Events

Rappel de Philips Brilliance 64 and Ingenuity CT/Core/Core 128 CT Systems

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
    20197
  • Date de mise en oeuvre de l'événement
    2016-05-25
  • 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
    1.Though internal testing the image orientation labels( l/ra/p) are not displayed during active scanning when switched from overview layout for volume interventional procedures., 2.Artifacts in the brain scans could be interpreted as finding hypo dense at bone brain interface while scanning using high resolution scan mode., 3. software issues found in the field and through internal testing were indentified on ict and ingenuity/ brilliance 64 with software v4.1.3 and 4.1.4., 4. varian rpm drive is not mapping in ct user profile after logout/login.
  • Action
    Software to be upgraded

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core 128 CT Systems
  • Modèle / numéro de série
    Model: , Affected: , Software version: CT systems running software V4.1.3, 4.1.4, or 4.1.5
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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