Events

Rappel de Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)

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-2014-RN-00361-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-25
  • 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-2014-RN-00361-1
  • 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 possibility that the lock washer and screw that secures the monitor onto the shape arm may not be present. if the shape arm lock washer and screw are not present the monitor could separate and dislodge from the arm potentially resulting in injury.
  • Action
    Stryker is inspecting all affected Shape Arms to determine if the lock washer and screw are missing. If missing a new lock washer and screw will be fitted.

Device

Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)
  • Modèle / numéro de série
    Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)Shape Arm Kit LeftCatalogue Number: 0682000976 Serial Numbers: 080924DC001 through 120227DC025Shape Arm Kit RightCatalogue Number: 0682000977 Serial Numbers: 080909DB001 through 131021DB013ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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