Events

Rappel de MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication 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 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-2014-RN-00462-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-00462-1
  • 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
    Philips healthcare has identified a software defect that results in incorrect display of absolute values when measuring pixel density and statistics for region of interest. this issue occurs when enhanced mr and enhanced ct images are sent to the pacs with modality lut (look up tables) as defined in dicom functional group. there could be misdiagnosis if a clinician relies on the incorrect density measurements displayed. this issue does not affect images that are not enhanced image objects.
  • Action
    Philips is advising their customer that they must configure the MRI and CT devices to send regular CT and MR DICOM image objects (not enhanced) to PACS. Philips is developing a software update to address the issue. This action has been closed-out on 18/02/2016.

Device

MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)

Manufacturer

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