Alerta De Seguridad para Equipment for angiography ALLURA XPER, brand PHILIPS, Risk class: III, model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registry: 10216710153; ///// ALLURA XPER ANGIOGRAPHY EQUIPMENT, model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD 20/15; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; ALLURA XPER FD 20/15 OR Table .. risk class III, registration 10216710206.

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 Nederland 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
    1741
  • Fecha
    2015-11-09
  • 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
    The manufacturer makes it clear that real-time images and still images can lead to misinterpretation of still images as real-time images. The system is working according to the specification and purpose of the use.
  • Causa
    According to the record holder, the use of the allura xper, allura clarity, allura cv, allura centron and uniq systems in real time and still images can lead to misinterpretation of still images as real-time images. this can happen when: /// 1. when performing fluoroscopy, the user presses the single-shot exposure pedal, resulting in the display of a single-shot static image on the screen. the user does not realize that the single-shot exposure pedal is still active, and that exposure is therefore still active. conceptually, exposure image acquisition has priority over fluoroscopy imaging, so fluoroscopy is not started until the exposure pedal is released. at the same time, the user does not realize that real-time x-ray image acquisition is not active, although the static image icon is displayed and all legally required real-time x-ray indicators (such as dose, active x-ray icon, fluoro timer, and audible signal-x-ray company) are inactive. 2. while a fluoroscopy pedal is pressed and the fluoroscopy is active, the user (accidentally) presses a second fluoroscopy pedal and then releases the first fluoroscopy pedal. by releasing the first fluoroscopy pedal, the system terminates image acquisition in real time. the user does not realize that the first pedal was still pressed by pressing the second fluoroscopy pedal. at the same time, the user does not realize that real-time x-ray image acquisition is not active, although the static image icon is displayed and all legally required real-time x-ray indicators (such as dose, active x-ray icon, fluoro timer, and audible signal-x-ray company) are inactive.
  • Acción
    The field action deals with the sending of Safety Notice for customer orientation. The warning gives the following recommendations to the customer / user: • The user must ensure that the audible signal (X-ray company) is activated. • The user must be aware of the indicators related to the X-ray, ) as described in the instructions for use (IFU). // • The user must activate only ONE fluoroscopy pedal at a time. // • To avoid the simultaneous use of two fluoroscopy pedals, the predicted measurements are working for all pedal models and available for use with the system. // • Users are strongly advised to set the foot switch to the default setting of Philips. // • The user must be aware that pressing a single-shot exposure pedal results in the display of the static exposure image while the single-shot exposure pedal is pressed as described in the instructions for use (IFU) .//// Philips reminds customers to only use one fluoroscopy pedal at a time. Action code: FCO 72200276.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA