Events

Rappel de syngo Workflow MLR

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-2018-RN-00097-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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-2018-RN-00097-1
  • 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
    While creating or modifying a report using microsoft word application in classic client, when content is pasted form an external source including the formatting 'section break' or by inserting it manually, data from the pre-defined sections of the template might not be saved to the syngo workflow mlr database. this incomplete report from the database issued for distribution to external systems e.G. his, pacs or fax. in the classic client report viewer the content is complete.To date, no harm has been reported as a result of this issue.
  • Action
    Siemens is preparing a correction to rectify this issue. In the interim, users are advised to always use the standard report creating options of syngo Workflow MLR Classic Client: 1. Use the online speech recognition to dictate the report with the supplied microphone. 2. Type content in the report editor. 3. Use auto text module to speed up the reporting process. 4. Only copy/paste from ASCII view of prior reports in syngo Workflow MLR Classic Client. In the case that users cannot avoid copy and pasting within the same document or from external applications, on all syngo Workflow MLR workstations the default paste option of the Microsoft Word application shall be set to 'KeepTextOnly'. Users may refer to the Customer Letter for further instructions regarding this. In the event that a report was created using copy and paste, users should always verify the content for completeness. Instructions for this are provided in the Customer Letter.

Device

syngo Workflow MLR
  • Modèle / numéro de série
    syngo Workflow MLRCatalogue Lot number: 10014099ARTG Number: 184557 - cancelled
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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