Events

Rappel de Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions

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-2017-RN-00455-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-19
  • 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-00455-1
  • 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 there is a remote likelihood that the eds light suspension, central axis may have an insufficiently assembled joint in the suspension. if the eds light suspension, central axis falls, it could potentially cause serious injuries to health care providers and/or patients. to date, there have been no adverse events reported to stryker for this issue worldwide.
  • Action
    A Stryker Technician will contact users to organise a time to perform an inspection of the product. If a correction is required the central axis will be replaced. In the interim, if the product malfunctions, users are to immediately discontinue its use and contact Stryker immediately.

Device

Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions
  • Modèle / numéro de série
    Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions Item Numbers (Serial Numbers):0682-001-566 (15K002818, 15K002498, 15K002518, 15K002508) 0682-400-142 (15L004128)0682-400-148I (16C001798)0682-001-567I (15L006528)ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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