Events

Recall of CARESCAPE MONITOR B650 - MONITOR FRAME TYPE

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
    40900
  • 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
    Ge healthcare has recently become aware of potential issues associated with the carescape monitor b860. the issues are enumerated below. 1) spo2 saturation limit alarm does not always activate when nellcor spo2 is used in pdm and saturation seconds is not switched on. 2) detachable non-volatile flash memory (udom) is used as the permanent memory for application and service software and to store clinical and platform settings. when the carescape monitor b650 is started the monitor may enter into a constant boot loop causing monitor to reboot continuously. during startup period following messages may be seen on the monitor display: a) "disk boot failure" b) "insert system disk and press enter" the constant reboot will cause loss of overall monitoring and may lead to delayed treatment. 3) when the carescape monitor b650 is connected to the unity id and information from a 3-lead ecg cable is transferred through dri (s/5) network the monitor may reboot. 4) upgrading the software for carescape monitor b650 may not update the software for power management card (pmc). in this case the monitor remains in the status displaying message "updating pmc. please wait." until monitor is re-started and the pmc will not be updated. 5) when the usb cable connected to the carescape monitor b650 is insecurely connected or faulty and is able to move the monitor may reboot. the reboot will cause loss of overall monitoring and may lead to delayed treatment. 6) carescape monitor b650 remote printing issue with currently printing prn 50 recorder a) if the recorder prn 50 is currently printing when carescape monitor b650 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. also after this the later printing requests will not be saved and therefore not printed if the recorder is again busy. 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. c) cic pro does not get the local prn 50 recorder status messages from carescape monitor b650. 7) carescape monitor b650 reboots due to an x server freeze. the carescape monitor b650 may reboot when the monitor is viewed from cic pro or when the printing is initiated from cic pro.

Device

CARESCAPE MONITOR B650 - MONITOR FRAME TYPE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)