Events

Recall of CARESCAPE MONITOR B850 SYSTEM - C1 CPU W/THIRD VIDEO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18137
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)