Events

Rappel de Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (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 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-00872-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-07
  • 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-00872-1
  • 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 because the cross reference lines a.K.A. cut lines or localiser lines may not display properly. this is due to math error when calculating the cut line position for studies with extremely high precision in the dicom tag image orientation patient (0020,0037) containing values of greater than 15 significant digits. the patient tag on affected images includes the value "e-16". when the problem is encountered the cross reference lines will move erratically as the user stack scrolls through the study. this may impact diagnosis when images are unavailable for viewing.
  • Action
    Merge is working on correcting the issues and will inform customers once a fix is available. In the interim, users are advised that in order to view the study with the cross reference lines, it is recommended to view the study on another workstation of the modality device. Also, examine the image orientation patient tag to see if there are values with "e-16" included to see if a study in question could be affected. This action has been closed-out on 27/02/2017.

Device

Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater...
  • Modèle / numéro de série
    Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia