Events

Rappel de Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40A

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-00183-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-27
  • 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-00183-1
  • 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 became aware of possible incorrect tube current calculations by the care dose4d algorithm for scans that include the head, when based only on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dosedistribution is not appropriate and could lead to unnecessary radiation exposure. the described issue will not occur when using a lateral topogram instead of a p.A. or an a.P. topogram. there have been no injuries reported as a result of this issue.
  • Action
    Siemens is strongly recommending using lateral topograms for all head scans. Considering that the p.a. or a.p. topogram is preferred in specific protocols such as in CarotidAngio scans and RT_ HeadNeckShoulder, it is strongly recommended to deactivate the CARE Dose4D function for this type of scan. For software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B, VC40A, to prevent any possible deterministic radiation effects on the patient's skin or eye lenses, Siemens Healthcare implemented a dose alert according to the technical standard IEC 60601-2-44. A warning will be shown and has to be confirmed by the user if the accumulated CTDIvol for the ongoing examination exceeds the alert threshold in any z-position. The default setting for the threshold is adjusted to 1000 mGy.

Device

Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B...
  • Modèle / numéro de série
    Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40AARTG Numbers: 142119 and 274034(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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