Events

Rappel de Ingenuity TF PET/CT System with software version 4.0.3.26129

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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
    RC-2017-RN-01314-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-10-17
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01314-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Philips is advising of an issue with the qc baseline test. during the pet daily quality control (qc) baseline test, customers may see a popup message on the console stating “communications error. do you wish to continue?”, with the options of “ok” or “cancel”. answering either way may cause the daily qc to fail. in some cases, once this message appears, it will re-appear each time the daily qc is run.
  • Action
    Where Daily QC is unable to be run due to a continual Communication Error, Philips is advising customers to contact their Philips Service Representative to resolve the issue. Philips will correct the issue in an upcoming software release.

Device

Ingenuity TF PET/CT System with software version 4.0.3.26129

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA