Events

Rappel de STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2015-RN-00323-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-13
  • 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-00323-1
  • 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
    Steris has learned through customer feedback and field service experience that should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, it is possible that the circulation pump or ultrasonic generator may stop functioning. the machine does not provide an alert notifying the user of this device malfunction. no injuries or adverse health outcomes have been reported due to this issue.
  • Action
    Device Technologies representative will contact customers to arrange an upgrade to correct the problem. Customers may continue to operate all Caviwave Pro Ultrasonic Cleaning System and are advised that if they experience a malfunction prior to the upgrade, the equipment in the cycle should be reprocessed. This action has been closed-out on 19/08/2016.

Device

STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to...
  • Modèle / numéro de série
    STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation) Product codes: ST-CRP1172 and ST-CRP1172401 ARTG number: 158370
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd