Events

Retiro De Equipo (Recall) de Biomerieux Vitek MS Instrument

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 Kratos Analytical 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
    15506
  • Fecha de inicio del evento
    2014-10-02
  • 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: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Causa
    The vitek ms instrument is equipped with a transient recorder (tr) board associated with a specific firmware. this association is used to compute the time of flight of detected ions. some issues have been reported when firmware version 3.13 was installed on systems equipped with the old tr board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots.
  • Acción
    Software to be upgraded

Device

Biomerieux Vitek MS Instrument
  • Modelo / Serial
    Model: , Affected: All instruments with a Serial Number lower than #50039, Serial Number #50050, or Serial Number greater than #60000
  • Manufacturer
    Kratos Analytical Ltd

Manufacturer

Kratos Analytical Ltd