Events

Rappel de Gas/Water Feeding Valve – PTX-OF-B194 (Used with PENTAX GI Video Endoscopes - 90i/90K series and i10/K10 series )

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-2013-RN-00909-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-28
  • 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-2013-RN-00909-1
  • 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 has been informed about a product issue involving the of-b194 gas/water feeding valve. the reported defect may prevent stoppage of the supply of co2 gas during an endoscopic procedure with the potential for serious hazard to the patient, including bowel perforation.
  • Action
    Device Technologies is advising customers to stop use of the PTX-OF-B194 Gas/Water Feeding Valve. Device Technologies will arrange for the affected stock to be collected. New stock of PTX-OF-B194 will be available by the end of September 2013. In the interim, customers are asked to use the alternative OF-B188 valve provided.

Device

Gas/Water Feeding Valve – PTX-OF-B194 (Used with PENTAX GI Video Endoscopes - 90i/90K series and ...

Manufacturer

Device Technologies Australia Pty Ltd