Events

Rappel de CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    18137
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-05-29
  • 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
    The monitor may enter into a constant boot loop causing it to reboot continuously and will cause loss of overall monitoring and may lead to delayed treatment. when the usb cable connected to the carescape monitor b850 cpu or display is insecurely connected or faulty and is able to move the monitor may reboot. reboot may also happen if the display is continuously set on and off several times. the reboot will cause loss of overall monitoring and may lead to delayed treatment. there is a remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is currently printing when carescape monitor b850 sends printing request to that prn 50 the printing will be saved only after 12 seconds. the print job will be printed after the printer is ready if the waiting time is less than 30 seconds. b) when the user starts the printing from cic pro to the prn 50 located at the cic pro the printing jobs are printed locally at the bedside if the network prn 50 is busy. the monitor reboots due to an x server freeze and may reboot when the monitor is viewed from cic pro or when the printing is initiated from cic pro.

Device

CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO
  • Modèle / numéro de série
    Model Catalog: 2020913-003 (Lot serial: all); Model Catalog: 2020913-002 (Lot serial: all)
  • Description du dispositif
    CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)