Events

Rappel de MX 16-slice CT x-ray systems with software version v1.1.4.21426.

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-2016-RN-00616-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-12
  • 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-2016-RN-00616-1
  • 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
    The following issues have been found in mx 16-slice systems.1) during the filming operation, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2) during the bolus tracking scan, if the auto voice in tracker scan is enabled, the tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.3) if the scan protocol with sas (spiral auto start) function is selected to plan the scan, the sas option may not be displayed on the contrast tab of the scan protocol parameter area or the sas option is displayed but not enabled as pre-configured in the protocol. this issue only occurs on the first helical scan after system startup that applies sas function.There have been no reports of injuries.
  • Action
    Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 02/03/2017.

Device

MX 16-slice CT x-ray systems with software version v1.1.4.21426.

Manufacturer

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