Events

Rappel de DIMENSION VISTA SYSTEM - V-LYTE INTEGRATED MULTISENSOR - NA K CL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    24109
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-11-02
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    May cause reduced v-lyte integrated multisensor on-board use life as demonstrated by increases in urine qc sodium results within 48 hours after installation of a new imt sensor. the qc results can be elevated approximately 10-20% which results in urine qc results rising out of acceptable qc ranges.

Device

DIMENSION VISTA SYSTEM - V-LYTE INTEGRATED MULTISENSOR - NA K CL
  • Modèle / numéro de série
    Model Catalog: K825 (Lot serial: KE1K01); Model Catalog: K820 (Lot serial: KE1K01); Model Catalog: K835 (Lot serial: KE1K01); Model Catalog: K820 (Lot serial: KA1G01); Model Catalog: K825 (Lot serial: KA1G01); Model Catalog: K835 (Lot serial: KA1G01); Model Catalog: K820 (Lot serial: KA1H01); Model Catalog: K825 (Lot serial: KA1H01); Model Catalog: K835 (Lot serial: KE1J01); Model Catalog: K825 (Lot serial: KE1J01); Model Catalog: K820 (Lot serial: KE1J01); Model Catalog: K835 (Lot serial: KE1H01); Model Catalog: K825 (Lot serial: KE1H01); Model Catalog: K820 (Lot serial: KE1H01); Model Catalog: K835 (Lot serial: KB1K01); Model Catalog: K825 (Lot serial: KB1K01); Model Catalog: K820 (Lot serial: KB1K01); Model Catalog: K835 (Lot serial: KB1J01); Model Catalog: K825 (Lot serial: KB1J01); Model Catalog: K820 (Lot serial: KB1J01); Model Catalog: K835 (Lot serial: KB1G02); Model Catalog: K825 (Lot serial: KB1G02); Model Catalog: K820 (Lot serial: KB1G02); Model Catalog: K835 (Lot serial: KA1J01); Model Catalog:
  • Description du dispositif
    DIMENSION VISTA SYSTEM- V-LYTE INTEGRATED MULTISENSOR Na K Cl
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC