Events

Rappel de Merge OrthoCase with software versions 3.7.3 and earlier (a picture archiving and communications 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-00869-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-30
  • 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-00869-1
  • 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
    When using the perpendicular line tool, there is an option to 'snap' the lines together, which prevents the perpendicular lines from extending past the straight/base line. when a perpendicular line measurement is made and saved in a plan, the line measurement value changes when the plan is reloaded. this is due to when the “snap to line” feature is enabled, it doesn’t apply automatically when the perpendicular line is drawn. it only gets applied when the saved plan is reloaded, so to the user, the measurements look different from what was saved. however, in each case (before/after “snap to line” is applied), the line measurement is accurate.If the line end point is within 20 pixels of the base line, it will adjust its location to snap perfectly to the base line. this may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.This may cause delay in diagnosis or treatment of patient, however the actual measurement of the line is accurate.
  • Action
    Emergo is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been clsoed-out on 27/02/2017.

Device

Merge OrthoCase with software versions 3.7.3 and earlier (a picture archiving and communications ...

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia