Events

Rappel de Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)

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-01082-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-06
  • 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-01082-1
  • 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
    In 2d and filming function, when image is zoomed and saved as derived dicom format, the measurement on new created image is incorrect. this issue only occurs on mx16 systems with software version v2.0.0.21479, including mx16 evo2 systems and mx 16 systems upgraded to mx16 evo2 using the mx16 idose4 upgrade kit.Image with incorrect measurement value may be used to guide clinical procedures where measurement is critical. this may lead to misdiagnosis.
  • Action
    An initial workaround is provided for users in the Customer Letter. Philips will release Field Change Order (FCO) 72800646 to upgrade the software free of change. A Philips Field Engineer will contact users to schedule this correction. This action has been closed-out on 31/08/2016.

Device

Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0....
  • Modèle / numéro de série
    Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)Affected Products: Philips MX 16-slice CT Systems with software version v2.0.0.21479 ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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