Events

Recall of CARESCAPE R860 ventilators with software version 10SP05

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-2017-RN-01523-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01523-1
  • 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
    There is a potential for the display processor to experience an unexpected failure. if this failure occurs, the device screen will temporarily go blank and will then display an error code “ec01 xx”. the blank display results in loss of monitored data being displayed to the user. there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users that the system can continue to be used. In the event this issue occurs, an audible alarm will sound. Mechanical ventilation will continue at previous settings. A device restart is required to clear the alarm condition. Consider using appropriate alternative means of ventilation such as a self-inflating bag or another ventilator to prevent patient injury while restarting the device. GE Healthcare will be implementing a software upgrade as a permanent correction.

Device

CARESCAPE R860 ventilators with software version 10SP05

Manufacturer

GE Healthcare Australia Pty Ltd