Events

Retiro De Equipo (Recall) de SOMATOM go.Up and SOMATOM go.Now

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-00377-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-01
  • 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-00377-1
  • 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
    Siemens has identified that the following issues with somatom go.Up and somatom go.Now may require an additional scan that exposes the patient to an additional x-ray dose: 1: software stability problems preventing the start of a reconstruction after the ct examination. if these problems occur, this is indicated by a red cross in the “job status” table. 2: impact on image quality: if the detector is still in adjustment mode at the time the scan command is provided from the control box, severe streak artefacts may occur. 3: only for customers using syngo osteo ct: if the scan/recon tab card is closed after an osteoporosis scan of a patient but before the intended osteo reconstruction has been completed, the osteo reconstruction cannot be continued or completed at a later point in time. in this case, a rescan would be necessary to complete the osteo reconstruction.
  • Acción
    Siemens is advising that the stability and quality issues are solved by the software updates VA10A_SP2 and VA20A. The Osteo reconstruction issue is solved with the VA20A software update. Siemens will be informing users as soon as the update(s) are available for their systems. In the interim, users should refer to the information provided in the Customer Letter for an Operator workaround for the issues identified.

Device

SOMATOM go.Up and SOMATOM go.Now
  • Modelo / Serial
    SOMATOM go.Up and SOMATOM go.NowCatalogue numbers: 11061628 and 11061618ARTG number: 142119(Siemens Healthcare - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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