Events

Rappel de Biograph mMR with software version syngo E11P

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-00113-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-06
  • 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-00113-1
  • 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 been notified by the manufacturer that a mismatch has been identified between orientation labels and displayed anatomy (e.G. in the 3d task card) within the software version syngo e11p. this will lead to wrong attenuation correction of the pet data.The issue occurs when changing the image numbering in transversal mrac protocol (e.G. mrac_caipi_hires protocol) from the default setting "feet>>head" to a customised setting "head>>feet". the original images are labelled correctly, but the composed images are flipped by 180 degrees and shifted.There have been no injuries reported as a result of this issue.
  • Action
    Siemens is advising that this issue will be corrected in the next service pack syngoE11P-SP03. In the interim, do not change the numbering of images in transversal MRAC protocols (within an MRPET workflow). Follow the user manual. Don't rely only on composed images; always additionally refer to the original images for diagnostic purposes.

Device

Biograph mMR with software version syngo E11P
  • Modèle / numéro de série
    Biograph mMR with software version syngo E11PCatalogue Number:10433372ARTG Number: 274035
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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