Events

Rappel de Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS 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 GE Healthcare 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-2013-RN-00326-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-16
  • 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-2013-RN-00326-1
  • 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
    There is an issue related with the direct multi-planar reformat (dmpr) function and screen saved images on the scanner. the dmpr and screen save functionality may possibly generate the same series uid. it has been seen that some picture archiving and communication system (pacs) may combine series under a patient using only the series uid, although all images are correctly annotated. this issue can cause additional images from a different patient and images from two or more patients to appear in one exam. please note that this issue has only been seen on pacs systems manufactured by intelerad (intelepacs 4-3-1-p350 and intelebrowser -4-3-1-p350) at this time.
  • Action
    GE Healthcare is recommending that customers discontinue using the DMPR functionality, if they are using the above PACS version or if they see similar issues from their current PACS and utilise an alternative capability, such as Batch-mode Reformat on the GE AW, AW server or scanner operator console or 3D reformat save on their 3D PACS viewer. GE Healthcare is planning to implement the permanent correction to affected systems when it is available.

Device

Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with ...
  • Modèle / numéro de série
    Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems)ARTG Number: 156650
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd