Events

Rappel de Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes

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-01053-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-25
  • 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-01053-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer is informing users of an important change in the instructions for use (ifu) for the reliance endoscope processing system (eps) when processing specific fujinon g5 and g8 type flexible gi endoscopes. when set up as defined in the ifu the air pipe on specific fujinon endoscopes doesn’t receive forced flow during the processing cycle. a new steris flow unit 7 has been developed to facilitate forced flow of high level disinfecting solution through the air pipe and is required for reliance eps processing of any impacted fujinon devices. a new “quick reference guide” has been developed to incorporate these changes.
  • Action
    Device Technologies is providing their customers with a new “Quick Reference Guide” and requesting that reprocessing G5 and G8 type endoscopes is discontinued until the correct flow unit #7 is provided.

Device

Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes
  • Modèle / numéro de série
    Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI EndoscopesMultiple FUJINON G5 and G8 Type Flexible GI Endoscope series affectedARTG Number: 112590
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd