Events

Rappel de ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licenses

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-2018-RN-00115-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-06
  • 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-00115-1
  • 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 3d esie pisa volume analysis application quantifies valvular regurgitation. while imaging with the z6ms volume transesophageal echocardiography transducer, this application may underestimate the eroa (effective regurgitant orifice area) in comparison to the same patient results obtained with the 4z1c volume transthoracic echocardiography transducer.There is a low risk of misdiagnosis occurring from underestimating the patient's mitral regurgitation severity when using the esie pisa analysis application with the z6ms volume transesophageal echocardiography transducer.
  • Action
    Siemens is advising that users should continue to rely on a combination of several quantitative parameters for evaluation of mitral regurgitation rather than solely on the EROA derived from eSie PISA analysis with the Z6Ms transducer.

Device

ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIM...
  • Modèle / numéro de série
    ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licensesCatalogue Number:10433816ARTG Number:139591
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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