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-00667-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-31
  • 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-00667-1
  • 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 is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm {1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
  • Acción
    As an immediate measure, Siemens' service organisation limits the maximum manual LAO/ RAO rotation from 25°/sec to 20°/sec and Cran/Caud rotation from 20°/sec to 10°/sec. All other system parameters as well as 3D acquisition and Perivis ion/Peristepping remain unaffected. Siemens are working on a solution to restore the system back to the original settings, and their service organisation will contact affected users to arrange an appointment to carry out the corrective action.

Device

ARTIS pheno systems

Manufacturer

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