Events

Rappel de Acuson 2000 ultrasound system (with structural foam core).

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare 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-00360-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-24
  • 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-00360-1
  • 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 metal component used to engage the lock on the wheels may disconnect, preventing the user from locking and unlocking or steering the wheels.In the event this issue occurs when the wheels are in the “unlocked” position and the user attempts to move the system, the user may lose balance. if the wheels are in the “locked” position and the user attempts to move the system, the user may sustain soft tissue damage or strain. to date, no patient injury has been reported.
  • Action
    Siemens is advising that there are no known steps the user can take to prevent the issue from occurring. Siemens will be modifying the wheel assembly on affected systems as a permanent correction.

Device

Acuson 2000 ultrasound system (with structural foam core).
  • Modèle / numéro de série
    Acuson 2000 ultrasound system (with structural foam core).Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA