Events

Rappel de Switch Point Infinity 3 (Operating Room Management System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-2015-RN-01190-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-12-07
  • 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-2015-RN-01190-1
  • 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
    Stryker has become aware that for sources utilising s-video and composite inputs, phase alternating line (pal) signals appear with jagged edges on all diagonal lines resulting in poor video quality. the potential hazard associated with this failure is a pal signal used with s-video or composite input that produces an image that is not clear and free of artefacts.
  • Action
    A Stryker Technical Service Representative will coordinate the update of affected devices. The update will correct the poor video quality as well as support for additional PAL resolution. This action has been closed-out on 29/08/2016.

Device

Switch Point Infinity 3 (Operating Room Management System)
  • Modèle / numéro de série
    Switch Point Infinity 3 (Operating Room Management System)Catalogue Number: 0678001000All serial numbers affectedARTG Number: 232446
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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