Events

Rappel de Acuson SC200 ultrasound systems

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-00353-1
  • 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-00353-1
  • 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
    Due to an alignment issue with the bezel on the front panel, the plastic cover around the transducer ports prevents full contact of the connector on the transducer to the transducer port on the system. this issue causes the system to lock up.This may result in a delay in diagnosis while an alternative exam is performed.
  • Action
    Siemens is advising users that in the event a transesophageal transducer is inserted in a patient, the user should first disconnect and reconnect the transducer. If the system still locks up, the user should then follow the instructions on the screen and disconnect the transducer, remove the transducer from the patient, and contact a Siemens service representative. Siemens will be replacing the front panel of the system as a permanent fix.

Device

Acuson SC200 ultrasound systems
  • Modèle / numéro de série
    Acuson SC200 ultrasound systemsAffected Serial Numbers: 400300 and belowCatalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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