Events

Rappel de Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carestream Health Australia Pty 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-2014-RN-00031-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-17
  • 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-2014-RN-00031-1
  • 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
    There were two incidents in the united states where the previous patient image was displayed on the console with the current patient's name. carestream health has determined that this only occurs when the user interrupts the daily offset refresh detector calibration by switching the active detector from one bucky to another (e.G. table to the wall) and cancels detector calibration within 30 seconds of initiating this process. there have been no reports of misdiagnosis or injuries related to this issue.
  • Action
    Carestream Health is recommending that the daily detector calibration process should not be interrupted once initiated and completed only when patients are not being imaged. Carestream Health is installing the software modification as a permanent correction.

Device

Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)
  • Modèle / numéro de série
    Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system)ARTG Number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd