Events

Retiro De Equipo (Recall) de Siemens Dimension Vista 500

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 (NZ) 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
    19961
  • Fecha de inicio del evento
    2016-03-29
  • 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
    Siemens healthcare diagnostics has received customer complaints of discrepant patient results on dimension vista intelligent lab systems. siemens healthcare diagnostics has confirmed a software defect which, in a very specific set of circumstances, results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system. omission of the aliquot probe rinse may result in carryover of residual sample estimated up to 10% when the sample is dispensed into the aliquot well. carryover of residual sample from the outside of the aliquot probe into the sample tube is estimated at less than 0.1%.
  • Acción
    Software to be upgraded

Device

Siemens Dimension Vista 500

Manufacturer

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