Events

Rappel de Allura Xper Allura software versions: 8.1.25; 8.1.25.1; 8.1.25.5; 8.2.25; 8.2.25.5; and 8.2.27

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-2018-RN-00796-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-20
  • 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-2018-RN-00796-1
  • 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 have identified that the first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. if the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
  • Action
    Philips is advising this issue will be resolved in a software update, expected to be available in the second half of 2018. Philips will notify users when this software update is available. Until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor.

Device

Allura Xper Allura software versions: 8.1.25; 8.1.25.1; 8.1.25.5; 8.2.25; 8.2.25.5; and 8.2.27
  • Modèle / numéro de série
    Allura Xper Allura software versions: 8.1.25; 8.1.25.1; 8.1.25.5; 8.2.25; 8.2.25.5; and 8.2.27ARTG Number: 225815(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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