Events

Rappel de Merge CADstream with software versions earlier than 5.2.6. Distributed prior to March 2008 CADstream version 5.2.6 and newer are not affected by this recall.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00868-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-30
  • 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-00868-1
  • 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
    This recall is due to a necessary modification to the cadstream difference threshold when used in conjunction with ge phased array uniformity enhancement (pure) for dynamic mri imaging & a lack of notification when cadstream detects the pure filter has been used.The pure feature is designed to minimise coil intensity variations through a calibration process & may affect the signal intensity values of images. for dynamic series, cadstream kinetic analysis relies on a consistent image acquisition protocol for each individual series in the dynamic series. if pure is applied to individual phases, it may change signal intensity values for the individual series, thus affecting the kinetics. this may result in a change in the amount of colour in the cadstream angiomap. scanning protocols and/or contrast agents that are inconsistent with background filter multiplier settings may result in a sub-optimal angiomap. this may result in a delay in diagnosis or treatment, or patient misdiagnosis.
  • Action
    Merge has released software fix for this issue. The CADstream software fix will detect when a PURE filter is being used and display a notification to the end user. Emergo is providing users with a set of work around instructions to follow as an interim measure. This acion has been closed-out on 27/02/2017.

Device

Merge CADstream with software versions earlier than 5.2.6. Distributed prior to March 2008 CADstr...
  • Modèle / numéro de série
    Merge CADstream with software versions earlier than 5.2.6. Distributed prior to March 2008 CADstream version 5.2.6 and newer are not affected by this recall.ARTG Number: 165390
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia