Events

Rappel de INTELLISPACE PORTAL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20539
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-07-30
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    There are software issues in the affected product. 1-when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application the ejection fraction (ef) may be different. 2-when processing using one of the following nm clinical applications: autoquant emory cardiac toolbox corridor4dm or neuroq the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. 3-while using the nm viewer application an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. 4-while displaying pet images within ct viewer the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi-modality tumor tracking applications.

Device

INTELLISPACE PORTAL
  • Modèle / numéro de série
    Model Catalog: 4598 003 15411 (Lot serial: N/A); Model Catalog: 4598 003 56911 (Lot serial: N/A); Model Catalog: 4598 001 31111 (Lot serial: N/A); Model Catalog: 4598 001 30491 (Lot serial: N/A)
  • Description du dispositif
    INTELLISPACE PORTAL
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC