Events

Rappel de 740 VITAL SIGNS MONITOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par C A S MEDICAL SYSTEMS INC ALSO TRADING AS CASMED.

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
    71630
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2008-06-24
  • 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
    A software change from version 2.9 to 3.0/3.1 inadvertently permitted users to turn off the alert sound on the monitor.

Device

740 VITAL SIGNS MONITOR
  • Modèle / numéro de série
    Model Catalog: 740M-3NN (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-2MS (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-2NL (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-2NN (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-2T (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-3MS (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-3NL (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-3NN (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740M-1 (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740M-2MS (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740M-3NL (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740-1 (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740M-3MS (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740M-2T (Lot serial: Serial No. 0809834 to 0823035); Model Catalog: 740M-2NN (Lot serial: Serial No. 0809834 to 0823035); Mo
  • Description du dispositif
    740 Vital Signs Monitor
  • Manufacturer
    C A S MEDICAL SYSTEMS INC ALSO TRADING AS CASMED

Manufacturer

C A S MEDICAL SYSTEMS INC ALSO TRADING AS CASMED