Events

Rappel de ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)

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-2014-RN-00539-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-13
  • 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-2014-RN-00539-1
  • 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 following issues may occur with cardiovascular studies after upgrading from software version 2.0 or 3.0 to software version 3.5 and restoring user-defined presets. this applies to all transducers except the 9l4 and 6c1 hd transducers:- the system may incorrectly display the colour flow data in the wrong position. the potential risk to the patient is misdiagnosis based on erroneous color flow data.The following issue may occur with software version 3.5:- when you adjust the doppler frequency, the system does not restart the pulsed wave doppler or continuous wave doppler waveform. however, the system displays previous doppler data using the new doppler scale which may result in inaccurate measurement values. the potential risk to the patient is misdiagnosis based on the same doppler profile providing two different velocity measurement values.
  • Action
    Siemens is advising their customers to use factory default presets with software version 3.5 instead of user defined presets restored from software version 2.0 or 3.0. After adjusting the Doppler frequency, freeze and un-freeze the system to refresh the display of the Doppler spectrum resulting in the correct measurements. Siemens will be replacing the software of all affected devices. Thia action has been closed-out on 28/01/2016

Device

ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)
  • Modèle / numéro de série
    ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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