Events

Rappel de SOMATOM go.Up and SOMATOM go.Now

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-00377-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-01
  • 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-00377-1
  • 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 has identified that the following issues with somatom go.Up and somatom go.Now may require an additional scan that exposes the patient to an additional x-ray dose: 1: software stability problems preventing the start of a reconstruction after the ct examination. if these problems occur, this is indicated by a red cross in the “job status” table. 2: impact on image quality: if the detector is still in adjustment mode at the time the scan command is provided from the control box, severe streak artefacts may occur. 3: only for customers using syngo osteo ct: if the scan/recon tab card is closed after an osteoporosis scan of a patient but before the intended osteo reconstruction has been completed, the osteo reconstruction cannot be continued or completed at a later point in time. in this case, a rescan would be necessary to complete the osteo reconstruction.
  • Action
    Siemens is advising that the stability and quality issues are solved by the software updates VA10A_SP2 and VA20A. The Osteo reconstruction issue is solved with the VA20A software update. Siemens will be informing users as soon as the update(s) are available for their systems. In the interim, users should refer to the information provided in the Customer Letter for an Operator workaround for the issues identified.

Device

SOMATOM go.Up and SOMATOM go.Now
  • Modèle / numéro de série
    SOMATOM go.Up and SOMATOM go.NowCatalogue numbers: 11061628 and 11061618ARTG number: 142119(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