Events

Retiro De Equipo (Recall) de SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic computed tomography x-ray system)

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-2016-RN-00950-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-18
  • 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-2016-RN-00950-1
  • 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 have identified that when using the affected devices with software version va48a-sp2, problems can occur with the contrast agent injectors, regardless of the brand of injector involved. due to an internal communication error between the firmware and the software of the components involved, the planned ct scan is properly executed, however the injector is not started. this affects only the automatic mode, which is also called the "coupled mode", i.E. does not concern the manual control of the injector. as a result of this error, the contrast agent is not injected and the desired examination result is not achieved.
  • Acción
    Siemens is advising users to stop using the automatic "coupled mode", and to only use control manually. Siemens will be implementing a firmware correction as a permanent fix. This action has been closed-out on 22/02/2017.

Device

SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast age...
  • Modelo / Serial
    SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic computed tomography x-ray system)ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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