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-00320-1
  • Classe de risque de l'événement
    Class III
  • 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-00320-1
  • 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 determined that under certain circumstances the evotech endoscope cleaner and reprocessor system may not properly calculate the expiration date of the cidezyme xtra multi enzymatic detergent from the information entered by the user. in these circumstances, the expiration date displayed on the evotech ecr screen is one month after the labelled expiration date.
  • Action
    Johnson & Johnson is providing instructions on how to identify if there is any discrepancy between the calculated expiration date and the labelled expiration date. Users are advised to adhere to the labelled expiration date.

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 code: 50004All lot/serial numbers affected.ARTG number: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd