Events

Rappel de EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-00319-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-12
  • 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-00319-1
  • 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
    Johnson & johnson medical is issuing a product correction for the evotech endoscope cleaner and reprocessor system after receiving reports of smoke emanating from the system and upon further investigation has discovered that a circuit board malfunction may occur in the channel control manifold sub-assembly. this failure can potentially cause the following outcomes for the cycles: 1. full reprocessing cycle (cleaning and hld) - if this issue were to occur while running a full automated cleaning and high level disinfection (hld) cycle, there is potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes, 2. hld-only cycle - if this issue were to occur during reprocessing of endoscopes qualified for the hld only cycle, there is potential for an inadequate amount of high-level disinfectant solution to be sent through some endoscope channels.
  • Action
    Johnson & Johnson Medical Pty Ltd is providing the users with the instructions to prevent the issues from occurring.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
  • Modèle / numéro de série
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)Product number: 50004ARTG: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd