Events

Retiro De Equipo (Recall) de ARTIS pheno systems

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-00471-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-18
  • 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-2018-RN-00471-1
  • 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 an issue with artis pheno systems. if the c-arm is moved manually longitudinal to a fully extended position it may occur rarely, that the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the movement and can drop up to 20 mm (0.8"). this can happen during an ongoing procedure.If this issue occurs, the system performs a safety stop. all c-arm movements are blocked and can only be reactivated by a field service engineer.
  • Acción
    Siemens are currently working on a solution to eliminate the root cause of the problem. In the interim, users are advised to avoid driving the C-arm into a fully extended longitudinal position. A fully extended longitudinal position is reached when the stand arms are almost completely stretched out.

Device

ARTIS pheno systems

Manufacturer

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