Events

Rappel de da Vinci Xi Surgical System P6b Software

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-2017-RN-01543-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-01-04
  • 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-2017-RN-01543-1
  • 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 has learned from the manufacturer, intuitive surgical, that the updated da vinci xi surgical system user manual and the updated da vinci xi instrument and accessory user manual were not provided when the system upgrade was performed. the user manuals will be forwarded to affected customers.
  • Action
    1. Device Technologies Australia will forward the updated manuals to affected customers. Once the updated System User Manual and the updated Instruments & Accessories User Manual have been received, disregard the previous versions of the system User Manual and the Instruments & Accessories User Manual. 2. Ensure all relevant personnel at your facility are fully informed of this notice, including medical staff who perform da Vinci® XiTM Surgery procedures. 3. Complete and return the supplied Reply Form to acknowledge receipt of this notice. 4. Retain a copy of this letter and the acknowledgement form within the updated System User Manual and the updated Instruments & Accessories User Manual of the da Vinci® XiTM System.

Device

da Vinci Xi Surgical System P6b Software

Manufacturer

Device Technologies Australia Pty Ltd