Retiro De Equipo (Recall) de Siemens Artis zee Ceiling 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
    15653
  • Fecha de inicio del evento
    2013-11-22
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • 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
    Cables in the cable harness inside the ceiling carriage may have received wear and tear or damage., in versions before a modification in 2009, a protective sleeve was covering the total length of cabling inside the ceiling carriage. this modification was made in a way that the protective sleeve is no longer covering all cables in total length inside the ceiling carriage. there is now friction between individual cables causing stress over a period of time which for smaller dimensioned cables may result in tearing and system malfunction.
  • Acción
    Product to be modified

Device

  • Modelo / Serial
    Model: Catalogue number – 10094137, Affected:
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NZMMDSA