Events

Rappel de GE Centricity PACS RA1000 Workstation

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Medical Systems Information Technologies.

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
    15225
  • Date de mise en oeuvre de l'événement
    2013-08-20
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    The manufacturer has become aware of several potential safety issues due to out of context and measurement issues associated with specific workflows with this device:, 1/ in centricity ris-ic, and a ris-driven integration, the "close" button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation,, 2/ interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation,, 3/ interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation,, 4/ centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag.
  • Action
    Software to be upgraded

Device

GE Centricity PACS RA1000 Workstation

Manufacturer

GE Medical Systems Information Technologies