Events

Rappel de InTouch Critical Care Bed

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-00727-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-04
  • 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-00727-1
  • 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 received complaints from the field regarding intouch beds, which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. these broken casters are identified when the intouch beds are hoisted or lifted from the floor during regular maintenance. if more than one caster on a unit is damaged, brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged, brake functionality continues to meet specifications.
  • Action
    A Stryker representative will perform an onsite inspection to determine if casters are affected. If affected the casters will be replaced. End users are reminded to not use the electronic brake to slow or stop the bed while it is in motion.

Device

InTouch Critical Care Bed
  • Modèle / numéro de série
    InTouch Critical Care Bed Item Number: 2156000000 All lots affectedARTG Number: 202755 (cancelled 21 March 2014)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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