Events

Retiro De Equipo (Recall) de SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"

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-2015-RN-01057-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-29
  • 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-2015-RN-01057-1
  • 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
    The use of the combination phs1600 table with the perfusion scan mode 'adaptive 4d spiral' (typically used for critical diagnostic examinations) could occasionally initiate scan aborts. there is an increased risk of a scan abort when using the perfusion scan mode in combination with the phs1600 table, especially when applying contrast media. please note that the decreased performance stability is not affecting any other scan modes or the mechanical stability of the table in general.
  • Acción
    Siemens is developing a solution for the use of the patient table PHS1600 in combination with the "Adaptive 40 Spiral" scan mode. Users are advised that they should be aware of the increased risk of a scan abort while using the perfusion scan mode in combination with the PHS1600 table. This action has been closed-out on 31/08/2016.

Device

SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D ...
  • Modelo / Serial
    SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"ARTG Number: 164065
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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