obtaining images or fluoroscopic exposures in real time. If the fluoroscopy pedal is tilted and real-time fluoroscopy is not available, the footswitch display pedal or manual key can be used to generate a real-time image to complete a procedure. This will lead to a larger dose. For additional clarifications, access the Safety Notice issued by the company: http://portal.anvisa.gov.br/wps/wcm/connect/dd65d280479e0478916efbfe096a5d32/Aviso+de+Seguran%C3%A7a_1525.pdf?MOD=AJPERES
  • Causa
    Tilted pedal switch pedal may cause image interruption or exposure to real-time fluoroscopy.
  • Acción
    The user should check the pedal conditions of the equipment before use. The record holder is initiating corrective action for the product.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA