Events

Retiro De Equipo (Recall) de syngo Workflow MLR

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00097-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00097-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    syngo Workflow MLRCatalogue Lot number: 10014099ARTG Number: 184557 - cancelled
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA