Events

Rappel de Philips IntelliSpace Portal Diagnostic Imaging System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems (USA).

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
    17324
  • Date de mise en oeuvre de l'événement
    2014-09-09
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    The manufacturer has identified several software issues with this system which could lead to misdiagnosis., 1. when reopening a bookmark generated from processing a muga scan the ejection fraction displayed may be different to the originally displayed value, 2. a patient study may be presented to the revieweing physician with the incorrect patient data, 3. while using the nm view application an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximised or if the image is 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.
  • Action
    Software to be upgraded

Device

Philips IntelliSpace Portal Diagnostic Imaging System

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA