Events

Rappel de syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology 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 Siemens 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-00425-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-00425-1
  • 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
    Sensis reference numbers greater than 1,000,000 are wrongly modified during transfer to syngo dynamics. in this case during “in-progress” a study will get a sensisrefno for the wrong study in sensis. this will cause an incorrect link between syngo dynamics images and the sensis study data. when a patient study is opened in syngo dynamics a sensis report of another patient study is shown.The preconditions for this to occur are:- sensis-syngo dynamics integration- sensis study is opened from syngo dynamics while still "in progress"- sensis reference number is > 1000,000this could result in patient mismatch or a persistent unintended change to patient data could result. the patient mismatch is detectable when the study is opened for the first time if the toolbar is not configured to auto-hide.
  • Action
    Siemens is preparing a service patch modification that will resolve the potential malfunction. In the interim, end users are requested to discontinue opening "in progress" studies and to configure the “AXIOM Artis AE” title in syngo Dynamics to "Other" type of station. This action has been closed-out on 02/02/2016.

Device

syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and commu...
  • Modèle / numéro de série
    syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and communication system)ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

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