Events

Rappel de Philips DigialDiagnost X-Ray System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Medical Systems DMC GmbH.

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
    13858
  • Date de mise en oeuvre de l'événement
    2012-11-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    With digitaldiagnost (didi) r 2.0.2 a mirrored "r in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. when such an image is mirrored back inside the pacs system, an unmirrored "r in a circle" appears in the lower left corner. this can be mistaken for a "right patient side" marker, although this can appear on the left patient side., philips previously notified owners of affected digitaldiagnost systems that software release 2.1.3 would be installed on their systems to modify the appearance of the mirror icon, as described below. however, software release 2.1.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side if an image is rotated.
  • Action
    Software to be upgraded

Device

Philips DigialDiagnost X-Ray System

Manufacturer

Philips Medical Systems DMC GmbH
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA