Events

Rappel de IntelePACS(Image management 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-2015-RN-00404-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-15
  • 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-2015-RN-00404-1
  • 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
    Images successfully transmitted to intelepacs may not be available for reading in all studies, and the reader could be unaware of missing images.. this failure can be detected if the client has image count verification protocols. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy.This issue can arises in two scenarios:1. for the three clients that employ ingest servers to provide temporary store-and-forward capabilities in their architecture, in some conditions, these servers fail to forward all received images to the permanent storage servers and no record of these images persist in the main archive. 2. for the remaining client architectures that do not employ temporary ingest servers, there is still a very low probability of failure for the device to properly replicate and register images when transferring them to another server.
  • Action
    For the three clients using a configuration with ingest servers as temporary storage, an immediate update process was undertaken via the Client Specific Release process (completed as of 2015-04-23) to avoid the possibility of data loss. For the remaining clients, the normal Full Release Update (FRU) will be expedited. This action has been closed-out on 5/08/2016.

Device

IntelePACS(Image management system)
  • Modèle / numéro de série
    IntelePACS(Image management system)Software versions:4.7.1 R27 and up 4.8.1 R20 and up 4.9.1 R17 and up 4.10.1 R9 and up 4.11.1 R3 and up ARTG number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia