Events

Rappel de PowerPro Ambulance Cots

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-2016-RN-00754-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-07
  • 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-2016-RN-00754-1
  • 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 the supplier has made a manufacturing transfer from their tier two supplier which affected the quality of the boards supplied to stryker. as a result of workmanship issues, the boards have the potential to short circuit and overheat. there is a high probability of limited (minor, transient) harm, specifically minor respiratory irritation, not requiring medical intervention and untended lowering or cot dropping to the lowest position (no cot tip). faulty units will not work as intended. there have been no reports of injury associated with this issue.
  • Action
    Stryker is advising users to inspect stock for the affected lot numbers. Any affected devices will be corrected, and can continue to be used until the correction has been completed. This action has been closed-out on 15/03/2018.

Device

PowerPro Ambulance Cots
  • Modèle / numéro de série
    PowerPro Ambulance Cots Catalogue Number: 6506000000Multiple Lot NumbersARTG Number: 197659
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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