Events

Rappel de Biomerieux Vitek MS Instrument

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Kratos Analytical Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    15506
  • Date de mise en oeuvre de l'événement
    2014-10-02
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Cause
    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.
  • Action
    Software to be upgraded

Device

Biomerieux Vitek MS Instrument
  • Modèle / numéro de série
    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