Events

Recall of T2100 Treadmill

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-2015-RN-00259-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00259-1
  • 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
    A performance issue with the t2100 treadmills can cause uncontrolled walking belt motion during a stress exercise test. this motion can be seen as an unexpected slowing, followed by sudden belt acceleration in either the forward or backward direction. when this occurs, engaging the emergency stop button (estop) will not immediately stop the belt. rather, it will coast to a stop within 35 seconds when slowing from maximum speed. the sudden change in belt speed and/or direction can result in a fall and injury to the patient.
  • Action
    GE Healthcare is providing work around instructions to minimise the risk of an unexpected change in speed or direction. GE will correct all affected units onsite. This action has been closed-out on 12/08/2016.

Device

T2100 Treadmill

Manufacturer

GE Healthcare Australia Pty Ltd