Events

Recall of DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012

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-00258-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00258-1
  • 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
    Ecg and respiration signal noise caused by dash, pdm and/or tram ecg cable connector movement may result in reduced ecg, respiration and arrhythmia detection performance.
  • Action
    End users have been provided with work around instructions to help mitigate the issue. GE Healthcare is currently in discussion with TGA as how to best expedite identification of, and prioritised correction of affected units. A follow-up letter will be forwarded once there is a consensus as to the process to be undertaken. This action has been closed-out on 12/02/2016.

Device

DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and ...
  • Model / Serial
    DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012Dash 3000/4000/5000Product codes: SHQ and SD0Patient Data Module (PDM)Product code: SA3Tram 451, 451N, 451M, 851, 851N, 451N5, 851N5Product codes: RT1, RT4, RT5, RT7, RT8, RTW, SCE and SBBARTG Number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd