Events

Rappel de INTELEPACS Version 3.8.1 and up (Radiology 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-2014-RN-00662-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-23
  • 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-00662-1
  • 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
    Intelerad medical systems inc. following internal testing, is providing additional information regarding the proper usage of the intelepacs software. this issue relates to the compression of images into jpeg 2000 (2c) format. in specific circumstances, when writing image data to storage that has filled up, the image data may become truncated.
  • Action
    In order to correct this issue, a new software release will be installed on affected systems. Intelerad will run an audit on the entire PACS to identify all image data that may be truncated. For any affected studies, Intelerad will be able to restore a full fidelity image if required by the customers. This action has been closed-out on 29/01/2016.

Device

INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia