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-00486-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-29
  • 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-00486-1
  • 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 when using the stress echo feature:- shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. this computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. the issue may also cause the system to change from systolic-only captures to full beat (r-r).- intermittently, some post-exercise clips may not be captured during continuous capture acquisition. - post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system. the potential risk to the patient may be a repeated stress echo study.
  • Action
    A software update will be provided to correct this problem. End users are advised to avoid the potential risks associated with this issue by: - Discontinue use of the stress echo feature with software version 3.5 - For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed.

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)ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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