Events

Rappel de FlexTherm Heater Cooler Device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par LivaNova 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-2017-RN-00252-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-14
  • 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-2017-RN-00252-1
  • 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
    After a thorough review of the flextherm heater cooler design, which has been marketed since june 2015 livanova has come to conclusion that the design concept does not fully meet user requirements. livanova has discontinued the production of the flextherm and does not intend to offer it again to the market in the future.
  • Action
    A LivaNova representative will contact the customer to agree on the return of the affected product. LivaNova will replace the affected product with a heater cooler HC3T including new connectors and tubing at no charge. Customers may continue to safely use the heater cooler devices in accordance with the Operator’s Manual and the supplied instructions below until the necessary device removal has been completed.

Device

FlexTherm Heater Cooler Device
  • Modèle / numéro de série
    FlexTherm Heater Cooler DeviceProduct Code: 16-70-00Affected Serial Number in Australia: 16E01091ARTG Number: 194514
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd