Events

Rappel de AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)

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-2016-RN-00618-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-12
  • 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-00618-1
  • 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
    The manufacturer, accriva diagnostics has confirmed that some avoximeter 1000e instruments shipped to customers from july 2015 and april 2016 may have been sent to customers with the diagnostic mode enabled. with the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. if these features are altered, there is a potential for erroneous results to be displayed. to date accriva has not received any reports of injuries or harm to users due to this issue. instruments in diagnostic mode perform per accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode.
  • Action
    Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings. This action has been closed-out on 03/02/2017.

Device

AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)
  • Modèle / numéro de série
    AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)Product Code: AVOX1000ESerial Numbers: 5696-5725, 5816-5977ARTG Number: 262420
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd