Events

Rappel de Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)

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-2015-RN-00995-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-10-09
  • 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-2015-RN-00995-1
  • 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 healthcare has discovered through customer feedback and internal testing a software failure that could lead to an intermittent and short term unavailability of the fluoroscopy function. upon initiating fluoroscopy the user may encounter a user message “fluoro failed, please retry” and fluoroscopy will be unavailable. retrying fluoroscopy resolves this situation in most cases. you may need to retry more than once in about 2% of the events.The failure mode has no impact on an active fluoroscopy run. once started, an active fluoroscopy run continues until releasing the pedal.
  • Action
    Philips is advising end users that they must retry fluoroscopy if the failure mode occurs. Philips Field Service Engineers will install Software R8.2.16.1 which will correct the issue. The expected date of the correction release is October 2015. This action has been closed-out on 26/08/2016.

Device

Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography)
  • Modèle / numéro de série
    Allura Xper FD Release 8.2.16(Flouroscopic x-ray used in angiography) ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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