Events

Alerta De Seguridad para CT Scanner Equipment INGENUITY; Brand Philips; Risk class III; registry: 10216710209; Serial numbers: 31001/32054/32065/32067/52067/52010/52030/52031/52044.

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 (Cleveland), Inc..

¿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
    1562
  • Fecha
    2015-04-02
  • 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
    According to the company during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have the real-time feedback of the needle placement when it is close to the vital structures (large vessel, organ, etc.). .). #### UPDATED ON 07/18/2017, the company sent the completion report of the field action proving the accomplishment of correction, as planned.
  • Causa
    According to record holder information, "during the conduct of the tcc in the ingenuity ct system, the first image was marked as" last capture "instead of the current" last capture "acquired. by pressing the pedal for the first exposure, the images were displayed as the "last shot". subsequent requests did not result in an immediate reconstruction of the image and the first image remained on the screen identified as the "last capture". eventually all images appeared. the problem is caused by incorrect settings for increasing the number of slices in the user set for the tcc protocol resulting from the conversion of the protocol to the exam card during software upgrade from v3.X to v4.0.0 / v4.0.1. in normal tcc mode, the images are reconstructed without delay and the "last capture" is displayed properly with the last reconstructed result. ".
  • Acción
    The record holder's recommendations, affected users should check the TCC examination card and correct it if this problem exists. The guidance is to refer to the steps in the Addendum to the safety notice (see annex).

Device

CT Scanner Equipment INGENUITY; Brand Philips; Risk class III; registry: 10216710209; Serial numb...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA