Events

Rappel de Philips IntelliSpace PACS 4.4

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 Healthcare Informatics Inc.

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
    17290
  • Date de mise en oeuvre de l'événement
    2014-09-03
  • 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
    A problem has been detected in the philips intellispace pacs 4.4 software that, if it were to occur, could pose a risk for patients. although the data is correct in intellispace pacs, any changes to data may not be updated before auto export. if diagnosis is performed utilizing exported data on a 3rd party device the user may not be aware of any unchanged patient. if this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient.
  • Action
    Software to be upgraded

Device

Philips IntelliSpace PACS 4.4

Manufacturer

Philips Healthcare Informatics Inc
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA