Events

Rappel de STERIS 5085 and 5085SRT Surgical Table

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-01185-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • 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-2014-RN-01185-1
  • 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
    The manufacturer, steris corporation, has learned through customer feedback and field service experience that the shroud cover for the hydraulic column may become misaligned and damaged as a result of extreme articulation or excessive pressure on the side or base of the table. in most instances, the shroud damage is minor and does not affect the vertical up/down movement of the hydraulic column. in cases of sever shroud damage, the shroud sections may become misaligned such that vertical movement of the hydraulic column is impeded. no patient injury or adverse health outcomes have been reported due to this issue.
  • Action
    Device Technologies Australia (DTA) representative will contact the customer to arrange an upgrade to correct the problem. DTA is also advising customers that the 5085/5085SRT Surgical Tables can continue to be operated in the interim. This action has been closed-out on 11/08/2016.

Device

STERIS 5085 and 5085SRT Surgical Table
  • Modèle / numéro de série
    STERIS 5085 and 5085SRT Surgical Table Product codes: ST-01-410-1, ST-01-460-7, ST-480-7 and ST-01-480-06 Serial Number Range: 0403809001-0425514019ARTG number: 149156
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd