Events

Rappel de Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fujifilm Australia 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-01329-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-20
  • 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-01329-1
  • 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
    An issue has been identified with the image processing software module when two or more patient fcr images (fuji computed radiology images stored in a proprietry format) from synapse pacs are sent simultaneously to another manufacturer's pacs . when fcr images (comprised of pixel data and the dicom header) are sent via cmove or forwarded by ebf (event based forwarding) on multiple associations simultaneously, in rare situations, one or more of the following issues can happen: a) patient a’s pixel data is changed to patient b’s pixel data and forwarded to the destination. b) the output image is corrupted and may appear as random noise. c) dicomserver crashes. if issue a) or b) happens, only the image in the destination archive is affected. images in the source synapse system are not affected. the potential risk is that pixel data for a patient’s image may not be correct in the destination (non-fujifilm) pacs. however, the radiology reports will be correct.
  • Action
    Fujifilm has applied a corrective software patch to affected PACS as a permanent fix. This action has been closed-out on 20/11/2017.

Device

Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication ...
  • Modèle / numéro de série
    Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system)ARTG Number: 203605
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd