Events

Rappel de Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014

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-00871-1
  • 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-00871-1
  • 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 recall has been initiated because studies that have qc, pde or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. use of this product may result in demographic changes to studies not being passed downstream to other pacs servers whether in-house or used for tele-radiology transfers.Not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis as the physician may not receive the required study. there have been no reports of injuries as a result of this issue.
  • Action
    Emergo is advising users to use DICOM transfers rather than telmed transfers to receiving sites. If there is a valid failure, retrieve the study from archive and resend. It is recommended that logs are reviewed to ensure that all studies have been sent to receiving physicians. Emergo will be implementing a software correction as a permanent correction. This action has been closed-out on 22/02/2017.

Device

Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture ar...
  • Modèle / numéro de série
    Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia