Events

Recall of Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function 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-2014-RN-00114-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00114-1
  • 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
    The solar 8000m/i automatic view on alarm (avoa) feature will stop functioning if the patient monitor is discharged from the cic central station while a remote automatic bedside alarm view is currently being displayed on the solar. once this issue occurs, subsequent remote avoa alarms will not automatically appear on the left side of the solar display. in addition, the user interface menus on the discharged patient monitor will not function correctly. this may result in delayed treatment due to missed alarms that may be serious. this issue can be fixed by rebooting the solar 8000m/i.Parameter, waveforms and alarms associated with the patient directly connected to the solar 8000m/i patient monitor are not affected.
  • Action
    GE Healthcare is advising users that if patients are discharged from the CIC central station to discontinue use of the AVOA feature and is providing instructions to disable the feature. If patients are not discharged from the CIC central station the AVOA feature can continue to be used. This action has been closed-out on 29/01/2016. GE Healthcare will be implementing a software upgrade for all Solar 8000i / M monitors.

Device

Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function pati...
  • Model / Serial
    Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function patient monitor)ARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd