Events

Recall of B20, B30, B40 Patient Monitors (used for ECG monitoring)

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-2013-RN-01027-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01027-1
  • 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 b20, b30 and b40 patient monitors set the ecg filter setting incorrectly if the monitor starts with impedance respiration set in the on position. instead of the user selected filter, an additional 0.5 hz high pass filter is used. the additional 0.5 hz high pass filter causes changes to the ecg waveform morphology and incorrect display of st values. the st-elevation measurement can be under estimated in this situation and treatment of the patient can be delayed.Please note that there is no issue when the monitor starts with impedance respiration set in the off position.
  • Action
    GE Healthcare is providing users with work around instructions to follow until a software correction is available.

Device

B20, B30, B40 Patient Monitors (used for ECG monitoring)
  • Model / Serial
    B20, B30, B40 Patient Monitors (used for ECG monitoring)Serial Numbers: B20 - SGF11030001WA to SGF13176741WA (software version 1)B30 - SF309380033WA to SF313177120WA (software version 2)B40 - SG211210001WA to SG213172146WA (software version 1)B40 - SJF13010005WA to SJF13180144WA (software version 2)ARTG Number: 92726
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd