Events

Rappel de Ultrasound Q-Station version 3.0 or higher

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

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-2015-RN-00491-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-10
  • 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-2015-RN-00491-1
  • 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
    If a user opens a study for review on q-station before its transfer from the ultrasound system cart has completed, measurements from that study (structured report) may be appended to subsequent studies for other patients. as a result, measurements from one patient may be presented in another patient’s study, due to a failure to clear previous patient information when selecting the new study.This hazardous situation will exist only if all of the following events occur: a user performs and completes a study (study a) on the ultrasound system that includes sr (structured report) measurements and initiates the export of study a to q-station (‘manual’, ‘auto’ or ‘send as you scan’).The user opens study a for review on q-station using view/report/export before the transfer of the sr is complete. no reports of misdiagnosis or harm as a result of the data mixing have been received.
  • Action
    Philips has corrected this issue via software version 3.3.2 and is sending a CD with this latest version of Q-Station to the affected customer, free of charge. This action has been closed-out on 17/08/2016.

Device

Ultrasound Q-Station version 3.0 or higher

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA