Events

Retiro De Equipo (Recall) de Siemens Somatom Emotion 6 / 16 Slice Configuration 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 Shanghai Medical Equipment 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
    18657
  • Fecha de inicio del evento
    2015-06-16
  • 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
    The bolts used to fix the balance weight of the data measurement system (dms) may show signs of metal fatigue. the function of these bolts may potentially degrade over time and impact stability. it should be noted that the rupture of a single bolt does not pose a hazard, however in the unlikely situation that all bolts break over time, this could cause the dms balance weight to drop into the gantry.
  • Acción
    Product to be modified

Device

Siemens Somatom Emotion 6 / 16 Slice Configuration Systems

Manufacturer

Siemens Shanghai Medical Equipment Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA