Events

Rappel de Zoll X Series Defibrillators with system software version 02.10.02.00 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 Zoll Medical Australia Pty 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-2014-RN-00348-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-20
  • 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-2014-RN-00348-1
  • 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
    Zoll medical corporation has received 8 field reports where the device displayed an internal error reset required message and then entered acontinuous “system reset” loop. the device cannot be used if it is in a continuous system reset loop. zoll medical's investigation has identified a software error associated with the device's “full disclosure log.” the error may occur during specific conditions, and in particular when the full disclosure log reaches its memory capacity (150 cases) due to invalid data in the overwriting of a full disclosure log. the probability of having an event is low under normal operating conditions.
  • Action
    Customers who are having devices with the affected software versions are advised to immediately erase the device full disclosure log per the instructions provided in the customer letters. Users should continue to erase the device log once/month (or before 150 cases are stored in the log) until the device software has been updated. To permanently mitigate the issue, a software upgrade pack will be provided to customers which is anticipated to be available by the week commencing March 24, 2014.

Device

Zoll X Series Defibrillators with system software version 02.10.02.00 or higher

Manufacturer

Zoll Medical Australia Pty Ltd