Events

Rappel de ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Karl Storz Endoscopy 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-00200-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-23
  • 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-00200-1
  • 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
    A manufacturing defect has been detected which could lead to the loosening of the rivets of the interface plate that connects the monitor and touch screen to the articulating arms on the trolley (vesa 75/ 100 adaptation with rotation). the riveting of the rotation may not have been carried out according to the manufacturer's specifications.In rare cases, it can lead to a loosening of the connection plate and result in injuries to patients and/or users.
  • Action
    KARL STORZ is advising customers that they can opt for their own engineers to replace the adaptor plates or nominate KARL STORZ to replace the affected component on site.

Device

ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)
  • Modèle / numéro de série
    ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)Lot Numbers: HA.2200.902 and HA.2237.902Multiple Serial Numbers affectedManufactured between 1 June - 26 November 2015.ARTG Number: 168578
  • Manufacturer
    Karl Storz Endoscopy Australia Pty Ltd

Manufacturer

Karl Storz Endoscopy Australia Pty Ltd