Events

Rappel de Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option

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 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-2015-RN-00595-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-03
  • 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-2015-RN-00595-1
  • 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
    Siemens healthcare received complaints that when repositioning the virtual touch iq region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. the maximum error in position between the measurement tool and shear velocity data is 3.8 mm. the issue of concern is a potential underestimation of maximum shear wave velocity of a lesion. this underestimation may lead to a user deciding not to biopsy a cancerous lesion. the potential risk of misdiagnosis associated with this issue is low.
  • Action
    Siemens Healthcare is requesting the customers not reposition the Virtual Touch IQ region of interest from the original (default) location. Siemens is also requesting the customers to review previously performed studies to ensure the results are as expected. This issue will be resolved in a future software release. This action has been closed-out on 01/03/2018.

Device

Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option
  • Modèle / numéro de série
    Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ optionARTG Number: 137563
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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