Events

Recall of Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter 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-00805-3
  • 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-00805-3
  • 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
    The dash monitor may exhibit an unexpected loss of custom automatic nbp measurement cycling. custom automatic nbp measurement is a feature introduced in dash version 6.0 which allows the user to program up to 4 different nbp auto mode sequences. when a view of another patient with an nbp parameter on the network occurs, if the custom automatic nbp measurement cycling function is enabled, the function will turn off unexpectedly. the issue can occur when manually viewing another bed on the network using the view other beds option or automatically with the automatic view on alarm (avoa) feature.
  • Action
    GE Healthcare is providing users with work around instructions to mitigate the issue. A software update will be implemented to permanently fix the issue when available.

Device

Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient m...
  • Model / Serial
    Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).Monitors with software versions 6.0 and later may be affectedARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd