Events

Rappel de ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B

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-00657-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-06-23
  • 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-00657-1
  • 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
    A potential measurement error may occur in all exams (except cardiac) when using the auto-stats tool or the velocity tool during live imaging and when adjusting one of the following parameters with the auto-stats tool enabled:- changing the transmit frequency of the active transducer using the pw multihz control. - adjusting the position of the spectral baseline using the baseline control.- adjusting the pulsed repetition frequency (prf) using the scale control. during system freeze, the measured results indicate the scale values prior to adjustment of any of the above parameters. as a result, the measurements and/or calculations will be incorrect. to date, no patient injury has been reported as a result of this issue.
  • Action
    Siemens is advising operators that the issue can be avoided by not using the Auto-Stats tool and to only use the Velocity tool on frozen images. A Siemens service engineer will be in contact to update to software to correct the issue. Users are advised that a look back at previously reported results should be considered at the discretion of the clinician. Thia action has been closed-out on 28/01/2016.

Device

ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B
  • Modèle / numéro de série
    ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30BARTG Number: 137563
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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