Events

Recall of Carescape Monitor B850, all software versions (mutliparameter patient monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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
    RC-2012-RN-00807-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00807-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ge healthcare has recently become aware of potential issues with the carescape monitor b850 as outlined below:1. carescape monitor b850 udom failure. it is possible that the carescape monitor b850 may enter into a constant book loop causing monitor to reboot continuously. 2. carescape monitor b850 unstable usb communication. when the usb cable is connected to the cpu or display is insecurely connected or faulty, the monitor may reboot. reboot may also happen if the monitor display is continuously set on and off several times. 3. carescape monitor b850 remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is busy when the carescape monitor b850 sends a printing request, the printing may not be saved and therefore not printed.4. carescape monitor b850 reboots due to an x server freeze.
  • Action
    GE Healthcare will be implementing a software and hardware correction.

Device

Carescape Monitor B850, all software versions (mutliparameter patient monitor)
  • Model / Serial
    Carescape Monitor B850, all software versions (mutliparameter patient monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd