Events

Rappel de e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)

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-2016-RN-00419-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-11
  • 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-2016-RN-00419-1
  • 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 determined that e.Cam or symbia systems with foresight detectors performing gated or dynamic acquisitions may lose some detector time-information. the resulting risk is that the framing of the image data and the calculated ejection fraction values may be lower. although misdiagnosis could be possible if ejection fraction values are used as a sole input to diagnosis. in the lifetime of the product, siemens have received three complaints, none of which led to misdiagnosis or adverse events.
  • Action
    A software patch (Ml16-001) and corresponding operator manual addendum will be implemented. Once the software patch is installed on the affected system, the improvements will further reduce the likelihood of the issue occurring. In the interim, users are advised they may continue to use your system since the probability of occurrence is remote. To reduce the likelihood of this issue, they are advised to perform Daily Shutdown and Start-up as described in the operator manual. This action has been closed-out on 26/05/2017.

Device

e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)
  • Modèle / numéro de série
    e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)Catalogue Numbers: 10151532, 8717733, 10275009, 10275010, 10275879, 8717741, 10275008, 10275007, 10764804, 10764803, 10764801, 10764802, 10910501, 10151531ARTG Number: 186317
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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