Events

Rappel de Vadi Heater

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AHC Solutions 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-2018-RN-00041-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-15
  • 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-2018-RN-00041-1
  • 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
    Ahs solutions p/l has been made aware of an issue regarding overheating of vadi heater vh220 causing shrinkage of the filter due to dysfunction of the cut-off switch. the root cause analysis found that the dysfunction of the switch is due to the distance from the tape to glue the switch to the heating scroll not being attached closely enough. as a result, there is a gap between switch and aluminium heating scroll, which, after a long term use, can damage the switch. the damaged switch will therefore be unable to control the temperature, causing overheating which deforms the filter.
  • Action
    AHC Solutions is advising users to dispose of VH220 heaters that are currently in use. Customers will be provided with replacement heaters.

Device

Vadi Heater
  • Modèle / numéro de série
    Vadi Heater Part Number: VH220ARTG Number: 212166 (AHC Solutions Pty Ltd - Filter, ventilator)
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd