Events

Rappel de Synapse Cardiovascular (CV) Client application, version 4.0.8 (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-2014-RN-00482-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-07
  • 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-2014-RN-00482-1
  • 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
    The “switch user” feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to emr. there is the potential that patients’ medical records may be altered as a result of utilizing this windows 7 function through the unintentional modification of the outbound hl7 files. this issue does not occur if individual users logout of windows 7.
  • Action
    Fujifilm does not support the use of the “Switch User” function in Windows 7 with Synapse CV. The function should be disabled on Windows 7 workstations that operate the Synapse CV application. There are several options to allow multiple users on a workstation and, if required, Fujifilm Customer Support will assist users with determining which option is best suited for each facility.

Device

Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communicatio...
  • Modèle / numéro de série
    Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system)ARTG number: 164422
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd