Events

Rappel de INTELEPACS Versions 4.5.1 to 4.12.1(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-2016-RN-00346-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-01
  • 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-00346-1
  • 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
    Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred.The user may not be aware that images might be missing. a misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets.
  • Action
    In order to correct this problem, Intelerad is: 1- providing concerned clients with a list of affected studies and possibly recover the missing images; 2- deploying a software update that includes both a fix and a mitigation for all clients potentially affected by the problem; and 3- periodically auditing all concerned client systems to find and report to the concerned client any new occurrences of this problem until the software update is in place. This action has been closed-out on 27/01/2017.

Device

INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system)
  • Modèle / numéro de série
    INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system) Affected software identifier contains an “R” but with a number below the following:PACS-4-5-1-R77PACS-4-6-1-R85PACS-4-8-1-R46PACS-4-10-1-R36PACS-4-11-1-R28PACS-4-12-1-R4ARTG Number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia