Events

Rappel de IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7

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-2017-RN-01434-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-27
  • 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-2017-RN-01434-1
  • 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 received a complaint from a client notifying a problem that could occur on the intelepacs software. the issue is triggered when plain text reports from external sources have been modified to be html compatible, and by the presence of the less than (<) character in the report. when viewing a report, the less than character is not present while it was there in the original report received by intelepacs. in other cases, when the character is present in a combination with other characters, parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.There is a possibility that incomplete information is presented to the radiologist or referring physician. the absence of the information in the report could affect the decision made in relation with the patient care.
  • Action
    Emergo is advising users who utilise reports with HTML from external sources, that the affected issue may occur depending on the HTML formatting provided by the external source. If users are affected, a review of configurations of the external source is recommended. Intelerad is advising users that a configuration change and software upgrade will be implemented as a permanent correction.

Device

IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-...
  • Modèle / numéro de série
    IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7ARTG Number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia