Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1562
  • Date
    2015-04-02
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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. ".
  • Action
    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.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA