Events

Rappel de Power-LOAD (Cot Fastener)

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-2018-RN-00296-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-09
  • 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-2018-RN-00296-1
  • 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
    After installation of the power-load, the floor plate attachment brackets (pn: 6390-101-108) which allow the power-load anchor to be secured to the power-load floor plate may be found to be broken after removing the anchor. the manufacturer has advised that broken floor plate attachment brackets will not result in unintended movement of the cot under normal conditions. the holding strength of the cot is reduced as a result of this issue which may result in a detached cot with fastener or a detached fastener component in the event of an emergency service vehicle accident. to date, there have been no reported injuries as a result of this issue.
  • Action
    Stryker is advising that they will be replacing potentially affected parts on all Power-LOAD units manufactured within the suspected time frame. A Stryker Technician will contact users upon receipt of the Notification Response Form provided with the Customer Letter (issued to affected users) to co-ordinate the correction.

Device

Power-LOAD (Cot Fastener)
  • Modèle / numéro de série
    Power-LOAD (Cot Fastener)Item Numbers: 6390000000, 6390BASIC, 6390SSPAUnits manufactured between Jan 1 2016 to Dec 31 2016All serial numbers beginning with “16” are within scope of this action ARTG Number: 275902
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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