Events

Retiro De Equipo (Recall) de Siemens Advia Centaur XPT System

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
    18834
  • Fecha de inicio del evento
    2015-07-09
  • 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 has identified a number of workflow issues with advia centaur xpt system software v1.0.1 and v1.0.2:, * the system does not display any indication of a missing required probe wash pack on the results screen., * the data shown on the "utilities->assay utilization" screen is incorrect for the totals of calibrators run on the instrument, * the data shown on the "utilities->assay utilization" screen and the printout report for assay utiliization may not match, the following issues are related to instruments connected to a lab automation system (las):, * if the instrument receives work orders while transition from the in-process state to the ready state, the sample will be routed to the instrument but may not be processed, *the system may stop processing samples from the las and hold a tube at the las sampling station.
  • Acción
    Software to be upgraded

Device

Siemens Advia Centaur XPT System

Manufacturer

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