Events

Retiro De Equipo (Recall) de Siemens Artis Imaging Systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens AG.

¿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
    15359
  • Fecha de inicio del evento
    2013-09-12
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Under certain conditions, x-ray release on artis system version vc1x may get blocked. this potential malfunction will only occur if a) the system is ready for operation, and b) the c-arm was moved into the “patient transfer position” for patient transfer (in this position x-ray is blocked), and c) at the same time the c-arm is in “patient transfer position”, a hardware failure in the image acquisition system is occurring. even if the c-arm is moved out of the “patient transfer position” (the problem with the ias was solved by the system itself), x-ray remains blocked.
  • Acción
    Instructions for use to be updated

Device

Siemens Artis Imaging Systems
  • Modelo / Serial
    Model: Catalogue Numbers: 10094141, 10094143, Affected: Version: VC1x software
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA