Events

Rappel de Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Trumpf Med Aust 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-00316-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-20
  • 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-00316-1
  • 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
    Allen medical has become aware that the rail section clamps used to attach the leg support of the t3 trumpf table may fail during use, which could result in critical harm to the patient. the t3 trumpf table top rail section clamps, f-t3railsc, are designed and labelled for use with armboards only but were shipped to be used with the leg support. the instructions for use (d-720595-a3) incorrectly guides the user to connect the top rail section clamp to the leg support.Three complaints without any allegation of injury have been reported since introduction in september 2009.
  • Action
    Trumpf are advising users to ensure that the T3 Trumpf Table Top Rail Section Clamps are used with armboards only. Users should inspect beds and remove any clamps currently in use with the Leg support. Allen Medical will be providing users with new Rail Section Clamps along with revised Instructions for Use. These are expected to be available by May 2018.

Device

Trumpf Table Top Spinal System (T3SYSTEM) Manufacturing Dates: March 2009 to November 2016
  • Modèle / numéro de série
    Trumpf Table Top Spinal System (T3SYSTEM)Manufacturing Dates: March 2009 to November 2016ARTG Number: 252619(Trumpf Med Aust - Table, operation)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd