Events

Rappel de Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for 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 Getinge 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-2016-RN-01216-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-09-15
  • 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-2016-RN-01216-1
  • 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 become aware that due to a software issue, if the compressed air supply of the machine is lost right before or during product supply (dlc detergent, aperlan poka-yoke agent a/b disinfectant), and after cycle start, and not re-established before cycle end, the machine does not launch or complete the product supply when reprocessing a scope. as a result, no alarm is triggered.
  • Action
    Getinge is advising users of interim instructions to follow. Users are advised to carefully examine the printer ticket at the end of each reprocessing cycle to ensure there are 3 lines printed for DLC weight, Disinfectant A and B weights are OK. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 20/02/2017.

Device

Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)
  • Modèle / numéro de série
    Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)Model Number: 01280010Serial Numbers: 4H120383, 4H120384ARTG Number: 228574
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA