Events

Retiro De Equipo (Recall) de Siemens Advia Centaur XPT

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
    19549
  • Fecha de inicio del evento
    2015-12-10
  • 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, 55 Hugo Johnston Drive, Penrose, Auckland
  • Causa
    Siemens healthcare has identified several issues with specific versions of the advia centaur xpt system software that may affect the operation and workflow of the system., issues include, * using the replicates option with the final result rule, * delta check units, * units on the calibration data details report, * using the copy configuration utility, * printer driver resets, * calibrating tsto, * laboratory automation (las) offline due to vacuum error, * monitoring the laboratory automation (las) communication, * priming needed error reported to las, * sample status reported to las, * non-siemens las - general status message, * non-siemens las - immediate index, * using dilution for automated repeats, * printing of results for replicates, * workstation services may restart, * rinse system maintenance task, * on board stability (obs) for hbsii, * enhance liver fibrosis (elf) test results, * archiving and deletion may fail, * processing repeats with multiple reagent lots.
  • Acción
    Software to be upgraded

Device

Siemens Advia Centaur XPT

Manufacturer

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