Events

Retiro De Equipo (Recall) de AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35D

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-00945-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-29
  • 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-00945-1
  • 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
    A possible position sensor fault in the swivel base axis is not being detected by the system software and this may cause the c-arm to move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision with a patient or operator.There have been no complaints from australian customers regarding this issue.
  • Acción
    This issue will be remedied with software update AX047/15/S. Until such time users are alerted to this issue and are asked to exercise the necessary caution.

Device

AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35D
  • Modelo / Serial
    AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35DCatalogue/Lot Number – 7555373 (dFA), 7412807 (dFC), 7727717 (dFCM) 7555357 (dBA) 7728392 (dBC) 7555365 (dMP) with SW version VB35DARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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