Events

Recall of Carescape Monitor B650 (Multi parameter 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-00806-3
  • 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-00806-3
  • 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
    1) spo2 saturation limit alarm does not always activate when nellcor spo2 is used in pdm and saturation seconds is not switched on.2) when the carescape monitor b650 is started the monitor may enter into a constant boot loop causing monitor to reboot continuously.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).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. 6) carescape monitor b650 remote printing issue with currently printing prn 50 recorder.7) carescape monitor b650 reboots due to an x server freeze. it may reboot when the monitor is viewed from carescape cic pro or when the printing is initiated from carescape cic pro.
  • Action
    GE Healthcare is providing users with work around instructions to mitigate the issue. A software and hardware update will be implemented to permanently fix the issue when available.

Device

Carescape Monitor B650 (Multi parameter patient monitor)

Manufacturer

GE Healthcare Australia Pty Ltd