Retiro De Equipo (Recall) de Siemens Dimension Vista 400 & 1500 UDM Flex Assignment

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 Healthcare Diagnostics Inc.

¿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
    15494
  • Fecha de inicio del evento
    2013-10-09
  • 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
    Siemens healthcare diagnostics has confirmed that under a rare set of conditions when utilizing the routine inventory screen to enter a user defined method (empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system, and then use the incorrect flex cartridge to process the user defined method. investigation of the issue has determined that this error will only occur if the assign empty reagent cartridge window has been left open and the flex inventory on the system changes.
  • Acción
    Software to be upgraded

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NZMMDSA