Events

Rappel de Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16

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-01104-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-13
  • 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-01104-1
  • 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
    It has been discovered through customer complaints and internal testing that there is an intermittent electronic product defect. in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. no injuries attributed to the problem have been reported.
  • Action
    The sponsor will perform a software update to the affected devices. In the meantime, the user is advised to always observe real time dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. This action has been closed-out on 05/12/2016.

Device

Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x o...
  • Modèle / numéro de série
    Allura Xper and Allura Clarity - software releases 1.2.7, or 2.0.6, or 7.2.x where x<8 or 7.6.x or 7.8.x or 8.1.x where x< 16 or 8.2.x where x<16Product Codes: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059, 722003, 722005, 722006, 722008, 722010, 722012, 722013, 722015, 722023.Allura Xper FD R2.xProduct Code: 722006Allura Xper FD R8.2.0 Product Code: 722035ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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