Events

Rappel de syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQ

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 Healthcare 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-01088-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-23
  • 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-01088-1
  • 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
    Syngo rt therapist is specified in a way that it will always use the plan unique identifier (uid provided by ois mosaiq. if a plan has changed many times and one of the previous changes is reverted, mosaiq will apply the uid of the previous plan, before the change has been made in the past. in this case, from a treatment point of view mosaiq sends a previously used plan uid that may cause the rt therapist to choose an out-dated treatment plan according to the plan uid provided by mosaiq. as a consequence all performed changes on rt therapist, for example setup changes like added pauses or gating flags, will not be active. this behaviour might lead to a collision or a mistreatment.
  • Action
    Siemens has notified users that from a syngo RT Therapist software point of view, it is not possible to distinguish between correct and incorrect UID provided by MOSAIQ. Therefore no technical solution for this issue can be provided by Siemens. The “RT Therapist Release Notes for MOSAIQ” have been updated with the according information in chapter 10.1. This action has been closed out on 16 June 2017.

Device

syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Inform...
  • Modèle / numéro de série
    syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQCatalogue Numbers: 8162815 and 8168754ARTG Number: 171515
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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