Events

Rappel de IntelePACS InteleViewer software version 4.11.1 P144 (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-00199-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-25
  • 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-00199-1
  • 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
    Since the introduction of a fix to the measurements algorithm (bz55214), inteleviewer now uses the ratio of the distance from the source to patient over distance from source to detector to compute a scaling factor to apply to measurements when the estimated radiographic magnification factor (dicom (0018,1114)) is not present. that scaling should only be applied when dealing with a projection radiography modality (cr, dx, mg, px, rf, or xa), however, it ended up being applied to other modalities, such as ct, generating erroneous measurements.This software defect could lead radiologists to base their diagnosis/report on wrong anatomical measurements. no patient incidents have been reported at this time.
  • Action
    Emergo is advising users to ensure that they uninstall the affected software version from their workstations and install an alternative version of lnteleViewer (e.g. IV 4-11-1 P143 or IV 4-11-1 P145). Also, users are advised to review the studies that were done with lnteleViewer 4-11-1 Pl44 and determine appropriate follow-up with patients. Users will be provided with the list of potentially affected studies.

Device

IntelePACS InteleViewer software version 4.11.1 P144 (Radiology picture archiving and communicati...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia