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
    97284
  • Event Risk Class
    II
  • Event Initiated Date
    2012-03-12
  • 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
    1) the carescape monitor b650 may freeze in the middle of the start-up sequence or enter into a continuous reboot cycle. 2) the carescape monitor b650 may lose audible alarms and qrs beep tone. 3) the alarm priority on the carescape monitor b650 may automatically change to the startup level of the escalation. 4) audible alarms may continue on the carescape monitor b650 after alarm deactivation.

Device

CARESCAPE MONITOR B650 - MONITOR FRAME TYPE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)