Events

Rappel de Merge PACS (Amicas PACS) with software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 (used for medical imaging acquisition)

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-00861-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-29
  • 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-00861-1
  • 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 action has been initiated due to potential incorrect display of mammographic measurements. the problem is that there is variability of how the estimated radiographic magnification factor (ermf) is provided in the dicom header data. when measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the hologic imager (different image) the measurements are not the same. use of this product may lead to additional imagining, such as mri and/or biopsy follow-up, before referring a patient to any surgical procedures. particularly if an mri or ultrasound is done the incorrect measurements would be identified as erroneous. this may result in a delay in diagnosis or treatment or patient misdiagnosis.
  • Action
    A software upgrade will be implemented as a permanent correction. In the interim, users are advised not to use Merge PACS mammographic measurements until upgraded. The ability to create any measurements and annotations are controlled by together by a set of privileges which should be disabled until upgraded. This action has been closed-out on 22/02/2017.

Device

Merge PACS (Amicas PACS) with software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 (used f...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia